Analysis Drawn from Medidata's PICAS Database Uncovers a Significant
Increase in the Number of Distinct Procedures Impacting Both Trial Cost
and Site and
Drug Development Sponsors Can Use Data to Benchmark Against Organizational Practices and Help Optimize Protocol Design
The study found that the mean number of distinct procedures carried out per protocol increased significantly for Phases I, II and III, most notably among Phase II and III protocols. The frequency with which each distinct procedure was performed grew at an even faster rate, leading to higher growth in the mean number of total procedures and resulting in greater burden on study staff administering protocols and on patients participating in them.
"The study findings are compelling given the increased attention that
drug developers are placing on improving clinical trial speed and
Phase I protocols were the most complex, with the highest mean number of distinct procedures (36) and total procedures (253) carried out in the 2011-2015 period. Phase III protocols saw the highest relative growth in total procedures carried out, increasing by 70% from a mean of 110 procedures in 2001-2005 to 187 in 2011-2015. A mean of 22 distinct procedures were carried out for each Phase III protocol in 2001-2005, compared with 35 in 2011-2015 — a 59% increase.
"The increasing complexity of clinical trials is taxing for patients,
researchers and sponsors," said
The dataset used for the analysis is based on clinical trial protocols drawn from Medidata's PICAS database of negotiated research grants. The PICAS database contains detailed protocol and investigative site contract data from more than 170 global pharmaceutical and biotechnology companies. A total of 9,737 protocols were evaluated; 76% of the protocols were provided by companies in the top 25 largest globally and 24% by mid-sized and smaller companies. All protocols included in this analysis received ethical review board approval between 2001 and 2015.
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