Newsletter - January 14, 2016
FDA Launches Multiple Initiatives for Patient-Focused Clinical Trials
Under PDUFA V, FDA committed to obtain patient perspectives on at least 20 disease areas and their treatment options by the year 2017. The purpose was to include patient perspectives on their conditions, its impact on daily life, and available therapies for better patient-focused and patient-centric clinical trials. FDA committed to hold public meetings to provide patients an opportunity to present their comments directly to the regulators. Read More..
About 20% of Cancer Clinical Trials Fail Due to Low Patient Recruitment
Patient recruitment challenges plague all clinical trials. Sponsors of clinical trials need to plan robust recruitment campaigns and involve creative solutions to find patients willing to participate in their trials. However, little systematic analysis has been conducted so far to evaluate the impact of poor recruitment on trial failure. That is till now. Read More..
FDA Launches Multiple Initiatives for Patient-Focused Clinical Trials
Under PDUFA V, FDA committed to obtain patient perspectives on at least 20 disease areas and their treatment options by the year 2017. The purpose was to include patient perspectives on their conditions, its impact on daily life, and available therapies for better patient-focused and patient-centric clinical trials. FDA committed to hold public meetings to provide patients an opportunity to present their comments directly to the regulators. Read More..
About 20% of Cancer Clinical Trials Fail Due to Low Patient Recruitment
Patient recruitment challenges plague all clinical trials. Sponsors of clinical trials need to plan robust recruitment campaigns and involve creative solutions to find patients willing to participate in their trials. However, little systematic analysis has been conducted so far to evaluate the impact of poor recruitment on trial failure. That is till now. Read More..