In the not-too-distant past, the use of imaging as an endpoint in clinical trials was at best considered a novel approach by pharmaceutical and device manufacturers alike. The times, however, are changing, and bringing with them a new revenue stream for the radiology community.
Opening the floodgates are partnerships with nonprofit and for-profit contract research organizations (CROs) that have begun to recruit clinicians and academic physicians aggressively to serve as independent blinded readers. Compensated by sponsors primarily on a per-study or per-service basis, these organizations pay third-party blinded readers what one executive deemed a fee that could average $2,000 to $4,000 per day, approximately. Radiologists jumping on the bandwagon find themselves assessing images that involve a wide range of modalities and questions, depending on the CRO.
Industry analysts at Goldman Sachs and Frost & Sullivan peg the worldwide CRO market as growing at a rate of 15% annually for the foreseeable future, up from $17.8 billion in 2007. Bruce J. Hillman, MD, FACR, is chief scientific officer of ACR Image MetrixTM, a CRO based in Philadelphia, Pennsylvania. He affirms, “Demand for imaging CRO services is literally exploding because imaging endpoints are now being recognized as a way to make clinical trials much more efficient. Manufacturers realize that imaging can hasten the process of obtaining trial results and limit investments in seemingly ineffective drugs and devices.”
A for-profit entity, ACR Image Metrix is located at the ACR Clinical Research Center in Philadelphia. The ACR Research Center also houses Radiation Therapy Oncology Group and ACR Imaging Network (ACRIN), which are largely funded by large National Cancer Institute grants. ACR Image Metrix draws on the more than 160 staff of the Clinical Research Center, purchases access to the ACR Core Lab technologies, and maintains a broad network of leading institutions and researchers to serve industry clients.
Changes in FDA directives as to what constitutes evidence of therapeutic agents’ effectiveness have also pushed the envelope for CROs and, in turn, contract radiologists seeking to augment their service lines, according to Rick Taranto, vice president of business development, WorldCare Clinical, Boston, Massachusetts. Founded in 1992 as part of the Massachusetts General Hospital (MGH) department of radiology, the organization became an independent for-profit company three years later. ProScan Imaging, LLC, Cincinnati, Ohio, acquired 51% ownership of WorldCare Clinical from its parent company, WorldCare Limited, in 2006.
Many Questions and Many Modalities
Providing image interpretation is, not surprisingly, the core component of a CRO’s business. Some organizations focus on a wide spectrum of modalities to address functional and anatomical questions alike. BioClinica Inc, Newtown, Pennsylvania, represents a case in point. Its offered modalities include:
- angiography (quantitative coronary
and quantitative vascular studies);
- CT (angiography, lung-density/volume
studies, and quantitative CT);
- dual-energy x-ray absorptiometry
body-composition studies, and hip
- MRI (angiography, body/neurological
studies, cardiac studies, and dynamic
- nuclear medicine (planar studies,
multiple-gated acquisition scans,
SPECT, and whole-body studies);
- optical-coherence tomography;
- ultrasound; and
“Our mode of operation and growth is to serve all pharmaceutical and medical-device manufacturers for which imaging is a valuable endpoint, and this necessitates the use of so many different modalities by our experts,” Mark Weinstein, president and CEO, explains. The organization has 11,000 sites in 83 countries and employs (in addition to in-house radiology staff for patient management) 45 project managers to assist in executing all study facets for which it is engaged. It is currently involved in 200 studies for 100 sponsors.
WorldCare Clinical, which reports that it has processed more than a million images and has enrolled 4,000 sites in over 50 countries, employs myriad modalities, among them bone scanning, CT, dual-energy x-ray absorptiometry, echocardiography, MRI, PET, SPECT, ultrasound, and radiography.
Richard Walovitch, MD, chief medical officer, says that the CRO is experiencing heightened demand