Adaptive trials are heating up
Association (DIA) Annual Meeting, held in Atlanta. The first of a
free seminar series on the subject will also be run by three
industry pioneers next week.
Much interest has been generated by this topic, as adaptive trials are seen as a way of accelerating drug development without "breaking the rules," the panelists of the DIA Media Roundtable told Outsourcing-Pharma.com. The uptake of such studies is growing at a "rapid pace," they said. "Three hot factors have recently converged to transform the concept of adaptive trials from the realm of theoretically possible to hot." The forces driving the uptake of these trials are creative statisticians; willing managers and regulators; and enabling technology, said the panel, who consisted of Alberto Grignolo, DIA annual meeting programme chair; Cynthia Kirk, president, DIA board of directors; Ronald Fitzmartin, president-elect, DIA board of directors; and William Brassington, acting executive director, DIA USA . "The clinical trials industry has clear potential for strong growth in the future, driven by technological and scientific advances. This trend is complemented by the development of new trial designs, with a view to rationalising and accelerating the drug discovery process by identifying failures at an earlier stage." "Such modifications are increasingly receiving regulatory approvals and encouragement, as agencies become more aware of the benefits of such strategies," the panel said. Indeed, through the use of adaptive study designs, clinical trial sponsors effectively have the flexibility to examine early results of a trial half way through and modify its design in order to improve the chances of a positive result, or cancel the study if it appears ineffective. However, they are still somewhat of a regulatory grey area and their use has been limited so far. There are six ways of approaching a trial in an adaptive way - four that have for a long time been used to a small degree in earlier phase trials, and two that have only recently began to be recognised and accepted by the US Food and Drug Administration (FDA). The regulator announced a year ago that it would begin providing guidance for the pharmaceutical industry on the use of adaptive research. As regulatory attitudes are now changing, it is expected by many that the industry will soon embrace the use of new adaptive methods wherever possible - their use has the potential to cut the duration and ultimately the cost of clinical trials by one third. Normally it takes at least six-to-nine months between phases for the approval and drug manufacturing processes to be completed. Any time savings are therefore very important as the industry's R&D spending reached an all-time high of $40bn (€30.3bn) in 2006, while the number of new drug approvals dropped to an eight-year low of 18. However, the use of such studies will take a lot of adjusting to and there are still significant misunderstandings as to the meaning of 'adaptive' in clinical research and the various ways in which it can be applied. Eight sessions on this topic were offered at the DIA meeting and three US technology firms have also joined together to offer a series of free webinars that will help provide education and clarity on these studies. The first of the six planned webinars, called "Operational Challenges and Strategic Planning," will take place on 11 July. Free registration is available at www.enablingadaptivetrials.com. It will discuss the business and regulatory factors accelerating the adoption of adaptive clinical trial designs. Participants will learn about the benefits associated with well-planned adaptive clinical trials when process, technology and know-how are successfully applied, said the three firms hosting the sessions, United BioSource Corporation (UBC), Medidata Solutions and Tessella. "While the benefits are potentially huge, adaptive clinical trials are still a challenge, and few have determined exactly how to implement them successfully," said Tom Parke, Tessella's head of clinical trial solutions. Michael Borkowski, general manager of clinical technologies at UBC added: "By understanding how to prepare for this multi-disciplinary approach, sponsors will be able to fundamentally improve their processes and thereby realise the return on investment adaptive trials can bring."