Clinical trials form an essential part of the overall drug development process, evaluating the safety and efficacy of a drug candidate. Studies suggest that around 40% of the total investment made for the development of a drug candidate is dedicated to clinical trials.
However, the conduct of such trials is often fraught with challenges, including scientific and operational complexity, concerns associated with recruitment and retention of suitable patients, issues related to data handling and increasingly stringent regulatory guidelines. Further, owing to the inherent complexity of the overall process and involvement of several different stakeholders, these trials are prone to delays. It is worth mentioning that around 80% of the clinical trials are delayed due to insufficient patient recruitment.
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Further, retaining patients is also a major concern in pharmaceutical research and development; 15% to 40% of the enrolled patients drop out before the studies are completed, significantly impacting product approvals / launch timelines. Therefore, patient outreach, recruitment and retention strategies have evolved significantly, especially with the availability of a variety of digital data generation, management and marketing solutions. In fact, a number of modern technology-enabled offerings are now available to support various aspects of clinical research and patient recruitment.
Several players do not have dedicated patient enrolment teams and lack the necessary capabilities / expertise to successfully recruit desired number of patients in clinical trials. In some cases, the clinical studies are too large or geographically broad to be managed by internal staff. Further, the stringent ethical and regulatory guidelines associated with patient enrollment in trials impose a significant burden on drug developers. As a result, outsourcing has become a popular operating model with regards to patient retention. The advantages of engaging contract service providers are numerous and enable sponsors to meet their clinical research timelines and thereby, launch respective offerings as planned. Presently, more than 155 companies have the required capabilities to offer patient recruitment services and patient retention services across different geographical locations.
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