Medical Device CRO Blog

For clinical researchers, our “grade card” comes when the FDA inspects us.  We all want to be told that we’ve operated in a compliant manner and that there were no findings.  The alternative is to receive a Form FDA 483 (483) for significant deviations at the close of the inspection.  When I got my first 483 as a research coordinator 18 years ago, I remember thinking to myself “I’m not going to let that happen again.”  In my opinion, it was an indication that we had not delivered A+ work.  Since the stakes are so high in this environment, and we’re asking patients to trust us to perform, it was a big wake up call for me. 

In the clinical research industry approvals for investigational products are not granted- they are earned. With FDA and International inspections on the rise, so are stress levels of everyone involved in clinical studies. Auditing can be looked at as a quality improvement process, and a way to prepare for inspections and approval by:

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar year.

On July 12, 1974, President Richard Nixon signed the National Research Act into law.  In doing so, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created.  The main purpose of the act was for the newly established commission to identify basic ethical principles to be followed when conducting biomedical and behavioral human subject’s research.  Additionally, the commission was tasked with developing guidelines that would help the medical community conduct research in accordance with the principles they set forth.  Some concepts the commission were to consider included: 

On April 1st, the FDA issued a draft guidance that provides more comprehensive information for industry and CDRH on the processes associated with panel device meetings.  The new draft guidance document, Procedures for Meetings of the Medical Devices Advisory Committee, pertains to the to 17 of the 18 Medical Devices Advisory Committee (MDAC) panels overseen by FDA's Center for Devices and Radiological Health (CDRH), the FDA center in charge of regulating medical devices.

Once finalized, the updated guidelines will replace a 2000 CDRH guidance document on the panel process and a 1991 blue book memo.  Thus, the guideline clarifies the circumstances in which the CDRH consults with a device advisory panel, the conduct of panel meetings and the expected timelines to prepare for a panel meeting.

When documenting your research observations, it is important to remember the adage, “If it wasn’t documented, it wasn’t done”. As research professionals, we have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. We must take credit for what we do - and to take credit for what we do, we must properly document our work.

IMARC Research’s new whitepaper examines the similarities and differences between the current US regulations and places them within the context of any number of roles found within the realm of clinical research. While there are no direct references within the regulations as to what types and to what degree training is required, a well-developed training curriculum is a prerequisite for quality research.

The informed consent process is arguably one of the most important parts of a clinical research study. Fromthe Principles of ICH GCP: the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. Proper informed consent ensures that the patient is aware of the risks and requirements of being in a research study and has voluntarily agreed to participate in research.  The regulations, CFR part 50 also cover the importance, rules and process of informed consent.

Proper training assures sponsors organizations that their research meets all the industry standards of compliance, and that their clinical studies will be conducted in a well-controlled, high quality manner that will withstand the rigors of regulatory inspection.

Former FDA Commissioner Margaret Hamburg says FDA is still honing its medical device regulatory process so it strikes a balance between patient safety and industry’s desire to market their products. Speaking at the National Press Club in Washington D.C., which might be her last public appearance as commissioner. She indicated that she is not sure the U.S. or Europe have gotten the balance right yet.

Recent widespread recalls of investigational products have led to harsher scrutiny and stricter rules from the Food and Drug Administration (FDA). Steps take to prepare for trials in the past are no longer enough. The path to FDA approval requires tremendous organizational skills and attention to detail to navigate; but with the right preparation and commitment to compliance, all of these challenges can be overcome.