RFI for Decentralized Clinical Studies Healthcare Delivery Network

Title: RFI for Decentralized Clinical Studies Healthcare Delivery Network Disclaimer Pursuant under Federal Acquisition Regulation (FAR) Part 10, the intent for this Request for Information (RFI) / Sources Sought is to conduct market research. This is NOT a solicitation for proposals, proposal abstracts, or quotation. This announcement does not constitute an Invitation for Bids (IFB), Request for Quote (RFQ), or a Request for Proposal (RFP), and it should not be construed as a commitment of any kind by the Government to issue a formal solicitation or ultimately award a contract. Responses to this notice cannot be accepted as offers. The sole purpose of the RFI is to assist the Agency in crafting the appropriate solicitation and shall be used for information purposes only. Any proprietary information will be protected, if appropriately marked. The information provided is entirely voluntary and will not impact the ability to submit on future requirements. The RFI is for planning purposes and shall not be considered a Broad Agency Announcement. The Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), is issuing this Request for Information (RFI) to collect feedback from organizations at the forefront of implementing decentralized healthcare delivery and clinical study models that incorporate virtual and remote care. These organizations include, but are not limited to, telemedicine, urgent care, direct to patient testing, integrated payor-providers, and retail pharmacy. BARDA is seeking to substantially improve its ability to respond to future public health emergencies (PHEs) by better utilizing novel healthcare delivery models to: develop drugs and devices, including medical countermeasures (MCMs), designed for use in more distributed settings (e.g., retail pharmacies, the home); assess effectiveness and utility in those distributed settings; implement novel technologies and understand the impact on real-world patient outcomes; and ultimately reach more patients during a PHE, for both testing and use of MCMs. Information collected from this RFI will serve as continued market research for the development of a potential future program within BARDA's Division of Research, Innovation and Ventures (DRIVe) to support the establishment of a decentralized clinical studies and healthcare delivery network. BACKGROUND: The COVID-19 pandemic both demonstrated and accelerated the need for rapid assessment and accessibility of MCMs during PHEs. Patients now increasingly access healthcare providers in settings away from hospitals and outpatient clinics (e.g., retail, telemedicine, wearables) including at home. This creates a wealth of opportunity for improving access to care, especially for Americans without immediate access to primary care physicians. The rapid evaluation of MCMs relies on recruiting, enrolling, and retaining a diverse set of patients. With this shift in care settings, relying alone on traditional hospital-based care models or other centralized models for conducting clinical studies and/or distributing MCMs, may become inadequate, especially considering preparedness for future pandemics. Some of these challenges were apparent during COVID-19. Many MCM developers of both drugs and devices had difficulty identifying, enrolling, and retaining patients for clinical trials as well as making their products available to the right individuals at the right time. BARDA DRIVe has identified an opportunity to establish a network of organizations focused on implementing decentralized clinical trials and healthcare delivery models across multiple settings. This network could allow for experimental clinical studies, observational studies, and piloting of new interventional care models relevant to PHEs and pandemic preparedness. In addition, providing a network for testing medical products across multiple settings may help de-risk the path to market and accelerate the product pipeline. Through this RFI, BARDA DRIVe is seeking to explore the trend towards healthcare decentralization and to determine whether BARDA's interests align with commercial capabilities in decentralized healthcare delivery and clinical study models. Specifically, we envision that such a network could benefit the development and validation process for products/technologies intended for remote use and allow for agility of product/technology development and delivery of care during a PHE. In addition, potential network benefits include, but are not limited, to: reaching patients in the clinical settings for which they would like to receive care (i.e., outside of the hospital) increasing access, patient participation and diversity improving timing and accessibility of patient touch points for delivery of care enhancing continuity and temporal access of data collection across the care continuum supporting data collection from a broader range of sources including patient generated and patient reported data to better evaluate real-world patient outcomes enabling more robust clinical studies representative of real-world patient outcomes CAPABILITIES OF INTEREST: BARDA has preliminarily identified capabilities and characteristics thought to be relevant to an individual organization (and their associated partners), participating within such a future network, including: Rapid access to, or ability to operate via pharmacies, retail locations, telemedicine platforms, the home, and other non-hospital settings; Ability to reach patients facing physical and temporal barriers to care such as proximity/location, cost, time to scheduling appointments/receiving care, and/or other limitations that make an office visit difficult; Ability to reach diverse patient populations, including: underserved and at-risk populations; those without a primary care physician (PCP); those without insurance; and other factors that limit regular interaction with the healthcare system; Ability to implement existing or new products and tools (e.g., wearables, at-home/POC diagnostics, digital therapeutics); Ability to pilot new models of care (e.g., delivery of services, delivery decision support, process of care, care coordination) including pressure-testing changes in clinical processes/workflow and collecting user feedback; Ability to conduct an array of clinical studies including but not limited to traditional research and development clinical trials for products seeking regulatory approval, clearance or licensure, quality improvement or other pragmatic clinical studies which may monitor patients and capture clinical and real-world data continuously or in near real-time that provide value for developers, the U.S. government (USG), patients, providers, and payors and that improve the quality of care (i.e., not limited to studies designed for regulator decision-making by FDA); Ability to track patients and collect longitudinal data throughout the care continuum (e.g., healthy patients before they become sick, while sick/hospitalized, and post-illness); Ability to address challenges that exist with centralized clinical study design and reduce or eliminate hurdles with patient identification, recruitment, enrollment and follow up appointments typically associated with traditional clinical study sites. STUDY AREAS OF INTEREST: The following clinical study areas represent three potential functions of the network: Area 1: Validate technologies in real-world environments: Evaluate the clinical performance and/or utility of specific medical countermeasures (e.g., therapeutics, vaccines, drugs, devices, digital health tools), technologies or approaches, developed and marketed, or in development, as identified by BARDA. These studies will largely involve prospective clinical study design, execution, data collection and evaluation in decentralized settings outside the hospital, as defined above. Area 2: Leverage health data for new insights: Analyze data from the normal course of care/treatment being implemented with existing technological capabilities and care models. This would include the ability to collect and mine real-world data to identify potential challenges and /or opportunities for future care delivery/medical countermeasure development. Study designs may be prospective or retrospective with the aim of testing and/or generating hypotheses. Data can also be collected over longer timeframes and in real-world settings which can offer a broader understanding of disease etiology, progression, and patient outcomes. Area 3: Test new healthcare delivery models: Evaluate new technologies and models of care relevant to PHE response in decentralized care settings outside the hospital, as defined above. This will involve prospective study design, implementation, data collection and evaluation based on piloting new clinical workflows that may not be in existence before study start to determine feasibility. RESPONSE REQUESTED ON THE FOLLOWING QUESTIONS: BARDA encourages input from a variety of organizations, including, but not limited to: urgent care centers; pharmacies and other retail establishments involved in decentralized healthcare delivery or services; direct to patient testing companies; technology developers for providers of telehealth, remote exams and monitoring; and organizations providing a hybrid of in-person and telehealth care. Small businesses and first?time government contractors are also strongly encouraged to provide input. Input from traditional provider groups or healthcare systems that rely primarily on office visits; clinical trial networks/CROS that rely on in-person visits and/or referral from primary care physicians or have defined clinical sites (i.e., centralized models) that have interest in expanding into decentralized care would also be of interest. It is important to note that care provided in the hospital setting alone is not the target of interest for the RFI, though information from the hospital setting along with the ability to provide information prior to and/or after hospitalization would be of interest. BARDA is soliciting input from organizations with relevant knowledge and experience. Interested organizations are invited to respond to the questions below and submit at: RFI Submission Link. In the submission form you will not be able to save your work and return to edit, so it is recommended that you have prepared answers for all the questions at the time of submission. In the event you are unable to access the form please email responses to the questions to HI3@hhs.gov.