| Patient recruitment planning strategies can be something of a minefield. BBK Worldwide’s Elizabeth Gargill takes a country-by-country study planning approach for multinational trials
After a sponsor company employs both feasibility assessments and business rationale to the country selection process for a multinational trial, study leaders must begin to formulate a patient recruitment strategy to enrol the study. Although some recruitment tactics will be universal to all countries, this process will not be successful with a cookie-cutter approach. Healthcare systems in different countries vary significantly in their method of patient care and how physicians, institutions and regional medical facilities interact.
What’s more, how physicians in each country treat specific diseases and conditions also varies. A first-line treatment for type 2 diabetes in Austria, for example, may be diet and exercise, while physicians in Canada may take a more aggressive approach and start a newly diagnosed patient on metformin, for example, immediately. Patients diagnosed with irritable bowel syndrome in the Netherlands may be immediately referred to a specialist, while in Spain, they remain with their general practitioner for the course of their treatment.
All of these nuances will have a significant impact on how study leaders go about recruiting patients for a particular protocol within each country. Will you be able to seek physician referrals as a source for patients? Will the principal investigator’s (PI’s) panel provide sufficient patients to enrol the study? The only way to answer these questions is by gaining an understanding of the protocol and its particular challenges, and by conducting countryspecific research on how target patients are commonly treated and referred through the country’s healthcare system. Gaining knowledge of physician and patient motivations in relation to the condition and study participation will also provi
de valuable insight to apply toward recruitment strategy. Ultimately, all of this research will not only allow you to designate recruitment tactics customised to the specific needs of each country, but will also inform the cultural adaptation of recruitment messaging and serve as a research-based rationale for recruitment tactics when seeking study team buy-in and ethics committee approval. The result will be a specific recruitment strategy and successful enrolment.
BEGIN WITH PROTOCOL ANALYSIS
Reading and analysing the protocol is the important first step in recruitment planning. The inclusion and exclusion criteria will provide important rules to define the target patient, which will hold significance for each country and potentially create recruitment challenges or opportunities.
For example, in recent studies of a progressive immunological disease, one protocol required that patients be naïve to a specific drug that is a common first-line treatment in many countries. A second protocol for the same condition required patients who tried the first-line drug without successful results. The tactics for finding patients for each of these protocols for the same condition were quite different. |
