Enrolling research subjects from clinical practice

Ethical and procedural issues in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial

Jonathan E. Alpert, Melanie M. Biggs, Lori Davis, Kathy Shores-Wilson, William R. Harlan, Gregory W. Schneider, Amy L. Ford, Amy Farabaugh, Diane Stegman, A. Louise Ritz, Mustafa M. Husain, Laurie MacLeod, Stephen R. Wisniewski, A. John Rush

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial is a multi-site effectiveness study funded by the National Institute of Mental Health (NIMH) with the aim of identifying successful, acceptable and cost-effective treatment strategies for outpatients with unremitted depression. With enrollment of 4041 adults with major depressive disorder (MDD), it is the largest controlled psychiatric treatment study ever undertaken. In the course of developing procedures to ensure that ambitious enrollment goals were met, a number of ethical and practical issues became apparent that underscore the conflicts between effectiveness research and human subject protections. These are delineated as they relate to study design; eligibility criteria; incentives to subjects; investigators and clinical sites; the complementary roles of clinical research coordinators (CRCs) and study clinicians; and recruitment and consent procedures. The STAR*D trial exemplifies the interplay and tension between those strategies that integrate research and clinical aims and roles in the service of enhancing external validity, site participation, and recruitment and retention versus those strategies that differentiate research and clinical treatment in the service of research integrity and human subject protections. We hope that a discussion of these key challenges and dilemmas and how they have been addressed will help inform future discussions concerning design and conduct of ethical effectiveness trials designed to optimize care in real world clinical settings.

Original languageEnglish (US)
Pages (from-to)193-200
Number of pages8
JournalPsychiatry Research
Volume141
Issue number2
DOIs
StatePublished - Feb 28 2006
Externally publishedYes

Fingerprint

Research Subjects
Ethics
Human Experimentation
Depression
Research
National Institute of Mental Health (U.S.)
Major Depressive Disorder
Therapeutics
Health Care Costs
Psychiatry
Motivation
Outpatients
Research Personnel

Keywords

  • Major depressive disorder
  • Randomized clinical trial
  • Recruitment

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Biological Psychiatry
  • Psychology(all)

Cite this

Enrolling research subjects from clinical practice : Ethical and procedural issues in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. / Alpert, Jonathan E.; Biggs, Melanie M.; Davis, Lori; Shores-Wilson, Kathy; Harlan, William R.; Schneider, Gregory W.; Ford, Amy L.; Farabaugh, Amy; Stegman, Diane; Ritz, A. Louise; Husain, Mustafa M.; MacLeod, Laurie; Wisniewski, Stephen R.; Rush, A. John.

In: Psychiatry Research, Vol. 141, No. 2, 28.02.2006, p. 193-200.

Research output: Contribution to journalArticle

Alpert, JE, Biggs, MM, Davis, L, Shores-Wilson, K, Harlan, WR, Schneider, GW, Ford, AL, Farabaugh, A, Stegman, D, Ritz, AL, Husain, MM, MacLeod, L, Wisniewski, SR & Rush, AJ 2006, 'Enrolling research subjects from clinical practice: Ethical and procedural issues in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial', Psychiatry Research, vol. 141, no. 2, pp. 193-200. https://doi.org/10.1016/j.psychres.2005.04.007
Alpert, Jonathan E. ; Biggs, Melanie M. ; Davis, Lori ; Shores-Wilson, Kathy ; Harlan, William R. ; Schneider, Gregory W. ; Ford, Amy L. ; Farabaugh, Amy ; Stegman, Diane ; Ritz, A. Louise ; Husain, Mustafa M. ; MacLeod, Laurie ; Wisniewski, Stephen R. ; Rush, A. John. / Enrolling research subjects from clinical practice : Ethical and procedural issues in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. In: Psychiatry Research. 2006 ; Vol. 141, No. 2. pp. 193-200.
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