Screening Methods for Phase I Healthy Research

Screening is of paramount importance in Phase I Healthy clinical trials. It is not considered ethical—and, indeed, would likely be considered exploitative—to include an individual who is not capable of understanding the associated risks, and who, therefore, is unable to provide consent to participate in Phase I Healthy research without a legally authorized representative (LAR).[1]

Less readily identifiable are those prospective participants who may be competent but may yet be motivated by payment, without regard for safety or science. According to a 2004 study, monetary payments appeared to influence respondents’ propensity to neglect to tell researchers about restricted activities engaged in either before or during a study.[2] In fact, a 2015 article, reported that 43% of participants who had participated in more than one clinical trial in the recent past failed to disclose concurrent enrollment.[3] Yet, according to a 2015 meta-analysis of Pfizer Phase I Healthy trials from 2004 – 2011, the majority of participants had not previously participated in a Phase I Healthy trial.[4] Also, the 2004 study found that, while certainly an incentive for participation, payments did not blind subjects to risk.[5] Illustratively, the riskier the research, the less likely respondents were to neglect to tell.[6] Also notable, the severity of adverse events during the seven years of Pfizer phase 1 trials did not differ significantly between healthy volunteers who participated in only one study and those who had previously participated in other studies.[7] These data paint a complex picture and present numerous challenges in the context of Phase I Healthy research.

As a general rule, enrollment should be proscribed within 30 days or within a certain drug half-life of a prior study. Various methods can be implemented to help ensure participant compliance. These include:

  • Registries
  • Background-check services
  • Fingerprinting
  • Comprehensive laboratory tests
  • Positive reinforcements for honesty
  • Exclusion (if necessary)[8]

To learn more about how you can optimize study flexibility and subject protection for Phase I Healthy clinical trials, download the Optimize Your Phase I Healthy Trial Design Whitepaper from Kinetiq, the consulting and technology division of Quorum Review.

 


[1] See U.S. Food & Drug Admin., Guidance For Industry: E6 Good Clinical Practice, Consolidated Guidance 20 (1996), last visited Jan. 19, 2016.

[2] J.P. Bentley and P.G. Thacker, The influence of risk and monetary payment on the research participation decision making process, 30 J. Med. Ethics 293 (2004).

[3] David B. Resnik and David J. McCann, Deception by Research Participants, 373 N. Engl. J. Med. 1192 (Sept. 24, 2015) (citing a 2013 study).

[4] Ezekiel J. Emanuel, et al., Quantifying the risks of non-oncology phase 1 research in healthy volunteers: meta-analysis of phase 1 studies, 350 British Med. J. h3271 (2015) (finding that 53% of participants have not previously participated in clinical trials).

[5] Bentley, supra note 2.

[6] Id.

[7] Emanuel, supra note 4.

[8] Resnik, supra note 3.

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