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This use of adaptive clinical trials is letting researchers work faster and collaborate better to find solutions for the Covid-19 pandemic. Viruses like SARS-CoV-2 can circle the globe with astonishing speed by taking advantage of human networks. The global medical research community couldn’t immediately contain it because it had no comparable network for defense — but we are moving quickly to create one. Employing adaptive clinical trials will help. The initial response to Covid-19, driven by the best intentions, was to stand up more than 1,000 clinical studies. Many were small, uncontrolled, and unlikely to yield reliable information. This is one reason vaccines and definitive cures continue to elude us. Even so, researchers have scored some remarkable wins. Less than a month after the first Covid-19 cases surfaced in late December, a research team sequenced the virus. Since then, other teams have identified cellular proteins that bind to it, shared data in open-access journals, and kicked off at least two dozen credible Phase 3 trials for vaccines, antivirals, and other treatments.
More milestones will follow as we expand research networks and exploit major innovations in clinical trial design. One advance in particular — an iterative, long-duration study known as an adaptive platform trial — is helping researchers up their game. The use of adaptive clinical trials allows them to simultaneously test multiple interventions against a single, shared control arm, add and eliminate treatments as the trial progresses, and update the study design as the treatment landscape changes. In contrast, each traditional standalone Phase 3 trial must recruit patients to its own control group and test just one hypothesis. Even designing in techniques such as subset analysis and adaptation, these are extravagant undertakings that can’t match the supple efficiency and productivity of well-managed adaptive platform studies.
The adaptive clinical trials approach has already led to a series of high-value, actionable research results:
- In April, data from an adaptive platform study called the Adaptive Covid-19 Treatment Trial, or ACTT, from the National Institutes of Health, validated the clinical benefits of remdesivir, an antiviral agent, in patients hospitalized with Covid-19.
- A few weeks later, the similarly-designed Randomised Evaluation of Covid-19 Therapy (RECOVERY) trial in the United Kingdom demonstrated the benefits of dexamethasone, a widely used steroid.
- RECOVERY further showed that the malaria drug hydroxychloroquine provides little help for people with Covid-19, an invaluable contribution in the face of public confusion and pressure to use the medicine. It also showed that a combination of HIV treatments, lopinavir and ritonavir, was ineffective in treating the disease....
Imagine how the Covid-19 picture might look today if initiatives like these had been staged in advance — anticipating an inevitable pandemic — and networked into a globe-spanning adaptive platform ecosystem. Such an uber-program would allow researchers on every continent to pool knowledge, data, analytics, materials, and other resources, and adding and deleting trial arms based on interim rea..douts, real-world data, and insights from the field. Adaptive platform trials are not new. The methodology was already gaining traction in oncology and other areas before Covid-19 struck. They’re a subset of master protocol trials that Janet Woodcock, the Food and Drug Administration’s long-serving director for drug evaluation and research, and Lisa LaVange explored in a review article in the New England Journal of Medicine in 2017. This May, the FDA’s updated guidance on Covid-19 drug development recognized the potential of these trial designs, and the agency is likely to issue further recommendations....
