Can the Clinical Research Enterprise be Fixed?
Before these problems can be fixed, the challenges, not just in isolation, but their inter-relationships, must be identified. The clinical research enterprise is inherently complex, and solutions must necessarily address that complexity, including:
- Lack of Uniform Global Standards, Processes and Procedures. When every site, sponsor, CRO and regulatory agency has its own way of doing things, inefficiency, non-compliance, mistakes, delays and confusion are unavoidable.
- Burdensome Regulatory Systems and Ineffective Ethics Committees.
Although international efforts have attempted to harmonize regulatory requirements, ethical review and oversight processes, they have failed to achieve their full value because they have failed to standardize and to develop common-sense reciprocity to avoid redundancy.
- Lack of Interoperable, Integrated Information Technology Approaches. Only 20% of the world’s clinical research sites have implemented electronic data capture (EDC) and clinical trial management systems (CTMS) despite their proven value and ready availability. Data that could be extremely valuable for safety, operational improvement and quality management are fragmented and lack interchangeability.
- Persistent Quality and Safety Concerns. Often months pass before important safety information is aggregated and acted upon meaningfully, needlessly putting patient subjects at risk.
- No fully developed Safety Engineering Models. Important safety engineering models developed by other industries have never been utilized in designed effective systems for clinical research safety
- Deafness to Site Concerns about Protocols, Time Frames, Lack of Support, Payments. Many sites are marginal at best and face significant challenges to their sustainability, but the industry has failed to listen to their concerns or to properly value quality, high-performing sites.
No Patient Voice. The limiting factor in all clinical trials is recruitment and enrollment of patient subjects, and yet, subjects have essentially no voice in the process, apart from their signature on a consent form that is too long and too legalistic to be useful.