Initiating a clinical trial is a complex and time-consuming process, involving suitable planning and execution. In addition, there are several other challenges, including inefficiencies related to data handling, and difficulties associated with patient enrollment and retainment, which further complicates the process. It is worth mentioning that around 80% of the clinical trials are delayed due to insufficient patient recruitment. Further, 15% to 40% of the enrolled patients drop out before the studies are completed, significantly impacting product approvals / launch timelines.
Patient Recruitment Process
Recruitment of patients for clinical studies can be tedious and challenging, often requiring a lot of time and money. Therefore, a comprehensive plan is necessary for the successful enrollment of study participants in a clinical trial.
Factors Influencing Participation In Clinical Trials
There are various factors that influence the willingness of an individual to participate in clinical research.
Patient Outreach Methods and Retention Strategies
In order to meet the enrollment goals, sponsors, clinical research organizations and patient recruitment firms adopt a diverse range of patient outreach and recruitment strategies. Traditional media (newspapers, radio and television) is a widely used tool for targeting local audience and encouraging them to participate in clinical trials. However, there are certain emerging techniques, including electronic medical records, mobile applications, patient advocacy groups and social media that are revolutionizing the patient recruitment domain and are expected to reduce the timelines as well as cost of the clinical trials significantly.
In addition to patient enrollment, retention of the patients in the clinical trials is equally important for the success of the research study. Presently, a number of players offer different patient retention services, such as study-branded gifts and reminders, education and support materials, reimbursement programs, transportation programs, patient engagement websites, patient reconnect programs and mobile applications.
Outsourcing of Patient Recruitment
One of the biggest challenges in patient recruitment services and patient retention services market is that some trials are too large or geographically broad to be managed by internal staff. It is worth mentioning that only 15% of the drug manufacturers have dedicated patient recruitment groups in place. In addition, the patient enrollment process in clinical studies is governed by various ethical and regulatory standards. As a result, sponsors are outsourcing almost all the non-core activities while retaining in-house research and development. Using the services of patient recruitment firms, a drug developer can expedite the enrollment of individuals in trials. Further, these firms have specific teams to develop promotional strategies for better patient enrollment.
The availability of various digital data generation and management platforms has contributed significantly to the advancement of patient recruitment and retention domain. However, very few companies have the required expertise and resources to carry out effective patient enrolment and engagement in the clinical studies. In addition, clinical trials evaluating orphan drugs and personalized therapies require a specialized pool of eligible patients, having a specific and potentially rare, genetic / phenotypic / indication-related profile, which is a major challenge for drug developers. As a result, outsourcing the patient recruitment operations to contract service providers has gained popularity as an operational model.
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