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The State Of Study Startup: 4 Key Themes



By Deborah Borfitz

March 19, 2019 | In early 2017, clinical trial sponsors and contract research organizations (CROs) weighed in on the state of the study start-up process in a survey conducted by the Tufts Center for the Study of Drug Development (CSDD) in collaboration with goBalto (recently acquired by Oracle). The findings were published last year in Therapeutic Innovation & Regulatory Science, highlights of which were presented by lead author Mary Jo Lamberti, professor and associate director of sponsored research at Tufts CSDD, at the 2019 Summit for Clinical Ops Executives in Orlando.

Dissatisfaction with the start-up process is nothing new, making it perennial topic of interest to those trying to get at root causes of clinical trial delays and enact change. An earlier Tufts CSDD study with goBalto found patient recruitment and retention issues were the big showstoppers from a timeline perspective. Another indicates the cost of drug development continues to mushroom, with companies now spending close to $2.6 billion per drug—a steep but steady climb from the average $1 billion they were investing back in 2003.

The big news emerging from the latest study can be grouped under one of four key themes:

1. CROs are outperforming sponsors on multiple fronts. Across the board, CROs have faster study cycle times than sponsors—an average 21.8 weeks for repeat sites and 28 for new ones vs. 27.4 and 39 weeks, respectively, for sponsors. CROs are also faster than sponsors in completing all site-related activities by six to 11 weeks. Notably, CROs spend considerably less time on activities related to site initiation and study startup. But this does not appear to be related to the fact that CROs more often have a centralized, dedicated startup function (58% vs. 43%), says Lamberti.
2. Nothing seems to be moving the needle. Only about 10% of sponsors and CROs are “very satisfied” with their study startup processes and at least three times more are “somewhat or very unsatisfied,” Lamberti says. Only one in five think technology is adequate, although CROs are investing more in it. Sponsors are disproportionately fond of spreadsheets to manage startup activities. Organizations having a centralized functional group are more likely to report large time savings due to technology.
3. Smaller players making strides. More companies not on the top-50 pharma list have drugs in the pipeline. It’s a trend that began in 2000 and continues, Lamberti notes.
4. Same old speed and efficiency hurdles. Sponsors and CROs have been struggling with many of the same issues for years—lack of site or investigator responsiveness, poor site performance, and sites selected that are never activated (still hovering at around 11%). The challenges include budgeting and contracting problems, protocol demands, investigators losing interest and, especially in oncology and rare disease areas, too many competing studies, Lamberti reports. Bottom line: the study startup process remains the five- to six-month ordeal it was a decade ago, despite an abundance of technology designed to speed things up.

The study concludes that forthcoming research from Tufts CSDD to understand variation in site identification through site activation by geographic area may provide insight into best and worst practices.

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