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. 2014;22(5):407-415.
doi: 10.3109/16066359.2013.868446.

Research staff training in a multisite randomized clinical trial: Methods and recommendations from the Stimulant Reduction Intervention using Dosed Exercise (STRIDE) trial

Robrina Walker  1 , David W Morris  1 , Tracy L Greer  1 , Madhukar H Trivedi  1
Affiliations

Research staff training in a multisite randomized clinical trial: Methods and recommendations from the Stimulant Reduction Intervention using Dosed Exercise (STRIDE) trial

Robrina Walker et al. Addict Res Theory. 2014.

Abstract

Background: Descriptions of and recommendations for meeting the challenges of training research staff for multisite studies are limited despite the recognized importance of training on trial outcomes. The STRIDE (STimulant Reduction Intervention using Dosed Exercise) study is a multisite randomized clinical trial that was conducted at nine addiction treatment programs across the United States within the National Drug Abuse Treatment Clinical Trials Network (CTN) and evaluated the addition of exercise to addiction treatment as usual (TAU), compared to health education added to TAU, for individuals with stimulant abuse or dependence. Research staff administered a variety of measures that required a range of interviewing, technical, and clinical skills.

Purpose: In order to address the absence of information on how research staff are trained for multisite clinical studies, the current manuscript describes the conceptual process of training and certifying research assistants for STRIDE.

Methods: Training was conducted using a three-stage process to allow staff sufficient time for distributive learning, practice, and calibration leading up to implementation of this complex study.

Results: Training was successfully implemented with staff across nine sites. Staff demonstrated evidence of study and procedural knowledge via quizzes and skill demonstration on six measures requiring certification. Overall, while the majority of staff had little to no experience in the six measures, all research assistants demonstrated ability to correctly and reliably administer the measures throughout the study.

Conclusions: Practical recommendations are provided for training research staff and are particularly applicable to the challenges encountered with large, multisite trials.

Keywords: certification; multisite trials; research staff training; training; training recommendations.

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Conflict of interest statement

DECLARATION OF CONFLICTING INTERESTS

Drs. Walker and Morris have no conflicts to disclose. Dr. Greer has received research funding from NARSAD and is a paid consultant for H Lundbeck A/S. Dr. Trivedi has received research support from the Agency for Healthcare Research and Quality (AHRQ), Corcept Therapeutics, Inc., Cyberonics, Inc., Merck, National Alliance for Research in Schizophrenia and Depression, National Institute of Mental Health, National Institute on Drug Abuse, Naurex, Novartis, Pharmacia & Upjohn, Predix Pharmaceuticals (Epix), Solvay Pharmaceuticals, Inc., Targacept, and Valient, and consulting and speaker fees from Abbott Laboratories, Inc., Abdi Ibrahim, Akzo (Organon Pharmaceuticals Inc.), Alkermes, AstraZeneca, Bristol-Myers Squibb Company, Cephalon, Inc., Evotec, Fabre Kramer Pharmaceuticals, Inc., Forest Pharmaceuticals, GlaxoSmithKline, Janssen Pharmaceutica Products, Libby, LP, Johnson & Johnson PRD, Eli Lilly & Company, Meade Johnson, Medtronic, Neuronetics, Otsuka Pharmaceuticals, Parke-Davis Pharmaceuticals, Inc., Pfizer Inc., Sepracor, SHIRE Development, Sierra, Tal Medical/Puretech, Transcept, VantagePoint, and Wyeth-Ayerst Laboratories.

References

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