The decision-makers in doctors’ offices and contract research organizations (CROs) too often let their enthusiasm for winning a study cloud their business judgment, warns Sabrina Ramkellawan, vice president of operations at Apollo Applied Research. “They need to ask some clear-headed questions before signing any agreement,” Ramkellawan stresses.
For example, if a sponsor offers a competitive enrollment study, be sure to ask how far along it is in terms of meeting the enrollment targets. “If they’re at 80% and you don’t think you can enroll patients quickly,” you might want to bow out of that one, Ramkellawan advises—no matter how exciting it might feel to be selected; the sponsor could easily finish the trial recruitment via other sites before yours even gets its operation up and running. Physicians and CROs may be exposing themselves to significant financial risk on trials they’d be better off avoiding—especially if they are new to the business, she says.
In addition to hiring new staff for a study that might fall through at your site, overenthusiasm can lead to money spent gaining institutional review board approval, training internal staff, and booking potential subjects. Worse still, some sites “go overboard” in an effort to impress their new customer. “They hear the sponsor offer $20,000 per subject and think they’re going to make a lot of money easily,” Ramkellawan says. Wrong.
Potential sites should take a cold, hard look at how much it will cost to set up the required trial infrastructure if it is not already in place. “Many have no idea how much it will cost, and then underestimate it,” Ramkellawan says.