FDA regulations can seem all encompassing at times, especially when trying to run a clinical trial in compliance with the various rules and standards. While many in clinical research would not argue that there are not enough regulations governing clinical research practices, the question remains: Are there too many gray areas?
How many times have you encountered a research subject who did not remember all he/she had agreed to when he signed the informed consent? Research has shown a staggering statistic. According to the Journal of the Royal Society of Medicine (JRSM), “40-80% of medical information provided by healthcare practitioners is forgotten immediately.” So, it is not surprising that they may not remember all that is involved with participation in clinical research. Although, this underscores the importance of providing the subject with a copy of the signed informed consent (21 CFR 50.27), is this cause for concern? Informed consent is the focus at the start of a subject’s clinical trial involvement, but should it be considered an ongoing process that continues for the duration of the research study?
The Investigator:As demonstrated in many FDA warning letters, a commonly cited source of bias in clinical research can be found in the financial ties between investigators and sponsors. It is not unusual for the innovations of individual physician investigators to receive research and development funding from larger organizations that possess the resources to bring these innovations to market, and under 21 CFR 54, it is the responsibility of sponsors to collect for each investigator who is not a full-or part-time employee either a certification of no financial conflict of interest (Form FDA 3454), or a disclosure of the financial arrangements between the sponsor and investigator (Form FDA 3455). If an investigator has a significant stake in the outcome of an investigation, how can one ensure that patients understand the details of what this means and document their understanding? How can potential bias be further minimized?
A recent article published by the Cochrane Group examined industry sponsorship and research outcome. In order to gather the necessary data, researchers conducted a systematic review of 48 reports of studies involving drugs and medical devices. The researchers observed that drug and device “studies sponsored by the manufacturing company more often had favorable results and conclusions than those that were sponsored by other sources.” Could this be a potential gray area for clinical research? Are the clinical trials being run without bias?
What are your thoughts on navigating through the gray areas of clinical research? Obviously the most important aspect of the equation is the patient. How do you go the extra step to ensure the rights, welfare, and safety is the utmost priority when things aren’t exactly black and white?
Share your experiences below.
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