A Delicate Balance
January 2008
Leslie Cate, vice president of access to patients at Quintiles, explains how building relationships with investigators improves recruitment and reduces clinical trial timelines.
Recruiting patients for clinical trials is one of the biggest hindrances to efficient drug development. Ineffective recruiting results in a protracted timeline for the development program and may put off drug development and approval. But a concerted effort to bolster relationships with trial investigators can have a positive impact on patient recruitment, saving sponsors both time and money.
A main contributor to ineffective patient recruiting is the shortage of qualified investigators, as more than 90 percent of practicing physicians in the United States have never participated in a clinical trial. Many physicians either don’t know how to get involved with clinical research or aren’t in a position to make the necessary commitment. There’s naturally a cost—in both time and money—to get started as an investigator, and not all physicians are going to want to make that investment without assurance it will lead to better care for their patients. So there’s an awful lot of legwork to be done by a trial’s sponsors or CRO to get a physician motivated to become an active and recurring investigator.
As recruitment obstacles have increased in the United States and Europe, many trial sponsors began conducting clinical research in Asia and South America. But developing a network of qualified investigators in emerging regions can be equally demanding because many countries in these areas are just beginning to conduct research according to GCP and ICH standards. And although having a large potential pool of patients to draw from—and providing care to patients who might not otherwise receive it—are benefits, getting these sites up to speed requires a significant amount of training and investment. But no matter where the trial site may be, establishing true relationships with investigators—in which they feel they’re treated as real partners in the research program—is a critical step for trial sponsors and CROs.
That’s what Quintiles is looking to change through its Partners Site Program. We identify sites based on their performance, and our commitment to them is just like our sponsors’ commitments to us: “If you do a good job, we’re going to keep coming back to you.” In the United States, we work with about 8,000 study sites every year, so we can’t have a managed partnership with every investigator. But for our Partner Sites, we’re now placing a lot of emphasis on performance metrics. We look at enrollment rates, screen fail rates, startup time and query rates.
To better prepare the sites, particularly those that hope to grow and build up their practice, we provide them expertise on building research and in many cases we provide them a study coordinator. We have also launched a Web-based GCP and ICH training program for our partners, which includes CME accreditation. And our evidence shows that the investigators are not only better prepared and more motivated, but that patient recruitment has improved at our partner sites as well. Globally, our partner investigators are outperforming our non-partner investigators.
Another critical component for investigators is having an identified relationship manager. There naturally are many complexities in conducting trials, and questions are bound to come up. When the investigators have a good relationship with us, then they know whom to call and we can help them through the process. We meet with our partners on an ongoing basis to discuss metrics, performance, upcoming studies and the relationship as a whole.
The entire drug development industry needs more investigators and Quintiles is very proud to be at the forefront, helping develop well-trained and highly motivated investigators. Yes, we are looking for a certain amount of loyalty, and we want them to work on our program. But we see this as doing our part to help the industry. We want plenty of clinical trial patients and good-quality data, and that’s what we have to keep in mind. But there are different ways for us to get that and have the sites get what they need as well.
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