A digital ecosystem for clinical trials

The many different clinical trial stakeholders operate in relative isolation, each applying their own systems, data formats, workflows, and organizational structures. Stakeholders are reluctant to share research data across institutional boundaries in fear of security and privacy breaches. As a result, data is often scattered across different databases, hampering oversight, accountability and auditability in clinical trials.

In the past decade, a plethora of clinical IT solutions have emerged that aim to smoothen clinical operations and data management. Ironically, the majority of these function-specific solutions are unable to communicate with each other. Fully-integrated platforms do exist, but are far too costly for most clinical research professionals and therefore exclusively for large corporations. As a consequence, many clinical trials lack oversight and significant time and resources are wasted just on staying informed on the trial’s progress.

Clinical trial stakeholders are required to maintain and store trial-related ‘essential’ documents in compliance with quality standards and applicable regulations. To support the correct and effective management of these filing responsibilities, these documents are collected in an electronic Trial Master File, the ‘eTMF’. The essential documents contained within the eTMF should enable regulatory authorities to reconstruct trial activities and key decisions made, providing conclusive evidence that a medicinal product candidate is safe and effective, and qualifies for market introduction. The organization and maintenance of the eTMF can be difficult, especially in multi-country trials that involve a large number of research sites. Consequently, failure in adequate recordkeeping is a persisting industry pain point, leading to significant trial delays and costly reiterations of research activities.

Whereas the industry was once held in high regard for its pivotal role in the advancement of human health, cases of error or misconduct have reduced trust in the clinical trial industry among consumers and regulators as several marketed drugs have been recalled for lacking safety or efficacy. As a result, clinical researchers experience problems with recruiting patients for their clinical trials, and resources are wasted on promotional practices. Furthermore, these issues have led to even more stringent regulatory requirements, adding to the burden of documentation for clinical research professionals.

Safeguarding patient engagement throughout the full length of a trial (ranging from several months to multiple years) is considered another major challenge. With an average drop-out rate of 30%, around 85% of clinical trials fail to retain enough patients. This often results in costly delays. Moreover, issues around patient retention can have a profound impact on the outcome of a clinical trial and thereby add to the already significant risks in today’s clinical development.

The increased complexity and globalization of today’s clinical research stimulates sponsors to outsource a substantial part of their trial-related activities to specialized service providers: contract research organizations (CROs). Selecting the right CRO can make the difference between study success and failure. If any of the contracted CROs fails to be compliant, it can have a significant negative impact on the conduct of the clinical trial, the quality of the trial’s data and the safety of the patient.