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Patient Recruitment And Retention Strategies In Clinical Research Organizations
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In order to take care of these various types of challenges in patient recruitment and retention, it requires study-specific, country-specific and site-specific result-oriented customized strategies to accelerate patient enrolment on clinical trials. As per facts and figures given by the Center for Information and Study on Clinical Research Participation (CISCRP), six per cent of clinical trials are completed on time, and 72% of trials run over schedule by more than one month3. The complex, ‘difficult to recruit’ kind of clinical trials warrant a more systematic approach to patient recruitment. Most of the time, investigational sites provide their total patient enrolment by reaching into their own database of patients. However, due to the complexity of the current protocols, rigorous eligibility criteria and rarity of the disease condition, sites need to go beyond their practice to achieve their recruitment targets on time. The longer it takes to complete the recruitment, the more money and resources sponsors have to spend to complete a clinical trial. Moreover, due to delays in patient recruitment, sponsors can fail to achieve their important, planned milestone of “time to reach market”, and each day’s delay in reaching market costs a lot to sponsors.
The patient recruitment strategies currently used in practice can be broadly classified as in-reach and outreach activities. In-reach activities are mainly site-based activities where one can work within a site to optimize the patient pool and accelerate enrolment, whereas outreach activities are the activities carried on outside, around a given site - i.e. nearby areas and communities - to identify potential patients.
After assessing a site’s capability, best practices, study-specific challenges, needs and willingness to recruit patients, one has to decide a site-specific patient recruitment plan which can be a combination of various in-reach and outreach activities. The sole purpose behind these strategies is to create study awareness to attract potential patients to investigational sites. These in-reach and outreach patient recruitment activities are carried out mainly as:
•Field-based activities by dedicated trained resources who work within and around investigational sites to identify potential patients;
•Advertising media outreach where one can use a compelling and ethical message to target study-
•specific population; and
•Call centre support for initial screening and patient follow-up.
Patient recruitment and retention are challenges that the industry has been facing for many years, and they warrant a systemic, practical approach, especially for some complex and ‘difficult to recruit’ kinds of studies to ensure successful completion of the clinical development phase. The challenges with regard to patient recruitment and retention should be anticipated thoroughly during study planning and the protocol development phase itself. Accordingly, proactive planning can be done to ensure patient recruitment on time and to maximize retention. The success lies in effectively addressing study challenges and hurdles in patient recruitment and retention with country- and site-specific, innovative, practical and result-oriented strategies within the framework of regulations to provide timely and cost-effective results.
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