Literature DB >> 21854283

Site selection in community-based clinical trials for substance use disorders: strategies for effective site selection.

Jennifer Sharpe Potter1, Dennis M Donovan, Roger D Weiss, John Gardin, Robert Lindblad, Paul Wakim, Dorian Dodd.   

Abstract

BACKGROUND: The importance of conducting substance use disorder treatment research in real-world settings is now well recognized. While this approach to clinical trials research offers a variety of benefits, challenges also arise. Selecting high-quality sites to participate is critical to recruitment, retention, and overall trial performance when conducting multi-site, community-based clinical trials of treatments for substance use disorders.
OBJECTIVES: Over the past 10 years, the National Institute on Drug Abuse-sponsored National Drug Abuse Treatment Clinical Trials Network (CTN) has strived to conduct high-quality, well-managed clinical trials. This includes developing methods for site selection to be used by investigators conducting CTN trials.
METHODS: We review site selection strategies from two community-based multi-site clinical trials conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network.
RESULTS: Issues relevant to site selection include the clinical trial design, availability of appropriate clinical population, and organizational attributes of potential clinical research sites. Site selection strategies include reviewing regional epidemiologic data, collecting standard site selection surveys, evaluating clinic data on existing patient populations, and site selection interviews and visits.
CONCLUSION: This article describes considerations for selecting research sites and identifies specific strategies to employ when selecting community-based sites for participation in clinical trials.

Entities:  

Mesh:

Year:  2011        PMID: 21854283      PMCID: PMC3160724          DOI: 10.3109/00952990.2011.596975

Source DB:  PubMed          Journal:  Am J Drug Alcohol Abuse        ISSN: 0095-2990            Impact factor:   3.829


  11 in total

Review 1.  Community-based intervention research: coping with the "noise" of real life in study design.

Authors:  Ann A Hohmann; M Katherine Shear
Journal:  Am J Psychiatry       Date:  2002-02       Impact factor: 18.112

2.  A conceptual framework for transferring research to practice.

Authors:  D Dwayne Simpson
Journal:  J Subst Abuse Treat       Date:  2002-06

3.  Investigator and site selection and performing GCP clinical studies in India.

Authors:  Krishan Maggon
Journal:  Control Clin Trials       Date:  2004-08

4.  Research participation and turnover intention: An exploratory analysis of substance abuse counselors.

Authors:  Hannah K Knudsen; Lori J Ducharme; Paul M Roman
Journal:  J Subst Abuse Treat       Date:  2007-03-21

5.  Issues in the development of subject recruitment strategies and eligibility criteria in multisite trials of matching.

Authors:  A Zweben; D M Donovan; C L Randall; D Barrett; K Dermen; E Kabela; B McRee; R Meyers; C Rice; D Rosengren
Journal:  J Stud Alcohol Suppl       Date:  1994-12

6.  The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT): clinical center recruitment experience.

Authors:  J T Wright; W C Cushman; B R Davis; J Barzilay; P Colon; D Egan; T Lucente; C Nwachuku; S Pressel; F H Leenen; J Frolkis; R Letterer; S Walsh; J N Tobin; G E Deger
Journal:  Control Clin Trials       Date:  2001-12

7.  The first decade of the National Drug Abuse Treatment Clinical Trials Network: bridging the gap between research and practice to improve drug abuse treatment.

Authors:  Betty Tai; Michele M Straus; David Liu; Steven Sparenborg; Ron Jackson; Dennis McCarty
Journal:  J Subst Abuse Treat       Date:  2010-06

8.  Staff beliefs about drug abuse clinical trials.

Authors:  Robert F Forman; Gregory Bovasso; George Woody; Laura McNicholas; Cynthia Clark; Charlotte Royer-Malvestuto; Stephen Weinstein
Journal:  J Subst Abuse Treat       Date:  2002-07

9.  Direct care workers in the National Drug Abuse Treatment Clinical Trials Network: characteristics, opinions, and beliefs.

Authors:  Dennis McCarty; Bret E Fuller; Cynthia Arfken; Michael Miller; Edward V Nunes; Eldon Edmundson; Marc Copersino; Anthony Floyd; Robert Forman; Reesa Laws; Kathy M Magruder; Mark Oyama; Kristi Prather; Jody Sindelar; William W Wendt
Journal:  Psychiatr Serv       Date:  2007-02       Impact factor: 3.084

10.  Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience.

Authors:  Leslie Amass; Walter Ling; Thomas E Freese; Chris Reiber; Jeffrey J Annon; Allan J Cohen; Dennis McCarty; Malcolm S Reid; Lawrence S Brown; Cynthia Clark; Douglas M Ziedonis; Jonathan Krejci; Susan Stine; Theresa Winhusen; Greg Brigham; Dean Babcock; Joan A Muir; Betty J Buchan; Terry Horton
Journal:  Am J Addict       Date:  2004
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  9 in total

1.  Predictors of 12-Step Attendance and Participation for Individuals With Stimulant Use Disorders.

Authors:  Mary Hatch-Maillette; Elizabeth A Wells; Suzanne R Doyle; Gregory S Brigham; Dennis Daley; Jessica DiCenzo; Dennis Donovan; Sharon Garrett; Viviana E Horigian; Lindsay Jenkins; Therese Killeen; Mandy Owens; Harold I Perl
Journal:  J Subst Abuse Treat       Date:  2016-06-16

2.  Successful recruitment methods in the community for a two-site clinical trial.

Authors:  Eileen Fairbanks; Shivani Shah; Mary H Wilde; Margaret V McDonald; Judith Brasch; James M McMahon
Journal:  Appl Nurs Res       Date:  2014-04-18       Impact factor: 2.257

3.  Is level of exposure to a 12-step facilitation therapy associated with treatment outcome?

Authors:  Elizabeth A Wells; Dennis M Donovan; Dennis C Daley; Suzanne R Doyle; Greg Brigham; Sharon B Garrett; Michelle H Ingalsbe; Mary A Hatch-Maillette; Harold I Perl; Robrina Walker
Journal:  J Subst Abuse Treat       Date:  2014-06-14

4.  Systematic data ingratiation of clinical trial recruitment locations for geographic-based query and visualization.

Authors:  Jake Luo; Weiheng Chen; Min Wu; Chunhua Weng
Journal:  Int J Med Inform       Date:  2017-10-04       Impact factor: 4.046

5.  Relation of study design to recruitment and retention in CTN trials.

Authors:  Paul G Wakim; Carmen Rosa; Prasad Kothari; Mary Ellen Michel
Journal:  Am J Drug Alcohol Abuse       Date:  2011-09       Impact factor: 3.829

6.  The design and analysis of multisite effectiveness trials: a decade of progress in the National Drug Abuse Clinical Trials Network.

Authors:  Edward V Nunes
Journal:  Am J Drug Alcohol Abuse       Date:  2011-09       Impact factor: 3.829

7.  Stimulant abuser groups to engage in 12-step: a multisite trial in the National Institute on Drug Abuse Clinical Trials Network.

Authors:  Dennis M Donovan; Dennis C Daley; Gregory S Brigham; Candace C Hodgkins; Harold I Perl; Sharon B Garrett; Suzanne R Doyle; Anthony S Floyd; Patricia C Knox; Christopher Botero; Thomas M Kelly; Therese K Killeen; Carole Hayes; Nicole Kau'i Baumhofer; Nicole Kau'ibaumhofer; Cindy Seamans; Lucy Zammarelli
Journal:  J Subst Abuse Treat       Date:  2012-05-31

8.  Factors Associated With Time to Site Activation, Randomization, and Enrollment Performance in a Stroke Prevention Trial.

Authors:  Bart M Demaerschalk; Robert D Brown; Gary S Roubin; Virginia J Howard; Eldina Cesko; Kevin M Barrett; Mary E Longbottom; Jenifer H Voeks; Seemant Chaturvedi; Thomas G Brott; Brajesh K Lal; James F Meschia; George Howard
Journal:  Stroke       Date:  2017-08-02       Impact factor: 7.914

9.  Improving site selection in clinical studies: a standardised, objective, multistep method and first experience results.

Authors:  Anahí Hurtado-Chong; Alexander Joeris; Denise Hess; Michael Blauth
Journal:  BMJ Open       Date:  2017-07-12       Impact factor: 2.692

  9 in total

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