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

e enrollment based on poor image evaluations affects sample size calculations, number of evaluable patients, costs, and can create ethical and legal issues. A dedicated training program and ongoing oversight of enrollment readers can maximize reader performance and ensure appropriate enrollment.
  • Train readers for disease progression confirmation. It should be emphasized that central confirmation is not the remote practice of medicine, but is analogous to the manner in which central ECG and lab data are used. Currently, technology exists for 24-48 hour turnaround on these reads, providing an additional data point to the principal investigator when making decisions on disease progression. Readers for progression confirmation can also be the same readers as those for enrollment, but never the same as efficacy readers.
  • Ongoing training. Reader drift happens during a trial. Re-training during a clinical trial is crucial to obtaining quality data, particularly for lengthy or concurrent trials. Training must be ongoing throughout the trial to capture new site personnel and update those that who are participating.
  • Accept help from experts. Most companies do not have broad in-house imaging expertise or in-house imaging training programs. Seek out targeted experience to supplement your existing study-specific training and incorporate imaging training for all study personnel. A better understanding of trial imaging by study personnel (data and project managers, etc.) improves the ability to better assess imaging data quality.
  • (1) According to ClinicalTrials.gov, a U.S. government database of clinical trials, as of October 27, 2009

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    RadMD LLC (www.rad-md.net) provides consulting, training, and blinded reader services to the pharmaceutical and biotech industry. Services include defining and developing imaging stra
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