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Perlmutter J.,Gemini Group | Roach N.,Fight Colorectal Cancer | Smith M.L.,Research Advocacy Network
Seminars in Oncology | Year: 2015

Advocates can play an important role in cancer research. In 2010, the National Cancer Institute (NCI) Advocate in Research Working Group (ARWG) defined a “research advocate” as an individual who brings and can convey a nonscientific viewpoint to the research process and can communicate a collective patient perspective through knowledge of multiple disease experiences. Experiences cited in this review are related to publically funded research. They, exemplify challenges and successes of advocate engagement and involvement in the cancer research process. © 2015 Elsevier Inc.


Fridlyand J.,Genentech | Simon R.M.,U.S. National Cancer Institute | Walrath J.C.,Friends of Cancer Research | Roach N.,Fight Colorectal Cancer | And 6 more authors.
Nature Reviews Drug Discovery | Year: 2013

As diagnostic tests become increasingly important for optimizing the use of drugs to treat cancers, the co-development of a targeted therapy and its companion diagnostic test is becoming more prevalent and necessary. In July 2011, the US Food and Drug Administration released a draft guidance that gave the agency's formal definition of companion diagnostics and introduced a drug-diagnostic co-development process for gaining regulatory approval. Here, we identify areas of drug-diagnostic co-development that were either not covered by the guidance or that would benefit from increased granularity, including how to determine when clinical studies should be limited to biomarker-positive patients, defining the diagnostically selected patient population in which to use a companion diagnostic, and defining and clinically validating a biomarker signature for assays that use more than one biomarker. We propose potential approaches that sponsors could use to deal with these challenges and provide strategies to help guide the future co-development of drugs and diagnostics. © 2013 Macmillan Publishers Limited. All rights reserved.


Stoffel E.M.,University of Michigan | Mangu P.B.,American Society of Clinical Oncology | Gruber S.B.,Fight Colorectal Cancer | Hamilton S.R.,University of Southern California | And 5 more authors.
Journal of Clinical Oncology | Year: 2015

Purpose To provide recommendations on prevention, screening, genetics, treatment, and management for people at risk for hereditary colorectal cancer (CRC) syndromes. The American Society of Clinical Oncology (ASCO) has a policy and set of procedures for endorsing clinical practice guidelines that have been developed by other professional organizations. Methods The Familial Risk-Colorectal Cancer: European Society for Medical Oncology Clinical Practice Guideline published in 2013 on behalf of the European Society for Medical Oncology (ESMO) Guidelines Working Group in Annals of Oncology was reviewed for developmental rigor by methodologists, with content and recommendations reviewed by an ASCO endorsement panel. Results The ASCO endorsement panel determined that the recommendations of the ESMO guidelines are clear, thorough, and based on the most relevant scientific evidence. The ASCO panel endorsed the ESMO guidelines and added a few qualifying statements. Recommendations Approximately 5% to 6% of patient cases of CRC are associated with germline mutations that confer an inherited predisposition for cancer. The possibility of a hereditary cancer syndrome should be assessed for every patient at the time of CRC diagnosis. A diagnosis of Lynch syndrome, familial adenomatous polyposis, or another genetic syndrome can influence clinical management for patients with CRC and their family members. Screening for hereditary cancer syndromes in patients with CRC should include review of personal and family histories and testing of tumors for DNA mismatch repair deficiency and/or microsatellite instability. Formal genetic evaluation is recommended for individuals who meet defined criteria. Copyright © 2015 American Society of Clinical Oncology.© 2014 by American Society of Clinical Oncology.


Grothey A.,Mayo Medical School | Flick E.D.,Genentech | Cohn A.L.,Rocky Mountain Cancer Center | Bekaii-Saab T.S.,Ohio State University | And 6 more authors.
Pharmacoepidemiology and Drug Safety | Year: 2014

Purpose: This analysis from Avastin® Registries: Investigation of Effectiveness and Safety (ARIES) examined the association between exposure to bevacizumab after disease progression (PD) and postprogression survival (PPS) in bevacizumab-exposed metastatic colorectal cancer (mCRC) through the application of time-dependent and time-fixed analytical methods. Methods: Patients with mCRC who were treated with first-line bevacizumab and who survived first PD (PD1) were included. A time-dependent Cox regression model was fitted to assess the effect of cumulative bevacizumab exposure on PPS, while controlling for potential confounders. In addition to support findings from previous studies, a modified intent-to-treat (mITT) analysis compared PPS in patients who received bevacizumab beyond disease progression (BBP) with those who did not (No-BBP). Results: Of 1550 patients, 1199 survived PD1 and had a median PPS of 13.4months. Cumulative bevacizumab exposure was associated with improved PPS (p=0.0040). After adjusting for confounders, the hazard ratios (HRs) for PPS decreased, on average, by 1.2% (range, 1.1-1.3%) with each additional dose of bevacizumab. In the mITT analysis, the median PPS for BBP (n=438) was 14.4months vs 10.6months with for No-BBP (n=667). BBP was found to be independently associated with longer PPS in a multivariable Cox regression analysis (HR, 0.84; 95% confidence interval, 0.73-0.97). Protocol-specified adverse events suspected to be associated with bevacizumab occurred in 13.0% of patients with BBP. Conclusion: This analysis supports the observation that bevacizumab exposure after PD1 is associated with longer PPS in mCRC. © 2014 John Wiley & Sons, Ltd.


PubMed | Fight Colorectal Cancer, Rti International and University of North Carolina at Chapel Hill
Type: | Journal: The patient | Year: 2016

Patient-centered communication (PCC) is an essential component of patient-centered care and contributes to patient satisfaction, health-related quality of life, and other important patient outcomes.The aim of this study was to develop and test survey questions to assess patients experiences with PCC in cancer care.We used a conceptual model developed by the National Cancer Institute as our framework. The survey questions align with the six core functions of PCC defined in the model: Exchanging Information, Managing Uncertainty, Enabling Patient Self-Management, Fostering Healing Relationships, Making Decisions, and Responding to Emotions. The study focused on colorectal cancer patients. We conducted two rounds of cognitive interviewing to evaluate patients ability to understand and provide valid answers to the PCC questions. Interviews were conducted in Maryland and North Carolina in 2014. We involved a patient advocacy group, Fight Colorectal Cancer, and a multidisciplinary panel of stakeholders throughout the measurement development process to ensure that the survey questions capture aspects of PCC that are important to patients and meet the needs of potential end users, including researchers, healthcare organizations, and health professionals.Patient and other stakeholder input informed revisions of draft survey questions, including changes to survey instructions, frame of reference for questions, response scales, and language.This study demonstrated the feasibility and value of engaging patients and other stakeholders in a measurement development study. The Patient-Centered Outcomes Research Institute (PCORI) conceptual model of patient-centered outcomes research provides a useful guide for patient engagement in research. Research funders should call for meaningful roles for patients and other stakeholders in health research, including in the development of patient-centered outcomes.


PubMed | Johnson & Johnson, U.S. Food and Drug Administration, European Medicines Agency, Astrazeneca and 4 more.
Type: Journal Article | Journal: Clinical trials (London, England) | Year: 2016

Stakeholders across the clinical trial enterprise have expressed concern that the current clinical trial enterprise is unsustainable. The cost and complexity of trials have continued to increase, threatening our ability to generate reliable evidence essential for making appropriate decisions concerning the benefits and harms associated with clinical interventions. Overcoming this inefficiency rests on improving protocol design, trial planning, and quality oversight.The Clinical Trials Transformation Initiative convened a project to evaluate methods to prospectively build quality into the scientific and operational design of clinical trials (quality-by-design), such that trials are feasible to conduct and important errors are prevented rather than remediated. A working group evaluated aspects of trial design and oversight and developed the Clinical Trials Transformation Initiative quality-by-design principles document, outlining a series of factors generally relevant to the reliability of trial conclusions and to patient safety. These principles were then applied and further refined during a series of hands-on workshops to evaluate their utility in facilitating proactive, cross-functional dialogue, and decision-making about trial design and planning. Following these workshops, independent qualitative interviews were conducted with 19 workshop attendees to explore the potential challenges for implementing a quality-by-design approach to clinical trials. The Clinical Trials Transformation Initiative project team subsequently developed recommendations and an online resource guide to support implementation of this approach.The Clinical Trials Transformation Initiative quality-by-design principles provide a framework for assuring that clinical trials adequately safeguard participants and provide reliable information on which to make decisions on the effects of treatments. The quality-by-design workshops highlighted the value of active discussions incorporating the different perspectives within and external to an organization (e.g. clinical investigators, research site staff, and trial participants) in improving trial design. Workshop participants also recognized the value of focusing oversight on those aspects of the trial where errors would have a major impact on participant safety and reliability of results. Applying the Clinical Trials Transformation Initiative quality-by-design recommendations and principles should enable organizations to prioritize the most critical determinants of a trials quality, identify non-essential activities that can be eliminated to streamline trial conduct and oversight, and formulate appropriate plans to define, avoid, mitigate, monitor, and address important errors.


News Article | February 24, 2017
Site: www.npr.org

Increasingly, advocates for patients are in the room when big medical studies are designed. They demand answers to big questions: "Will the results of this study actually help anybody?"(Image credit: Andrew Wortmann/Courtesy of Fight Colorectal Cancer)


News Article | February 24, 2017
Site: www.npr.org

Increasingly, advocates for patients are in the room when big medical studies are designed. They demand answers to big questions: "Will the results of this study actually help anybody?"(Image credit: Andrew Wortmann/Courtesy of Fight Colorectal Cancer)


What:  Fight Colorectal Cancer, a leading national colorectal cancer nonprofit and Exact Sciences Corp. (Nasdaq:EXAS), a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer will visit the Nasdaq MarketSite in Times Square. Today kicks off Colorectal Cancer Awareness Month, a period where advocates stress the importance of screening against the nation’s second leading cause of cancer deaths. To mark the occasion, Kevin Conroy, Chairman of the Board, CEO and President of Exact Sciences and Luke Perry, Celebrity Ambassador, will ring the Closing Bell. Social Media: For multimedia features such as exclusive content, photo postings, status updates and video of bell ceremonies please visit our Facebook page at: http://www.facebook.com/NASDAQ. For photos from ceremonies and events visit our Instagram Page: http://instagram.com/nasdaq For news tweets, please visit our Twitter page at: http://twitter.com/nasdaq For exciting viral content and ceremony photos visit our Tumblr Page: http://nasdaq.tumblr.com/ Webcast: A LiveStream of the Nasdaq Closing Bell will be available at: https://new.livestream.com/nasdaq/live or http://www.nasdaq.com/about/marketsitetowervideo.asx Photos: To obtain a hi-resolution photograph of the Market Close, please go to http://www.nasdaq.com/reference/marketsite_events.stm and click on the market close of your choice. About Fight Colorectal Cancer Fight Colorectal Cancer (Fight CRC) is a national nonprofit advocacy organization fighting for a cure. It was founded in 2005 by Nancy Roach, a nationally-recognized patient advocate who witnessed the need for colorectal cancer advocacy after her mother-in-law’s diagnosis. The organization plays an important role in rallying colorectal cancer advocates to action. Fight CRC is known for activism and patient empowerment throughout patient, academic, political, scientific, medical and nonprofit communities. With a mission focused on advocacy, research, patient education and awareness, the organization serves advocates in every state of the U.S. and many others around the world. Fight CRC is a 4-star rated charity by Charity Navigator and 93 cents of every dollar donated goes directly to colorectal cancer programs. To learn more, visit FightCRC.org. About Exact Sciences Corp. Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society and stool DNA is included in the U.S. Multi-Society Task Force on Colorectal Cancer. For more information, please follow us on Twitter @ExactSciences or find us on Facebook. About Nasdaq Nasdaq (Nasdaq:NDAQ) is a leading provider of trading, clearing, exchange technology, listing, information and public company services across six continents. Through its diverse portfolio of solutions, Nasdaq enables clients to plan, optimize and execute their business vision with confidence, using proven technologies that provide transparency and insight for navigating today's global capital markets. As the creator of the world's first electronic stock market, its technology powers more than 85 marketplaces in 50 countries, and 1 in 10 of the world's securities transactions. Nasdaq is home to approximately 3,800 listed companies with a market value of $10.1 trillion and nearly 18,000 corporate clients. To learn more, visit: business.nasdaq.com.


PubMed | The Gemini Group and Fight Colorectal Cancer
Type: Journal Article | Journal: Seminars in oncology | Year: 2015

Advocates can play an important role in cancer research. In 2010, the National Cancer Institute (NCI) Advocate in Research Working Group (ARWG) defined a research advocate as an individual who brings and can convey a nonscientific viewpoint to the research process and can communicate a collective patient perspective through knowledge of multiple disease experiences. Experiences cited in this review are related to publically funded research. They, exemplify challenges and successes of advocate engagement and involvement in the cancer research process.

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