Before new drugs make it to market, they must undergo clinical “trials” or investigations to test for efficacy and safety, and on humans, of course.
The adaptive clinical trial is gaining steam in the world of pharmaceutical testing. What differentiates the adaptive design from the standard design is that throughout the course of the investigation, researchers make changes or modifications.
“This method allows modification of key trial parameters, allowing more efficient trial conduct utilizing fewer patients and shorter trial durations while gaining broader dose-response information without compromising trial validity,” explains Susan Bain, Professor of Practice, Clinical, Regulatory and Quality; Program Director, MBS Clinical and Regulatory Affairs, Keck Graduate Institute, in California. I consulted her for this article.
“This method can predict future success at an earlier point in the development cycle of the product,” adds Bain.
The flexibility of adaptive clinical trials cuts costs, improves success rate and gets the drug to market faster, continues Bain. She adds that more than 20 percent of clinical trials are adaptive.
Further more, Bain explains that the FDA’s Center for Devices and Radiological Health has endorsed over 120 adaptive design studies for medical devices.
“Adaptive trials also allow for more opportunities to decide whether to continue or end the study,” says Kevin McNulty, Director of Product Marketing for Life Sciences at Intralinks, whom I consulted with for this article.
McNulty says that quite a few drugs, studied under the traditional trial design, never make it to market. This creates a huge expense for the pharmaceutical company. The adaptive trial is designed to eliminate these costly burnouts.
Expense aside, there are other benefits that the adaptive clinical trial has over the traditional design. Safety of the study subjects always needs to be considered.
The adaptive approach means that doses of the drugs that they take evolve as scientists gather data. This way, rather than setting a fixed dose for the duration of the trial, researchers adjust it. This helps minimize dangerous side effects occurring.
“An adaptive trial design has the potential to be more successful,” says McNulty. This means that we are getting closer to the point where we won’t have to wait endlessly for trial phases to be completed before a truly remarkable new drug with minimal adverse effects is available to the general public.