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RadMD Offers Tips on Optimizing Clinical Trial Efficiency
Date:10/27/2009

DOYLESTOWN, Penn., Oct. 27 /PRNewswire/ -- Lengthier cancer trials and new regulations have forced pharmaceutical companies to look for new ways to minimize costs and increase efficiency. As a result, the use of medical imaging, which is currently being used in 3000 clinical trials(1), has come to the forefront. Since imaging is a very specialized field, focused training of clinical trial personnel must be conducted in a standardized fashion to optimize imaging data.

RadMD LLC (www.rad-md.net), provider of consulting, training, and blinded reader services for the pharmaceutical and biotech industries, offers the following tips on making more efficient use of medical imaging during the clinical trial process.

  1. No add-ons. The FDA and regional regulatory agencies require documentation of extensive standardized training for clinical trial personnel, and efficacy and safety raters. In order for training to be effective, it needs to be part of a clinical trial plan from the beginning.
  2. Standardize - Train both onsite readers and independent reviewers. All clinical trial evaluators should be trained radiologists experienced in the clinical trial process. The on-site methodology for controlling training, testing, and ongoing reader performance monitoring should be pre-defined and well-documented.
  3. Identify site readers prospectively. When forming clinical teams for a specific site, it's essential to identify the radiologist performing the image evaluations, particularly if imaging is an important efficacy or safety endpoint. This provides more consistent results within and across sites and less noise/variability in the results.
  4. Train enrollment readers. Radiologists reviewing images to confirm whether patients qualify for study enrollment play a critical role in assuring that each subject enrolled is appropriate to the trial. Inappropriat
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SOURCE RadMD
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