What you should know:
“No.” data from Tufts i Medable they reveal, on average, that decentralized clinical trials (DCTs) are associated with shorter-term clinical trials and can achieve net financial benefits ranging from five to 14 times for phase II and phase III trials, respectively.
– He findings are based on financial modeling and data analysis from the Tufts Center for the Study of Drug Development (CSDD) trials, Tufts University School of Medicine, and more than 150 clinical trials enabled by Medable software. .
Background to the report
The drug development process is fraught with risks, high failure rates, and high costs, and if we want to meet the growing needs of unmet patients, “the status quo is no longer a viable option.” While many have discussed the potential of decentralized clinical trials (DCTs) to reduce the cost of drug development, so far, a demonstration of the real benefit with a quantifiable amount in dollars has been elusive. A new research by Tufts CSDD, with the support of Medable, Inc., a DCT software technology provider, found substantial net benefits for the use of DCT in drug development. An evaluation of previous industry data combined with data from more than 150 DCTs deployed on the Medable platform showed that:
– In phase II studies, the typical deployment of DCT for a clinical trial with a time saving of 1 to 3 months produces a net benefit up to five times greater than the initial investment required.
– In phase III studies, a similar time saving produces a net profit up to 14 times greater than the initial investment required.
The benefits of deploying DCTs that were measured and applied to financial modeling were derived from published benchmarks on the time, cost, and performance of the clinical trial cycle in the literature, as well as conservative assumptions about the impact and the investment required to deploy a DCT. .
“Our research found that, on average, drug sponsors’ financial performance from shorter development times, lower clinical trial screen failure rates, and fewer DCT-associated clinical trial protocol modifications they substantially exceeded the costs of investing in DCT technologies, “said Joseph DiMasi. , director of economic analysis at Tufts CSDD.
The analysis includes the following key conclusions:
– Net financial benefits: In phase II studies, the typical deployment of DCT for a clinical trial that translates into a time saving of one to three months produces a net benefit up to five times greater than the initial investment required. In phase III studies, a similar time saving produces a net profit up to 14 times greater than the initial investment required.
– Shorter clinical trial times: The reductions in cycle time associated with DCT deployments had a substantially greater impact on net financial benefits than any other factor. Nearly 85 percent of all clinical trials will experience some form of delay, with a financial impact of $ 600,000 to $ 8 million per day of delay. Completing the test faster using decentralized methodologies can lead to significant cost savings.
– Fewer detection failure rates: Less than 5 percent of the U.S. population participates in clinical research and up to 50 percent of trials are not completed due to insufficient enrollment. DCTs are changing the paradigm to allow for greater patient participation, reduced travel time and load, faster screening, more convenient consent and enrollment, and, in some cases, remote delivery of an intervention and measurement of results.
– Fewer protocol changes: Protocol modifications often cause delays and dramatically increase the costs of developing new therapies. The potential for fewer research sites in a DCT leads to fewer institutional review boards and a corresponding reduction in regulatory costs and greater flexibility around protocol changes.
The high-level conclusions of the analysis were published today. Researchers will present a more detailed paper for publication later this year, detailing how Tufts CSDD calculated the net financial benefits, as well as additional details on the assumptions and calculations used in the analysis. The study is one of the first to provide quantifiable evidence of the value of DCTs.
“Drug development is too complex, expensive and time consuming and delays access to new medical products and safe and effective treatments available to patients,” said Dr. Pamela Tenaerts, scientific director of Medable. “We need to reverse these trends and use the funds efficiently and effectively to improve the generation of evidence in drug development, thus helping to improve the lives of patients. Decentralized trials are an increasingly important and evolving part. We are confident that these findings and future research on the implementation of DCTs will help to promote more innovation by lowering the cost and increasing the pace of drug discovery. “
For more details, download the report here.