There is no question that pharmaceutical companies large and small are feeling the financial pressures associated with deploying large clinical trials. Traditional trial designs can be overly cumbersome and expensive, particularly when applied to large populations of patients over the course of a lengthy investigation. This inescapable fact has lead many investigators to consider alternative pathways to gathering the safety and efficacy data they need for regulatory purposes, with adaptive trials leading the way.
Adaptive clinical trial design has emerged as a valuable tool for companies focused on achieving significant cost savings without sacrificing quality or endangering the health of patients. The key element of managing cost-efficiency via the implementation of an adaptive design trial has to do with the ability to undertake mid-trial analyses in order to better understand the data being generated, and then to implement a pre-planned adaptation to more effectively deliver the objectives of the trial.
By avoiding time spent pursuing unsuccessful dosage strategies and instead focusing on trial elements that provide useful data, costs are more effectively controlled. This is especially useful in Phase I and Phase II trials, where traditional clinical trials often lack enough information at the outset in order to develop a confident design. Adaptive trials which can fine-tune dosage early on are also capable of setting up more effective Phase III trials, generating further cost savings and efficiencies.
Adaptive trials are also more efficient than traditional clinical trials at making use of each patient as a resource[BH1]. This can enable the use of smaller population sizes that are capable of gathering more appropriate data than a larger traditional clinical trial, further reducing costs and saving time. Inventory management – that is to say, the reduction in supply overages attached to a trial – is also superior in an adaptive trial, adding further to cost-efficiency.
Overpowered trials are no longer a necessity in drug development, and in fact could be construed as budget-busting luxuries that are incompatible with the current economic reality of the industry. Adaptive trials represent a light at the end of the spending tunnel for pharma companies retooling their trial design thinking, and enable these companies to be nimble and agile enough to respond to the realities of the market.
adapted and republished from Aptiv Solutions BlogSUBSCRIBE TO OUR MONTHLY NEWSLETTER>>