There are many stakeholders involved in conducting a clinical trial today; however there can be many challenges to the infrastructure of running a clinical trial. Challenges that are seen with running medical device trials can vary anywhere from securing funding to lacking time and having dedicated study personnel. Another challenge that is faced is the time to market new devices that are ensured to have safety, quality and effectiveness. Although protecting human research subjects is the top of all priorities, can this regulatory pathway be shortened?
Last year, a priority of the Center for Devices and Radiological Health (CDHR) was to shorten the review time for marketing applications for medical devices. Recently, during the Research!America’s 27th Annual Meeting that was held on March 16, 2016, the new Food and Drug Administration (FDA) commissioner, Dr. Robert Califf, M.D. reported that his number one priority is to strengthen the workforce. Since “strengthening the workforce” can be interpreted in many different ways, what does this mean for Sponsors, Investigators, and Clinical Research Organizations? What type of changes will we see if the regulatory pathway is shortened when changes are being made in the FDA?
Regardless, whichever changes are implemented, the responsibilities of clinical research associates, as well as all involved in clinical trials, should remain the same, which are:
- To ensure the protection of human subjects;
- To ensure data integrity;
- To ensure compliance with federal regulations, agreements, the clinical investigational plan (CIP), and the requirements of the Institutional Review Board (IRB);
- To identify and address non-compliance; and
- To identify research misconduct or fraud;
What are your thoughts about these priorities? Do you believe this regulatory pathway can be shortened with new staff? Let us know your thoughts!