Trending PR+R News: EMA’s Demands for Plain-Language Summaries for Clinical Trial Results that can be Understood by Anyone Could Create new Challenges for Sponsors
From 2019, to comply with requirements for greater transparency around clinical research as part of the EU Clinical Trials Regulation 536/2014 (EU CTR Article 37), life sciences firms will be expected to prepare plain-language summaries (PLSs) for all Phase I through IV interventional trials, which can be understood by patients, the general public, and experts. For trial sponsors, this is a significant undertaking. Its perceived magnitude is reflected in the concerns now being raised by study teams and those who will be responsible for delivering the PLSs.
Digital R&D: 4 Ways To Maximize Patient Engagement In Clinical Trials
The Deloitte Center for Health Solutions recently interviewed 43 biopharmaceutical industry stakeholders to explore where the industry sees value and opportunities for using digital technologies in the clinical development process; understand reasons behind the relatively slow pace of digital adoption; and uncover strategies to overcome barriers and accelerate the use of digital in clinical trials.
3 Common Misconceptions about Physician Referrals to Clinical Trials
Research organizations aren’t adequately engaging healthcare providers to encourage more patient referrals. As revealed during a discussion at the inaugural Bridging Clinical Research and Health Care collaborative forum, there are a number of assumptions about patients, health care providers and the referral process that seem to inhibit productive conversations between researchers and physicians. Discover some of the misconceptions that act as barriers for physician referrals to clinical trials.
Blockchain Concepts Emerge in Clinical Trials
The application of AI, blockchain technology, and machine learning in clinical trials is sparking a lot of interest in the biopharmaceutical industry, and there was much discussion on the topic at PanAgora’s AI & Machine Learning in Clinical Trials Summit last month. In this interview, Munther Baara, Head of New Clinical Paradigms at Pfizer, discusses his perspectives on how blockchain may be a game changer in how we conduct clinical trials.
Women Are Still Underrepresented in Clinical Trials for Cardiovascular Disease Drugs
Women continue to be less represented than men in clinical trials of drugs to treat cardiovascular disease. The authors suggest that factors before screening, such as identification of potential trial participants, and the ability of a candidate to participate, may be more important than screening practices in creating lower enrollment of women. Another possibility is that women are less likely than men to consider participating in trials. Read more for details.
Patient Centricity: A positive shift for the patient experience
It’s harder to get into trials, and the inclusion and exclusion criteria, as a whole, for clinical research studies have increased 61%, which significantly adds to the screen fail rate. Additionally, 15% to 20% of sites never enroll a single patient and actual enrollment timelines are typically double that of planned timelines. Sponsors’ heightened awareness of the importance of patient engagement in the design and execution of research studies has led to the discovery of crucial information about participation pain points. The information often reveals huge disconnects in what patients prefer and what they experience. Resolving these disconnects can have a significantly positive impact on patient recruitment.
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Mosio is a two-way text messaging company specializing in mobile solutions for clinical research. Our award winning Patient Engagement Platform enables researchers to engage and retain study participants through text message alerts, reminders, surveys and interactive “TextChat” features.