At the end of the Clinical Trial: Does access to investigational technology end as well?

Richard S. Saver | Western New England Law Review | Volume 31, Issue 2 | 2009

Medical research subjects increasingly are demanding (and litigating about) continued access to investigational technology after the clinical trial has concluded. The Article undertakes a critical review of the legal, ethical, and policy issues that arise in post-trial access disputes. A study’s conclusion is a critical juncture and can become a flashpoint for general conflict. The regulatory and reimbursement objectives of many key stakeholders affected by the clinical trial testing process are not always aligned, leading to difficult tensions. At the end of the study, many of the stakeholders have already invested and committed significant resources (both personal and financial) to the clinical trial, yet now may find their expectations for what should happen next abruptly frustrated or overridden by other interests. This Article considers the primary arguments for offering research subjects greater post-trial access to investigational technology and also explores the dangers and possible counterproductive effects of unbounded post-trial access. Two preliminary suggestions are offered for improvement:

(1) requiring more review of plans and budgets for post-trial access before trial protocols are approved; and

(2) providing research subjects, in certain situations, other benefits as an alternative to continued access to the study technology.

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