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News Article | May 17, 2017
Site: www.businesswire.com

NEW YORK--(BUSINESS WIRE)--Stage IV Colorectal Cancer Survivor Dr. Tom Marsilje, known to many as “Dr. Tom” or the “Currently Incurable Scientist,” released version two of his microsatellite stable colorectal cancer (MSS-CRC) clinical trial finder tool today, now called the “Late Stage MSS-CRC Trial Finder: A curated list powered by patients.” For over two years, Marsilje has personally curated MSS-CRC clinical trials and shared them through a spreadsheet, later converted to an app, with late-stage patients he met online. He partnered with Fight Colorectal Cancer in January 2017 to amplify his efforts and reach more patients, as well as secure curation support for the trials database. The tool can be accessed at TrialFinder.FightCRC.org. The new-and-improved Late Stage MSS-CRC Trial Finder is an update of Marsilje’s spreadsheet. Flatiron Health, a healthcare technology and services company focused on accelerating cancer research and improving patient care, built the latest version of the tool, turning Marsilje’s dream into a reality. “For over two years, my spreadsheet has served patients (and their caregivers) and offered them a curated list of potential clinical trials for them to subsequently discuss with their medical team,” said Marsilje. “The filtered list is generated from all potential MSS-CRC patient-enrolling trials, and it is based upon parameters that are most important from the viewpoint of stage IV MSS-CRC patients. This comes from not only my own personal experience as a MSS-CRC patient, but also the feedback I’ve received over the years after helping hundreds of other patients search for trials.” As part of Flatiron’s latest internal hackathon, a team from the company not only built a patient-friendly, online platform, but programmers also automated many parts of Marsilje’s curation process. The content of the app is based on an automated search that hits AACT, a publicly available repository of all trials listed on ClinicalTrials.gov, that is maintained by the Clinical Trials Transformation Initiative. The search is refreshed each day for new and existing trial updates, and is then monitored by Marsilje and long-time research advocate Maia (Cee Cee) Walker. Together they systematically use Marsilje’s logic model to review each trial, and post only the trials most relevant for late-stage, MSS-CRC patients to the Trial Finder website. They’re currently working with Fight CRC to train additional patient advocates who will help power the curation process. It’s important to note that the Trial Finder tool is not a comprehensive list of all CRC clinical trials - only trials that may be of greatest interest to a stage IV patient with MSS-CRC (such as Marsilje himself) and based on Marsilje’s review criteria, are included. When commenting on which trials appear in the Trial Finder, Marsilje explained: “From my stage IV patient viewpoint, I decided I was only interested in two types of trials: 1) Trials which had a “reduced” chance of potential failure and 2) Trials that had the biggest “potential” long-term benefit. As a patient, I had no interest in participating in a trial which had both the highest risk of failure as well as limited long-term benefit, even if the experimental therapy worked as designed. I knew that I may only have one shot at a trial, so I wanted to choose that trial wisely and make that potentially single shot count the most!” This approach to curating a list of clinical trials is innovative, as it focuses on underscoring the patient point of view, looking specifically at the relationship between patient values and the desire to find clinical trials with meaningful impact. This effort, led by Marsilje and research advocates across the country, illustrates that patients are keenly aware of the role clinical trials can play in their lives as they search for better, more effective treatment options. Social media and information on the web have changed the game in cancer research. “Stage IV patients and their caregivers have a sense of urgency that isn’t reflected in the systems of research,” said Nancy Roach, founder of Fight CRC. “Tom’s curating logic reflects this sense of urgency and the priorities of patients, especially patients who’ve received multiple lines of therapy. The logic will evolve over time as new approaches to treatment evolve, and we hope to use information from patients who use the tool to inform our ability to comment constructively on trial design.” Powered by patients, goodwill and talent, the tool was built and designed during Flatiron’s most recent internal “hackathon,” a two-day event that provides Flatiron employees an opportunity to take on a grassroots side project outside of their daily work. These quarterly hackathons have been a part of Flatiron’s tradition since its founding almost five years ago. A team from Flatiron chose to partner with Marsilje and Fight CRC for one of their many projects in this latest hackathon, which they blogged about here. “The Flatiron team includes many exceptionally talented engineers, data scientists, product managers, and oncologists, and we all have one thing in common: we are all eager to increase the number of cancer patients who participate in cutting-edge research,” said Vineeta Agarwala, M.D., Ph.D., and director of product management at Flatiron Health. “From the very first time that we spoke with Tom, we were inspired by his passion and focus to help fellow cancer patients. We immediately realized that our collaboration on the Late Stage MSS-CRC Trial Finder could have a direct and immediate impact on stage IV colon and rectal cancer patients and their families, which was the driving force behind our decision to be a part of this project." Flatiron created a robust platform with search boxes, tool tips and printable reports to meet patient needs. While most of the software build was done over the course of the two-day hackathon by Flatiron, the full project was completed in three months, with Fight CRC’s support through volunteer time advancing research efforts. Those using the tool must be aware of its limitations and understand the disclaimer that reads: The information contained in this website is not intended to recommend the self management of health problems, medical conditions or wellness. It is not intended to endorse or recommend any particular type of medical treatment, physician or treatment facility. Should any reader have any healthcare related questions, promptly call or consult your physician or healthcare provider. The information contained in this website should NOT be used by any reader to disregard medical and/or health related advice or provide a basis to delay consultation with a physician or a qualified healthcare provider. Fight Colorectal Cancer disclaims any liability based on information provided in this website. All patients are encouraged to discuss their clinical trial options with their medical team. “To facilitate a discussion with a patient’s medical team, the trial finder supplies linked scientific and medical information that explains how the experimental therapeutic is designed to work and/or presents preliminary clinical data,” said Marsilje. For more information about the story behind the tool, visit Marsilje’s post on his blog, “Adventures in Living Terminally Optimistic” and the tool’s FAQ. For more information on clinical trials, visit FightCRC.org. 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 charity by Charity Navigator and 93 cents of every dollar donated goes directly to colorectal cancer programs. To learn more, visit FightCRC.org. Flatiron Health is a healthcare technology and services company focused on accelerating cancer research and improving patient care. Our platform enables cancer researchers and care providers to learn from the experience of every patient. Currently, Flatiron partners with over 265 community cancer clinics, three major academic research centers and 11 out of the top 13 therapeutic oncology companies. Flatiron is backed by Google Ventures, First Round Capital, Roche and others. For more information, please visit www.flatiron.com or follow us @FlatironHealth.


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.

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