Clinical Trials and COVID-19: Challenges and Guidance

As the COVID-19 pandemic unfolds, pharmaceutical, biologic, and medical device companies conducting or planning to conduct clinical trials may be faced with challenges related to quarantines, travel limitations, site closures or access restrictions, infection transmission concerns of site research personnel and study subjects. These companies want to ensure that the trial participant’s safety and the integrity of the trial are being maintained and are aligned with FDA and European Medicines Agency (EMA) guidance regarding the conduct of clinical trials during the COVID-19 pandemic.

Most foreign clinical trial insurance policies do not contain exclusions in relation to COVID-19 (Coronavirus) or any derivative thereof. However, companies should not assume there is coverage because there can be other attributable factors to any claim. As with any potential claim, the facts, circumstances, and policy language must be carefully reviewed in order to provide any specific advice on how coverage may or may not respond.

During this unique time of “shelter-in-place”, the biggest challenge is a trial participant’s access to the hospital/site and vice versa. And with that challenge are the distribution and administrative requirements to complete trial assessments/visits, patient monitoring, particularly in situations where trial participants are being required to self-isolate and the difficulties this will present to effectively provide medical oversight/direct patient care. Additionally, there is the issue of availability and suitability of investigators/trial staff where the pandemic has had an impact on their own personal lives.

The alternative methods introduced to satisfactorily navigate through these challenges will vary from trial to trial, and according to each country. In most instances, this will be achieved via protocol deviation or adopted according to study protocol amendment. The latter regarded by insurance carriers as the preferred method. However, in either scenario, insurance carriers need to be notified to ensure coverage is not prejudiced.

The health and safety of the trial participant should always be paramount, and it is imperative that all participants are fully informed of any changes to their experience as a trial participant, treatment regime, and process, and that the Informed Consent (ICF) is obtained via an ICF addendum. Provided a Sponsor adheres to the COVID-19 guidance and/or the contingent recommendations issued by respective national authorities, and that the trial continues to be conducted in accordance with national legislation, insurance carriers can remain comfortable with the continuation of trials during this pandemic.

From a documentation standpoint, there is the potential issue for countries where coverage is site-specific and home visits are taking place. How the regulatory bodies will approach this remains uncertain today. Take Spain for example, where site specific certificates of insurance are issued – due to privacy laws, insurance carriers would not be able to specify a patient’s home address. So, while the trial is not taking place at the hospital/site, it is the medical team at that specific location carrying out the trial, and therefore in addition to the Sponsor, are covered by the respective clinical trial policy.

COVID-19 has created an unprecedented and constantly developing situation. The ABD Life Science Practice is available to answer any questions you many have and will continue to provide important updates affecting life science companies.

Leave a Reply

Your email address will not be published. Required fields are marked *