Food and Drug Law Commons^™

The Inclusion Of Pregnant Women In Clinical Research, Barbara A. Noah

Faculty Scholarship

In the past three decades, there has been unprecedented growth in medical research utilizing human subjects, with much promise for new treatments that extend life, improve quality of life, and prevent disease and disability. Safe prescribing of drug therapies requires that researchers design clinical trials to test products for the benefit of all persons who are likely to utilize them, not just a limited population. For this reason, it is essential that clinical trials include women, pregnant women, children, and racial minorities, as appropriate, because these populations sometimes exhibit different patterns of response or adverse reactions.

Despite some significant progress …

Rethinking The Role Of Clinical Trial Data In International Intellectual Property Law: The Case For A Public Goods Approach, Jerome H. Reichman

Faculty Scholarship

This article is a later version of the author's presentation at the Eleventh Annual Honorable Helen Wilson Nies Memorial Lecture March 26, 2008. Clinical trials are currently used to test drugs; however, the risk and cost of clinical trials are increasing so drastically that the clinical trials may become unsustainable. This article evaluates the legal and economic trends of intellectual property protection for pharmaceutical clinical trial data. The protection of clinical trials has become an alternative to patents as market exclusivity encourages the development and testing of unpatentable pharmaceuticals. This author argues that clinical trials should be treated as a …

Knowledge Commons: The Case Of The Biopharmaceutical Industry, Arti K. Rai

Faculty Scholarship

No abstract provided.

Making Clinical Trials Safer For Human Subjects, Michael S. Baram

Faculty Scholarship

Clinical trials, in which new biotech and other medical products are tested on human subjects, provide much of the data used by the FDA to determine whether the products are suitable for routine use in health care. Thus, the trials are of obvious importance to medical progress and improvement of public health, and to those who have career and financial interests at stake. But clinical trials are also important to the human subjects involved because the products being tested on them may remedy their illnesses, but may also pose risks since the products have usually not been previously tested on …