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U.S. Department of Health and Human Services

Drugs

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Building Quality into Clinical Trials

To determine the safety and effectiveness of medical products, they must be studied in humans. In these studies, called clinical trials, volunteers help determine if the products should be approved for wider use in the general population.

Amid increasing concerns regarding the safety of medical products, and reports that the general public is losing confidence in clinical trials, FDA is promoting ways to build in quality from the start as well as ways to rescue on-going studies when issues occur.
Quality in clinical trials and the data produced is paramount to understanding how and if a drug product, medical device, or procedure works, as well as its potential risks. Equally important is the welfare of the volunteers.
To FDA, quality is characterized by the ability to effectively and efficiently answer the intended question about the benefits and risks of a medical product or procedure, while ensuring protection of human subjects.
 
FDA’s bioresearch monitoring program (BIMO), which conducts on-site inspections of clinical studies, provides one method for ensuring the protection of human subjects and the integrity of the data. Program objectives include: 
  • Protection of the rights, safety, and welfare of subjects in FDA-regulated trials
  • Determination of the accuracy and reliability of clinical trial data submitted to FDA in support of research or marketing applications; and
  • Assessment of compliance with FDA’s regulations governing the conduct of clinical trials, including those for informed consent and ethical review

However, you cannot inspect in quality; it must be built in from the start. Elements of a quality clinical study include:

  • Scientifically valid and ethically sound experimental design
  • Adequate protection of subjects rights, safety, and welfare
  • Qualified personnel
  • Adequate monitoring
  • Current, complete, and accurate data
 
To learn more about FDA’s BIMO program, elements of a quality clinical study, and associated training, compliance and data requirements, view the webinar: “Building Quality into Clinical Trials – an FDA Perspective,” May 14, 2012, at 11AM ET.