Literature DB >> 30138717

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

Chuen Peng Lee1, Tyson Holmes2, Eric Neri3, Clete A Kushida4.   

Abstract

Deceptive practices by participants in clinical research are prevalent. It has been shown that as high as 75% of participants withheld information to avoid exclusion from studies. Self-reported adherence has been found to be largely inaccurate. Overcoming deception is a critical issue, since the safety of study participants, the integrity of research data and research resources are at risk. In this review article, we examine deception from the perspective of investigators conducting clinical trials; we describe the types (concealment, fabrication, drug holidays and collusion), prevalence, risks, and predictors of deception, and propose an approach to reduce the impact of deception, especially on adherence, in clinical trials.
Copyright © 2018 Elsevier Inc. All rights reserved.

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Year:  2018        PMID: 30138717      PMCID: PMC6203693          DOI: 10.1016/j.cct.2018.08.002

Source DB:  PubMed          Journal:  Contemp Clin Trials        ISSN: 1551-7144            Impact factor:   2.226


  107 in total

1.  Compliance with cyclosporine in adolescent renal transplant recipients.

Authors:  D L Blowey; D Hébert; G S Arbus; R Pool; M Korus; G Koren
Journal:  Pediatr Nephrol       Date:  1997-10       Impact factor: 3.714

2.  Concealment and fabrication: the hidden price of payment for research participation?

Authors:  Neal W Dickert
Journal:  Clin Trials       Date:  2013       Impact factor: 2.486

3.  Ensuring the normalcy of "normal" volunteers.

Authors:  S C Risch; R J Lewine; R D Jewart; M B Eccard; J S McDaniel; E D Risby
Journal:  Am J Psychiatry       Date:  1990-05       Impact factor: 18.112

4.  Monitoring compliance with pilocarpine therapy.

Authors:  S E Norell
Journal:  Am J Ophthalmol       Date:  1981-11       Impact factor: 5.258

5.  Beliefs and behavior of deceivers in a randomized, controlled trial of anti-smoking advice at a primary care clinic in Kelantan, Malaysia.

Authors:  Alison A Jackson; Wan A Manan; Abdullah S Gani; Sandra Eldridge; Yvonne H Carter
Journal:  Southeast Asian J Trop Med Public Health       Date:  2004-09       Impact factor: 0.267

6.  Payment expectations for research participation among subjects who tell the truth, subjects who conceal information, and subjects who fabricate information.

Authors:  Eric G Devine; Clifford M Knapp; Ofra Sarid-Segal; Sean M O'Keefe; Cale Wardell; Morgan Baskett; Ashley Pecchia; Katie Ferrell; Domenic A Ciraulo
Journal:  Contemp Clin Trials       Date:  2014-12-18       Impact factor: 2.226

7.  Noncompliance and treatment failure in children with asthma.

Authors:  H Milgrom; B Bender; L Ackerson; P Bowry; B Smith; C Rand
Journal:  J Allergy Clin Immunol       Date:  1996-12       Impact factor: 10.793

8.  Self-reported vs measured compliance with nasal CPAP for obstructive sleep apnea.

Authors:  H Rauscher; D Formanek; W Popp; H Zwick
Journal:  Chest       Date:  1993-06       Impact factor: 9.410

9.  CNS sites cooperate to detect duplicate subjects with a clinical trial subject registry.

Authors:  Thomas M Shiovitz; Charles S Wilcox; Lilit Gevorgyan; Adnan Shawkat
Journal:  Innov Clin Neurosci       Date:  2013-02

10.  "White coat compliance" limits the reliability of therapeutic drug monitoring in HIV-1-infected patients.

Authors:  Thomas J Podsadecki; Bernard C Vrijens; Eric P Tousset; Richard A Rode; George J Hanna
Journal:  HIV Clin Trials       Date:  2008 Jul-Aug
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  7 in total

1.  Point-of-Care Test for Assessing Tenofovir Adherence: Feasibility and Recommendations from Women in an Oral PrEP Program in Kenya and Their Healthcare Providers.

Authors:  Nicholas Thuo; Madison Polay; Anna M Leddy; Kenneth Ngure; Purba Chatterhee; Monica Gandhi; K Rivet Amico
Journal:  AIDS Behav       Date:  2021-04-24

2.  Use of a Novel Couples' Verification Tool in a Male Partner Treatment Study of Women With Recurrent Bacterial Vaginosis.

Authors:  Christina A Muzny; Angela Pontius; Nicole Woznicki; Kathryn E Hudak; Shelly Y Lensing; Jack D Sobel; Jane R Schwebke
Journal:  Sex Transm Dis       Date:  2020-12       Impact factor: 3.868

3.  Ethical considerations around volunteer payments in a malaria human infection study in Kenya: an embedded empirical ethics study.

Authors:  Primus Che Chi; Esther Awuor Owino; Irene Jao; Philip Bejon; Melissa Kapulu; Vicki Marsh; Dorcas Kamuya
Journal:  BMC Med Ethics       Date:  2022-04-20       Impact factor: 2.834

4.  Are Payments to Human Research Subjects Ethically Suspect?

Authors:  David B Resnik
Journal:  J Clin Res Best Pract       Date:  2019-06

5.  Association Between Financial Incentives and Participant Deception About Study Eligibility.

Authors:  Holly Fernandez Lynch; Steven Joffe; Harsha Thirumurthy; Dawei Xie; Emily A Largent
Journal:  JAMA Netw Open       Date:  2019-01-04

6.  Audio-digital recordings for surveillance in clinical trials of major depressive disorder.

Authors:  Steven D Targum; Christopher J Catania
Journal:  Contemp Clin Trials Commun       Date:  2019-01-08

Review 7.  Remote Methods for Conducting Tobacco-Focused Clinical Trials.

Authors:  Jennifer Dahne; Rachel L Tomko; Erin A McClure; Jihad S Obeid; Matthew J Carpenter
Journal:  Nicotine Tob Res       Date:  2020-12-12       Impact factor: 4.244

  7 in total

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