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Furlan G.,EU QPPV Helsinn Birex Pharmaceuticals | Edwards B.,NDA Regulatory Science Ltd. | Mastroianni A.,Aros Performance Management | Koski G.,Alliance for Clinical Research Excellence and Safety ACRES
Pharmaceutical Medicine | Year: 2016

Clinical research is at a cross-roads of sustainability due to the current cost of development, amount of regulation, and irrational use of medicine. There are also too many silos in clinical research and development, post-marketing safety, as well as a lack of standards, and effective communication. This paper covers the future of pharmacovigilance and argues that it needs to re-focus and not be a silo in the last phase of clinical research. In fact, the integration of pharmacovigilance is an integral part of much needed change in clinical research and development based on the application of systems thinking. Clinical research and development must improve as a whole system through the synergy of all parts. © 2016, Springer International Publishing Switzerland. Source


Klepper M.J.,M&D Inc. | Edwards B.,NDA Regulatory Science Ltd.
Drug Safety | Year: 2011

Background: The building blocks of a pharmacovigilance system depend primarily on good quality individual case safety reports (ICSRs), which are stand-alone summaries describing one or more suspected adverse reactions that occur while a subject is taking either an investigational or marketed medicinal product and may require expedited reporting to regulatory authorities. For regulatory reporting purposes, the information of an ICSR is usually captured on forms such as MedWatch 3500/3500A, CIOMS I, Vaccine Adverse Event Report System (VAERS) or Adverse Events Following Immunization (AEFI). ICSRs that are sent electronically must meet the standards for electronic transmission specified in the International Conference on Harmonisation (ICH) E2B (R2) guideline. In filling out these regulatory forms, there are some areas of ambiguity. One of these is what the 'date of event' (MedWatch) or 'reaction onset date' (CIOMS) is interpreted to be. Objective: The aim of the survey was to determine the uniformity of responses for the onset date of an adverse reaction. Methods: A pilot and three surveys of pharmacovigilance professionals were undertaken between February and July 2009 to determine the range of responses for the onset of an adverse reaction. A narrative of a subject admitted to hospital with a diagnosis of pneumonia was presented and the respondent was asked to pick the date of onset of the adverse reaction. Results: The total number of respondents was 129. The results of the surveys indicated there was considerable variation in responses. These differences were based on different perspectives regarding the suspected adverse reaction. Some viewed the 'reaction' to be the first onset of signs and symptoms (even if nonspecific), others considered the onset of the reaction to be the date of the diagnosis, while others considered the date to be when the reaction became serious. Conclusion: By means of a survey, we have illustrated an example of the variability of determining the onset date of a suspected adverse reaction, and recommend that a criterion for onset time, i.e. beginning of signs or symptoms of the event, or date of diagnosis, be chosen as the standard. Once decided, this information should be incorporated into the company's case assessment documentation and staff appropriately trained, thus ensuring consistency across cases and minimizing the time spent in determining what date to use. © 2011 Adis Data Information BV. All rights reserved. Source


Stanulovic V.,Semmelweis University | Stanulovic V.,Advanced Drug and Device Services SAS | Venegoni M.,Centro Regionale Of Farmacovigilanza Della Lombardia | Edwards B.,NDA Regulatory Science Ltd.
Drug Safety | Year: 2013

Rechallenge is defined as the readministration of a medication suspected of being a possible cause of an adverse reaction and which has been discontinued as result. It may be unintentional when the appearance of a reaction was initially not attributed to the medication. A rechallenge may be intentional when a prescriber decides that the benefit of rechallenge will outweigh its risk. When considering intentional rechallenge, one should take into account the benefit/risk balance of the suspected causative medication, and the benefit/risk balance of the best available alternative treatment or no treatment. Clinical knowledge is essential in benefit/risk assessment but there is currently no suitable tool to guide the decision on rechallenge. This article aims to propose points to consider in the creation of reaction-specific algorithms for risk assessment and management in the case of drug rechallenge. © 2013 Springer International Publishing Switzerland. Source


Miossec P.,University of Lyon | Verweij C.L.,VU University Amsterdam | Klareskog L.,Karolinska Institutet | Pitzalis C.,Experimental Medicine and Rheumatology | And 17 more authors.
Annals of the Rheumatic Diseases | Year: 2011

Rheumatoid arthritis (RA) is one of the most appropriate conditions for the application of personalised medicine as a high degree of heterogeneity has been recognised, which remains to be explained. Such heterogeneity is also reflected in the large number of treatment targets and options. A growing number of biologics as well as small molecules are already in use and there are promising new drugs in development. In order to make the best use of treatment options, both targeted and nontargeted biomarkers have to be identified and validated. To this aim, new rules are needed for the interaction between academia and industry under regulatory control. Setting up multi-centre biosample collections with clear definition of access, organising early, possibly noncommitting discussions with regulatory authorities, and defining a clear route for the validation, qualification and registration of the biomarker-drug combination are some of the more critical areas where effective collaboration between the drug industry, academia and regulators is needed. Source


Smolen J.S.,Hietzing Hospital | Boers M.,VU University Amsterdam | Abadie E.C.,Afssaps | Breedveld F.C.,Leiden University | And 19 more authors.
Current Medical Research and Opinion | Year: 2011

Since 2003, the European Medicines Agency (EMA) document, 'Points to consider on clinical investigation of medicinal products other than NSAIDs (nonsteroidal anti-inflammatory drugs) for the treatment of rheumatoid arthritis' has provided guidance for the clinical development of both biologic and non-biologic disease-modifying antirheumatic drugs (DMARDs). In the last few years, several new products have been developed or are in development for the treatment of RA, which offer significant efficacy with regard to disease control, including prevention of structural damage and disability. Concurrently, novel insights have been gained with respect to the assessment of disease activity, joint damage and disability. New treatment strategies have been established which relate to early therapy, tight control and rapid switching of medication. Accordingly, several new EULAR/ACR recommendations have been or are being developed. Several important additions and changes are needed in the 2003 guidance to incorporate the current scientific knowledge into clinical trial design for the development of future products. Under the auspices of the Group for the Respect of Ethics and Excellence in Science (GREES), a group of experts in the field of RA and clinical trial design met to provide a consensus recommendation for an update to the 2003 EMA guidance document. © 2011 Informa UK Ltd All rights reserved. Source

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