Improving the efficiency of clinical trials has become one of the most important priorities for pharmaceutical companies around the world. In its annual R&D management report, the Tufts Center for the Study of Drug Development (CSDD) recently estimated the full price of bringing a new drug to market at over $1.3 billion. The report indicated that any areas where R&D costs can be curtailed are extremely interesting to Pharma’s major players.
It is this desire to reduce drug development time and lower the overall investment in each product that has caused a greater number of pharmaceutical companies to shift from traditional clinical trials to adaptive trial design. The real benefit of an adaptive design trial is the increased value of the information that arises from the trial which enables drug developers to make better decisions, leading to cost efficiency, reduced rework, and the selection of the right treatment to carry forward into future studies. Thus, the total value of an adaptive approach has to be measured across the entire development program and not just at a single step.
The Tufts CSDD noted in its report that many executives in the pharmaceutical industry are seriously considering the incorporation of adaptive trials in their R&D strategies. These same companies have begun to look into the advantages offered through partnerships with contract research organizations that offer expertise and experience in adaptive trial execution. The ability for CROs to eliminate many of the costs associated with traditional clinical trial designs has become a key aspect of the relationships between these entities and Pharma. CROs now employ the majority of the world’s clinical development experts – many of whom see the advantages of an adaptive approach – and the depth of institutional knowledge represented by these groups is providing additional weight to support the promulgation of adaptive trials.
adapted and republished from Aptiv Solutions Blog