Best Practices in Study Feasibility
Applied Clinical Trials
Survey drills down on the preferred methods of sponsors, CROs, and sites in conducting feasibility analysis.
Successfully navigating the medical, clinical, logistical and regulatory challenges associated with establishing the feasibility of a clinical trial is not easy. Insights from sponsos, contract research organizations (CROs) and sites have been compiled in ISR’s Best Practices in Study Feasibility report. A particular area of interest for readers of the report are the techniques and innovations proffered by sponsors and CROs for conducting feasibility analyses. Both groups identified that the integration of statistical modeling and knowledge of past performance into feasibility analyses is positively impacting the process.
Sponsors also see value in making direct, personal contact with investigators to build better relationships and a greater use of electronic medical record (EMR) data as positive innovations. CROs point to improved feasibility surveys and better targeting questions as ways to improve study feasibility estimations. ISR also collected insights to improve the accuracy of study feasibility estimates including: the percentage of trials that require a feasibility analysis, and whether the analysis is conducted in-house or outsourced; awareness of feasibility analysis service providers and frequency of use; and the data sources utilized for feasibility analyses and a ranking of which data sources contribute to the accuracy of the estimate.
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.
