A recent survey of more than 12,000 patients and their friends and family found that the public sees clinical trial research as important, but doesn’t know much about the research process, and sees trial participation as burdensome. Federal agencies are actively exploring ways to make drug development more patient-focused, which could reduce the burden of participation and encourage greater trial enrollment. (Business Insider)
FDA wants sponsors to use patient-reported outcomes in phase 3 trials
Patient-reported outcomes (PROs) can enhance drug development, but the integration of PRO measures as end points in phase 3 clinical trials has been slow. The FDA held a two-day workshop to gather input on a series of drug development documents they are developing to provide guidance to stakeholders on collecting information on patient experiences to inform product development. (ajmc.com)
FDA’s CDRH publishes list of upcoming 2019 guidance documents
The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has published three lists of guidance documents that could be published in the next fiscal year. On the “A-list” of guidance documents that the agency “fully intends to publish” is a Draft Guidance, “Patient Engagement in Clinical Trials.” (Regulatory Focus)
Number of women in gynecological cancer trials drops 90%
The number of women with gynecologic cancers enrolled in phase 3 trials has fallen by 90 percent, and the number of gynecologic cancer clinical trials has also declined. The Foundation for Women’s Cancer (FWC) is lobbying patients to speak up to government leaders about the inadequate number of clinical trials available to them, and the NCI is responding to the crisis. (CureToday.com)
2,000 immunotherapy drugs in trials- where will we get the trial participants?
The race to develop new immunotherapy treatments against cancer has sparked an unprecedented expansion in the oncology drug pipeline, with more than 2,000 immune system boosting agents now in development. The result is a scramble for patients to enroll in clinical trials; this year alone, 469 new clinical studies were started, with a target enrollment of 52,539 patients. (Newsmax Health)
Are you ready to do a virtual trial? The “Crawl, Walk, Run” approach to conducting remote patient research
John Reites, Chief Product Officer and Partner at THREAD Research, provides an informal and high-level review of the 3 ways to engage in remote patient research. He introduces the “Crawl, Walk, Run” approach to help you get your organization started on the path towards the fully virtual clinical trial. (THREAD)
FDA considers setting up a new “Office of Patient Affairs”
As part of its efforts to capture patients’ perspectives, the U.S. FDA is considering establishing an “Office of Patient Affairs” that would be tasked with coordinating patient engagement across the agency. The move to create the office would be part of the agency’s efforts to offer a single entry point to the Agency for the patient community and patient stakeholders. (Regulatory Focus)
San Diego startup Veyo corners the market for providing non-emergency healthcare transportation
Each year, 3.6 million Americans miss or delay medical care due to transportation issues. Ride-sharing apps have been cited as one of three technologies disrupting healthcare logistics. San Diego-based Veyo is adapting Uber-like, on demand technologies specifically for healthcare needs. The one-year old startup provides non-emergency medical transport (NEMT) services to their customers, and currently provides rides for Medicaid beneficiaries in six states. (HealthcareDIVE)
The “must have” factors for creating a patient-centric clinical trial
Catherine Bonuccelli, VP, Respiratory Therapy Area Head, at GlaxoSmithKline discusses the “must have” factors for creating a patient-centric clinical trial. (YouTube)
Patients Increasingly Influence The Direction Of Medical Research
AUDIO http://www.npr.org/sections/health-shots/2016/11/28/502904826/patients-increasingly-influence-the-direction-of-medical-research?utm_medium=RSS&utm_campaign=health