The ongoing COVID-19 pandemic has disrupted many aspects of our lives and businesses, and clinical trials are no exception.
Clinical trials typically require participants to follow a rigorous schedule of visits and failure to attend visits within the allotted window may constitute a protocol deviation. This may impact the quality of the data generated by the investigators and jeopardize the standard of care normally offered to study participants.
Some governments are slowly increasing their response to the global health crisis while others have already implemented drastic measures. To be sure, methods such as physical distancing, travel restraints and lockdowns will have an important impact on all short term study visits and clinical trials more generally.
Tip #1: Use a tailor-made approach in consultation with the medical professionals
Adaptations may be necessary given the restrictions on travel and the deferrals of non-essential medical services that are currently being implemented. In Quebec, for example, travel to and from certain regions has been limited. Additional measures are being announced daily by the federal government as well as all provinces. Bearing this in mind, it may not be possible to maintain all protocol-mandated procedures.
This situation calls for a case-by-case evaluation as every trial is different and participants may be facing unique challenges of their own.
Of course, continuity of treatment for serious and life-threatening conditions remains the top priority for all stakeholders. Where visits to a healthcare facility are required purely for research purposes, however, concern for individuals' well-being may call for adaptation or cancellation. As investigators and their teams may be in the best position to evaluate what is feasible in the context of their practice, their jurisdiction, and their patients' individual circumstances, consultation with them is in order.
Tip #2: Don't forget the participant's right to information
Now that the sponsor, the institution and the investigator have agreed to a proper course of action to manage the threat to the health and security of participants, it may be time to consider the impact that pandemic may have on patients' consent.
As a general rule, if changes to a trial are liable to have an impact on participants' willingness to remain in the study, they must be informed of those changes as soon as possible. As per ICH-GCP, "The subject or the subject's legally acceptable representative should be informed in a timely manner if new information becomes available that may be relevant to the subject's willingness to continue participation in the trial. The communication of this information should be documented." (s. 4.8.2) While this typically refers to new information that may emerge about a drug, it may also apply to adaptations made in response to the current pandemic.
With that in mind, changes to the consent form or the addition of an addendum may be required, and such changes remain subject to research ethics board approval.
At the very least, sponsors and investigators should consider whether a letter providing additional information and explaining any new measures applicable to the trial in order to reassure the participants.
Tip #3 : Make good use of the technology
Obviously, it may be advisable to adapt trial procedures to minimize the need for participants to travel, and hence minimize their potential exposure to the coronavirus. This would be especially important in the case of patients who are immunocompromised or subject to age-related travel restrictions.
Traveling may become very difficult for patients. Relevant measures may include conducting certain visits by phone or videoconferencing, particularly where the visit does not require any hands-on procedures. Another option may be to have study drugs delivered by courier where less supervision is required.
Tip #4 : Look at the bigger picture and consider what is coming
Adaptations should be made not only to address the immediate situation, but also in preparation for, and anticipation of worst case scenarios. In some jurisdictions, authorities have been imposing stricter and stricter restrictions on travel, including in some cases, roadside stops in which citizens are asked whether there travel is essential and even ordered to return home if it is not.
This context calls for an assessment of whether travelling to hospital for a clinical trial visit is indeed essential. In certain exceptional cases, a sponsor may consider sending study staff to the participant's home to avoid exposing vulnerable individuals.
Where the study participant has to attend an in-person visit at the hospital, the sponsor and the investigator may want to provide participants with a written document stating the purpose of their trip in laymans' terms and the destination, and attesting to the fact that the trip is indeed essential. While this travel document will not act as a guarantee against the enforcement of travel restraints by authorities, it could make the discussion with law enforcement a lot easier for a participant stuck at roadside stop.
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Of course, all clinical trials are different and other measures may be relevant to protect study participants and reduce the impact of the crisis on the quality of clinical data.
Our regulatory team is working day and night with stakeholders to assess various scenarios and develop creative, compliant solutions in these trying times. Feel free to communicate with us should you need to discuss these matters.