Overcoming inefficiencies in clinical research by fostering a systems approach and core competencies for biomedical professionals involved in medicines development

Authors

  • Honorio Silva IFAPP Academy, New York. Faculty of Life Sciences & Medicine at King’s College London.
  • Larry Kennedy The Site Accreditation and Standards Institute (SASI), Metheun MA. Quality Management Institute, Orlando FL-
  • Greg Koski Alliance for Clinical Research Excellence and Safety, Boston. Harvard University Medical School (Boston).
  • Stephen Sonstein Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard, Boston. Commission on Accreditation of Academic Programs in Clinical Research, Fort Myers.
  • Peter Stonier Faculty of Pharmaceutical Medicine, Royal Colleges of Physicians. School of Cancer and Pharmaceutical Science, King’s College London, UK.

Keywords:

Biopharmaceutical industry, clinical research, medicines development, competency-based education.

Abstract

Clinical trials constitute the largest single component in medicines development, representing nearly 40% of the related expenses. However, there is broad agreement that the current clinical trial system is inefficient. The biopharmaceutical industry, governments, regulatory agencies, academic researchers, the medical profession, and the media should work collaboratively and create efficient clinical trial networks.

Los estudios clínicos representan casi el 40 % de los gastos de desarrollo de nuevos medicamentos. Sin embargo, el sistema actual de investigación clínica es considerado ineficiente e insostenible. La industria farmacéutica, las agencias regulatorias, investigadores clínicos y académicos, la profesión médica y los medios de comunicación masiva deberían trabajar en colaboración para crear redes eficientes de sitios de investigación.

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How to Cite

Silva, H., Kennedy, L., Koski, G., Sonstein, S., & Stonier, P. (2020). Overcoming inefficiencies in clinical research by fostering a systems approach and core competencies for biomedical professionals involved in medicines development. Gaceta Médica De Caracas, 128(4), 607–618. Retrieved from https://saber.ucv.ve/ojs/index.php/rev_gmc/article/view/20638

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