The U.S. Food and Drug Administration (FDA) advised drugmakers and medical device firms last month to fine-tune their oversight of clinical trials by focusing on the most important risks. Manufacturers were advised to consider making greater use of remote monitoring instead of on-site inspections. In a guidance document, the FDA described several pieces of data as almost always critical to the integrity of a study, including verification of informed consent and adherence to criteria meant to exclude participation by patients who might be uniquely susceptible to a product’s potential side effects.
It’s vital that there be reliable documentation of adverse events and that researchers ensure preservation of a study’s blinding. That means patients and sometimes doctors are kept in the dark about aspects of the drug or device each person receives. The FDA’s guidance said that directing extra resources toward the most common and serious threats to a trial’s trustworthiness and ethics is a sounder strategy than trying to avoid every conceivable shortcoming. The FDA wrote:
There is a growing consensus that risk-based approaches to monitoring, focused on risks to the most critical data elements and processes necessary to achieve study objectives, are more likely than routine visits to all clinical sites and 100 percent data verification to ensure subject protection and overall study quality.
While the FDA recommended that drug and device sponsors pay extra attention to the most consequential aspects of a trial, at the same time the agency also cautioned that it wasn’t calling for tunnel vision. The agency wrote:
A risk-based approach to monitoring does not suggest any less vigilance in oversight of clinical investigations. Rather, it focuses sponsor oversight activities on preventing or mitigating important and likely risks to data quality and to processes critical to human subject protection and trial integrity.
The guidance also nudged manufacturers in the direction of “centralized monitoring” that relies on remote data collection. In the FDA’s view, such oversight “can provide many of the capabilities of on-site monitoring as well as additional capabilities,” the guidance says.
Assuming a drugmaker has a strong electronic record-keeping system in place, one major advantage of remote monitoring is that it can more easily accommodate trials that are dispersed across many geographic areas, the FDA said. Despite its stated preferences, however, the agency conceded that it lacks certainty about the best approaches to monitoring, saying that there are “limited empirical data to support the utility of the various methods employed to monitor clinical investigations.”
As a result, simply put, there isn’t a one-size-fits-all approach, and manufacturers need to take many factors into account before settling on a method of oversight. Those factors include the study’s complexity, the severity of disease or condition being studied, the amount of professional experience of the clinical trial’s investigators and a product’s relative riskiness, the FDA said. Also, trials being conducted in countries with less mainstream standards of medical practice could warrant stronger scrutiny, according to the guidance. The guidance comes at a busy time for clinical trial regulation. Device companies, for example, recently torched the FDA’s proposed overhaul of standards for clinical trials conducted overseas.
Also, the Centers for Medicare & Medicaid Services last month laid out new criteria for when it will reimburse certain costs of clinical trials involving Medicare patients, saying that some of the new standards were developed in response to “egregious misconduct in the past in endeavors to conduct clinical research by placing individuals at the risk of harm for the good of others.” That’s a strong indictment of the system and hopefully all concerned will get the message.
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