February 19, 2016: Harms, Benefits, and the Nature of Interventions in Pragmatic Clinical Trials

February 19, 2016: Harms, Benefits, and the Nature of Interventions in Pragmatic Clinical Trials

Topic

Harms, Benefits, and the Nature of Interventions in Pragmatic Clinical Trials

Presenter

Joseph Ali, JD, Berman Institute of Bioethics at Johns Hopkins University

Keywords

Intervention types; Intervention targets; Pragmatic clinical trials; Research ethics; Human subjects protection; Net potential risk

Key Points

  • Pragmatic clinical trials are diverse in the type of intervention, which could be medical, behavioral, or technological. PCTs are also diverse in the target of intervention, which could involve patients, clinicians, or healthcare system processes.
  • Variability and overlap in the types and targets of PCT interventions compels a more nuanced assessment of net potential risk. A broader framework is proposed to clarify the types of potential harms and benefits for patients, clinicians, and healthcare systems that are engaged in different kinds of PCT interventions.
  • The balance of potential harms and benefits for each type of participant must be examined thoroughly. IRBs, sponsors, and investigators should ensure that the risks to each type of participant are reasonable in relation to the possible benefit.
  • A clearer perspective on risks and benefits of PCTs can inform ongoing federal regulatory and institutional policy development and inform discussions about whether stakeholders ought to be expected to conduct or participate in particular types of PCTs given the nature/balance of risks and benefits.

Discussion Themes

Do different types of interventional PCTs draw out particular kinds of potential harms or benefits?

Is beneficence about averages or individuals? For example, even if random assignment does not affect average risk or harm, it may affect the allocation of risk or harm to individuals.

For More Information

Read more about harms, benefits, and the nature of PCT interventions in Ali et al. (2015): http://1.usa.gov/1TsKZUz.

Tags
#PragmaticClinicalTrials, #ResearchEthics, #pctGR
@PCTGrandRounds, @Collaboratory1, @PCORnetwork

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