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Many Clinical Trial Protocol Changes Avoidable, Costly

Doctor with tablet

(Wesley Wilson, Pexel

12 April 2016. When clinical trials make changes in plans, known as protocol amendments, after they’re underway, the impact in time and costs are substantial, with many changes considered avoidable. These are conclusions of a review of clinical trial protocol amendments carried out by Center for the Study of Drug Development at Tufts University in Boston and the clinical research technology company Medidata Solutions, published recently in the journal Therapeutic Innovation and Regulatory Science (paid subscription required).

Clinical trials for testing pharmaceuticals and medical devices are often complex undertakings, even at early stages with smaller numbers of participants. Kenneth Getz, who studies clinical trial management at Tufts, was joined by researchers from Medidata in New York that funded the project, contract research organizations, and pharmaceutical companies to assess the impact of unplanned changes in clinical trials, and better understand their causes. This new inquiry updated a similar study done in 2010.

Getz and colleagues reviewed records from 836 clinical trials from early stage studies to late-stage and post-approval follow-up inquiries with protocols, or plans, approved between 2010 and 2013. The team identified and tallied the trials with changes in protocols, then sampled 136 of these protocol amendments to gauge their overall impact. The researchers then drilled down further into 52 protocol amendments to calculate direct costs for implementing the changes, which they outlined in the journal article and companion Tufts report.

The team found more than half (57%) of the clinical trials had to make 1 or more major changes in protocols once the studies were underway. Moreover, nearly half (45%) of the changes were considered avoidable, an increase from 2010 when about 1 in 3 (33%) of the changes were deemed avoidable. Many of the changes resulted from problems encountered in recruitment or retention of participants, as well as changes in study procedure, which the authors believe could have been avoided through better trial planning or design.

In addition, a little more than 1 in 3 (35%) of changes were caused by typographical corrections. Only about 1 in 5 protocol changes were requested by regulatory authorities, of which the vast majority (86%) were considered unavoidable.

The impact of these changes in dollars and cents was substantial. For intermediate stage studies, the median direct cost of the change came to $141,000. For late-stage studies, median costs for making changes rose to $535,000. The most costly changes involved adding fees for ethical review committees — median of $151,000 in late-stage trials — and change orders to vendor contracts, with a median cost of $88,000 in intermediate-stage trials.

Not only were protocol amendments costly in money, they added substantially to the duration of the clinical trials. Protocol changes added on average 85 to 90 days each to the enrollment, conduct, and close-out of the trials.

“Biopharmaceutical companies are looking in earnest for ways to optimize their protocol designs and improve study execution feasibility,” says Getz in a Medidata statement. The company points to Transcelerate Biopharma as a resource for improving clinical trial processes. Transcelerate Biopharma a joint industry effort to apply technology and predictive analytics to optimize the design of clinical trials, begun in September 2012, and as reported by Science & Enterprise, has the backing of top pharmaceutical companies in the U.S. Among its initiatives is a common protocol template, to reduce complexity and increase consistency, making automation more feasible.

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