Search the Library

Abstract: This is the primary outcomes paper for CTN-0070-Ot. Federal regulations (42 CFR Part 2) provide special privacy protections for persons seeking treatment for substance use disorders. Primary care providers, hospitals, and health care organization have struggled to balance best practices for medical care with adherence to 42 CFR Part 2, but little formal research has examined this issue. The aim of this study was to explore institutional variability in the interpretation and implementation of 42 CFR Part 2 regulations related to health systems data privacy practices, policies, and information technology architecture. This was a cross-sectional qualitative study (CTN-0070-Ot) using purposive sampling to conduct interviews with privacy/legal officers (n=17) and information technology specialists (n=10) from 15 integrated healthcare organizations affiliated with 3 research nodes of the NIDA Clinical Trials Network. Trained staff completed a short survey and digitally recorded semi-structured qualitative interviews with each participant. Interviews were transcribed and coded within Atlas.ti. Framework analysis was used to identify and organize key themes across selected codes. Participants voiced concern over balancing patient safety with 42 CFR Part 2 privacy protections. Although similar standards of protection regarding release of information outside of the health system was described, numerous workarounds were used to manage intra-institutional communication and care coordination. To align 42 CFR Part 2 restrictions with electronic health records, health systems used sensitive note designation, “break the glass” technology, limited role-based access for providers, and ad hoc solutions (e.g., provider messaging). Conclusions: In contemporary integrated care systems, substance-related EHR records (e.g., patient visit history, medication logs) are often accessible internally without specific content for sharing despite the intent of 42 CFR Part 2. Recent amendments to 42 CFR Part 2 have not addressed information sharing needs within integrated care settings. Related protocols: CTN-0070-Ot

Abstract:

Institutional Review Boards (IRB) ensure that studies with human subjects are conducted ethically and meet federal standards. When trials include multiple study sites and multiple IRBs, variation in IRB processes and regulatory interpretation may delay implementation. NIH policy now requires that multi-site studies must use a single IRB in order to streamline the review process while maintaining standards for human subjects protection, but little has been documented about the actual use of single IRBs in multi-site trials.

This paper describes the single IRB process used by the Western States Node of the NIDA Clinical Trials Network (CTN) for protocol CTN-0067, a clinical trial testing the use of an opioid antagonist (extended-release naltrexone) versus opioid agonists (buprenorphine or methadone) for opioid use disorders among individuals living with HIV.

Using CTN-0067 as a case study, the authors discuss the processes and challenges associated with using a single IRB. These lessons are also informed by other single IRB experiences within the CTN. The intention of the NIH single IRB policy is to facilitate efficient IRB processes. Advanced planning and transparent communication, however, are critical to avoid stalling IRB approval and protocol implementation. Research teams need to account for local IRB willingness to cede to a single IRB and understand the variations in interpretations of abbreviated reviews.

In order to facilitate the effective use of single IRBs, recommendations include assigning staff at each study site for IRB submission coordination and interaction with the lead site IRB staff, training investigators and key regulatory staff on expectations for working with single IRBs, dedicating a regulatory specialist at the lead site to manage the process, developing a communication plan, and supporting the development of strong working relationships with local regulatory staff and the single IRB. The CTN experiences with single IRBs may provide insights for other investigators.

Related protocols: CTN-0067

Abstract:

Maintaining the privacy and confidentiality of research participants is a critical aspect of conducting quality research investigations and reflects compliance with Good Clinical Practice guidelines and regulations. There are specific rules and protections established for nondisclosure of research and medical records of study participants with substance use disorders (SUDs) and currently changes proposed to ensure the privacy protections sufficiently meet the needs of a changing healthcare environment.

This one-hour webinar, sponsored by the NIDA Clinical Coordinating Center, acquainted attendees with 42 CFR Part 2 privacy protections, discuss the proposed changes, and implications for SUD treatment programs and healthcare provider interactions in various clinical settings.

Presenters were be Dr. Maureen Boyle, Chief of the Science Policy Branch in NIDA’s Office of Science Policy and Communications; and Carmen Rosa, MS, Regulatory Officer at the CCTN providing regulatory consultations to investigators and NIDA staff.

Additional Resources:

• Download slides (pdf)
• Download handout (pdf)

Abstract:

This workshop, led by Carmen Rosa of NIDA’s Center for the Clinical Trials Network, featured three presentations focused on the use of various types of new media in the design and conduct of clinical trials. Over 82% of adults now use internet or email, including 53% of those age 65 and older. Additionally, 67% of online adults use social networking sites. Mobile devices such as smartphones, tablets, netbooks, and laptops are now a primary source of Internet connectivity, and 79% of cell phone owners say they use text messaging. As use of these tools continues to grow, exploring ways to put them to use in clinical trials seems increasingly relevant.

The first presentation, by Erin Winstanley, “Using New Media Tools in the Design and Conduct of Clinical Trials,” provided an overview of the concept of “new media” and ways it can be applied to research, including advertising of studies, recruiting/tracking participants, communicating with participants, and disseminating research findings. An introduction to Facebook and Twitter is provided, as well as a look at the use of blogs, Pinterest, and LinkedIn.

Gloria Miele presented on “Social Media Communication Strategy,” giving participants a look at ways to think about and draft policies regarding the use of social media in your study or workplace. A variety of legal considerations, as well as examples of using social media to recruit study participants is also provided. Sample IRB guidance is included, along with IRB Best Practices for using new media. The presentation ends with a case study based on CTN-0044 (“Web Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders”), which used social media platforms like Facebook, as well as email and texting, to contact and follow-up with participants.

The third presentation, by Lynn Simpson, was a demonstration of the variety of uses for “REDCap, Research Electronic Data Capture, A Data Management and Survey Tool.” REDCap is a web-based application designed to give researchers and clinicians the capacity to create and manage databases and surveys in order to support data capture for research.

Related protocols: CTN-0044

Abstract:

This 1-hour session will focus on Institutional Review Board (IRB) requirements and oversight in the conduct of research trials, particularly in the CTN, as well as the requirements for regulatory document management at the site, Node compliance, and regulatory document obligations to the sponsor.

Objectives include:

• Identifying critical aspects of IRB oversight and compliance
• Determining appropriate regulatory documentation practices
• Explaining roles and responsibilities involved in reporting progress to regulatory bodies.

Target Audience: Everyone is welcome! You do not have to be a CTN member to register for this webinar.

Presented by Emily Dorer, University of Cincinnati, OV Node, and Ro Shauna Rothwell, PhD, Wayne State University.

Additional Resources:

• Download slides (pdf)

Abstract:

This one-hour webinar, produced by the National Drug Abuse Treatment Clinical Trials Network (CTN) Clinical Coordinating Center for CTN members and the public, discusses the ethical considerations and importance of the informed consent procedures in the CTN. The webinar, intended for all clinical research staff in the CTN, will review the principles behind informed consent, describe the documentation required, and explain the informed consent development, review, and approval procedures.

Presented by Andrea Dedier and Carolyn Baron-Myak, EMMES Corporation.

Additional Resources:

• Download slides (pdf)

Abstract:

This one hour webinar, produced by the National Drug Abuse Treatment Clinical Trials Network (CTN) Clinical Coordinating Center for CTN members and other researchers, explains the Certificate of Confidentiality (CoC), its purpose, protections, limitations, and the CTN study staff’s role in assuring its protection is in place and applied appropriately across CTN studies.

Presented by Kathy Shores-Wilson, PhD (UT Southwestern Medical Center, TX Node), and Katie Morales (EMMES Corporation).

Additional Resources:

• View flowchart (pdf)
• Download slides (pdf)

Abstract:

Training research staff to implement clinical trials occurring in community-based addiction treatment programs presents unique challenges. Standardized patient walkthroughs of study procedures may enhance training and protocol implementation. The objective of this study was to examine and discuss cross-site and cross-study challenges of participant screening and data collection procedures identified during standardized patient walkthroughs of multi-site clinical trials. Actors portrayed clients and “walked through” study procedures with protocol research staff (the study completed 57 walkthroughs during implementation of four clinical trials). Observers and walkthrough participants then identified three areas of concern (consent procedures, screening and assessment processes, and protocol implementation) and made suggestions for resolving the concerns.

Conclusions: Standardized patient walkthroughs capture issues with study procedures previously unidentified with didactic training or unscripted rehearsals. Clinical trials within the National Drug Abuse Treatment Clinical Trials Network are conducted in addiction treatment centers that vary on multiple dimensions. Based on walkthrough observations, the national protocol team and local site leadership can modify standardized operating procedures and resolve cross-site problems prior to recruiting study participants. The standardized patient walkthrough improves consistency across study sites and reduces potential site variation in study outcomes.

Abstract:

This one-hour webinar, produced by the National Drug Abuse Treatment Clinical Trials Network (CTN) Clinical Coordinating Center for CTN members and the public, provides guidelines on methods that have improved adverse event and serious adverse event identification and reporting in behavioral trials. The webinar includes discussion of the clinical and regulatory importance of monitoring safety in research studies; process recommendations for identifying, reviewing, reporting, and resolving safety events; and information about who is resonsible for what, and what resources are available to facilitate the process.

The target audience includes novice and experienced CTN or other research staff working in community treatment programs in the substance abuse field.

Presented by Blake Apple (University of Texas Southwestern Medical Center, TX Node), Maria Campanella, RN, BSN (EMMES Corporation), and Robert Lindblad, MD (EMMES Corporation).

Additional Resources:

• Download slides (ppt)

Abstract:

Safety reporting in psychosocial trials is controversial. Reporting of all adverse events yields limited relevant safety information and is burdensome to clinical sites. Since 1999, the National Institute of Drug Abuse’s National Drug Abuse Treatment Clinical Trial Network (CTN) has conducted 24 randomized clinical trials in the field of drug abuse. Safety reporting was variable reflecting the numerous investigator’s and data center’s variety of prior experience and study type. In 2004 the CTN created a centralized safety office. Several distinct entities with a vested interest in safety reporting including the sponsor, the Institutional Review Board, a Data Safety Monitoring Board and the Food and Drug Administration, impact safety reporting strategies. We describe strategies to standardize safety data collection, reduce site reporting burden, problems encountered and maintain appropriate safety monitoring.

Protocols and safety data from the 17 completed trials available from the CTN public data share web site were reviewed. A total of 11,302 AEs and 1,330 SAEs were reported across approximately 6,700 participants enrolled in three investigational pharmaceutical intervention, one combination investigational pharmaceutical / psychosocial intervention, one combination marketed pharmaceutical / psychosocial intervention and twelve psychosocial intervention alone. Safety reporting variability resulted in problematic across-study comparisons. Since 2004 the safety office has instituted systematic processes to standardize safety reporting including consistent definitions and characterizations of adverse events and serious adverse events and clearly defining in the protocol which identified events require reporting in the central data base. Driven by lessons learned, the current strategies were developed to standardize adverse event reporting, support cross study comparisons, reduce reporting burden for clinical sites and preserve appropriate safety monitoring of clinical trial participants.

Abstract:

This two-hour webinar, produced by the National Drug Abuse Treatment Clinical Trials Network (CTN) Clinical Coordinating Center for CTN members and the public, is intended to assist CTN affiliated research staff in the identification, assessment, differentiation and reporting of adverse events and serious adverse events in behavioral research trials.

The target audience includes CTN members and interested members of the public.

Additional Resources:

• Download slides (pdf)

Abstract:

Human subjects protection policies developed for pharmaceutical trials are now being widely applied to psychosocial intervention studies. This study examined occurrences of serious adverse events (SAEs) reported in multicenter psychosocial trials of the National Institute on Drug Abuse Clinical Trials Network (protocols CTN-0004, -0005, -0006, and -0007). Substance-abusing participants (N=1,687) were randomized to standard care or standard care plus either contingency management or motivational enhancement. Twelve percent of participants experienced 1 or more SAEs during the 27,198 person-weeks of follow-up. Of the 260 SAEs recorded, none were judged by the data safety monitoring board to be study related, and there were no significant differences between experimental and control conditions in SAE incidence rates.

These data underscore the need to reconsider the rationale behind, and appropriate methods for, monitoring safety during psychosocial therapy trials.

Related protocols: CTN-0004, CTN-0005, CTN-0006, CTN-0007

Abstract:

Staff from 10 community-based addiction treatment organizations in the National Drug Abuse Clinical Trials Network participated in an educational session about addiction research practices and human subject protections.

This 1.5-hour presentation addressed “informed consent,” “confidentiality of research information,” “inclusion and exclusion criteria,” “random assignment,” “patient protections,” and “patient payments.” Pre- and post-session surveys were administered to 115 staff members measuring their beliefs about clinical trials. At baseline, 52% of staff believed patients could transfer out of a study even if they were doing poorly, and 55% believed staff had this right; 44% agreed that patients could participate in a clinical trial without understanding what would take place in the study. After the educational session, staff beliefs about patient protections were significantly increased in five of the seven items. A fourth of staff continued to believe patient payments were harmful, and 37% did not believe participation in a clinical trial would increase a patient’s chances at recovery.