Clinical Trials’ Bottlenecks as Critical Impediment to Translational Medicine

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Authors : Orgah Adikwu Emmanuel

Abstract:

Translational medicine has made impact and have come to be accepted (Dai, et al., 2013) as a global medical strategy for improving Medicare such that, funding of translational medicine globally has increased, it is treated with priority and many institutes for translational studies have been established, (Zhang, 2012). Demonstrating this critical significance of translational medicine to modern medical practice is the emphasis by the World Medical Association (WMA Ethics Manual, 2009), that ‘physicians must know how to interpret research results and apply them to patients’.

However, as noted by Zerhouni, (2007) and Qian et al., (2012), a lot remains to be understood and lessons need to be learned on the best strategies for translational medicine which may not be unconnected with observed issues of clinical research bottlenecks. Mankoff, et al., (2004), had earlier identified “three major obstacles to effective translational medicine”. The first two revolves around the subject of clinical research; – “the challenge of translating basic science discoveries into clinical studies”, and “the translation of clinical studies into medical practice and health care policy”. This second issues hinges on the core challenges of the practical conduct of clinical research. Sung, et al., (2003) opined that the two “translational blocks can be removed only by the collaborative efforts of multiple system stakeholders”

Essential for research translation is data generated from clinical research. Clinical trials operations require cooperation among a diverse group of stakeholders including research sponsors (industry, academia, government, non-profit organizations, and patient advocates), clinical investigators, patients, funders, physicians, and regulators. This was aptly captured by Dai, et al., (2013), who noted that “enormous collaborative and multidisciplinary work is required prior to when the results of scientific research can be translated into effective clinical practice”. Each stakeholder offers a different set of tools to support the essential components of a clinical trial. These resources form the infrastructure that currently supports clinical research (English, et al., 2010). Time, money, personnel, materials (e.g., medical supplies), support systems (ICT as well as manpower), and a clear plan for completing the necessary steps in a trial are all part of the clinical research infrastructure.

Significant time, energy, and money from the different collaborators are spent on bringing the disparate resources together. Because these resources are not streamlined, clinical trials infrastructure pose challenges to investigators working on new research questions and most times must start afresh without drawing on existing resources. This imminent lack of harmony and disparate clinical research resources imposes bottlenecks that constitute impediments on the planning, execution and outcome of research which by implication either slow down or prevent translation outright.

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