According to an expert, the rise in the number of protocol amendments occurring before the first patient has even received the first dose reflects a failure in planning trial design. Amending a protocol often involves making the study more complex, which impacts study costs and participant satisfaction. (CenterWatch)
Participants in failed Alzheimer’s trials react
Biogen and Eisai recently stopped two phase 3 trials of the Alzheimer’s treatment aducanumab after 36 months due to lack of efficacy. The 3,200 people in the trials and their families reacted with a sense of hopelessness and resign, particularly as there is no other treatment or clinical trial option for them. (STAT)
Gottlieb encourages drug sponsors to provide expanded access
FDA Commissioner Scott Gottlieb and his top aides are encouraging drug sponsors to continue providing a study drug that may have provided a benefit to especially needy clinical trial patients, after the study ends and before the new treatment is officially approved. (CenterWatch)
Survey reveals patient perspective on clinical trials
www.appliedclinicaltrialsonline.com
A recent survey of 4,000 patients and care providers examined the patient perspective on clinical trials. The most important motivator to take part in a trial was safety- the clinical trial should do no harm. Institutional support from one’s physician was also important, as were health benefits– the potential to benefit their personal health. (Applied Clinical Trials)
“Hey Alexa, find a Clinical Trial for me….”
Article by Guest Blogger Kathy Perez In this age of smart phones, cloud-based voice helpers and all things “Google” the public and medical profession have many ways to find a clinical trial. The most comprehensive listing of clinical trials in the world can be found at www.clinicaltrials.gov but when you Read more
FDA publishes draft guidance on patient experience data
The U.S. Federal Drug Administration (FDA) is offering the opportunity to stakeholders to submit to the FDA a proposed draft guidance on patient experience data, and has published new draft guidance (December 2018) to guide them. According to FDA Commissioner Scott Gottlieb, “Today’s guidance document is part of our commitment to advance patient focused drug development and is one of several guidances that we’re developing regarding the collection of patient experience data…” (Regulatory Focus)
FDA developing guidance on patient engagement in medical device trials
FDA’s Patient Engagement Advisory Committee (PEAC) is seeking public input to inform its draft guidance on developing patient-oriented medical device trials. This call for feedback is part of PEAC’s charter in 2017 to include patients in the device regulation process. The forthcoming FDA guidance intends to demystify patient engagement in the clinical trial process. (MEDTECHDIVE)
Blogger with cystic fibrosis (CF) excluded from CF clinical trials
Ella Balasa blog. Ms. Balasa is ineligible for clinical trials for treatment of symptoms of cystic fibrosis (CF) because most CF studies require participants to have a forced expiratory volume in one second (FEV1) of at least 40 percent, and hers is 25 percent. She suggests that FEV1 is an insufficient proxy for identifying “healthy” candidates for CF trials, and that current inclusion and exclusion practices be adjusted. (STAT)
New machine learning tool could reduce clinical trial attrition
Cambridge Consultants has designed a digital health tool that aims to help prevent patients becoming stressed and dropping out of clinical trials. The tool, known as Verum, uses biometric data and machine learning to measure and monitor a participant’s stress levels during trials, enabling trial coordinators to intervene and mitigate the effect of stress on compliance. (pharmaphorum)
Recruiting for clinical trials on social media? Don’t KISS!
A study conducted by Syneos Health found that many of the traditional advertising rules often don’t apply for clinical trial recruitment, particularly on social media. Photos of doctors perform well, images of a suffering patient got more clicks, and a longer more informative ad got more clicks. The top barriers to participating in a trial were: transportation issues, lack of payment, and fear of receiving a placebo. (MM&M)
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