Clinical Research Consultant, on behalf of the Clinical & Contract Research Association (CCRA)
The pandemic has made everyone reconsider how they conduct clinical research.
The use of remote consent, off site monitoring, ePro and other technologies had already started to make an impact in how we assess new therapies. The pandemic has accelerated the uptake of technologies and creative approaches, which has increased the engagement of patients and allowed trials to be conducted in the community.
Use of video calls for daily monitoring
Some technology such as the “Zoom” communication platform, unknown by many 18 months ago, has now become the normal way of communication and has been successfully implemented to maintain oversight of remote or hybrid trials. The daily Zoom calls, to observe dosing, monitor adverse events and support patients, have been welcomed and have enabled timely completion of successful, community-based trials.
The risk-based approach
Alongside technology implementation, the introduction of a risk-based approach has led to significant changes in processes, procedures, documentation and facilities. This is particularly useful in early phase or non-remote studies, where ensuring COVID-secure environments in accordance with COVID-19 guidance was essential.
For on-site trials, general controls were implemented for staff, contractors and clinical trial participants. Ongoing oversight ensured the continued evaluation of requirements including changes in government guidance, local infection rates and local NHS ICU bed capacity and updates to procedures.
Keeping priority research on track
The MHRA and HRA supported the rapid approval of COVID-19 studies and ensured timelines were maintained for all other priority research. Hopefully, the extension of the fast-track pilot will continue to improve review timelines across all phases of research moving forward.
There have been many benefits to clinical research over the past year, even in a challenging environment. Clinical trial participants and the wider community have a greater awareness of and, in some instances, an improved experience of clinical research.
The pace of change and adaptation has shown what is possible and shone a spotlight on the need for enhanced data sharing and optimisation capabilities and technologies. CCRA members have played a key part in this innovation and adoption, now we all have an opportunity to share experiences, develop best practice and collaborate to maintain momentum for all clinical trials.