It remains a bedrock fact that no health care system, anywhere in the world, can accomplish its goals and make progress without a productive pharmaceutical industry. Before pharma became an industry, physicians had little in the way of therapeutic medications they could offer their patients.
Some of pharma's greatest challenges now are organizational and analytical. In some ways these factors even dwarf the scientific hurdles. As a prime example of that, many observers see the problems involved in recruiting patients for clinical trials as presenting some of the greatest obstacles to advancing curative medicine. Patient recruitment constitutes one of several key, rate-limiting factors for testing new therapeutics and ultimately making them available to patients. So while improving patient recruitment will reduce expenses and speed the launch of revenue-generating products for pharmaceutical companies, this improved efficiency will also benefit public health at the same time.
Many people who work on clinical trials believe that the reasons for delayed patient recruitment are generally straightforward and, essentially, involve the complexity of study designs and protocols. The reality, however, is that while design plays its part, many other factors, even within the realm of difficult protocols, are more important.
It often happens that two separate studies may both be arduous for investigators and their staffs, yet one enrolls patients well within the sponsor's schedule while another one suffers delay after delay. Although complex designs create their challenges, the way a sponsor's clinical operations staff handles those designs determines the course of recruitment.
Staying just within the single issue of study design, several factors outside of formal protocol requirements will greatly affect patient recruitment. The following are examples.
- How well does the sponsor's clinical staff explain the design to study site personnel, the CRO and its research associates?
Last year my associates and I worked on assignment for a sponsor whose gastrointestinal product was behind schedule in recruiting patients. We quickly learned that study coordinators at the trial sites complained about the need for them to do psychiatric and genital evaluations. It turned out that the sponsor's project team had never adequately explained the purpose of those tests to nurses at the study clinics. As a result, frustrations among the study nurses seriously compromised the motivation of clinical staffs to screen patient candidates.
- While any study is apt to have protocol amendments, how does a sponsor roll them out?
Sponsors of some studies amend particular protocols several times and roll out the changes, one after another, in rapid succession. In some cases various protocol amendments even appear to contradict one another. Again in that gastrointestinal study last year, there weren't many amendments, but executing the ones that did occur required additional supplies and the sponsor failed to make those supplies available to the clinics on a timely basis. Nurse coordinators sitting with newly enrolled patients, ready for testing, were obliged to reschedule those patients for another visit. Such impositions on nurses and patients inevitably slow subsequent recruitment.
- How well does a sponsor prepare its operations side to execute a challenging study design?
The important variables here consist of a sponsor's clinical operations and whether it adequately fields a study for conducting a complex design on time. If a sponsor, for example, fails to hold its CRO's feet to the fire and, instead, allows it to assign too many clinical sites to each clinical research associate (CRA), then each one will lack the time and capability to help sites through a difficult protocol. On one study we assessed, each CRA was assigned to handhold a maximum of four clinics. As a result, study coordinators at the clinics told us "it was a pleasure to work on that protocol," because their CRAs could promptly and knowledgeably address questions and help solve problems that arose. On another equally demanding study by the same sponsor in the same therapeutic class, CRAs were assigned to twice the number of clinics. The first study enrolled patients according to schedule while the second one suffered delays and corresponding frustrations.
As noted above, these factors affecting patient recruitment apply just within the single realm of study design. There are many other issue areas that determine how rapidly or slowly a clinical study recruits patients. In view of the fact that methods exist for diagnosing and correcting these recruitment obstacles, the question is why pharma's R&D program teams hesitate to use them? Are they overly dependent upon their contract research organizations (CROs)? Do they fail to conduct these analyses simply because they haven't had to do so in the past? Are there other factors in play?
In the following weeks we will investigate some of the other factors that delay recruitment and see how pharmas can effectively address them.
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