The most challenging aspects of conducting a randomized controlled trial (RCT) include the timely setup of the systems required for the conduct of the study, recruitment, retention, and randomization of patients, and trial supply logistics.
The optimization of Randomization and Trial Supply Management (RTSM) is not always straightforward, especially as clinical trial designs become more complex (e.g., adaptive designs). Rapid changes in standard-of-care treatment— especially in oncology studies—can make a clinical trial protocol obsolete before the sponsor implements a study. Further, global clinical trials face mounting competition for patients in an environment with tightening privacy and security considerations for patients and trial supplies, respectively. Specifically, the recently passed General Data Protection Regulation (GDPR), which regulates personal data in the European Union,1 not only affects European drug sponsors but is relevant to every multinational company with a European presence.
Furthermore, expectations remain high that clinical development teams will successfully implement and execute clinical programs, despite few available resources.
In this context, drug sponsors turn to sophisticated RTSM systems, supported by highly proficient teams, for rapid and efficient implementation of clinical trials. This approach instantly configures systems to address all required trial elements (e.g., randomization, trial design considerations, trial supply dispensation, study endpoints).
Overall, selecting the optimal RTSM system can be a daunting task: there are dynamic components to track, and multiple systems and stakeholders are involved in the decision-making process. However, appropriate planning and implementation significantly minimize the risks and complexities associated with RTSM.
