Researchers at the Tufts Centre for the Study of Drug Development found that completed protocols across all clinical trials generally incur 2.3 amendments, with each requiring an average of 6.9 changes to the protocol, leading to significant expense and delay.
The analysis, reported in the September-October issue of the Tufts CSDD Impact Report, was heralded as the first to study the impact of protocol changes across the pharmaceutical and biotechnology industries.
Study leader, Ken Getz, Tufts CSDD senior research fellow and assistant professor at Tufts University, said he believed the group's findings suggest the root problem is rising protocol design complexity.
“Although amendments to protocols of clinical trials are sometimes necessary to optimise study results and ensure patient safety and ethical treatment, study sponsors can minimise the number of protocols through better initial study design and improved recruitment of study volunteers,” Getz told Outsourcing-Pharma.
“There are numerous causes of protocol amendments: changing development strategies, perceived and real regulatory pressures, difficulties recruiting patients, poor and hasty protocol authoring,” he added.
Industry re-evaluation
According to Getz, the results of his study highlight the need for the pharma and biotech industries to re-evaluate how protocols are written, along with their feasibility in real clinical trial settings.
Currently, as each new procedure is introduced amendments have to be made to existing protocols, making it an essentially never-ending process, with one-third of all amendments relating to protocol description and patient eligibility criteria, and the median total cycle time to identify and resolve a protocol problem standing at 61 days.
“Our study shows that a high percentage of amendments are made before the first patient has even been enrolled,” said Getz, “ suggesting that more time needs to be spent on the protocol before it is released.
But perhaps most startling is the level of profligacy involved in a high percentage of cases where protocol amendments were carried out.
“Nearly one third of all changes were deemed 'avoidable'," said Getz, "suggesting an opportunity for industry to save substantial time and billions of dollars through more streamlined, carefully authored and more feasible protocols.”