Trained And Certified Blinded Readers Help ICON Medical Imaging Complete Oncology Trial Ahead Of Schedule

Main Category: Clinical Trials / Drug Trials
Also Included In: Regulatory Affairs / Drug Approvals;  MRI / PET / Ultrasound;  Cancer / Oncology
Article Date: 07 Oct 2009 - 4:00 PDT

email to a friend   printer friendly   opinions  

Completing a major milestone in its three years of operation, RadMD LLC announced that it has sourced readers for 150 clinical trials.

The most recent trial, conducted by ICON Medical Imaging for a leading pharmaceutical company, was designed to test the efficacy of a new treatment for metastatic kidney cancer. The trial used medical imaging to support the primary analysis of Progression Free Survival based on an independent central radiological review.

"The results of the reads showed that the drug delayed tumor growth by five months, with patients living twice as long without tumor growth as other cancer victims in the study's control arm. Ultimately, this provided the FDA with the information it needed to approve the drug," said Ted Gastineau, president and co-founder, ICON Medical Imaging. "Quality reads are critical and delays cost money and keep drugs from getting to the people who need it most. We are confident that RadMD's blinded readers have the skills and experience necessary to help us support our clients through the drug development process."

RadMD sourced five radiologists with a specialty in oncology within one week of the request and helped with resources and scheduling - allowing completion of the analysis ahead of schedule. Each radiologist received formalized training and extensive testing on a variety of topics related to the use of medical imaging in clinical trials from the company's Blinded Reader and Investigator Training Institute (BRITI)TM. All CT scans, MRIs and bone scans obtained at baseline during the treatment period and the follow-up period were sent to the independent imaging core lab at ICON Medical Imaging.

Founded by medical imaging experts Kohkan Shamsi, MD, PhD, and Richard Patt, MD, RadMD sources clinical experts and provides consulting services for pharmaceutical, biotech and medical device trials and offers both CME-certified and non-CME courses on medical imaging in clinical trials for both on-site and offsite readers. The company's database of 600 readers come from multiple specialties including radiologists, pathologists, oncologists, cardiologists, medical physicists, medical technologists and others. RadMD has sourced readers for trials in cardiovascular, oncology, neurology, musculoskeletal, endocrinology and sports medicine.

"CRO's and pharmaceutical companies usually manage many concurrent trials and the availability of quality blinded readers saves money, decreases variability and expedites the trial process," said Dr. Shamsi. "By facilitating a key component of the clinical trial process, RadMD helps pharmaceutical, biotech and medical device companies reduce clinical development time, thus getting important anti-cancer and other treatments to the market more quickly."

Source:
Pablo Andreu
Feintuch Communications

• Additional
• References
• Citations