Why do some clinical trials take ten years to set up and run?
Covid has demonstrated that clinical trials can be set up, run and completed in less than a year. So why do other clinical trials take so much longer?
Mark Toshner from the University of Cambridge just wrote this brilliant explainer in The Conversation:
"As a clinical trials doctor, I am going to tell you what I do for most of those ten years – and it is not very much.
I’m not lazy. I submit grants, have them rejected, resubmit them, wait for review, resubmit them somewhere else, sometimes in a loop of doom. When I am lucky enough to get trials funded, I then spend months on submitting to ethics boards.
I wait for regulators, deal with personnel changes at the drugs company and a “change of focus” away from my trials, and eventually, if I am very lucky, I spend time setting up trials: finding sites, training sites, panicking because recruitment is poor, finding more sites.
I then usually have more regulatory issues and, finally, if my big pot of luck is not used up, I might have a viable therapy – or not."
Some comments from TranspariMED:
Even after a trial has been completed, researchers typically take 2-3 years to get their results published in a journal. They submit to the first journal, get rejected, second journal, another rejection, finally the third journal accepts it but the peer review and publication process takes many months. That is why the WHO has called for all clinical trial results to be made public on trial registries, where no such barriers exist, within 12 months of trial completion.
Regulators, ethics boards and journal editors have speeded up many processes for Covid trials because these trials are seen as "urgent". While this is welcome, people with incurable forms of cancer and other diseases are also in a situation where medical research is "urgent". Going forward, the medical research community needs to take a long and hard look at how patients' urgency can be translated into faster trial approval and publication, for all clinical trials.
The UK's Health Research Authority (which oversees ethics approvals) is piloting two ways to streamline clinical trials approval : a fast-track ethics review process, and a combined regulatory-and-ethics-approval application pathway for new drug trials.