Announcements

Post-Trial Access and Responsibilities (and Upcoming Conference, Sept. 18 at HLS)

By Zachary Shapiro Post-Trial Access (PTA) is emerging as an important topic in the design of ethical clinical trial protocols. PTA refers to the provision of study drug to the participants in a successful clinical trial (and maybe others) during the crucial period after a clinical trial phase is over, but before the drug is…

By Zachary Shapiro

Post-Trial Access (PTA) is emerging as an important topic in the design of ethical clinical trial protocols. PTA refers to the provision of study drug to the participants in a successful clinical trial (and maybe others) during the crucial period after a clinical trial phase is over, but before the drug is widely available or approved for the market (or maybe longer/in other circumstances). At issue is the question of the commitment a clinical trial sponsor owes the participants of their trial (and maybe others) in the period after a clinical trial phase, but before market approval of the tested pharmaceutical (or maybe longer).

While the provision of Post-Trial Access may seem to be an ethical “no-brainer,” there are numerous variables that make the decision of whether to provide PTA difficult. One major question is whether all arms of the trial deserve access to the therapy, even those who were on placebo or in the control arm. If the therapy tested shows less efficacy than a more or less expensive treatment modality, is there a responsibility to provide the more effective treatment, regardless of the cost? What if said therapy is far beyond the standard of care for the condition in the particular country where the trial took place? Furthermore, how long do PTA obligations extend? While the simple answer is that they end after market approval, the truth is that many drugs have long approval processes, with complicating factors that can result in significant delays. This is an even more difficult question if the trial is a multi-regional study, and takes place in a country where the sponsor does not intend to market the product.

The question of how to provide PTA also poses logistical issues, as many sponsor sites close after a clinical trial is finished. This can make provision of post-trial access extremely expensive, and perhaps unduly burdensome, especially if the trial is sponsored by a biotech start-up without the deep pockets of a large pharmaceutical company. These costs can skyrocket depending on whether we believe the sponsor should be responsible for costs that might result from improper use of the therapy, or failure of the participants to comply with proper treatment.

These issues are compounded if the setting of the clinical trial is an underdeveloped area in a foreign country, where routine access to medical care and infrastructure may be lacking. As it currently stands, courts in foreign countries have found themselves being asked to decide whether PTA is a necessary provision for sponsors who conduct trials within their borders. One such example is in Brazil, where courts are not hesitant to review clinical trial protocols, and enforce obligations on pharmaceutical companies sponsoring trials within the country. In fact, the Brazilian Federal Supreme Court, the highest court in the Brazilian Judiciary Branch, has signaled that it may consider Post-Trial Access to be a legal duty of pharmaceutical companies, even though no case has been decided on the issue. See https://www.ncbi.nlm.nih.gov/pubmed/22789039.

Another major concern in considering this issue is that different stakeholders have completely different ideas about how to best provide PTA. The pharmaceutical industry often argues that governments and health ministries are the best group to foot the bill, while governments and patient advocacy groups point to the deep pockets of industry as evidence that they should take the lion’s share of the burden. Even the question of who the sponsor is may be unclear, as many trials are co-sponsored by industry and governments.

On Thursday September 18th, the Petrie-Flom Center is co-sponsoring a conference related to Post-Trial Responsibilities with the Harvard Multi-Regional Clinical Trial (MRCT) Center. The aim of this conference is to bring stakeholders from industry, academia, patient advocacy, and research together in order to discuss the major problems related to providing PTA. This discussion that hopefully will lead to increased consensus on an approach to the complex problem of PTA.

If you find this topic particularly interesting, please consider attending the conference. I am including a link to the event page below, as well as a few links to articles that can provide background and further depth about this important issue.

Link to the Conference Page:

https://petrieflom.law.harvard.edu/events/details/save-the-date-post-trial-access-to-medicines

Short articles about Post-Trial Access:

https://www.ncbi.nlm.nih.gov/pubmed/22789039

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2891643/