Clinical Trials’ Bottlenecks as Critical Impediment to Translational Medicine

Download Article

Authors : Orgah Adikwu Emmanuel


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.


1.      45 CFR §46.111(a)(4).

2.      Aban, I. B., Wolfe, G. I. Cutter, G. R., Kaminski, H. J. Jaretzki III A., Minisman, G., Conwit, R., and Newsom-Davis, J., [on behalf of MGTX Advisory Committee], (2008). The MGTX Experience: Challenges in Planning and Executing an International, Multicenter Clinical Trial J Neuroimmunol.; 201-202: 80–84. doi:10.1016/j.jneuroim.2008.05.031.

3.      Beauchamp, T.L. and Childress J. (1996). The Principles of Biomedical Ethics. New York, NY: Oxford University Press;

4.      Califf, R. M. 2009. ACS and Acute heart Failure Models. Speaker presentation at the Institute of Medicine Workshop on Transforming Clinical Research in the United States, October 7–8, 2009, Washington, DC

5.      Dai, K-R., Yang, F., Gan, Y-K., (2013). Development of translational medicine in China: Foam or feast? Journal of Orthopaedic Translation, 1, 6-10

6.      Di Masi, J. A., R. W. Hansen, and H. G. Grabowski. 2003. The price of innovation: New estimates of drug development costs. Journal of Health Economics 22(2):151−185.

7.      English, R., Lebovitz, Y., and Griffin; R., (2010).Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary Forum on Drug Discovery, Development, and Translation; Institute of Medicine

8.      IOM. (2007). Learning What Works best: The Nation’s Need for Evidence on Comparative Effectiveness in HealthCare.

9.      Lane, H. C. 2009. Improving the Effectiveness and Efficiency of NIH Intramural Clinical Research. Speaker presentation at the Institute of Medicine Workshop on Transforming Clinical Research in the United States, October 7–8, 2009, Washington, DC.

10.  Mankoff S. P., Brander, C., Ferrone, S., and Marincola, F. M., (2004). Lost in Translation: Obstacles to Translational Medicine Journal of Translational Medicine 2:14

11.  McGlynn, E. A., S. M. Asch, J. Adams, J. Keesey, J. Hicks, A. DeCristofaro, and E. A. Kerr. 2003. The quality of health care delivered to adults in the United States. New England Journal of Medicine 348(26):2635−2645.

12.  Qian, M., Wu, D., Wang, E., Marincola, F., M., Wang, W., Rhodes, W., Liebman, M., Bai, C., Lam, Ching-Wan, Marko-Varga G., Fehniger T. E., Andersson, R., and Wang, X., (2012). Development and promotion in translational medicine: perspectives from 2012 sino-american symposium on clinical and translational medicine; Clinical and Translational Medicine, 1:25.

13.  Sun, X. G., Lin, D., Wu, W., Lv, Z., (2011). Translational Chinese Medicine: A Way for Development of Traditional Chinese Medicine. Chinese Medicine, 2, 186-190 doi:10.4236/cm.2011.24029 (

14.  Sung, N.S., Crowley, W.F. Jr, Genel, M., Salber, P., Sandy, L., Sherwood, L.M., et al.: (2003).Central challenges facing the national clinical research enterprise. JAMA; 289:1278-1287

15.  The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Washington, DC: US Government Printing Office; 1979.

16.  The Nuremberg Code. JAMA. 1996;276:1691

17.  World Medical Association Medical Ethics Manual, 2nd edition (2009)

18.  Zhang J M. (2012). Translational medicine in China. Sci China Life Sci, 55: 834–836, doi: 10.1007/s11427-012-4373-0

19.  Zerhouni, E. A., (2007). Translational research: moving discovery to practice. Clin. Pharmacol Ther 81(1):126–128.