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Impediments to clinical research in the United States

J M Kramer1, P B Smith, R M Califf

  • 1Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA. judith.kramer@duke.edu

Clinical Pharmacology and Therapeutics
|February 10, 2012
PubMed

Insights

Clinical trials face significant burdens that hinder the development of new therapies. Addressing these challenges is crucial for advancing medical research and patient care.

Area of Science:

  • Clinical research methodology
  • Health services research

Background:

  • Clinical trials are vital for evaluating new scientific discoveries and treatments.
  • The increasing burden of clinical trials threatens patient access to novel therapies and evidence-based care.

Purpose of the Study:

  • To identify and analyze the multifaceted burdens impacting clinical trials.
  • To explore factors beyond regulations that contribute to the unsustainability of clinical research.

Main Methods:

  • Review of existing literature on clinical trial operations.
  • Analysis of regulatory and non-regulatory components of the clinical trials enterprise.

Main Results:

  • While regulations are often cited, other operational and incentive-based elements significantly contribute to trial burdens.
  • These non-regulatory factors can impose requirements or create disincentives for clinical research.

Conclusions:

  • A comprehensive understanding of all contributing factors is necessary to alleviate clinical trial burdens.
  • Addressing these multifaceted challenges is essential to ensure the continued progress of medical innovation and patient benefit.

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