Learning from COVID-19 related trial adaptations to inform efficient trial design-a sequential mixed methods study.

Area of Science:

• Clinical Research
• Health Services Research
• Pandemic Preparedness

Background:

• The COVID-19 pandemic necessitated significant changes to in-person clinical trial procedures.
• UK Clinical Trials Units (CTUs) adapted trial processes to maintain continuity during the pandemic.

Purpose of the Study:

• To evaluate the potential of pandemic-induced clinical trial adaptations to enhance future trial efficiency.
• To identify specific adaptations that could improve trial operations post-pandemic.

Main Methods:

• A mixed-methods approach combining online surveys of UK CTUs and qualitative interviews with study staff.
• A literature review was conducted to assess existing evidence for the identified adaptations.
• A workshop with CTU and patient representatives was held to discuss the potential of adaptations.

Main Results:

• Forty studies reported adaptations; 14 were selected for interviews.
• No direct efficiency savings were identified for CTUs, but three adaptations showed potential for sites and participants: split remote-first eligibility, out-of-NHS recruitment, and remote consent.
• Remote consent is well-supported by literature, unlike the other two adaptations. Adaptations can improve participant flexibility.
• Barriers include scientific validity concerns, CTU role limitations, and technology access.

Conclusions:

• Remote consent, split remote-first eligibility, and out-of-NHS recruitment hold promise for improving clinical trials.
• Only remote consent is currently supported by substantial evidence.
• Future 'studies within a trial' (SWAT) could rigorously test these promising adaptations.