Low enrollment rates are the biggest cause of delays in clinical research. In fact, it’s common knowledge that approximately 80 percent of delays are tied directly to enrollment failures. And, delays cost money – a lot of money. Poor site selection is a costly misstep most organizations can’t afford to make. Here are three common site selection mistakes to avoid:
Mistake #1: Selecting clinical sites that enroll slowly or fail to meet recruitment goals altogether.
Site selection should always include a review of the site’s success rate with clinical trials of similar size and complexity. The site must have a population of patients to draw from that meet the study requirements. One mistake that is often made during the site selection process is relying too heavily on the number of subjects in the site’s investigator database. The database may be 500 subjects strong; however, how many of those 500 subjects qualify for the trial? Rather than focusing on the larger number, drill down and determine the number of “enrollable” subjects – the number of subjects that meet the inclusion and exclusion criteria for the study.
Additionally, sites almost always overestimate the number of patients they can enroll, a problem that puts trials at risk of failure. Once the number of enrollable subjects has been identified, cut that number in half to determine a realistic estimate of the number of patients the site can expect to enroll.
Study Site Red Flags: Site has a large investigator database but does not drill down into the number of patients that meet the study’s inclusion and exclusion criteria. Or, site requests large advertising budget to recruit patients. These red flags should serve as signs that the organization may not have access to the right type of patients to meet recruitment goals.
Questions to Ask CRO Candidates: Will the sites be able to identify and enroll the right patients – and enough patients – for the study? What questions will you ask to ensure the sites you select have access to an adequate number of patients who meet the study requirements?
Mistake #2: Failure to drive commitment of all on-site parties to enroll patients.
Once a site has been vetted to ensure it can enroll the right patients, the study must be effectively sold to each of the key stakeholders – primary investigators, coordinators and patients. When potential primary investigators and study coordinators aren’t on board with actively recruiting and enrolling patients, the risk of failure increases dramatically. Ideally, the CRO together with the sponsor will meet with potential investigators to discuss the trial and its benefits in detail. For example, investigators are often eager to publish study results in scientific journals. Extending this opportunity to potential investigators at the outset can solidify commitment and motivate them to enroll patients.
One of the main reasons recruiting patients is difficult is the simple fact that clinical trials are not generally part of the regular physician-patient dialogue as a treatment option. When assessing primary investigators, it’s important to determine if the investigator knows how to approach patients about the clinical trial and is prepared to sell the advantages of participating. This assessment typically involves an in-person conversation with the investigator to simply ask, “How do you plan to offer the trial to patients, and what do you feel are the advantages for your patients?” This type of dialogue is important because it enables the CRO to determine whether the investigator is onboard with the study, believes the new treatment will help patients, and has an interest in actively enrolling patients.
Study coordinators are also actively involved in recruiting patients. They are the first point of contact and they spend the most time with patients taking vitals, gathering information and determining whether the patient is a good candidate for the study. They often inform patients about studies and encourage them to talk with primary investigators about the possibility of participating. Therefore, it is critical study coordinators are trained on the details of the clinical trial and committed to actively recruiting patients.
Study Site Red Flags: The primary investigator is unavailable for the site selection visit. Or, a sense that the primary investigator is burdened with the trial as “one more thing” he must do. These red flags should serve as signs the investigator doesn’t have time to commit to the study and isn’t motivated to recruit patients.
Questions to Ask CRO Candidates: How will you determine if the sites are committed to actively recruiting patients for this specific study? How will you motivate the sites to commit to recruitment goals?
Mistake #3: Lack of adequate on-site staff to support the study.
Most study sites are over worked and understaffed. Sites often participate in multiple trials at any given time. If a site is running 20 studies, for example, the research team has 20 different studies to keep in mind when interacting with patients and they are likely stretched thin as they work to keep up with multiple studies.
In the instance the trial is recruiting patients who are in the workforce, the study may require early morning or evening staffing at the study site to accommodate treatments before and after work.
As noted, clinical trial coordinators are often relied upon to identify potential clinical trial participants and help recruit patients for the study. They also support the primary investigator by ensuring patients have and understand information about the trial’s potential benefits and risks. A study budget that enables the site to hire a study coordinator can go a long way toward ensuring the site is properly staffed to support the study.
Study Site Red Flag: The site is participating in multiple clinical trials. This should serve as a sign that the research team will be overburdened and have limited time to focus on your specific trial.
Questions to Ask CRO Candidates: Does the facility have the appropriate number of coordinators on-site to commit to the study? How do you assess the personnel on-site to ensure the study is appropriately staffed? Will the site have staff available during the days and times that are most convenient for patients? How will you determine if the site’s staff can handle our study?
Selecting a site for a clinical trial goes beyond having access to a facility that has the technical equipment to conduct the trial, properly store the drug, facilitate examinations and measure outcomes. Each of these components is crucial. However, the best performing sites often have the best people – primary investigators and study coordinators – who have time to focus on the trial and are highly motivated to recruit and enroll patients. These individuals can be highly qualified, but overburdened and unmotivated to enroll patients. When selecting a clinical trial site, don’t compromise.
Kevin Vernarec, Senior Vice President and Global Head of Late Phase Clinical Development for QPS, is a seasoned executive with more than 30 years of Clinical Research experience spanning both Pharmaceutical and CRO industries. For QPS, Vernarec oversees 14 Global Phase II-IV facilities, covering 20 specialty therapy areas. His expertise includes clinical operations, optimizing resource allocation, project profitability and project planning groups.