Organisational Fears Act as a Barrier to Adaptive Clinical Trial Designs, Not Regulatory Bodies
Internal organisational resistance hinders the adoption of adaptive clinical trial designs, which could improve R&D performance, quality and cost, rather than regulatory agencies.
A report by the US-based Tufts Centre for the Study of Drug Development (CSDD) discovered that while only 20% of current clinical trials use adaptive designs, this percentage will increase in the new few years, especially in the early phases of drug development.
Even though there are a variety of examples of sophisticated adaptive designs that exist, adoption of these models, which include adaptive dose-finding and flawless phase II/III studies, has been slow.
Director of sponsored research at Tufts CSDD Ken Getz explained this by stating that, “Study participants believe that internal functions, for example regulatory affairs, are risk-averse and prefer more clarity from regulatory agencies.
Regulatory agencies, on the other hand, have provided guidance, and appear to be receptive to exploratory-phase adaptive trial designs.”
Through a senior leadership roundtable discussion with industry participants from areas like clinical research and biostatistics, CSDD found that there is limited interest in flawless phase II/III studies as the results might be difficult to interpret. The industry also had other internal operating concerns such as patient participation, delays in the execution of the trial and distributing clinical trial supplies.
Additionally, there were issues concerning the lack of adaptive trial design experience among internal development teams and external contract research organisations and difficulties in monitoring data without introducing bias.
CSDD states that this internal resistance can be reduced by organisations starting with simple and straightforward adaptations, before adopting sophisticated trial designs. Other recommendations include internal clinical teams and adaptive trial design experts working together to apply the ‘best’ design, irrespective of simplicity or sophistication. This ‘best’ design can be achieved through effective trial simulation and scenario-planning.
Adaptive trial designs are pre-planned adjustments that could terminate various studies early to prevent patients from being exposed to ineffective drugs or to add relevant patients to a trial so it produces a statistically valued outcome. It is estimated that an extensive use of adaptive trial designs could produce savings from $100 - $200 million per year for sponsor organisations.
Pat Donnelly, chairman and chief executive officer of Aptiv Solutions, the organisation that funded the report, said, “The industry is investing heavily in improving clinical trial quality and efficiency and now years of evidence has made the promise of adaptive designs clear. Yet, barriers remain to this approach reaching its full potential to protect patients and free R&D dollars for more therapies and devices.
It's like crossing the road with your eyes open. The time is right for sponsor companies to expand their use of adaptive designs.”
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