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

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Clinical trial adaptations during COVID-19 show potential for future efficiency, particularly remote consent. Further research is needed to validate other pandemic-era changes for broader clinical trial improvement.

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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.