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Editor’s Note: This article is part of a series examining popular peer-reviewed articles from years past called “Peer-Reviews Revisited: Why You Should Read Today.” You can read the other articles in this series here.
In an article that sets the stage for why improvements in the contract negotiations with sites has and needed to improve for the past two years.
Managing clinical trial agreements and the agreement negotiation process can be an important source of delay and additional cost in any trial process.
“Clinical trial agreements influence the costs of a sponsor of a clinical trial in several ways,” said Myrthe Rijswijk-Trompert, CEO and Senior Legal Consultant, Salvius Legal, Zeist, The Netherlands. “A poorly drafted and/or negotiated agreement can create legal risk exposure (and) unexpected financial liabilities. Inefficiencies in negotiation can result in unnecessary additional costs. Troublesome negotiations may delay a clinical trial and delay the marketing of the investigational drug, resulting in severe loss of profit for a sponsor.”
An industry survey by Salvius Legal and Applied Clinical Trials found that nine percent of respondents identified specific damage resulting from poorly negotiated trial site agreements. More than six percent said their firm had been involved in legal actions in which a clinical trial agreement was key.
A third of respondents named communications skills as a key problem area in trial agreement negotiations. Most respondents (80 percent) said prior bad experiences with a site influences decisions on whether to work with that site in the future. Key causes of delays include:
“Contract negotiations with hospitals and investigators are time-intensive, however there are many opportunities to make the negotiation process more efficient and maintain a proper risk and quality standard,” Ms. Rijswijk-Trompert said. Improving clinical trial agreement negotiations is an opportunity to be seized.”