An adequate study budget is the most important factor for clinical investigators and site staff in judging how well a clinical trial is run, according to research by US benchmarking specialists Best Practices, LLC. Not far behind, though, is ease of access to the study sponsor.
In a poll of study sites, Best Practices found that 75% of respondents considered an adequate study budget among the four most important characteristic of a well-run clinical trial. Timely payments were cited by 60% of respondents, as was easy access to sponsors for help with the trial.
Next came financial support for recruiting, which 45% of respondents felt was one of the most important factors in a well-run trial; an efficient start-up process (40%); simple and transparent study processes (35%); frequent communication and updates (30%); frequent interactions with the clinical research associate (30%); and the quality of investigator meetings (30%).
The primacy of financial considerations in these responses does not necessarily mean payment is the main driver for investigative sites, Best Practices noted. It quoted one senior director of operations for a pharmaceutical company as saying: “They don’t want to go bankrupt, but when you ask them, they tell you money is the third or fourth level of importance.”
Pharma needs to be service-oriented
The same director believes the pharmaceutical industry “has to become more service-oriented for investigators”. This includes timely responses to questions about trials. One investigator interviewed by Best Practices warned that he would not participate in trials where there had been problems in the past with the responsiveness of monitors or contract research organisations (CROs).
A senior investigator at one CRO attributed the 90% satisfaction with her company among polled investigators to prompt return calls and accessibility of medical monitors. This CRO has built its business model around a total site management approach that includes support throughout the study process, Best Practices pointed out. The CRO even has a bank of study co-ordinators that can step in temporarily if a site loses its co-ordinator during a trial.
These observations are drawn from a Clinical Trial Excellence Series that combines Best Practices’ recent reports on clinical investigator recruitment/retention and clinical trial communication with access to the company’s Pharma & Life Sciences Database.