By Ed Miseta, Chief Editor, Clinical Leader
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Conducting clinical trials during the COVID-19 pandemic is no easy task. With nationwide shutdowns underway in most countries and businesses telling employees to stay home, just getting out of the house to purchase food and other necessities will be a challenge. All businesses will feel the impact of these policies, and drug developers are no exception. Trial participants opting to stay home as opposed to going out will impact trial participation and data collection as visits to the clinic slowly dwindle.
That problem does not even begin to address the challenge of study start-up. This process, which is always a challenge for sponsor companies, has now become increasingly difficult as a result of the worldwide pandemic. Reaching out to patients regarding study participation, and the process of finding clinics and bringing them on board, has suddenly become an almost insurmountable challenge.
Recognizing this unfortunate change in events caused by COVID-19, Eli Lilly and Company has made the difficult decision to delay most new clinical study starts and pause enrollment in most ongoing studies. This puts a damper on the company’s multi-million-dollar R&D operation and is likely to lead to similar actions at other drug discovery sponsor companies.
A Severe Burden
A press release issued by the company on March 23, 2020 notes the COVID-19 pandemic has substantially impacted the global healthcare delivery system, including the conduct of clinical trials. “Many healthcare systems have had to restructure operations to prioritize caring for those suffering from COVID-19 and limit or cease other activities,” states the release. “The severe burden on healthcare systems caused by this pandemic has also impaired the ability of many research sites to start new studies or enroll new patients.”
Tim Garnett, Lilly’s chief medical officer, stated the company hopes this action will ease the burden on participating healthcare facilities and allow physicians to focus more of their efforts on combatting COVID-19.
In addition to delaying the start of new trials, Lilly is working to help alleviate some of the pressure the global pandemic is placing on healthcare systems. The company has repurposed its laboratories to conduct diagnostic testing for patients. Lilly is also researching potential therapeutics for the COVID-19 virus. That will certainly cause a reallocation of the company’s human and capital assets.
Although Lilly is delaying study starts and pausing recruitment in ongoing studies, the company states it will continue ongoing clinical trials for patients who have already enrolled in studies. Patients currently participating in clinical trials may face new or increased risks due to the global pandemic. This situation was acknowledged by the FDA, which recently released guidance on the conduct of trials during this epidemic. Still, discontinuing those trials could have negative consequences as well.
No Disruption To Treatments
Garrett notes that for patients already enrolled in a trial, discontinuation of treatment would disrupt the treatment of patients and potentially diminish the society value of the research information to which they are contributing. For those patients already enrolled in a study, Lilly has decided to take several proactive steps in that will impact its ongoing clinical trial activities around the world. Those steps were not outlined in the release.
“Therefore, we will maintain ongoing studies, but with study-by-study consideration,” says Garrett. For those patients currently enrolled in a Lilly study, the company recommends continuing to follow study protocols and consultation with physicians if any questions or concerns arise.
While COVID-19 may prevent patient visits to clinics, the impact on trial timelines has not yet been determined to be detrimental. At this time, Lilly is not anticipating any adjustments to previously communicated timelines for ongoing late-stage studies, with the exception of mirikizumab's gastrointestinal indications. The company notes it will continue to closely monitor all aspects of its business in regard to the impact of COVID-19.
The challenges presented by COVID-19 will likely result in other drug developers having to take similar action. The impact of the virus on patient participation in trials will likely result in missed visits to the clinic, missing data, and possible modifications to study protocols. Although the recent FDA guidance on conduct of trials during the pandemic will help pharma deal with the challenges presented by the pandemic, sponsors will have to find ways to manage these issues until the crisis passes. This will be no easy task.
Many patients are desperately in need of medicines, especially those with rare diseases where there is currently no treatment option. Any delay in starting new trials will also delay the timelines in which new treatments make it to patients. As an industry, we can only hope any of these delays will be short-lived.