A look at some major aspects of clinical trial regulations in the U.S.

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Running a clinical trial is the only way to bring a new medical treatment or product to the market with a sufficient degree of safe oversight. Therefore, there is a significant need for professionals who understand the complex and evolving rules around the trial and approval process established by the National Institute of Health and the U.S. Food and Drug Administration.

Lawyers and other legal personnel, both at outside firms and within the medical businesses themselves, are tasked with maintaining complete understanding of the law and keeping their organizations in compliance. However, legal expertise is also relevant outside of these few departments and firms. The departments that commission and conduct clinical trials, along with the teams that market and manage the resulting medicines, can benefit from internal knowledge about relevant regulations as well.

Earning a master’s in health law and policy is one way to build experience with relevant and up-to-date concepts in the health care field, including clinical trials for new products. Professionals who are interested in taking on a more specialized or integral role in a medical organization can earn such a degree, using what they learn to help keep their companies compliant and effective.


A clinical-researcher works on trials with test tubes

FDA regulations regarding clinical trials

Every element of the trial process for new drugs and bio-pharmaceutical products is monitored and regulated by the FDA. The laws are complex because they must achieve several goals at once, making it possible for companies to develop and market novel processes that may save lives, while not letting the trials for those products become too perfunctory or unnecessarily risky to subjects.

The list of concepts that are subject to specific FDA rules is long, and it includes keeping electronic records, receiving consent from test subjects, appropriate financial disclosure, good laboratory practices, applications for marketing a new drug and more. Each general area of trial practices is considered its own part of the FDA regulations, with several related rules. Learning the applicability of each of these policies is an important role for personnel at medical organizations in both legal and other departments.

Every part of a clinical trial process, from the initial submission of a new product application to the registration of the resulting data with the FDA, is governed by these rules. Some policies have been amended multiple times over, with the oldest regulatory document presently available on the subject dating back to 1978. Understanding the legal processes by which Congress considers and approves new FDA directives is another potentially valuable skill for health care personnel to possess today.

Clinical trial registration and public accessibility

One important part of the clinical trial process to consider is the public release of findings. Employees within the medical product development side of the industry must manage findings carefully to ensure compliance, while those working with care providers and related organizations must be adept at finding and parsing trial results within the FDA’s system.

Transparency has been a high-priority element of clinical approvals since 1997, when the FDA modernized its database of information. The publicly accessible archive of study results has become a website, ClinicalTrials.gov, which is linked with the World Health Organization’s worldwide trial registration system. The site won the Innovations in American Government Award from the Harvard Kennedy School in 2004 in recognition of its potential as an inspiration to similar databases elsewhere in the public sector.

The WHO connection is not the only way in which the U.S. trials database is connected with international best practices and regulations. The Declaration of Helsinki, an essential ethics document maintained by the World Medical Association, received updates in 2008 and 2013 to mark the availability of publicly accessible trial data as a moral obligation for health care providers. Organizations are required to make their test results visible, whether they were positive or negative, to keep the public appraised of the potential risk of the medical products under development.

Clinical trial result submission guidelines received a significant update in 2016, when the FDA clarified the processes by which investigators and their sponsors must submit the results of trials, and whether they have complied with the law. Even unapproved products must have their trial results submitted to the database of publicly available clinical information, which is an expansion of the FDA’s previous stance on the matter. The NIH added in another 2016 ruling that all trials receiving its funds must also become part of the ClinicalTrials.gov database, whether they meet the FDA’s eligibility rules or not.

Earning a master’s in health law and policy online

With so many legal obligations to consider, it’s clear that any company dealing with clinical trial regulations and procedures, from laboratories that work with new drug breakthroughs to the firms that sell those products to the public, should possess staff members well-versed in the relevant rules. Companies that concentrate all their expertise on the law in legal departments or hired law firms may miss out on the benefits of receiving timely and accurate legal advice.

Graduates of the Master of Arts (M.A.) in Health Law and Policy program from the Maurice A. Deane School of Law at Hofstra University can provide their teams with a view of the latest policies around clinical trial regulation and all other elements of the new medical product development process. The degree program is designed for individuals who are not lawyers, paralegals or other members of legal teams, beginning with courses that encompass the basics of medical law and moving into more specific areas of study.

Law of Medical Product Discovery, Development and Commercialization is the most relevant course, covering topics such as the clinical trial process, delivering timely information on the government departments that oversee new drug development, as well as the state of the laws passed by these agencies. Staying in compliance can depend upon having a clear view of the organization’s obligations, and graduates of the course may be the ideal professionals to deliver such a perspective.

Individuals interested in earning an M.A. in health law and policy online don’t have to leave their present roles to return to school. The program is taught on a flexible schedule with classes designed to be taken asynchronously, on students’ own time. Professionals who want to become more helpful in medical organizations or interested in joining teams dealing with clinical issues can strengthen their knowledge and experience with an M.A. in health law and policy.

Contact Hofstra Law admissions to learn more about this program.

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U.S. Food and Drug Administration – Regulations: Good Clinical Practice and Clinical Trials

U.S. National Library of Medicine – History, Policies, and Laws