“From Ideal to Real”: Post-Trial Access, Expanded Access, and Use of Ancillary Treatments in Global Studies”, was the title of one of the plenary sessions at the 2015 Advancing Ethical Research Conference, that took place in Boston, MA this past November, 2015. The panel addressed several contemporary issues related to global clinical trials, such as: expanded access (sometimes referred to as compassionate use), post-trial access, and access to ancillary care. These topics were discussed by three panelists representing varying perspectives: a physician from the pharmaceutical industry, an expert on multi-regional clinical trials, and an international bioethicist with experience in the developing world.
Dr. Michael Turik, senior director from Indiana University and an employee from Eli Lilly discussed provisions for access to the study drug (if shown to be beneficial) to participants. While the primary goal should be rapid regulatory approval in the areas from which participants were recruited, provisions should also be made for access to the study drug prior to regulatory approval. Dr. Turik raised a number of lingering questions, such as 1) What type of post-trial access should be considered: the study drug (when proven to be effective in the trial) or the active comparator when the study drug is proved to be ineffective?; 2) What should be the duration of this access?; and 3) do other stakeholders have an obligation to share in the provision of post-trial access?
To address these questions, Dr. Turik presented a model based on two main aspects to be considered. First, the company/sponsor should have a company approach to bioethics and then second, the company should have a framework from which to assess bioethical issues. Within such a framework, the following ethical principles should be considered and weighed: Fiduciary responsibilities; justice as reciprocity (which implies that study participants deserve some post-trial benefits in return for their participation); beneficence, non-maleficence and autonomy. Fair access to post trial benefits can include: access to the research results; access to product under development; off-trial access to an investigational product; and continued access to an investigational product.
Dr. Turik also addressed the question of “How does the phase of development affect ethical obligations regarding continued access? Also, “Even though it is the responsibility of the sponsor to make the investigational product available to the general public in order to ensure that as many patients as possible are benefited; however , given the breadth of a typical clinical development program, it is not tenable for the sponsor to offer continued access to every patient in every study”.
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