DIA: Patient recruitment
| Ingrid Klingmann introduced the Tuesday afternoon session on more efficient approaches to patient recruitment infomation. She traced the history of investigator’s estimates and feasibility studies. She stated that, even with the best intentions, investigators frequently over-estimate patients’ interest in participating in a study. Ingrid challenged us to put ourselves into an investigator’s shoes, with drivers from meeting patients’ needs to running a smooth clinic or medical department. Involvement in a commercial clinical trial is often a low priority. Sites often feel overloaded with feasibility enquiries: when Ingrid worked as an investigator, she received a new study enquiry every couple of week, and the time to complete them detracts from existing work and patient time. She also gave examples of some impossible questions that are often asked, from patient numbers across multiple clinicians to attitudes of patients to clinical research. Many hospitals still have paper-based systems, with little retrospective information. The impact of exclusion criteria requires a medically-trained person to analyse patient data, limiting the time an invesigator can contribute. As this is already a low priority, Ingrid suggested that more companies pay for completing the feasibility study. Her overall recommendation was for a paradigm shift in feasibility studies. She suggested that companies should collect as much information as possible themselves, from disease prevalence to hospital infrastructure and availability of staff. Do not ask investigators to “guess” at enrollment figures, but collaborate with them to collect the information and establish the most suitable protocol (eg, to weed out inclusion/exclusion criteria that would hinder recruitment but actually have little impact on the scientific validity). Finally, enable the investigators to enrol by investing in their infrastructure and capacities by paying for all study-related activities, from feasibility onwards and offering other technologies and resources as appropriate.. Another key point was, once you have found an investigator who is keen and meets practical criteria, ask them to recommend other sites who they think can perform this study to a similar standard: within the same therapeutic area, they should have a good idea of who to target (or avoid). |
