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.
- 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.
- 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.
- 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.
- 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. Inappropriate 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
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 strategies in clinical development programs, education and training through BRITI (the Blinded Reader & Investigator Training Institute), and the sourcing and management of blinded readers for clinical trials.
BRITI is a trademark of RadMD LLC.
This release, and additional RadMD resources, is available online in the Feintuch Communications media room at www.feintuchcommunications.com.
Pablo Andreu / Steph Johnson
212.808.4903 / 212.808.4904
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