Notice Number: NOT-DA-14-002
Release Date: December 18, 2013
Response Date: February 14, 2014
National Institute on Drug Abuse (NIDA)
The National Institute on Drug Abuse (NIDA) is seeking input on the capacity of the field to use existing healthcare networks to conduct large-scale pragmatic/effectiveness research and point-of-care clinical trials to address issues that impact Substance Use Disorder (SUD) treatment practices. Advice is sought from the preventive and treatment research communities, stakeholders within healthcare delivery systems, and other interested groups on the current capacity of the field with regards to efficient use of user-friendly health information systems for the enrollment of patients with SUD or substance misuse into trials; efficient recruitment of providers to deliver novel interventions within research studies; and utilization of existing health information infrastructures, including Electronic Health Records (EHRs) and patient registries of healthcare delivery systems, for efficient clinical data collection to conduct low-cost pragmatic/effectiveness research trials and research analysis.
The cost of conducting large-scale effectiveness trials of preventive and treatment interventions to answer important SUD health research questions is prohibitive. The stand-alone trial enterprise, which requires identification of subjects, multiple strategies for recruitment, enrollment, randomization, data collection, and ongoing monitoring, limits the number of studies which can be launched anew within fixed research budgets. In general, large scale, pragmatic, and effectiveness trials rarely take advantage of potential efficiencies within large-scale research and practice networks, such as electronic methods for identifying suitable participants, contacting clinicians, and collecting predictor and outcome data. Recent healthcare reform legislation provides unprecedented opportunities for SUD treatment to be integrated into general medical settings. Therefore, NIDA is interested in exploring the potential for conducting pragmatic/effectiveness and point-of-care clinical trials of SUD preventive and treatment interventions in existing healthcare research and practice networks.
For purposes of this Request For Information (RFI), we define pragmatic/effectiveness studies as clinical trials of treatments of proven efficacy, conducted with a broadly-inclusive sample with few exclusion criteria, in real-world settings (general medical as well as specialty care facilities). Subjects in pragmatic/effectiveness treatment trials often present with co-occurring mental health, SUD, or physical disorders, for which medications or other interventions outside the research protocol are being utilized. Examples include, but are not limited to, pragmatic trials and comparative effectiveness research trials (for example, http://www.ncbi.nlm.nih.gov/pubmed/21707950), randomized registry trials (for example, http://www.ncbi.nlm.nih.gov/pubmed/23991656), and point-of-care (POC) randomized trials (for example, http://www.ncbi.nlm.nih.gov/pubmed/21478329, http://www.ncbi.nlm.nih.gov/pubmed/?term=battaglia+j+moss+s+rush+j).
With significant efforts needed to determine the comparative effectiveness of beneficial treatments and their capacity for widespread implementation, studies will require large samples of patients, an abundance of practicing clinicians, integrated data systems to identify, assess, monitor, and follow-up patients, and capacity to conduct pragmatic/effectiveness trials with rapidity, efficiency, safety, and quality. NIDA is interested in exploring the potential of expanding its Clinical Trials Network (CTN) research platform to include existing healthcare system networks with user friendly health information systems that might conduct large-scale pragmatic/effectiveness and comparative effectiveness research trials at costs below a traditional trial.
For these reasons, NIDA seeks perspectives of its multiple stakeholders to understand if and how existing healthcare delivery systems can be utilized to conduct pragmatic/effectiveness and comparative effectiveness research, for example supporting practice networks where such research can be conducted, or being available as a resource for identifying potential research participants for clinical trials.
Request for Information
Comments can include but are not limited to the following areas:
1. The description of existing, healthcare delivery systems within general medical settings that are candidates to conduct: a) large-scale research to address clinically-meaningful issues impacting SUD treatment practices, specifically, research on the effectiveness and comparative effectiveness of preventive, early intervention, and treatment interventions; b) patient and/or SUD disease registries
2. The most efficient methods of identifying, recruiting, and consenting patients and providers in general medical settings for inclusion in SUD pragmatic/effectiveness and comparative effectiveness research studies
3. The existing capacity within health information systems to use mobile health tools in pragmatic/effectiveness trials to increase efficiency of these trials, if any
4. The use of existing electronic resources, such as electronic health record systems, other health information systems, and/or patient registries within identified research/healthcare system networks (for example, http://www.pcori.org/assets/2013/06/PCORI-Comprehensive-Inventory-Research-Networks-061213.pdf) to decrease the cost and increase the efficiency of key aspects of the trial. Examples of key aspects of the trials include, but are not limited to, the identification, recruitment and consent of eligible patients; monitoring compliance or obtaining interim study data when necessary; and low-cost collection of study outcomes
5. The existing capacity within healthcare delivery network systems to collect and store biologic materials (for example, blood, hair, salivary samples, etc.) for research purposes, if any
6. Treatment research questions that are most relevant to healthcare delivery systems
How to Submit a Response
Responses will be accepted through February 14, 2014. Electronic responses are preferred and may be addressed to email@example.com (please include the Notice number NOT-DA-14-002 in the subject line). Responses may also be sent by letter or fax to the following address:
Udi Ghitza, Ph.D.
NIDA Center for Clinical Trials Network
6001 Executive Boulevard
Room 3126, MSC 9557
Bethesda, MD 20892-9557
This request is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government. The NIH does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information.
The NIH will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. However, responses to the RFI may be reflected in future funding opportunity announcements. The information provided will be analyzed and may appear in reports. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
Please direct all inquiries to:
Udi Ghitza, Ph.D.
National Institute on Drug Abuse (NIDA)