News Article | February 17, 2017
BARCELONA--(BUSINESS WIRE)--Today at the 12th Congress of the European Crohn’s and Colitis Organisation (ECCO), Celltrion Healthcare presented the primary outcome from its pivotal randomised controlled trial (RCT) of CT-P13 (biosimilar infliximab) in Crohn’s disease. The data indicate that the safety and efficacy of CT-P13 in patients with moderate-to-severe Crohn’s disease (CD) is comparable to those treated with reference infliximab.1 The Phase III RCT in 220 patients with CD examined whether CT-P13 is comparable to reference infliximab as determined by the Crohn’s Disease Activity Index (CDAI), a measurement used to quantify the symptoms of CD patients. According to the 6 week and 30 week data, similar clinical remission, CDAI-70 and CDAI-100 response rates were observed in both CT-P13 and reference infliximab treatment groups.1 Leading expert Jørgen Jahnsen, Professor of Gastroenterology at the University of Oslo, Norway commented on the study, “ This is the first RCT to examine the use of a biosimilar in inflammatory bowel disease. While we already have a wealth of extrapolated and real-world data for CT-P13, gastroenterologists have for some time wanted the reassurance of an RCT and it’s encouraging to see such positive data from Celltrion’s RCT trial.” Celltrion Healthcare also presented data from two observational studies. The first study evaluated the efficacy and safety of CT-P13 in 74 paediatric patients with CD (naïve patients: 26, switch patients: 25) or ulcerative colitis (UC) (naïve patients: 16, switch patients: 7). The data show that CT-P13 is effective in both treatment-naïve and switch paediatric patients over 30 weeks and is well-tolerated.2 The second study examined 204 CD patients (fistulising CD: 24, CD patients: 180) in South Korea from July 2012-2016. CT-P13 was found to be clinically consistent to reference infliximab and well tolerated up to six months in patients with moderate-to-severe CD and those with fistulising CD.3 Real-world cost savings associated with the use of CT-P13 across all indications were studied in five European countries from the beginning of 2015 to the first half of 2016. According to the data presented at ECCO, total cost savings observed for Germany, Italy, Spain and the UK amounted to €32.4 million and the findings suggest that this could allow an additional 5,428 patients a year access to this important biologic therapy. There were no cost savings in France, as the price of biosimilar and reference infliximab were the same, however despite this, use of CT-P13 has gradually increased in this country.4 Man Hoon Kim, President and CEO of Celltrion Healthcare, said, “ At Celltrion, we are committed to addressing the needs of the clinical community through robust scientific exploration. A pivotal RCT in Crohn’s disease is an important example of this, and the results from this pivotal trial are consistent with our other RCTs and many real-world IBD studies that have been conducted. More broadly, it’s rewarding to see the changes that CT-P13 is making in financially-constrained health systems in Europe.” Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic disabling gastrointestinal disorders that impact every aspect of a patient’s life.5 They affect an estimated 2.5-3 million people in Europe;6 CD affects about three people per 1,000 and UC about 5 people per 1,000.5 IBDs account for substantial costs to the healthcare system and society; the direct healthcare costs of IBDs are estimated to be €4.6-5.6 billion per year.6 Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines. For more information please visit: http://www.celltrionhealthcare.com/ The study is a randomised, double-blind, parallel- group, phase Ⅲ study to investigate efficacy and safety between CT-P13 and reference infliximab with CD patients. Out of 220 patients randomised in 58 study centres across 16 countries, 214 patients completed up to week 6 for the primary analysis, and 180 patients completed up to week 30. The study was funded equally by Celltrion and Pfizer. CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Medicines Agency (EMA). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and inflammatory bowel disease. It was approved by the EMA under the trade name Remsima® in September 2013 and launched in Europe in early 2015. The US FDA approved Celltrion’s CT-P13 in April 2016 under the trade name Inflectra™. Celltrion’s CT-P13 is approved in more than 79 (as of January 2017) countries including the US, Canada, Japan and throughout Europe. 1 Kim, Y.H. et al. Phase Ⅲ Randomised, Double-blind, Controlled Trial to Compare Biosimilar Infliximab (CT-P13) with innovator Infliximab (INX) in Patients with Active Crohn’s Disease: Early Efficacy and Safety Results. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017. DOP061 2 Choe, Y.H. et al. Effectiveness and Safety of CT-P13 under Routine Care in Paediatric Patients with Inflammatory Bowel Disease. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017. P487 3 Choe, Y.H. et al. Effectiveness and Safety in Crohn’s Disease Patients Who Were Treated with CT-P13. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017.P500. 4 Han, S. et al. The pharmacoeconomic impact of biosimilar infliximab (CT-P13) in Europe from January 2015 to June 2016. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017. P582 5 Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54. Available at www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Last accessed January 2017]. 6 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.
News Article | December 13, 2016
Philadelphia, PA, December 13, 2016 - Basal cell carcinoma (BCC), a type of skin cancer, is the most common form of human cancer. With a growing aging population, BCC rates are climbing at an alarming rate, with reported cases rising by as much as 10% per year. Rising demand makes a simple and effective treatment for BCC appealing to both practitioners and patients. A new study funded by Cancer Research UK and published in the Journal of Investigative Dermatology examines the effectiveness of imiquimod, a topical skin cream used to treat low-risk BCC lesions, over a five-year period. Currently, the gold standard of treatment for BCC is excisional or Mohs surgery, both of which require a dermatologist or plastic surgeon. Requiring specialized care for such a ubiquitous and mostly low-risk cancer can tie up resources that are needed for more serious and difficult cases. In order to help alleviate some of the burden, alternative treatments for BCC are emerging, many of which can be administered by general practitioners. One of these treatments is imiquimod, a topical treatment cream that boosts the body's immune response. This extension of a prior study, which looks at the effectiveness of imiquimod treatment, is based on a previously conducted randomized control trial (RCT) that followed BCC patients for three years post-treatment. The first study had an 83.6% success rate for patients treated with imiquimod, versus 98.4% for traditional surgery. In the additional two years of follow up time tracked in this new study, researchers found that 82.5% of imiquimod patients had successful outcomes at the five-year mark compared to 97.7% for surgery. "The absolute response rate for topical imiquimod of 83% at five years, although clearly inferior to the 98% for excisional surgery for low-risk BCC, might still represent a clinically useful treatment modality, because a cream treatment can be carried out in a primary care setting, and some patients may also prefer the option of a cream rather than surgery," remarked lead investigator Hywel C. Williams, DSc, FMedSci, NIHR Senior Investigator, Professor of Dermato-Epidemiology and Co-Director of the Centre of Evidence-Based Dermatology at the University of Nottingham, Nottingham, UK. "If you had told me 15 years ago that one day we would be treating low risk nodular and superficial BCC with a cream that enhanced the body's local immune response, I would have walked away. But it is a reality nowadays." Doctors have expressed concerns that the use of topical treatments instead of surgery may leave patients vulnerable to so-called "submarine lesions," which can emerge after the superficial cancer appears to have been treated. However, mirroring the results of the three-year follow-up, the extended five-year study illustrates that if imiquimod treatment is successful in the first year, BCC reoccurrence is unlikely. "Most treatment failures with topical imiquimod occurred in the first year of treatment, a finding that throws light on the possible mechanisms of topical immunotherapy of skin cancer, suggesting that once an immunological response has occurred, such a response is sustained," said Professor Williams. These new data are important information for practitioners and their patients to consider with treatment options for low-risk BCC. This new study confirms that if a benefit is seen from imiquimod treatment, those results are likely to hold over a five-year period. Added Professor Williams, "Very few RCTs have been conducted for BCC, which is odd considering that it is the most common form of human cancer. Only a handful of such RCTs have been followed up for five years, which is important as some treatments, such as photodynamic therapy, produce reasonable results in the short term, but seem to result in more and more recurrences the longer patients are tracked." Investigators hope that these findings will encourage further research to develop creams that work in a similar way, yet produce better results. For now, this information provides an important part of the roadmap for treating BCC and potentially alleviating some of the burden on specialized health care providers. "The most important results are the precise estimates of three- and five-year tumor clearance for imiquimod cream versus surgery," concluded Professor Williams. "This will allow patients and their doctors to engage in a shared decision-making conversation on a range of possible treatment options. Because BCC is reaching epidemic proportions, some countries like the UK are struggling to keep up. One possible strategy for the future is to treat more low-risk (biopsy proven) BCCs with imiquimod cream and only refer patients who don't respond to secondary care services."
News Article | March 2, 2017
Palbociclib (trade name: Ibrance) has been approved since November 2016 for the treatment of women with advanced hormone receptor-positive breast cancer who are not eligible for chemotherapy, radiotherapy or further surgery. In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) investigated whether this drug offers advantages for patients over the appropriate comparator therapies. According to the findings, such an added benefit is not proven: The dossier contained no data or no suitable data on several groups of patients. Where data were available, i.e. in the first-line treatment after menopause, severe side effects were more frequent under palbociclib in combination with letrozole than under letrozole alone, which resulted in an indication of lesser benefit. The new drug is approved for women with advanced breast cancer whose cancer cells carry receptors for hormones such as oestrogen or progesterone (HR-positive). In these patients, hormones such as oestrogen or progesterone accelerate the growth of the cancer cells. Palbociclib is used either in combination with an aromatase inhibitor or with the drug fulvestrant. Palbociclib is not approved for the treatment of tumours carrying the human epidermal growth factor receptor 2 (HER2). For the current assessment, the Federal Joint Committee (G-BA) distinguished between four treatment situations and specified a different appropriate comparator therapy for each of them. One criterion was whether the patients have already completed menopause, another one the line of treatment, i.e. whether and how many treatments have already been (unsuccessfully) conducted. The drug manufacturer presented data from two randomized controlled trials (RCTs) for one of the four treatment situations, i.e. the first-line treatment in postmenopausal women. Both RCTs tested palbociclib in combination with the drug letrozole against letrozole monotherapy. These data showed no relevant differences between the two study arms in several outcomes. This was the case for health status (morbidity), health-related quality of life and treatment discontinuation due to side effects. The differences were not statistically significant also in the outcome "survival" (overall survival). However, the manufacturer used results on progression-free survival (PFS), which were in favour of palbociclib. It wanted PFS to be understood as a surrogate for survival. Since it sometimes takes years before it is shown whether new treatments actually prolong life, cancer drugs in particular are often approved on the basis of such surrogates. It is a good sign when the tumour does not continue to grow or even shrinks under a new treatment. It is not certain, however, that patients actually survive longer. PFS would have to be "validated" as a surrogate for survival to be able to derive an added benefit. There is validity when a change in the surrogate outcome reliably predicts a change in the same direction of a patient-relevant outcome. In its dossier, the manufacturer tried to validate PFS as a surrogate. It chose a suitable scientific method to estimate the reliability of PFS (surrogate threshold effect analysis, STE). The study pool used by the manufacturer did not adequately represent the research question, however: On the one hand, the manufacturer used studies that compared two monotherapies. According to the approval, however, palbociclib can only be used as combination therapy. On the other, it precisely did not include studies on palbociclib in its analysis. IQWiG therefore conducted its own analysis, which included the palbociclib studies, but not the monotherapy studies. It was shown that PFS cannot be considered to be a valid surrogate parameter for survival in this treatment situation. Hence an added benefit cannot be derived from the better results for PFS. Relevant group differences were shown in severe side effects, however: These were notably more common under the combination therapy with palbociclib, from which an indication of greater harm can be derived. Since this disadvantage was not accompanied by advantages in other outcomes, IQWiG sees an indication of a lesser benefit of palbociclib in the overall consideration. The dossier contained no data for the first-line treatment in women before or during menopause. Regarding the second and subsequent line of treatment before, during or after menopause, the study presented was unsuitable for the assessment because palbociclib was not tested against the appropriate comparator therapy specified. An added benefit is therefore not proven. The dossier assessment is part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G-BA. After publication of the dossier assessment, the G-BA conducts a commenting procedure and makes a final decision on the extent of the added benefit. More English-language information will be available soon (Sections 2.1 to 2.7 of the dossier assessment as well as easily understandable information on informedhealth.org). If you would like to be informed when these documents are available, please send an e-mail to email@example.com.
News Article | February 17, 2017
BARCELONA--(BUSINESS WIRE)--Heute hat Celltrion Healthcare auf dem 12. Kongress der European Crohn’s and Colitis Organisation (ECCO) die primären Endpunkte seiner randomisierten kontrollierten Zulassungsstudie mit CT-P13 (Infliximab-Biosimilar) in Morbus Crohn vorgestellt. Die Daten weisen darauf hin, dass die Wirksamkeit und Unbedenklichkeit von CT-P13 in Patienten mit mittelschwerem bis schwerem Morbus Crohn vergleichbar ist mit Patienten, die mit dem Referenz-Infliximab behandelt wurden.1 Celltrion Healthcare hat darüber hinaus auch Daten aus zwei Beobachtungsstudien vorgestellt. Die erste Studie bewertete die Wirksamkeit und Sicherheit von CT-P13 in 74 pädiatrischen Patienten mit M. Crohn (MC) (bisher unbehandelte Patienten: 26, Wechselpatienten: 25) oder Colitis ulcerosa (CU) (bisher unbehandelte Patienten: 16, Wechselpatienten: 7). Die Daten belegen, dass CT-P13 sowohl in bisher unbehandelten pädiatrischen Patienten als auch in Wechselpatienten über 30 Wochen wirksam ist und gut vertragen wird.2 Echte Kosteneinsparungen beim Einsatz von CT-P13 für alle Indikationen wurden in fünf europäischen Ländern von Anfang 2015 bis in die erste Hälfte von 2016 untersucht. Nach den auf der ECCO vorgelegten Daten belaufen sich die in Deutschland, Italien, Spanien und dem Vereinigten Königreich festgestellten Einsparungen auf 32,4 Millionen Euro und die Ergebnisse lassen darauf schließen, dass dies weiteren 5.428 Patienten pro Jahr Zugang zu dieser wichtigen biologischen Therapie eröffnen könnte. In Frankreich wurden keine Kosteneinsparungen verzeichnet, da der Preis des Biosimilars und des Referenz-Infliximab gleich waren, und doch stieg auch in diesem Land die Verwendung von CT-P13 langsam an.4 Man Hoon Kim, President und CEO von Celltrion Healthcare, sagte: "Celltrion tritt durch belastbare wissenschaftliche Erforschung nachdrücklich für die Bedürfnisse von klinischen Anwendern ein. Eine randomisierte kontrollierte Zulassungsstudie für Morbus Crohn ist ein wichtiges Beispiel dafür, und die Ergebnisse dieser Studie stimmen mit anderen durchgeführten RCTs und vielen repräsentativen Studien zu entzündlichen Darmerkrankungen überein. Im weiteren Sinne ist es auch erfreulich zu sehen, was für Veränderungen CT-P13 in den finanziell überforderten Gesundheitssystemen in Europa hervorruft." Bei der Studie handelt es sich um eine randomisierte, doppeltblinde Phase-Ⅲ-Studie mit parallelen Gruppen zur Untersuchung der Wirksamkeit und Sicherheit von CT-P13 und Referenz-Infliximab in Patienten mit M. Crohn. Von 220 randomisierten Patienten in 58 Studienzentren in 16 Ländern haben 214 Patienten bis zu 6 Wochen für die Primäranalyse absolviert und 180 Patienten haben bis zu 30 Wochen abgeschlossen. Die Studie wurde zu gleichen Teilen von Celltrion und Pfizer finanziert. CT-P13 wurde von Celltrion Inc. entwickelt und hergestellt und war weltweit das erste monoklonale Antikörper-Biosimilar, das von der Europäischen Arzneimittel-Agentur (EMA) zugelassen wurde. Es ist zur Behandlung von acht Autoimmunerkrankungen, einschließlich rheumatoide Arthritis und entzündliche Darmerkrankungen, indiziert. Es wurde im September 2013 von der EMA unter dem Handelsnamen Remsima zugelassen® und Anfang des Jahres 2015 in Europa eingeführt. Die US-amerikanische Arzeimittelbehörde FDA hat CT-P13 von Celltrion im April 2016 unter dem Handelsnamen Inflectra™ zugelassen. CT-P13 von Celltrion ist in mehr als 79 (Stand Januar 2017) Ländern, einschließlich den USA, Kanada, Japan und zahlreichen europäischen Ländern, zugelassen. 1 Kim, Y.H. et al. Phase Ⅲ Randomised, Double-blind, Controlled Trial to Compare Biosimilar Infliximab (CT-P13) with innovator Infliximab (INX) in Patients with Active Crohn’s Disease: Early Efficacy and Safety Results. Kongress der European Crohn’s and Colitis Organisation (ECCO) 2017. DOP061 2 Choe, Y.H. et al. Effectiveness and Safety of CT-P13 under Routine Care in Paediatric Patients with Inflammatory Bowel Disease. Kongress der European Crohn’s and Colitis Organisation (ECCO) 2017. P487 3 Choe, Y.H. et al. Effectiveness and Safety in Crohn’s Disease Patients Who Were Treated with CT-P13. Kongress der European Crohn’s and Colitis Organisation (ECCO) 2017.P500. 4 Han, S. et al. The pharmacoeconomic impact of biosimilar infliximab (CT-P13) in Europe from January 2015 to June 2016. Kongress der European Crohn’s and Colitis Organisation (ECCO) 2017. P582 5 Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54. Verfügbar unter www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Letzte Aktualisierung: Januar 2017]. 6 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.
News Article | November 23, 2016
Four out of five collision investigators surveyed for the research indicated mobile phone involvement in non-fatal accidents was under-reported, with half agreeing the role of phones was even overlooked in fatal crashes. Three quarters of British officers participating in the online poll undertaken by the University of the West of England (UWE Bristol) were unable to report the full proportion of road accidents in their force area linked with mobile phone use each year. A similar percentage of officers indicated that better mechanisms to quickly analyse and investigate phone usage would be most likely to improve data collection. Dr Paul Pilkington, a senior lecturer in public health at UWE Bristol, worked with the National Roads Policing Intelligence Forum to survey 134 road traffic collision investigation officers as part of his study into the reporting and recording of mobile phone involvement in accidents. For his research, Dr Pilkington asked officers across the UK about the procedure they followed in the aftermath of a collision. He was told phones were only routinely seized and analysed in fatal and life-changing injury crashes. Among the responses from officers were: "Due to the costs and timeliness of such enquiries this is an area that, in my view, is under-investigated…if properly investigated each and every time, the proportion of RCTs where phone use was contributory would increase significantly." "We take persons to court where we have seen them on their mobile phones and it gets thrown out. That is with a police witness, so it wouldn't go through on 3rd party evidence." Dr Pilkington said the findings of the survey raised serious questions about investigation tactics, and described the under-reporting of mobile phone use in collisions as a 'massive problem'. He said: "Police officers recognise that using mobile phones while driving is an important risk factor for being involved in a road traffic crash. This is consistent with global estimates of the burden of road traffic related deaths and injuries caused by using a phone while driving. "But officers in our survey consistently registered concerns about having enough power or resources to investigate whether a mobile phone was being used at the time of a road traffic crash. Because of resource and legal considerations, only in fatal and life-changing injury crashes are phones seized and analysed. In all other crash types, including those involving serious injuries, use of mobile phones is usually not investigated. "To me, this is a massive problem. If the police can't detect the full extent of this behaviour then we are missing an important part of collision investigation. "It leaves a significant gap not only in terms of enforcement, but also monitoring of the role of phones in crashes. The result is significant under-reporting of the role of mobile phones in road traffic crashes, as well as inadequate justice for the victims of those affected by the actions of drivers using their phones behind the wheel." Dr Pilkington said investigating whether a mobile phone was being used at the time of a collision was resource intensive but technological solutions were on the horizon. He said: "Phones have to be sent away for specialist analysis, and there are sometimes issues in proving the exact time of use in relation to the crash. Time-ascertainment is made more difficult by the long process involved in the analysis of the phone. "However, there are possible technological solutions. In New York, a State Senate Bill currently in committee is discussing the introduction of a hand-held 'textalyzer' device, which allows officers to analyse mobile phone usage data at the roadside. Such technology offers the potential to improve enforcement and monitoring of the role of mobile phones in road traffic collisions." The results of an RAC survey revealed in September suggested the number of motorists illegally using mobile phones while behind the wheel was on the rise. Some 31 per cent of drivers taking part in the survey admitted they used a handheld phone behind the wheel compared with eight per cent in 2014. The Department for Transport will introduce tougher punishments for offending drivers from next year, with penalty points doubling from three to six and fines rising from £100 to £200. Dr Pilkington, who is now working on a review examining the effectiveness of legislation governing mobile phone use and driving, said: "People are using their phones because they don't think they will be caught. The penalty points have gone up, and the fine, but unless it's a sky-high fine or a ban, drivers will continue to chance it. "Distraction driving has become a big policy issue and the World Health Organisation has started to talk about it more. "When you see adverts for cars with built-in dashboard consoles for checking email and Facebook, it is at odds with reducing distraction driving. But those things are what appeal to people, in terms of staying connected to one another. "Unless technology has a solution, advances in phone technology are likely to make problems worse." Dr Pilkington has co-authored a literature review called 'Mobile phone use while driving: Underestimation of a global threat' published earlier this year in the Journal of Transport and Health. It can be accessed here. Explore further: Groundbreaking review on counteracting mobile phone distraction while driving More information: Janet Ige et al, Mobile phone use while driving: Underestimation of a global threat, Journal of Transport & Health (2016). DOI: 10.1016/j.jth.2015.11.003
News Article | March 3, 2017
Interventional studies used mobile technology and social media to recruit patients RESEARCH TRIANGLE PARK, NC--(Marketwired - March 02, 2017) - Sixty one percent of surveyed clinical trial teams favor traditional randomized controlled trials (RCTs) over other interventional study trial designs during Phase 4, according to a study by pharmaceutical business intelligence firm Cutting Edge Information. The recently published study, Post-Marketing Study Excellence: Design Phase 4 Trials to Demonstrate Real-World Outcomes, surveyed global, US and country-level post-marketing study teams. The study found that 30% of surveyed traditional RCTs are commitment trials -- those required by a regulatory agency -- because these types of studies are geared toward collecting product efficacy and safety, which are top priorities for regulatory agencies. In a similar vein, traditional RCTs are also very successful in gathering additional safety data and investigating new indications, patient populations or dosing -- each of which constitute 20% of surveyed studies. Although traditional RCTs tend to focus on efficacy, 20% of these surveyed studies do investigate long-term effectiveness. Finally, the remaining 10% of surveyed traditional RCTs are comparator trials. "Late-stage interventional studies are undergoing a transformation as researchers innovate new trial designs to explore different types of data and outcomes," said Natalie DeMasi, research team leader at Cutting Edge Information. "Interventional trial designs vary in their focus on internal validity versus external validity and efficacy versus effectiveness." The study also found that 32% of interventional trials use mobile technology to collect data, which allows for teams to collect data in real-time, faster than ever before. Using mobile technology also prohibits errors in transcribing physician or patient handwriting. Aside from data collection, the study found that 14% of interventional studies surveyed used mobile technology and social media to recruit patients. However, leveraging digital technology depends on a number of factors: Teams that weigh these considerations before including digital technology in their studies will maximize the benefits of mobile health (mHealth) and social media for clinical trials. Post-marketing Study Excellence: Design Phase 4 Trials to Demonstrate Real-World Outcomes, available at https://cuttingedgeinfo.com/product/phase-4-clinical-trials/, provides strategic insights and key performance metrics on post-marketing research ownership, spending and staffing levels, as well as trend analysis. Data are broken down for interventional and observational studies and the report outlines the effectiveness of study outcomes due to early planning. Report highlights include: To learn more about Cutting Edge Information and post-marketing study management, please download the brochure at: https://cuttingedgeinfo.com/preview/phase-four-clinical-trials/.
News Article | February 27, 2017
A first-ever guideline from the Canadian Task Force on Preventive Health Care on tobacco use by children and youth aged 5 to 18 years recommends that physicians should play a more active role in the prevention and treatment of cigarette smoking in this age group. The guidelines were published http://www. in CMAJ (Canadian Medical Association Journal). In Canadian children and youth between grades 6 and 12, 18% have tried cigarettes, with 3% of children in grade 6 and up to 36% in grade 12. Smoking in adulthood is linked to trying cigarettes as children or youth, with almost 90% of adult smokers having tried cigarettes by age 18. "Advice from primary care physicians and allied health care professionals is just one tool in the tool kit that society can use in the prevention and treatment of smoking, but it is a crucial tool for helping to reduce and prevent cigarette use among youth," said Dr. Brett Thombs, chair-elect of the task force and chair of the guideline working group. "We have no doubt that doctors can work effectively alongside governments, parents and schools to educate children and youth on the harmful effects of smoking. However, we still need more research to identify the most effective ways for them to do this." The task force recommends that physicians should ask children and youth (aged 5-18 years) and/or their parents about tobacco use by the child or youth and offer brief information and advice as appropriate during primary care visits to prevent or treat tobacco smoking. The guideline was developed by the Canadian Task Force on Preventive Health Care, an independent body of primary care and prevention experts who evaluated the strength and quality of evidence from randomized controlled trials (RCTs) of behavioural interventions (e.g., information and counselling) applicable to primary care settings. The guideline and tools for physicians are available at http://canadiantaskforce. . In a commentary http://www. , Dr. John Oyston, University of Toronto and Scarborough Rouge Hospital, Toronto, Ontario, suggests that "Canada should pass federal legislation banning the supply of all tobacco and nicotine-containing products -- excluding smoking cessation products -- to anyone under the age of 21." Other jurisdictions that have raised the legal age for tobacco use have seen smoking rates in youth decrease. In Needham, Massachusetts, which raised the legal age to 21, smoking rates declined 47% in high schools. In the six Canadian provinces where the legal age is 19, smoking prevalence is 11.7% compared with 14.8% in those where the legal age is 18 years. "As physicians, we should spare no effort in preventing young people from starting to smoke. Eighteen or 19 is too young to be allowed legal access to an addictive and carcinogenic product that can never be used safely," writes Dr. Oyston. "Raising the minimum legal age for access to tobacco is a scientifically proven, legally and politically quick, cheap and effective way to deprive the tobacco industry of recruiting a new generation of young people as their customers." About the Canadian Task Force on Preventive Health Care The Canadian Task Force on Preventive Health Care (CTFPHC) has been established to develop clinical practice guidelines that support primary care providers in delivering preventive health care. The mandate of CTFPHC is to develop and disseminate clinical practice guidelines for primary and preventive care, based on systematic analysis of scientific evidence.
News Article | December 8, 2016
First patient enrolled in EMIT-AF/VTE study (NCT02950168), a European registry to assess edoxaban management in patients undergoing medical procedures Daiichi Sankyo Europe GmbH (hereafter, Daiichi Sankyo) today announced that the first patient has been enrolled in the EMIT-AF/VTE (Edoxaban Management In diagnostic and Therapeutic procedures) study. This registry will collect real-world clinical data on the use of once-daily LIXIANA® (edoxaban) with regard to diagnostic and interventional procedures in patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE). Limited information is currently available regarding the use of edoxaban in patients undergoing medical procedures. Patients who are treated with non-vitamin K antagonist oral anticoagulants (NOACs), such as edoxaban, undergo diagnostic and therapeutic procedures at a rate of 10% a year, and if the surgical interventions carry a bleeding risk, NOAC treatment must be temporarily discontinued. The EMIT-AF/VTE study will provide further insight into the use of edoxaban in patients undergoing diagnostic and therapeutic procedures. Patients will be enrolled from primary and secondary care settings, as well as other specialty settings. The primary objective of the study is to document the peri-procedural management of edoxaban and collect data on safety and other outcomes in these patients. The primary safety outcome is the rate of major bleeding (within 30 days post intervention) using the ISTH definition. "The EMIT-AF/VTE registry is part of the extensive clinical research programme undertaken for edoxaban," said Dr. Juan-Carlos Jaramillo, Head of Market Access and Medical Affairs at Daiichi Sankyo Europe GmbH. "This registry will provide important information that expands our knowledge on the use of edoxaban and will ensure healthcare professionals are equipped to achieve the best possible outcomes for NVAF and VTE patients undergoing medical procedures." The EMIT-AF/VTE registry will comprise approximately 2,000 patients over the next two and a half years. Data will be collected from patients treated with edoxaban for 2,000 planned or unplanned procedures across 500 sites, including hospitals and office-based sites, in Belgium, France, Germany, Italy, The Netherlands, Spain, and the UK. Daiichi Sankyo is also reviewing options to expand the EMIT-AF/VTE registry to clinical sites beyond Europe. To access the latest news, media backgrounders, images, and videos please visit http://pressportal.lixiana.com/. Please note that the press portal is not intended for UK media. EMIT-AF/VTE is a real-world, multinational, multicentre, prospective observational, non-interventional study. The registry will include data from NVAF and VTE patients until 2,000 procedures have been documented over a period of around two and a half years. The study is being conducted across seven European countries, and Daiichi Sankyo is evaluating the inclusion of additional countries, beyond Europe. The primary objective of EMIT-AF/VTE is to collect data on the usage pattern of edoxaban in the context of diagnostic or interventional procedures in unselected patients with NVAF or VTE. The primary safety outcome is the rate of major bleeding within 30 days post-procedure. Secondary objectives include assessing efficacy outcomes as a composite of major cardiovascular events and collecting details on the types of diagnostic or therapeutic procedures. Edoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten A") inhibitor. Factor Xa is one of the key components in the coagulation cascade responsible for blood clotting. Inhibition of factor Xa reduces thrombin generation, prolongs clotting time and reduces the risk of thrombus formation. Edoxaban is currently marketed in Japan, the U.S., Switzerland, the U.K., Germany, Ireland, the Netherlands, South Korea, Taiwan, Italy, Spain, Hong Kong, Belgium and other European countries. Edoxaban is approved in Europe for the prevention of stroke and systemic embolic events in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA) and for the treatment of DVT and PE and prevention of recurrent DVT and PE in adults. The edoxaban Summary of Product Characteristics can be viewed here: Daiichi Sankyo is committed to expanding scientific knowledge about edoxaban, as demonstrated through our research programmes evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings in atrial fibrillation (AF) and venous thromboembolism (VTE). The edoxaban clinical research programme includes multiple RCTs (randomised, controlled trials), registries and non-interventional studies, with the goal of generating new clinical and real-world-data regarding its use in AF and VTE populations. Daiichi Sankyo expects that more than 100,000 patients will participate in the edoxaban clinical research programme, including completed, ongoing and future research. In addition, global and regional registry studies will provide important real-world data about the use of edoxaban and other oral anticoagulants in everyday practice, and include: We are committed to adding to the scientific body of knowledge around edoxaban in a variety of AF and VTE patients, including those who are vulnerable. Daiichi Sankyo is your partner in antithrombotic therapy with the discovery and development of innovative products, to help patients with a wide range of cardiovascular conditions. These include EFIENT® (prasugrel) for acute coronary syndromes and LIXIANA® (edoxaban) for non-valvular atrial fibrillation, deep vein thrombosis and pulmonary embolism. Daiichi Sankyo's ongoing commitment in this field is demonstrated by their continued investment into patient-relevant clinical development activities that aim to advance the care and improve the lives of people suffering with these diseases. For more information, please visit: www.daiichi-sankyo.eu. Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: http://www.daiichisankyo.com. This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of DAIICHI SANKYO Co., Ltd. Such forward-looking statements are uncertain and are subject at all times to the risks of change, particularly to the usual risks faced by a global pharmaceutical company, including the impact of the prices for products and raw materials, medication safety, changes in exchange rates, government regulations, employee relations, taxes, political instability and terrorism as well as the results of independent demands and governmental inquiries that affect the affairs of the company. All forward-looking statements contained in this release hold true as of the date of publication. They do not represent any guarantee of future performance. Actual events and developments could differ materially from the forward-looking statements that are explicitly expressed or implied in these statements. DAIICHI SANKYO Co., Ltd. assume no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.
News Article | February 15, 2017
The Cleft Palate-Craniofacial Journal – A majority of healthcare studies are conducted using a randomized control trial (RCT). These trials randomly assign participants into groups who either receive or do not receive treatment. However, until the mid-1990s, some of these studies were falling victim to inadequate reporting, thereby causing confusing and potentially biased results. Reviewing the quality of RCTs in various surgical specialties by using standardized methods is becoming a common practice. In an effort to test the validity of trial results pertaining to cleft lip and palate (CL/P), the researchers of a study published in the current issue of The Cleft Palate-Craniofacial Journal analyzed 65 articles that were written based on RCTs. The articles reviewed spanned a 10-year period from January 1, 2004 to December 31, 2013, and the authors used two tools to assess the articles: the Consolidated Standard of Reporting Trials (CONSORT) checklist and the Jadad Scale. The CONSORT was launched as a 25-point checklist to assist in the development and reporting of RCTs. The Jadad Scale is a process used to independently assess the methodological quality of a trial. The researchers were able to substantiate the legitimacy of clinical trials in relation to CL/P by combining the CONSORT checklist to focus on design and reporting and the Jadad Scale to test the quality and methodology of the RCTs. They were specifically focused on the RCT randomization, blinding, and exclusion criteria. The data suggested that there was a correlation between increasing the number of authors and the positive scores given by the CONSORT checklist and Jadad Scale. It is believed that by including more authors and researchers in the RCT, there will be more checks and balances during publishing, as well as a stronger study design in an effort to coordinate a larger collaboration. Aside from a large collaboration between authors, the outcome of this study did find deficiencies in the reporting of RCTs, such as implementing randomization, trial blinding, and participant flow. There was strength found in the trial intervention, the outcomes, and the overall interpretation of the data and results. The researchers believe that if studies adhere to the CONSORT checklist, the development of more reliable, concise, and unbiased RCTs will be published in all areas of study, including CL/P. Full text of the article, “Reporting of Randomized Controlled Trials in Cleft Lip and Palate: A 10-Year Review,” The Cleft Palate–Craniofacial Journal, Vol. 54, No. 2, 2017, is available at http://www.cpcjournal.org/doi/full/10.1597/14-267 About The Cleft Palate–Craniofacial Journal The Cleft Palate–Craniofacial Journal is an international, interdisciplinary journal reporting on clinical and research activities in cleft lip/palate and other craniofacial anomalies, together with research in related laboratory sciences. It is the official publication of the American Cleft Palate–Craniofacial Association (ACPA). For more information, visit http://www.acpa-cpf.org/.
News Article | February 21, 2017
New study published in the scientific journal, Contemporary Clinical Trials Communications, showed that innovative strategies used in the Kids' HELP trial resulted in significantly better retention of minority, low-income children Minneapolis - Recruiting and retaining minority participants in randomized, controlled trials (RCTs) continue to be major challenges for researchers. A new study published in the scientific journal, Contemporary Clinical Trials Communications, showed that innovative strategies used in the Kids' HELP (Health Insurance by Educating Lots of Parents) trial resulted in significantly better retention of minority, low-income children. "Previous studies have documented the challenge of lower minority trial enrollment, but little is known about how to retain minority participants in clinical trials," says Dr. Glenn Flores, Distinguished Chair of Health Policy Research and lead author of the study. "Our objective in this study was to develop, implement, and evaluate a new approach to retention of minority children, and to identify child and caregiver characteristics that predict attrition in RCTs. This study is part of the larger Kids' HELP trial, aimed at evaluating whether parent mentors are more cost effective than traditional Medicaid and Children's Health Insurance Program (CHIP) outreach and enrollment methods in insuring eligible, uninsured Latino and African-American children. The researchers developed a framework for maximizing retention in the Kids' HELP RCT based on their experience with attrition in two previous RCTs, which included the following strategies: Researchers found that the attrition rate in the Kids' HELP trial was only 11 percent, significantly lower than in two previous similar trials, which had 37 percent and 40 percent attrition rates. Analyses also revealed that missing the first follow-up outcomes assessment was a significant risk factor for future attrition, and that maternal age, marital status, and number of children in the household were not significantly associated with attrition. Researchers identified the following five elements as most important in minimizing attrition: "The retention strategies implemented and evaluated in our study were highly effective in retaining low-income minority children, who are traditionally at highest risk for attrition in clinical trials," stated Dr. Flores. "Recruiting and retaining diverse populations in clinical trials are important steps in eliminating health disparities that exist in research, healthcare, and population health." We are a non-profit, research organization determined to improve the health of underserved populations through contributing evidence that informs high value health care and public policy. We do this through independent, data-driven research that is placed in the public domain. To learn more, visit MedicaResearchInstitute.org.