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• A conceptual mistake in the definition of access in post-trial access implementation discussion?
  Ignacio Mastroleo
  Published on: 21 May 2018

• Published on: 21 May 2018

  A conceptual mistake in the definition of access in post-trial access implementation discussion?

  • Ignacio Mastroleo, Researcher, PhD in Philosophy CONICET, Program of Bioethics FLACSO Argentina

  Paul et al. (2018) “Implementing post-trial access plans for HIV prevention research” present a much-needed discussion on the implementation of post-trial access plans. Here, I just want to signal a mistake on the conceptual definition of access, to an otherwise flawless paper.

  If I am correct, the mistake would be related to the formulation of the following question:

  "it the responsibility of researchers and sponsors only to ensure that all participants have access to effective preventive therapies, or does that responsibility extend further, to ensuring that participants actually receive them?" (Paul et al 2018:4)

  I believe that "to ensure that participants have access to an intervention" is logically equivalent to "ensuring that participants actually receive an intervention". The MRCT Center's framework on post-trial responsibility defines access as “[…] the ability, right or permission of an individual to use an object or asset, and implies the removal of barriers to allow such use” (MRCT Center 2017:76). If a person does not actually receive an effective preventive therapy, she does not have the ability to use it. Therefor she has no access. Hence, distinguishing between the above expressions is conceptual mistake.

  Instead, what I believe that the authors wanted to discuss is how much sponsors and researchers need to do to ensure access to an investigational intervention. In fact, irrespective of the abo...

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  Paul et al. (2018) “Implementing post-trial access plans for HIV prevention research” present a much-needed discussion on the implementation of post-trial access plans. Here, I just want to signal a mistake on the conceptual definition of access, to an otherwise flawless paper.

  If I am correct, the mistake would be related to the formulation of the following question:

  "it the responsibility of researchers and sponsors only to ensure that all participants have access to effective preventive therapies, or does that responsibility extend further, to ensuring that participants actually receive them?" (Paul et al 2018:4)

  I believe that "to ensure that participants have access to an intervention" is logically equivalent to "ensuring that participants actually receive an intervention". The MRCT Center's framework on post-trial responsibility defines access as “[…] the ability, right or permission of an individual to use an object or asset, and implies the removal of barriers to allow such use” (MRCT Center 2017:76). If a person does not actually receive an effective preventive therapy, she does not have the ability to use it. Therefor she has no access. Hence, distinguishing between the above expressions is conceptual mistake.

  Instead, what I believe that the authors wanted to discuss is how much sponsors and researchers need to do to ensure access to an investigational intervention. In fact, irrespective of the above formulation of the question, the author’s discussion of this question is about whether "referring participants" to local healthcare is enough to fulfil sponsors and post-trial access obligations or not, especially when "referral alone" is shown not be sufficient in some circumstances described in the paper to guarantee responsible transition to appropriate healthcare. However, “referral alone” is not equivalent to access but just a “post-trial access mechanism” (MRCT Center 2017:78).

  Hence, I believe that the authors should reformulate the above question that may induce some conceptual confusion. Inspired by a question at the end of the paper, I suggest the following reformulation:

  Is referral [alone] sufficient to fulfil [sponsors and] researchers’ [part of post-trial access] obligations [in all cases], or ought they to go further [sometimes?] [...] (Paul et al 2018:5, edited by Mastroleo)

  Finally, what I believe that can be of help clarifying this conceptual mistake is to clearly distinguish between different questions, that is, (1) what would be the obligations entailed by post-trial access responsibility in a particular trial, including post-trial access, if any (Cho et al 2018); (2) what is the appropriate distribution of that responsibility between different responsible agents in a particular situation, and finally (3) what are the appropriate post-trial mechanisms that each agent has to fulfil to comply collectively with their part of the responsibility to (referral alone, improved referral, etc.).

  References

  Cho, H. L., Danis, M., & Grady, C. (2018). Post-trial responsibilities beyond post-trial access. The Lancet, 391(10129), 1478-1479. https://doi.org/10.1016/S0140-6736(18)30761-X

  Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center). (2017). MRCT Center Post-Trial Responsibilities Framework Continued Access to Investigational Medicines I. Guidance Document [Version 1.2, November 2017]. MRCT Center. Retrieved from http://mrctcenter.org/wp-content/uploads/2017/12/2017-12-07-Post-Trial-R...

  Paul, A., Merritt, M. W., & Sugarman, J. (2018). Implementing post-trial access plans for HIV prevention research. Journal of Medical Ethics, medethics-2017-104637. https://doi.org/10.1136/medethics-2017-104637

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  Conflict of Interest:
  None declared.

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