Deception in clinical trials and its impact on recruitment and adherence of study participants

Lee, Chuen Peng; Holmes, Tyson H.; Neri, Eric; Kushida, Clete A.

doi:10.1016/j.cct.2018.08.002

Cited by 18 publications

(18 citation statements)

References 107 publications

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“…Prior studies have raised concern that payment may lead research participants to mislead investigators, but the studies are limited to identifying cases in the published literature, retrospective self-report, hypothetical projections of potential behavior, and nonrepresentative populations. For example, Lee et al 3 identified 103 instances of deception, including concealment, fabrication, drug holidays, and collusion, in 90 studies selected from a literature review of articles that included the terms deception , deceit , and subversive subjects , among others. Most of these instances of deception were incidentally detected, and the authors of the review article acknowledge that “few studies have investigated deceit in research participants, and fewer studies have examined deceit as a primary objective.” 3 (p154) Our study did both.…”

Section: Discussionmentioning

confidence: 99%

“…Instead, it is necessary to develop, test, and implement comprehensive alternative approaches to minimize the likelihood of participant deception. 3 …”

Section: Discussionmentioning

confidence: 99%

“…Intentional misrepresentation of this nature, otherwise known as deception, may have serious consequences for participant safety and the validity of research results. 3 …”

Section: Introductionmentioning

confidence: 99%

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Association Between Financial Incentives and Participant Deception About Study Eligibility

et al. 2019

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Key Points Question Is payment associated with participant deception about research eligibility and, if so, is higher payment associated with more deception? Findings In this randomized survey experiment of a nationally representative sample of 2275 US adults, offers of payment to participate in an online survey were associated with substantial deception by participants about their eligibility compared with the control condition, with estimated proportions of ineligible individuals who engaged in deception ranging from 10.5% to 22.8%. Larger payments were not associated with increased rates of deception. Meaning Payment may be associated with deception about eligibility for study participation, but higher payment may not lead to higher rates of deception.

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Section: Discussionmentioning

confidence: 99%

“…Instead, it is necessary to develop, test, and implement comprehensive alternative approaches to minimize the likelihood of participant deception. 3 …”

Section: Discussionmentioning

confidence: 99%

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Association Between Financial Incentives and Participant Deception About Study Eligibility

et al. 2019

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“…Numerous studies in addiction science and elsewhere have emphasized concerns related to deceptive responding by research participants while assessing study eligibility (1,4,33). Although objective biomarkers (e.g., breath alcohol readings, urinalysis) are gold standard for verifying substance use status, there are times when collecting these samples may not be ethically or practically feasible.…”

Section: Discussionmentioning

confidence: 99%

Utilizing content-knowledge questionnaires to assess study eligibility and detect deceptive responding

Strickland

Stoops

2019

The American Journal of Drug and Alcohol Abuse

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Background: Deceptive responding during eligibility screening presents a significant concern for assessing inclusion/exclusion criteria. This problem is compounded in settings for which biomarkers or other objective verification (e.g., urinalysis) are not feasible. Objectives: Introduce and describe content-knowledge questionnaires as an objective method for collaterally assessing study eligibility. Methods: Participants (N = 3772; 66.1% female) recruited using the crowdsourcing resource Amazon Mechanical Turk (mTurk) completed a Cannabis Knowledge Questionnaire (CKQ). The CKQ contained four-items indexing knowledge of typical cannabis costs, weights, and terminology. Self-reported cannabis use history was collected and compared to individual item and total scale scores. A separate in-laboratory assessment evaluated participants during in-person screening for cannabis, alcohol, and cocaine research protocols (N = 43). Results: Good internal consistency (α = .74) was observed. The most common correctly answered question was about dabbing (41.4%) followed by cannabis cost (37.6%), hybrid strains (36.6%), and estimated weight (29.7%). Current cannabis use was associated with large effect size increases in the rate of correct responses (RR = 3.64) as well as odds of a correct response on individual items (OR = 5.88-21.48). In the laboratory study, participants with a positive urine drug test for cannabis or those reporting lifetime regular cannabis use scored higher than those without this history (RR = 1.89-2.61). Conclusion: These findings highlight the efficiency and efficacy of including content-knowledge questionnaires for collateral assessment of study eligibility, especially when biomarkers are not possible. Future studies will be useful for extending this initial demonstration to alternative settings and substances.

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“…Another-if subtle-aspect of Vulnerability relates to a recent article reporting that as high as 75% of participants withheld information to avoid exclusion from studies [28]. This creates the specter of Vulnerability once a patient has been included in a clinical trial.…”

Section: Additional Observationsmentioning

confidence: 99%

Vulnerability and Clinical Research: Mapping the Challenges for Stakeholders

Mermet-Bouvier¹,

Whalen

2020

Ther Innov Regul Sci

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Beyond what are characterized as Special Populations in U.S. FDA regulatory considerations is vulnerability of patient populations in a broader context of international guidance. Such a review suggests a rich appreciation for the diversity of patients. Vulnerable patients' status and the associated patient protections are of growing interest in the clinical research environment. To participate in the current developments and reflections, we selected 12 international & recognized core documents that are discussing human research protections and identify all references to them pertinent to Vulnerables. This allows the identification of 15 different categories of Vulnerability, that we group in five kinds of challenges. We then map significant regulatory and ethical interpretations and their implications toward applying what Vulnerability constitutes for the stakeholder ecosystem and its evolving direction as part of the overall protection for patients, defined as a "chain of protection." Different levels of understanding are proposed: Who are vulnerable (a 'macro'-mapping), what is Vulnerability (a 'meso'-mapping) leading to applications with practical questions (a 'micro'-mapping). We offer this analysis and mapping for practical benefit to a range of stakeholders with staffs whose functional responsibilities indirectly or directly essentially touch the broad spectrum of involvement with patients. The practical application is for multi-stakeholder consideration of patients-as-subjects in research, especially for Sites and Ethics Committees/IRBs, given the extended efforts of "patientcentricity"-the 'how's' and 'what's' of including patients in the clinical research process from discovery to RWE and its implications. Also considered is the value of education and training purposes on the true diversity of patients so that sensitivity to such matters from protocol development through informed consent and privacy protections are taken into account in the era of "new science," technological advances, and expansion of clinical research investigators, patient populations, and types of non-traditional research sites.

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Deception in clinical trials and its impact on recruitment and adherence of study participants

Cited by 18 publications

References 107 publications

Association Between Financial Incentives and Participant Deception About Study Eligibility

Association Between Financial Incentives and Participant Deception About Study Eligibility

Utilizing content-knowledge questionnaires to assess study eligibility and detect deceptive responding

Vulnerability and Clinical Research: Mapping the Challenges for Stakeholders

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