The COVID-19 pandemic has disrupted just about every national and global industry, and drug companies are certainly no exception.
One of the primary concerns for the pharmaceutical industry is the impact on clinical trials of drugs, medical devices, and biological products. These trials are an important method of proving the safety and efficacy of proposed new treatments. And with current travel restrictions and site closures severely impacting the supply chain, efficient collection of clinical trial results has suffered.
In an effort to prevent further disruption of important data collected through clinical trials, the FDA along with its Office of Good Clinical Practice (“OGCP”) has issued new guidelines for clinical trial sponsors, including home-based electronic data capture via telemedicine and telephone interviews.
Such dramatic changes to the trial process come with valid concerns about how to ensure patient safety while simultaneously ensuring adequate and accurate data collection. And for pharmaceutical companies, there's also the issue of protecting the integrity of their clinical trial processes while controlling the already high cost of such trials.
What Does This Mean for Your Business?
In view of the unprecedented nature of the COVID-19 pandemic and the diverse needs and goals of different life science companies, there appears to be no one-size-fits-all solution to the FDA's guidelines for home-based data collection. Each clinical trial, site and subject must be evaluated on a case-by-case basis to determine what amendments and deviations from the approved pre-COVID clinical trial protocol are appropriate.
According to the FDA, some amendments and deviations to a standard protocol must be reported as part of the clinical trial, but reporting is not necessary for all protocol deviations. For example, if a trial site is now mandating COVID-19 screening, the screening itself does not need to be reported as an amendment unless any data collected from the COVID-19 screening is specifically included in a new research objective.
However, amendments made in an effort to limit COVID-19 exposure to trial subjects must be reported in amendments to applications for investigational device exemptions and investigational new drug applications. But such amendments do not have to be approved by the Institutional Review Board.
That's an important element because of the additional cost and time involved in obtaining such approvals. And in clinical trial management, additional time and delay frequently means additional costs and logistical problems.
Depending on the location and type of clinical trials being conducted and the nature of the disease, medication, or device being studied, the impact of COVID-19 control methods will vary widely. Some of the most obvious and challenging impacts will likely include an inability to fulfill certain required procedures, such as the method of administering the product being studied or performing testing entirely in a laboratory setting.
If you are concerned about how the FDA's new guidance on clinical trials will impact your business, the skilled legal team at the Law Office of Philip P. Crowley LLC can help. Our experienced, highly-knowledgeable IP, science, tech, and drug company attorneys have been serving pharmaceutical industry clients throughout New York and New Jersey for more than 30 years.
Our team has a deep understanding of the rights, goals, and interests of this industry, and work tirelessly to ensure our clients are protected in the most efficient and cost-effective manner possible.
Contact the Law Office of Philip P. Crowley LLC today at (844) 256-5891 today for a free and confidential consultation.
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