Contract and budget issues for sponsor sites are most likely to bog down clinical studies, but Wyeth is one of the best in the industry at managing the process.
So say researchers and administrators at 612 clinical sites we at CenterWatch surveyed recently. We asked these front-line professionals which sponsor companies work best with investigative sites and found that overall, Wyeth, Lilly and Genentech came out in a dead heat at the top of the rankings. Lilly is no surprise, consistently ranking among the top three in our annual survey, but Wyeth’s shot to second this year is a wake-up call for the rest of the industry – Wyeth finished dead last in our 2003 survey.
Through its "Clinical Breakthrough" program, Wyeth has introduced significant changes to its contract and budget negotiation processes – an area in which it excelled in our survey – including in its sponsor-site contract.
Our survey respondents rated these negotiations as the number one factor leading to study delays, which can have broad implications for the drug development process, including holding up patient recruiting and enrollment, not to mention adding expense.
For Wyeth, getting the site contract right has helped. The company’s old contract was 17 pages and difficult to read without a legal background. It revamped that contract to 12 pages in plain English. It also changed its negotiating approach to sites. Instead of negotiating site by site, it’s now offering what it believes is a much fairer package up front.
Other biopharma companies would do well to follow Wyeth’s example of self-examination and solution. The contract and budgeting process is so often needlessly delayed by sponsor companies out of touch with investigators at these sites. Companies should know how long certain tasks take and pay appropriately to carry them out according to Good Clinical Practice (GCP).
Many in the clinical research industry believe that a standardized, industry-wide contract is the solution. In the meantime, there is plenty biopharma companies can do to make the contract negotiation process run more smoothly. The development process depends on it.