Implications of Mid-Study Clinical Trial Protocol Changes

Significant Procedural Changes Made in More than 50 Percent of Clinical Studies, Resulting in Delayed Timelines and Increasing Drug Development Costs

  NEW YORK, N.Y. – April 12, 2016 – Medidata, the leading global provider of cloud-based solutions for clinical research in life sciences, today announced results of a research study on the impact of protocol changes made while a clinical trial is underway, conducted with the Tufts Center for the Study of Drug Development (CSDD) and 15 pharmaceutical companies and contract research organizations (CROs). The study showed a high prevalence of mid-trial protocol changes, their avoidability and the major costs and time delays associated with these changes.   The study revealed that nearly half the changes, known as protocol amendments, were avoidable and a large percentage were due to adjustments made to study volunteer demographics and eligibility criteria. The cost of all delays averaged over half-a-million dollars for Phase III trials and increased the average duration of studies by three months. Better design of the clinical trial from the start could help prevent some amendments and reduce unplanned costs and time delays.   “Clinical trials are both critical and complex,” said Mike Capone, Medidata’s chief operating officer. “As a technology partner to the biopharmaceutical industry, it is Medidata’s mission to simplify the process while maintaining the necessary scientific and regulatory rigor that enables our life science customers to safely and swiftly bring their products to patients. Smarter trial design and optimization plays a key role in reducing protocol amendments and ultimately drives efficiencies in the drug development process.”   Published in the Drug Information Association’s Therapeutic Innovation & Regulatory Science (TIRS) journal, “The Impact of Protocol Amendments on Clinical Trial Performance and Cost,” pulled data from nearly 850 trials across a variety of therapeutic areas, shared by 15 large and mid-sized pharmaceutical and biotechnology companies and CROs.   To reduce the number of protocol amendments, clinical trial sponsors are increasingly leveraging new technologies in protocol design optimization and predictive analytics. TransCelerate BioPharma, a US-based membership organization made up of the world’s leading biopharmaceutical companies, is a key driver in this transformation, and has recently named protocol feasibility as one of its key focus areas.   “Biopharmaceutical companies are looking in earnest for ways to optimize their protocol designs and improve study execution feasibility,” said Ken Getz, an associate professor at Tufts CSDD and the study’s principal investigator. “The results of this important effort provide valuable insights into the causes and impact of protocol amendments – one of the most disruptive and costly by-products of highly complex study designs.”   For more information, download the Tufts CSDD Impact Report, “Amendments reduce number of patients, but at high cost, longer study times.”  

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Medidata is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. The Medidata Clinical Cloud® brings new levels of productivity and quality to the clinical testing of promising medical treatments, from study design and planning through execution, management and reporting. We are committed to advancing the competitive and scientific goals of global customers, which include over 90% of the top 25 global pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and contract research organizations.