Will CRAs slowly disappear under remote monitoring? FDA now accepting comments on draft guidances proposing more remote, less on-site monitoring.

 

FDA Says Industry Should Monitor Trials Remotely

By Emily P. Walker, Washington Correspondent, MedPage Today Published: September 02, 2011

WASHINGTON -- The FDA has issued draft guidance that calls for drug and device companies to move away from in-person monitoring of each site in a clinical trial, when appropriate, and rely more on electronic data monitoring. The FDA recently withdrew its decades-old guidance on monitoring clinical investigations that stated that the most effective way to monitor a trial was to "maintain personal contact between the monitor and the investigator throughout the clinical investigation." That guidance was from 1988, before the Internet and the ability to e-mail and webcast, which, in some cases, can be stand-ins for collecting crucial study data that previously had to be done in person. As the number of clinical trials has grown dramatically over the past several decades, it's less feasible to personally check in on each investigation site, but it's still important to monitor the familiarity individual investigators have with the study protocol; the treatment choices made at each study site; whether the clinical trial is being conducted ethically; and whether the data are sound; in addition to other variables that may impact outcomes and affect human safety, the FDA said in its draft guidance. But that data don't necessarily need to be collected in-person, according to the FDA. The agency issued its new guidance to "encourage more effective monitoring of clinical investigations, to ensure adequate protection of human subjects and [to ensure] the quality and integrity of clinical trial data," according to the draft guidance document, dated Aug. 24. The guidance reads as a message to companies seeking FDA approval for a product: they don't need to spend the time and resources to perform exhaustive on-site inspections when other data oversight methods may work just as well. Monitoring of clinical trial sites varies by the type of trial and the type of institution conducting it. For instance, for a large efficacy trial, drug, device or biologic companies will typically conduct on-site monitoring visits every four to eight weeks, partly because of the perception that that is what the FDA wants. On-site monitoring can identify data entry errors, missing data, proper documentation, compliance with the study protocol, and the overall conduct of the trial. On the other hand, some academic centers and government organizations will perform on-site monitoring less extensively, perhaps only once every two or three years, and some National Institutes of Health-sponsored trials and trials in the United Kingdom rely largely on centralized data monitoring, which should be considered by private companies as well when developing a risk-monitoring plan, according to the FDA. Remote monitoring can work just as well, if not better, than on-site monitoring to check on the data collected at the study site, conduct statistical analyses, and to complete certain administrative tasks, the FDA said. "FDA encourages greater reliance on centralized monitoring practices than has been the case historically, with correspondingly less emphasis on on-site monitoring," the guidance said. The FDA said each company should analyze the complexities and unique considerations for its trial and decide what mix of remote and on-site monitoring is appropriate. "We expect that the pharmaceutical and device industries will, for the foreseeable future, continue to use some amount of on-site monitoring," the agency said, adding, "FDA recommends that each sponsor design a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial. Ordinarily, such a risk-based plan would include a mix of centralized and on-site monitoring practices." The FDA cautions that certain parts of a study are more important and must be monitored more often, including assessments related to critical study endpoints; protocol-required safety assessments; evaluation and documentation of serious adverse events; and ensuring that the study blind is maintained. The FDA is accepting comments on the draft guidance through Nov. 28.