An inclusive online ecosystem for clinical trials

The recall of several marketed drugs in recent years has led to decreased consumer trust and has fuelled skepticism around industry bias. Scandals regarding fraud and misconduct (e.g. fabricated or concealed research data) have further impaired the reputation of pharmaceutical companies in the eyes of consumers and regulatory agencies.

The damage to the industry has been substantial, resulting in costly settlements and promotional practices, problems in patient recruitment, and product withdrawals. Furthermore, compliance issues have led to more stringent regulatory requirements, further raising the total cost of clinical trials and thereby hampering the development of novel medical solutions.

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 professional and therefore exclusive 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. In a recent industry-wide survey, virtually all respondents acknowledged having issues with trial management processes, including study performance metrics and reporting, study and research site management and resource management.

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 and the quality of the trial’s data.

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.

Regardless of today’s advancements in medicine, there are still many diseases that have no or only limited treatment options. Developing therapeutics to treat and cure these diseases is of major importance for global public health concerns and therefore is of increasing interest to international research funds and grant providers. Nevertheless, the current funding landscape for these ‘charity’ projects still remains scarce and innovators are challenged by tremendous competition to acquire such funds.