Loyola University Chicago School of Law, JD 2022
In early April of 2020, a high-tech, temperature-controlled cooler traveled halfway across the country on an airplane with a man whose sole job was to get the contents of that cooler –– a promising trial drug to treat a specific form of muscular dystrophy –– from a Baltimore-based research hospital to a family member of mine living in a west Chicago neighborhood. Ordinarily, this family member would make a monthly visit to Baltimore and take the trial drug under the supervision of researchers, but with a pandemic raging on, researchers made do. COVID-19 has undoubtedly changed the way people around the world are going about their lives and everyone is doing their best to be flexible. Clinical drug trials are no different.
What is being done to continue important medical research and trials despite COVID-19?
Travel restrictions have upended some research plans, while long-term lockdowns also simply shifted research priorities. However, with nearly 147,000 active clinical trials, it makes sense that they wouldn’t all just come to a halt when COVID-19 hit. In response to the pandemic, the U.S. Food and Drug Administration (“FDA”) put out recommendations for how to continue on with impending and active clinical trials. It seems that the key to these recommendations is flexibility. The FDA advises that sponsors should consider each circumstance, focusing on the potential impact on the safety of trial participants, and modify each study conduct accordingly.
Most of the suggested modifications from the FDA involve decentralized and remote trial coordination, taking advantage of tools like telemedicine, or using a patient’s local facility for laboratory investigations. Some study teams have bought and shipped protective equipment to personnel at clinical trial sites, secured special permits where necessary for trial participants to leave their homes for medical visits, and arranged their private transportation to avoid public buses.
Clinical trials already pose unique legal issues between the myriad of regulations they must navigate and the way these regulations intersect with patent law. Decentralized clinical trials raise concerns about things like data collection but may also illustrate the need to reevaluate if regulations are necessary. Regulatory authorities have been rather accommodating for ongoing clinical trials, poking holes in the necessity of some typically mandated practices. In a podcast from Foley and Lardner LLP, Laurie Halloran, founder of Halloran Consulting Group, gives an example of such a case. There is something called a six-minute walk test. Patients often travel great distances to have someone who is “qualified” watch them walk for six minutes across a straight line in order to define that the trial product is making the patient better. Halloran explains we are now in a situation where things like this can be done remotely and posits that maybe regardless of a pandemic, they should continue to be done this way.
It’s only natural to question the status quo during unprecedented times like these. While the FDA as a whole is certainly a worthwhile agency, the recent amendments to drug trial rules beg the question of necessity. As of now, this policy of relaxed trial rules from the FDA remains in effect “only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services.” However, if the FDA can be flexible during a pandemic, then that is arguably all the more reason to maintain those relaxed drug trial rules post-pandemic.
The primary benefit of maintaining these relaxed rules is efficiency. Most of the suggested modifications from the FDA involve decentralized and remote trial coordination, which is more efficient and economical since researches do not have to work within patients’ travel schedules. Efficiency is critical in any business, but especially in situations where patients are waiting for life-saving treatments. Inefficiencies may even cost lives because people die from diseases that might be treatable. Efficiency and necessity ought to be key considerations for regulators in a post-pandemic world.
Data Concerns and Long-Term Impact
The COVID-19 outbreak poses both obvious and more subtle data challenges. Trial participants who become infected with COVID-19 make it harder for researchers to pick up signals of benefit or to disentangle the negative side effects of the experimental treatment. Less obvious effects on data may be the result of stay-at-home orders affecting the day-to-day lives of participants. For example, the results of HIV prevention trials depend, in part, on participants’ risk of contracting the virus. Social distancing orders that limit intimacy might change that underlying risk. COVID-19 mitigation efforts interfere with all aspects of a successful clinical trial: efficient accrual and randomization, intervention adherence and delivery, and outcome collection. Accounting for these effects and doing so remotely are challenges for researchers. However, post-pandemic, it should remain within researchers’ discretion as to when in-person visits are necessary to overcome these data challenges rather than be mandated by the FDA.
Legal professionals and researchers in the field are optimistic. One cancer researcher believes hybrid clinical trial models incorporating decentralized components can increase efficiency. Diane Bourque, an attorney whose practice focuses on clinical research, believes a great deal of good can come from the changes made during the COVID-19 outbreak. All in all, despite some of the incredible barriers that COVID-19 has posed for researchers and clinical trial participants, the show goes on.