Newsletter - April 14, 2016
Multiple Efforts to Increase Recruitment of Subjects in Clinical Trials
It is well known that the most challenging aspect of running a given clinical trial is finding patients to participate in it. The main reasons are negative public perception of clinical trial participation, poorly designed clinical protocols and lack of planning by the clinical trial managers. And regulators are trying to help change that. Last month, NIH and FDA jointly released a template for clinical trial protocols to help companies design better clinical trials that would encourage higher participation by investigators and patients. Read More..
Do Physicians Lack Understanding of FDA Approval Processes?
A recent report based on a survey of about 1200 physicians provides a critique on how little prescribers know about the process of drug approval by the FDA. According to the report about 90% of the physicians surveyed could not correctly answer all three questions asked about FDA approval process. The survey asked two sets of questions; one set of 3 questions about general FDA review and approval process, and a second set of 5 questions about the breakthrough therapy designation. Read More..
Multiple Efforts to Increase Recruitment of Subjects in Clinical Trials
It is well known that the most challenging aspect of running a given clinical trial is finding patients to participate in it. The main reasons are negative public perception of clinical trial participation, poorly designed clinical protocols and lack of planning by the clinical trial managers. And regulators are trying to help change that. Last month, NIH and FDA jointly released a template for clinical trial protocols to help companies design better clinical trials that would encourage higher participation by investigators and patients. Read More..
Do Physicians Lack Understanding of FDA Approval Processes?
A recent report based on a survey of about 1200 physicians provides a critique on how little prescribers know about the process of drug approval by the FDA. According to the report about 90% of the physicians surveyed could not correctly answer all three questions asked about FDA approval process. The survey asked two sets of questions; one set of 3 questions about general FDA review and approval process, and a second set of 5 questions about the breakthrough therapy designation. Read More..
