Certara®, a global biosimulation technology-enabled drug development consultancy, and CISCRP, an independent nonprofit organization dedicated to educating and informing the public and patients about clinical research, announced that they are partnering to produce high-quality lay summaries of clinical trials.
Certara®, a global biosimulation technology-enabled drug development consultancy, and CISCRP, an independent nonprofit organization dedicated to educating and informing the public and patients about clinical research, announced that they are partnering to produce high-quality lay summaries of clinical trials. Lay summaries are brief descriptions of a clinical trial’s design, objectives and results, and are written for biopharmaceutical companies to share with the general public.
The recently published Institute of Medicine report, “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk,” outlined principles and shared a framework for the responsible sharing of clinical trial data. The tenets outlined in this report, along with EFPIA and PhRMA’s responsible data sharing principles and the new European Medicines Agency Clinical Trial Regulation have resulted in increased focus on clinical trials disclosure. Leading biopharmaceutical companies are now creating Scientific Review Boards to independently assess requests for clinical data and implementing broader clinical trials transparency programs with an emphasis on communications to both the research and lay communities.
Synchrogenix’s medical writers will develop the text and images for each lay summary and implement the company’s quality control processes to ensure data and message accuracy. CISCRP will deliver a critical, unbiased review of the report, engage and interact with investigative sites, and manage production, dissemination and communications of the report.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
March 27th 2024Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.