A new paradigm for clinical research
3rd-4th October 2005, Mandarin Oriental Hotel, Washington DC, USA
Current paradox
- The pharmaceutical industry’s investment in R&D is rising inexorably but success rates are falling, judged by the number of new molecular entities reaching the market in recent years.
- New medicines discovered using ‘new century’ science are being developed under a clinical trial paradigm from the middle of the last century.
- New technologies hold promise for addressing unmet medical needs but the current research, regulatory and commercial environment risks making them unaffordable for healthcare systems.
Future paradigm
Participants at the Workshop were unanimous that change to the current clinical research paradigm is essential and urgent. Discussion focused on whether change should represent an evolution of the existing framework or a more radical revolutionary approach, with particular emphasis on improving efficiency and identifying new business models to accelerate availability of important medicines.
Farewell to the four ‘Phases’?
There was general agreement that the traditional Phase I–IV paradigm has served the industry well but should be replaced by a more flexible model that takes advantage of new techniques such as adaptive trial design, biomarkers, disease modelling and Bayesian statistical approaches. A simplified ‘learn’ and ‘confirm’ model was proposed.
Where the costs lie
Priority should be placed on earlier identification and attrition of unsuccessful products rather than focusing solely on reducing late‑stage development costs. It was recommended that retrospective analyses be undertaken and commercial models developed to test the feasibility of earlier, monitored market access.