The world has unwillingly come to a grinding halt, unsure of where to turn, with the impact of the pandemic COVID-19. Even as we submit to social distancing and lockdown requirements based on our geographic location, we are confident that ‘this too shall pass’ and we will resume our lives, ready to pick up where we left off.
In the interim, let’s look at the huge impact this tough situation is having on the conduct of clinical trials. According to this article, clinical trials are set to be severely affected and even the FDA has issued the guidance on the measures needed to manage the anticipated disruptions to the conduct of clinical trials.
The fall in clinical trial sign-up numbers show us how, even as hospitals are engrossed in helping patients fighting the pandemic, others are unwilling or unable to go anywhere near them. This is affecting the initiation of new trials and the enrollment of new patients into them. Ongoing studies are seeing patient drop-offs. With incomplete visits, we have incomplete data on studies. All these are impacting clinical trial oversight and remote monitoring.
In these challenging times, we need to find new and innovative ways to keep the trials on track and mitigate the risk of having them delayed.
- When parents miss a scheduled visit, trials will have to find innovative ways to see that the patient can be reached, in these times of social distancing. Data need not be obtained only during a hospital visit. We can take the support of technologies supporting decentralized or virtual trial conduct supported by mobile devices, health wearables that capture patient reported data, surveys and still be in contact with the enrolled patients using audio/video conferencing. The wearables can transmit the information to a patient engagement platform. The subject may also be monitored remotely to reduce/eliminate exposure, while keeping the trial running.
- Such changes to the protocol may require approval for the modification to the protocol laid down, citing the deviation and the reason for which the deviation was deemed necessary. This could be a situation where the study subject was infected or the personnel interacting with the subject were infected and would have exposed the subject if they followed the laid down procedures. Either or both of them being subject to a lockdown order would also make it necessary to get the protocol deviation approved.
- Assessment may be relocated to a different laboratory or imaging center if the subject found travel was not possible, requiring the necessary permissions.
- The subject may have to issue a new set of permissions to provide informed consent to access their health data, using the revised protocol, to stay compliant with regulatory requirements.
- If there’s a need to change the method of collection, that would need to be filed for approval.
- Drug sponsors will need to consult the FDA review division when changes to the protocol lead to amendments to the Data Management Plan and Statistical Analysis Plan.
If the situation has in any way affected the information/data being collected, the reason for such disruption and its probable cause will have to be shared with the drug sponsor as well as the regulatory authorities. You may always consider closing the trial a little early and working with data collected till now on an interim analysis to avoid filing for any modifications and deviations and initiate adaptations for trials with additional recruitment later. Protocol changes need to happen quickly while ensuring safety. If some sites have to be closed, we can always adopt a remote approach, without losing control over patient safety, data quality, monitoring of the study and regulatory compliance.
To sum up, it’s time we adapted to our current circumstances and quickly revised the way we manage our trials while remotely maintaining oversight of them. Let’s keep fighting on all fronts, proving the adage that when the going gets tough, the tough keep going.