This Funding Opportunity Announcement (FOA) encourages UG3/UH3 phased cooperative research applications to conduct efficient, large-scale pragmatic or implementation trials to improve pain management and reduce the unnecessary use of opioid medications. Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to an implementation phase (UH3). UG3 projects that have met the scientific milestone and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA.
The overall goal of this initiative is to support the “real world” assessment of health care strategies and clinical practices and procedures in health care system that may lead to improved pain management along with a reduction in unnecessary opioid prescribing. This FOA requires that the intervention under study be embedded into health care delivery system, “real world” settings. Studies can propose to integrate interventions that have demonstrated efficacy into health care systems; or implement health care system changes to improve adherence to evidence-based guidelines. Trials or studies should be conducted across three or more health care systems (HCS) and will become part of and work with the NIH HCS Research Collaboratory supported through the NIH Common Fund. (See https://commonfund.nih.gov/hcscollaboratory). The NIH HCS Research Collaboratory Program has established a Collaboratory Coordinating Center (CCC) that is providing national leadership and technical expertise in all aspects of research with HCS. Awarded applicants will work with the HCS CCC (http://rethinkingclinicaltrials.org/about-nih-collaboratory/) to facilitate further planning and refinement of the proposed study in partnerships with health care delivery systems.
More than 25 million Americans suffer from chronic pain, a highly debilitating medical condition that is complex and difficult to manage. In recent decades, there has been an over reliance on the prescription of opioids for chronic pain, contributing to a significant and alarming epidemic of opioid overdose deaths and addiction. Extant data suggest that nonopioid pain management interventions show some efficacy for the treatment of acute and chronic pain. For example, the Agency for Healthcare Research and Quality (AHRQ) published a systematic review entitled, “Noninvasive nonpharmacological treatment for chronic pain: a systematic review.” The results describe a number of nonopioid interventions improved function and reduce pain beyond the end of treatment for conditions such as chronic low back pain, chronic neck pain, knee osteoarthritis, hip osteoarthritis, fibromyalgia, and chronic tension headache.
In addition, several pain treatment guidelines have been published by various government agencies, and clinical and professional societies now recommend the use of nonpharmacologic approaches as first tier treatment for the management of pain. The Centers for Disease Control (CDC) guideline for prescribing opioids for chronic pain, for example, states that “nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain.” The Clinical Practice Guideline from the American College of Physicians also recommends noninvasive, nonopioid treatments for acute, subacute, and chronic low back pain.
Pragmatic trials and implementation, therefore, are needed because policies, clinical practice guidelines, and tools and interventions have not been readily adopted and implemented by health care systems. However, compelling evidence suggests that this has not been the case. Research is needed to study strategies to most effectively, equitably, and efficiently implement evidence-based interventions and pain management guidelines.
The increased adoption of health information technology tools is not only changing how care is delivered but also providing opportunities for expanded participation of health care delivery organizations in research. Although the importance for biomedical research and strengthened partnerships with organizations that deliver health care is clear, many challenges exist, both cultural and practical. Many ethical and regulatory issues must be addressed to perform research in the health care delivery setting. Technical challenges to accessing and aggregating quality-controlled data from health care systems in understandable ways are not trivial. Research studies frequently use endpoints that are not part of the normal evaluation of patients during a routine visit or monitor the fidelity of intervention delivery in ways that are difficult in most care delivery settings, which may limit external validity. Education and engagement of providers and patients on the value of research in the care setting, and of researchers on the relevance of their work to health systems, are urgently needed to improve pain management for all people to decrease the reliance on opioid medications.
This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.
For the purpose of this FOA, we define “embedded pragmatic clinical trial” and “implementation research”, as follows:
Embedded pragmatic clinical trials are conducted within the health care delivery setting and are “primarily designed to determine the effects of an intervention under the usual conditions in which it will be applied”, which is in contrast with explanatory trials that “are primarily designed to determine the effects of an intervention under ideal circumstances” (http://www.bmj.com/content/350/bmj.h2147). “There are “three key attributes of pragmatic clinical trials (PCTs): (1) an intent to inform decision-makers (patients, clinicians, administrators, and policy-makers), as opposed to elucidating a biological or social mechanism; (2) an intent to enroll a population relevant to the decision in practice and representative of the patients or populations and clinical settings for whom the decision is relevant; and (3) either an intent to (a) streamline procedures and data collection so that the trial can focus on adequate power for informing the clinical and policy decisions targeted by the trial or (b) measure a broad range of outcomes (http://rethinkingclinicaltrials.org/chapters/pragmatic-clinical-trial/what-is-a-pragmatic-clinical-trial-2/).”
Implementation research seeks to understand the behavior of practitioners and support staff, organizations, consumers and family members, and policymakers in context as key influences on the adoption, implementation and sustainability of evidence-based health interventions and guidelines (e.g., Community Guide to Preventive Services, U.S. Preventive Services Task Force, and clinical and professional societies’ recommendations and guidelines). Implementation research studies should not assume that effective interventions can be integrated into any service setting and for consumer groups and populations without attention to local context, nor that a unidirectional flow of information (e.g., publishing a recommendation, trial, or guideline) is sufficient to achieve practice change.
The awards supported by this initiative will utilize the existing coordinating center of the Health Care Systems Research Collaboratory. The overall goal of the NIH Common Fund Health Care Systems (HCS) Research Collaboratory program is to strengthen the national capacity to implement cost-effective large-scale research studies that engage health care providers and delivery organizations and patients as research partners. The NIH HCS Research Collaboratory Program established a Collaboratory Coordinating Center (CCC) led by Duke University in 2012 (http://rethinkingclinicaltrials.org/about-nih-collaboratory/) that is providing national leadership and technical expertise. Awardees from this FOA will work with the NIH and CCC for both the planning and implementation of their pragmatic clinical trial or implementation study. All Projects must conduct research studies in partnership with at least three health care delivery systems, and work with the NIH and the CCC to ultimately make available data, tools, resources and lessons learned from Collaboratory research projects to facilitate a broadened base of research partnerships with HCS.
The HCS Research Collaboratory program encourages sharing of resources with broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication. In addition, the HCS Research Collaboratory program encourages sharing of study data from Projects in a timely manner with appropriate privacy and confidentiality protections, in accordance with the Data Sharing Policy developed by the HCS Research Collaboratory Steering Committee (https://www.nihcollaboratory.org/Products/Collaboratory.DataSharingPolicy_June232014.pdf). Thus, the HCS Research Collaboratory program requires awardees to implement a Resources and Data Sharing Plan consistent with achieving these program goals.
This FOA solicits applications for UG3/UH3 exploratory/developmental phased award cooperative agreements for projects for large-scale pragmatic trials or implementation research trials to be implemented through at least three HCS. The design of the proposed project should maximize external validity of the study, by testing generalizability, feasibility and sustainability of findings across distinct health care settings, and diverse staff and patient populations.
The proposed pragmatic trials or implementation research studies must meet the following criteria:
- The project must test an intervention, or coordinate several interventions (which can be treatments, preventive actions, or organizational changes) that are robust, apply broadly to pain patient populations and are suitable for use in multiple health systems, with the broad goal of determining whether the intervention(s) improves pain outcomes, and adds value to the utilization of the nation’s health care resources.
- The question must be of public health importance.
- The intervention(s) must be well-characterized and available such that it could be reliably delivered by clinical providers and/or HCS. If an intervention includes a drug, biologic or device, it must be a legally-marketed drug, biologic or medical device in the US, and used as approved/cleared for use by the Food and Drug Administration.
- The intervention(s) must be reasonably simple and not require a complex structure for implementation or monitoring. System level interventions may be particularly suitable.
- As in routine practice, the project must allow for interventions to be implemented with maximal flexibility and by all appropriate practitioners (not just those with high levels of training or competence).
- The project must leverage opportunities made available through the health care systems and use outcomes that can be captured with passive follow-up by electronic health records, with minimal need for adjudication. Augmentation of the electronic health record is allowable for patient reported data and outcomes, although this should be streamlined and collected only at necessary time points.
- The project outcome measure(s) must be clinically meaningful and important to stakeholders including patients, providers, health care systems, and policy makers. Additional outcome measures such as use of health care services or medications, and other resources may be included. Outcome measures must provide useful information to medical decision makers, whether patients, care providers, health care systems or payers.
- The project design must incorporate rigorous controls, prospectively identified, preferably by randomization. The design may incorporate novel randomization approaches, such as by cluster or timing of implementation. If another method is used to generate the comparison group, perhaps by staged assignment or staged implementation of the intervention, it should provide comparable rigor.
- Proposed analytic plans for projects that proposed cluster-randomized trials must address adequacy of sample size and study power, and employ analytic strategies relevant for such pragmatic trial designs. Applicants are strongly encouraged to consult Collaboratory Biostatistical Guidance documents (http://sites.duke.edu/rethinkingclinicaltrials/biostatistical-guidance-documents/) when developing pragmatic trial analytic plans.
- The study must address, and potentially overcome, important barriers to research in the setting of HCS partnerships.
- The project must enroll patients based on broad eligibility criteria to maximize diversity, and minimize intentional or unintentional exclusions based on risk, age, health literacy, demographics, or expected adherence.
Partnerships with health care delivery organizations will be critical in conducting this work. It is anticipated that the Projects will generally be performed with high volume electronically-supported integrated HCS to establish efficiencies. The HCS partnership must facilitate access to all data sources relevant to the project, which may include inpatient, outpatient, imaging, clinical laboratory, pharmacy and community data. Applicants, who may be from academic institutions or other organizations, must demonstrate experience in successful conduct of clinical or implementation research in partnerships with HCS. In general, applicants must identify at least three HCS as partners for the proposed Project. If an applicant identifies less than three HCS as partners for the proposed Project, they must provide a strong scientific rationale for limiting this aspect of the project and address generalizability and adequacy of sampling for the Project.
These projects will be funded as phased awards with a one-year planning phase (UG3) and a two-to-four-year implementation phase (UH3). Activities in both phases will depend on the specific study (e.g. disease domains, type of interventions, experimental design, randomization strategy and proposed outcome measures).
During the UG3 or planning phase activities will generally include, but are not limited to:
- Identify project staff that will participate in the Collaboratory Work Groups (see Section I.5 Additional Information https://www.nihcollaboratory.org/cores/Pages/default.aspx), which will develop guidelines and practices to be implemented across projects.
- Work with the Collaboratory to implement approved guidelines and practices for electronic data extraction and quality control methods and tools, as well as for electronic data sharing. In the planning phase, this will include developing and validating all electronic data methods and tools within the HCS needed for the Project (e.g. electronic health records, electronic methods for patient identification and outcomes assessment, patient reported data, biospecimens, images, high-throughput genomic data, family history data, data abstraction and survey instruments) and complete quality control testing at all sites.
- Assess adequacy and finalize clinically relevant outcome measures with other Collaboratory investigators. Awarded applicants will work with other Collaboratory investigators and NIH to identify common outcome measures (pain severity, pain interference, and pain functioning, as well as others); and will work with the CCC and NIH to develop metrics for resource utilization for planning and implementing Collaboratory pragmatic trials. If an award is made, NIH and CCC staff will work with the Program Directors/Principal Investigators to facilitate coordination among projects.
- Refine estimates of requirements with guidance from NIH and the CCC, for sample size, numbers of sites, site to site heterogeneity, and implementation timetable based on data derived from the partnering HCS.
- In general, all studies must use at least three HCS for implementation, unless a specific rationale for limiting this aspect of the project is provided.
- Develop detailed plans for site implementation, including site staff, method of identification, randomization (as applicable) and participant recruitment and acquisition and administration/implementation of the intervention if applicable.
- Address all ethical issues and issues related to human subject safety oversight for the Project, including development of informed consent documents or opt-out consent if applicable, and finalizing site of IRB review. Applicants must propose a consolidated or centralized IRB approach for trial oversight, to facilitate both appropriate and timely study implementation.
- Address all potential regulatory elements of the proposed trial (if applicable).
- Develop a detailed budget for conduct and completion of the Project, including preparation of a final study report.
- Finalize detailed plans for data coordination and quality control for the UH3 phase. The CCC will not provide these functions for individual Projects. Data coordinating activities for individual Projects must be separately budgeted as part of the UH3 budget.
Project Implementation Phase (UH3): The objective of the two-to-four-year UH3 implementation phase is to conduct the Project in accordance with activities planned in the UG3 phase. Implementation activities will depend upon the study, but in general the following goals should be achieved:
- Each project is expected to implement all aspects of the proposed pragmatic trial or implementation research study– including the identification and recruitment of proposed sample sizes of patients, practice sites, and clinicians, the execution of the intervention and its implementation, and the assessment of outcomes.
- Each project is expected to provide complete assessment of all issues related to patient, clinician and site identification, and EHR tools used in these steps.
- Each project is expected to provide definitive information about the execution of the intervention at all sites.
- Each project is to provide detailed and definitive testing of the validity of methods used for monitoring and outcome assessment.
Milestones and UG3/UH3 Transition
Utilization of milestones is a key characteristic of this FOA. A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project stage or activity. This FOA will utilize a two-phase, milestone-driven cooperative agreement (UG3/UH3) mechanism consisting of a start-up phase of up to one year (UG3) and a full enrollment and clinical or implementation trial execution phase (UH3). Projects should include well-defined milestones for the planning phase (UG3) and annual milestones for the implementation phase (UH3). It is understood that the proposed milestones for the UH3 phase will be revised as activities in the UG3 phase progress. In the event of an award, the PD/PI and NIH staff will negotiate a final list of milestones for each year of support.
At the completion of the UG3 planning phase, the applicant will be required to submit a detailed transition request for the UH3 Project implementation phase. UH3 transition requests will undergo an administrative review to determine whether the Project will be awarded the implementation phase (UH3). All regulatory approvals should be obtained prior to the end of the UG3 award. Training of intervention providers, comparison group providers, or other resources should be planned at the start of the UH3 award to allow for the successful launch and execution of the proposed pragmatic trial or implementation study in the UH3 phase. Prospective applicants should note that initial funding of the UG3/UH3 Phase Innovation cooperative agreement does not guarantee support of the UH3 Project implementation phase. Applicants should understand that transition to the UH3 phase of the project will occur only if an administrative review process recommends that the UG3 planning milestones have been successfully met, that the UH3 phase can proceed with confidence of success, and availability of funds. Continuation of the award is conditional upon satisfactory progress and subject to availability of funds. If, at any time, recruitment falls significantly below the projected milestones for recruitment, the NIH will consider ending support and negotiating an orderly phase-out of the award and retains, as an option, periodic external peer review of progress. NIH staff will closely monitor progress at all stages, milestones, accrual, and safety.
Research Areas of Interest
Applicants should propose a pragmatic or implementation trial to address one or more critical research questions important for improved pain management within health care systems. The following list provides examples of some of the potential research questions that might be addressed by such pragmatic trials:
- Studies to test the effect of system level innovations to improve implementation of established guidelines for nonopioid approaches to pain management and comorbid conditions;
- Assessment of the effectiveness of integrating evidence-based pain management strategies into health care delivery to reduce the transition from acute to chronic pain, for example in the peri-operative period;
- Comparative effectiveness studies utilizing different combinations of pain management treatments for chronic pain within health care systems
- Studies of implementation strategies to support the adoption and integration of effective pain management treatments, clinical procedures or guidelines into existing care systems;
- Studies to identify effective implementation strategies for integrating multiple evidence-based practices within community or clinical settings to meet the needs of pain patients and diverse systems of care;
- Studies testing the effectiveness and impact on utilization of health care services of implementation strategies to reduce health disparities and improve quality of pain management among rural, minority, low literacy and numeracy, and other underserved populations
National Center for Complementary and Integrative Health (NCCIH). The mission of NCCIH is to define, through rigorous scientific investigation, the usefulness and safety of complementary and integrative health interventions and their roles in improving health and health care. In the context of this FOA, NCCIH is particularly interested in encouraging applications that will study the integration of complementary health approaches into health care delivery, for those interventions that already have demonstrated efficacy or effectiveness in fully powered randomized controlled trials. In addition, NCCIH encourages applications that will study methods to improve adherence to evidence-based pain management guidelines that include complementary and integrative health approaches to reduce the unnecessary use of opioids, and ultimately reduce the occurrence of opioid use disorder. Applicants are encouraged to discuss applications the NCCIH contact listed in Section VII. Agency Contacts.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. In the context of this FOA, the NIAMS is interested in pragmatic clinical trials that reduce the burden of pain while reducing the unnecessary usage of opioids, improve physical function and prevent disability in children and adults with acute and chronic diseases and conditions within the NIAMS mission. Pragmatic clinical studies may include testing of evidence-based interventions of non-opioid medications, biologics, procedures, medical or assistive devices and non-pharmacologic approaches to improve decision-making in the management of back pain, OA pain, and post-surgical pain. Applicants are encouraged to discuss applications with the NIAMS contact listed in Section VII. Agency Contacts.”
National Institute of Dental and Craniofacial Research (NIDCR). NIDCR is interested in clinical trials aimed at reducing the burden of pain associated with acute and chronic oral and craniofacial diseases and conditions including temporomandibular joint disorders (TMD), trigeminal neuropathies, burning mouth syndrome, oral cancer pain, dental pain and other conditions. Examples of research topics that would be appropriate to the NIDCR include: 1) Clinical studies to test the implementation of effective opioid use disorder (OUD) screening and referral to treatment models in dental care settings; 2) Pragmatic clinical trials to test evidence-based clinical tools and/or interventions designed to modify dental practitioner opioid prescribing behaviors, especially for adolescent and young adult patients; and 3) Pragmatic clinical studies to test the implementation of evidence-based opioid risk mitigation strategies in dental practice settings. Applicants are encouraged to discuss applications the NIDCR contact listed in Section VII. Agency Contacts.
National Institute on Alcohol Abuse and Alcoholism (NIAAA). A significant portion of individuals with chronic pain consume alcohol in a manner or quantity that adversely impacts their experience of pain and the effect of medications or other treatments intended to address pain. For example, current or past heavy drinking or alcohol dependence occurs in 16% to 25% of chronic pain patients. Thus, NIAAA has a particular interest in studies that address alcohol use in the context of pain management and its implications for the delivery and effectiveness of evidence-based pain management practices.
National Institute of Nursing Research (NINR). The mission of the NINR is to promote and improve the health and quality of life of individuals, families, and communities. In the context of this FOA, NINR is interested in non-pharmacologic strategies with established efficacy for management of pain. Of particular interest are self-management approaches that are guided by an interdisciplinary team to address both the clinical and biopsychosocial aspects of persistent pain and which can be tested in real world settings. Outcomes of interest include psychological well-being, self-efficacy, and functionality for the affected individual and characteristics of patient/provider relationships that signify sustained pain management.
National Institute on Minority Health and Health Disparities (NIMHD). The mission of NIMHD is to lead, conduct and support scientific research to improve minority health and reduce health disparities. In the context of this FOA, NIMHD is particularly interested in encouraging applications that could include, but are not limited to: address the intersection of chronic pain management and opioid use disorder (OUD): ways to maintain continuity of care in patients with chronic pain, and strategies to improve services; research on the outcomes of implementation of the CDC Guidelines on management of opioid prescribing in treatment of chronic pain disorders; conduct subgroup analysis to determine which interventions work best for specific population groups, including medically underserved and under-represented groups with the intent to focus on reduction of Opioid prescribing. We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
National Cancer Institute (NCI). NCI is interested in pragmatic clinical trials aimed at reducing the burden of pain associated with cancer (metastatic bone pain, visceral pain, and neuropathic pain [plexopathies, radiculopathies]) and/or its treatment (post-surgical phantom limb pain, radiation induced plexopathies, mucositis, aromatase inhibitors, and chemotherapy induced peripheral neuropathy). Within the context of these pain conditions, NCI is interested in applications that will study the integration of guideline driven cancer pain management approaches into health care delivery. In addition, NCI encourages applications that will study methods to reduce the inappropriate or unnecessary use of opioids in patients experiencing pain arising from cancer and/or its treatment. For these types of trials, NCI encourages approaches that seek to improve adherence to evidence-based pain management guidelines, patient-provider communication, shared decision-making and incorporation of the EMR system. Applicants are encouraged to discuss applications with the NCI contact listed in Section VII. Agency Contacts
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). In the context of this FOA, NICHD is particularly interested in exploring the implementation of evidence-based pre-surgical education and training in pain management in the treatment of gynecologic disorders or after gynecologic surgery to reduce the unnecessary use of opioids and ultimately reduce the occurrence of opioid use disorder. Further NICHD is interested in implementation trials of evidence-based post-cesarean pain management approaches which reduce opioid prescription and increase the use of non-opioid alternatives to reduce the occurrence of opioid use disorder. Additionally, NICHD encourages applications for pragmatic trials to improve methods of referral and adherence to behavioral or rehabilitation approaches to pain which have demonstrated efficacy or effectiveness in fully powered randomized controlled trials in pediatric populations or for individuals with disability. NICHD is interested in research that includes the populations mentioned in the specific priorities indicated above and which include health disparity populations to the extent possible (i.e., diverse race/ethnicity, sexual and gender minorities, and underserved/low-resource communities).
National Institute of Neurological Disorders and Stroke (NINDS). The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. Pain is a frequent component of many neurological disorders including those involving traumatic injury to the central nervous system, as well as neurodegenerative and neuroinflammatory conditions. In the context of this FOA, NINDS is interested in pragmatic clinical trials of evidence-based interventions to reduce the burden of pain associated with neurological disorders and their treatment, as well as to prevent the transition from acute to chronic pain in these conditions. Interventions may include non-addictive drugs, biologics, natural products, devices, surgical procedures, motor training, brain stimulation, and behavioral strategies. Additionally, NINDS is interested in research on the use of strategies to adopt and integrate evidence-based interventions into clinical and community settings to improve patient outcomes.
Office of Behavioral and Social Sciences Research (OBSSR). Although OBSSR does not accept assignment of applications or manage awards that are funded through this announcement, OBSSR does encourage applications relevant to the OBSSR mission and may provide co-funding support to ICs that do manage the awards. OBSSR is specifically interested in studies that apply evidence-based approaches for behavioral change (e.g., provider prescribing practices, adherence to treatment and management guidelines for both the practitioner and patients, provider/patient communications, among other topics) to improve outcomes that include mitigating the transition from acute to chronic pain and enhancing effective management for those with persistent and chronic pain. Additionally, approaches to identifying characteristics of individuals most likely to benefit from evidence-based nonpharmacologic approaches for pain management are of interest to OBSSR.
Types of Clinical Trials Not Responsive to this FOA
The following types of clinical trials are not responsive to this FOA and applications proposing such activities will be deemed non-responsive and will not be reviewed:
- Phase I (first-in-human) trials whether single or multi-site
- Single site trials
- Studies to understand the mechanism of the intervention
- Studies to assess initial feasibility of an intervention
- Drug or device safety trials
- Studies that propose to conduct studies in animals or in vitro studies
Opportunities to submit other types of pain clinical trials for NIH support:
The Early Phase Pain Investigation Clinical Network (EPPIC-Net) will provide infrastructure for the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain. This network will support exploratory clinical trials of investigational drugs and biologics, investigational devices, natural products, and surgical procedures for the treatment of pain. These trials may include deep phenotyping, validation of biomarkers, and proof of mechanism, to support justification and provide the data for designing a future Phase 3 trial. The specific pain conditions of interests for EPPIC -Net include well-defined conditions with high unmet therapeutic needs in patients across the lifespan. Further information can be found at NOT-NS-18-057, NOT-NS-18-058, and NOT-NS-18-069.
The Pain Effectiveness Research Network will support cooperative agreement applications that propose clinical trials to establish the effectiveness of existing therapies and approaches for prevention and management of pain while reducing the risk of addiction. The studies must address questions within the mission and research interests of participating NIH Institutes and Centers and evaluate preventive strategies or interventions in well controlled trials The overall goal is to inform clinicians about the effectiveness of interventions or management strategies that reduce the risk of addiction that will improve functional outcomes and reduce pain across the continuum of acute to chronic pain associated with many types of diseases or conditions or pain presenting as a disease itself. Clinical trials will be conducted within the infrastructure of the HEAL Pain Effectiveness Research Network.
Governance: The awards funded under this FOA will be cooperative agreements (see Section VI.2 Cooperative Agreement Terms and Conditions of Award). Close interaction with the NIH staff and with the CCC will be required to accomplish the goals of this program.
HCS Research Collaboratory Work Groups have been established by the CCC and the NIH as the core collaborative activity of this program. The Work Groups provide a forum for discussion of challenges and solutions across projects. Harmonized and standardized policies and processes will be vetted in these groups. Work Groups have been established in the following areas: Electronic Health Records, Regulatory /Ethics, Biostatistics & Study Design, Health Care Systems Interactions, and Patient Reported Outcomes (http://rethinkingclinicaltrials.org/cores-and-working-groups/). Additional Work Groups may be identified as the HCS Research Collaboratory expands with new projects as part of this initiative. Work Groups will comprise individuals from each of the Projects, the Coordinating Center, and staff from the NIH. PD/PIs must identify study staff or investigators that will participate in Collaboratory Work Groups.
A Steering Committee has been established by the CCC to address issues that span all projects, provide input into the policies and processes of the HCS Collaboratory, and assist in dissemination of policies and processes that enable research in healthcare systems, involving their patients, and practitioners. At a minimum, the Steering Committee will have one representative from each of the Projects, one representative from each Work Group, one representative from the Coordinating Center, NIH Program Officers and Project Scientists for the CCC and Projects. All members are expected to actively participate in all Steering Committee activities. The combined vote of NIH membership may never exceed 40 percent. NIH may convene an external panel of experts to provide advice on the overall program progress.
Deadline: February 08, 2019 (letters of intent due 30 days prior to deadline)
Filed Under: Funding Opportunities