Pre-approvals for post-COVID-19 trials?

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    • #6926
      Lisa Reid

      Should we be seeking pre-approval of new studies now, so that when things ‘return to normal’ we can start up quickly? Should we/how do we notify our HREC of these plans?

    • #7128

      Great question.

      HREC approval as one of the steps in clinical trial startup is a lead measure. I am not in favor of creating another pre-approval pathway but think that HRECs should re-start or ramp up their activities as soon as possible in order not to create a bottleneck for future research projects down the road.

      The concerns that we all had at the beginning of this crisis regarding limited health care resources fortunately look less likely to materialize. Hence, let’s get back to normal at least with the lead measures…

    • #7206

      Hi – Ian Kerridge here.

      Pre-approval processes are certainly useful during crises – ie pandemics – but have less justification when time is less pressing. The experience of COVID may be an opportunity for us to think about whether there are situations in which pre-approvals may be useful. One example – and one that has been used during covid – has been for trials of convalescent sera in patients with viral infections. This has certainly been beneficial as it has enabled trials to get underway via LifeBlood quickly.

      Also worth thinking of other ways to optimise CT processes??


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