decision. Forty-one percent of participants were in aca­demia versus 26% of nonparticipants (p = 0.001). Par­ticipants had higher levels of academic achievement earlier in their career than did nonparticipants. Despite the selection bias and other confounding factors , it seems that the program is encouraging the development of successful research careers.

Where Do We Go From Here?

Performing methodologically rigorous scientific research in not a trivial task. It requires expertise in research methodology, which can only be obtained through ap­propriate training. The training should be practical in nature, relevant to the practice of radiology, and prefer­ably started during the radiology residency.

References 1. Beam C, Blackmore C, Karlik S, Reinhold C. Editors'

introduction to the series. AJR AmJ Roentgenol2001; 176:323-5.

2. Dunnick NR. Opinion. Report of the 2002 Intersociety Commission meeting: Radiology 2002-today's re­search Is tomorrow's practice. AJR Am J Roentgenol 2003; 180:925-8.

3. Blackmore cc. The challenge of clinical radiology research. AJR Am J Roentgenol 2001; 176:327-31.

4. Stolberg HO, Norman GR, Moran LA, Gafni A. A core curriculum in the evaluative sciences for diagnostic imaging. Can Assoc Radiol J 1998; 49:295-306.

5. Hillman BJ, Nash KD, Witzke DB, Fajardo LL, Davis D. The RSNA-AUR-ARRS introduction to research pro­gram for 2nd year radiology residents: effect on career choice and early academic performance. Radiological Society of North America. Association of University Radiologists. American Roentgen Ray Society. Radiol­ogy 1998; 209:323-6.

3:20 p.m. FACILITATED ROUNDTABLE DISCUSSION

3:45 p.m. BREAK

4:00 p.m. Regulatory Issues for Clinical Research Anne C. Roberts, MD UCSD Medical Center/Thomtol1 Hospital

La Jolla, CA

Medical devices primarily come under the jurisdiction of the Office of Device Evaluation (ODE) which is a part of the Center for Devices and Radiological Health (CDRH), one of the major centers of the Food and Drug Admin­istration (FDA). ODE has multiple divisions. These in­clude the Division of Cardiovascular, Respiratory and Neurological Devices, General and Restorative Devices; Clinical LaboratolY Devices; Ophthalmic Devices; Repro­ductive, Abdominal, Ear, Nose and Throat, and Radio-

logical Devices; Dental, Infection Control, and General Hospital Devices. The primary goal for ODE is to have safe and effective devices available for the medical com­munity to use.

History of Device Regulation

The FDA is mandated by Congress under the 1976 Med­ical Device Amendment to the Food, Drug and Cosmetic Act, and by subsequent acts, the 1990 Safe Medical De­vices Act and the 1992 Medical Device Amendment, to ensure that medical devices are safe and effective. These products must also be honestly, accurately and informa­tively represented (truth in labeling) and the products must be in compliance with Good Manufacturing Prac­tices (GMP). In order to satisfy these laws, the FDA must require information to be presented that demonstrates that the devices are safe and effective. Importantly, the law requires that the devices be studied prior to release in the general marketplace. This stems from a tragedy in 1938, when a sulfa preparation was developed which had di-ethylene glycol as a solvent. The initial Food and Drugs Act of 1906 had empowered the FDA to intervene on behalf of the American public to halt the sale of adulterated or mislabeled pharmaceuticals. However, it provided for FDA action only after the drug went to market. The FDA could then stop the sale of a drug if it could prove the drug was dangerous or mislabeled. The problem with this law was the potential for serious injury to the unsuspecting public before the drug could be removed from the market. The catastrophe occurred in 1938 and one hundred and seven people were killed,

mostly children. The result was The Food, Drug and Cosmetic Act of 1938 which required manufacturers to provide evidence of safety to the FDA before drugs could be marketed. This act also extended control to cosmetics and therapeutic devices.

The experience with thalidomide, led to the require­ment for the FDA to grant permission to begin clinical trials in humans and to begin sale of products. This meant that there was a requirement for premarket ap­proval of new drugs rather than simply premarket noti­fication. Amendments to the Act in 1962 added the re­quirement of demonstration of effectiveness to the condition of approval for drugs. In 1973, the Supreme Court upheld the 1962 drug effectiveness law and en­dorsed the FDA action to control products by regulation rather than relying only on litigation.

The occurrence of device malfunctions such as prob­lems with heart valves, pacemakers and the high rate of severe gynecologicaJ complications associated with the Dalkon Shield IUD in the 1960's and 1970's contributed to the growing momentum for the regulation of medical devices. In 1973, it was estimated that 10,000 injuries and 731 deaths had occurred due to medical devices in the previous 10 years. There was a sense that medical de­vices were out of contr?l and government supervision was required. The Cooper committee report proposed medical device regulation based upon a class system

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