{"doi":"10.1093/pm/pnae063","title":"Challenges in clinical data sharing—experiences of the pain management collaboratory","abstract":"The Department of Veterans Affairs (VA) and Department of Defense (DOD) generally follow the National Institute of Standards and Technology’s (NIST) guidance for data sharing environments and tools; however, implementation of standards, data access, and sharing processes still vary across these organizations. Furthermore, academic institutions across the United States follow their own internal standards, typically implementing processes set forth by research and academic funders. As such, variations in policy can provide roadblocks to successful implementation of research, including holdups in regulatory approvals, as data sharing and management plans are being developed for each data holder. As collaboration increases between the DOD, VA, and academic partners, data sharing and management issues become more complex. Providing governance and processes for effective data sharing has many challenges. For instance, issues surrounding privacy, consent, and data security are paramount, especially when dealing with sensitive information as well as higher level ethical and legal considerations. This can include where electronic health records data collected for a study is allowed to be accessed, stored, and analyzed and if the data need to be wholly deidentified prior to leaving the data owner. The process can become more onerous when data are being requested from a non-government entity, such as an academic institution, which must then ensure they meet requirements from the government data holder. Furthermore, any research teams which plan to store their data in a repository may encounter additional requirements, such as including special language in a consent document or providing detailed information on the information technology system where the researchers conduct their work. Establishing clear guidelines that comply with federal standards and ensuring research teams maintain rigorous data protection standards and practices are essential to navigate these challenges and ensure clinical trials which use or obtain data from DoD or VA populations and databases are successful. The Pain Management Collaboratory (PMC) was funded in 2017 to support pragmatic clinical trials (PCTs) examining nonpharmacologic approaches and interventions for pain management in military service members, their families, and veterans.1 The organizational structure of the PMC is similar to the National Institutes of Health (NIH) Pragmatic Trials Collaboratory with a centralized coordinating center (PMC3) and core Work Groups (WGs).2 Through the PMC,3 multiple Work Groups (WGs) were assembled to address research challenges, starting with the Ethics and Regulatory (ER) WG, with VA, DOD, and NIH subject matter experts in privacy and safety regulations. To begin addressing research challenges, the PCTs were provided an ER WG produced document, “Collection of Sample Consent Form and Protocol Language,” for inclusion in their Institutional Review Board paperwork for DOD and VA studies. This included language to address both data sharing and the potential for data to be transferred and housed in a federally approved data repository. Following establishment of the ER WG, the Data Sharing (DS) WG and Electronic Health Records (EHR) WG were formed within the PMC3 to facilitate discussions on data sharing challenges, harmonization of variables from the different EHRs, and best data sharing and management practices among PCTs. The PMC3 DS WG consists of core leadership, or chairs, which includes subject matter experts and managers from the DOD, VA, and NIH, as well as researchers from the PCTs and national experts from the coordinating center. The DS WG provides normalization of data and activities across projects and assures compliance with privacy and security policies of DOD, VA, and NIH. This is in addition to the overarching goal of facilitating the use of common data elements and data sharing between DOD, VA’s national healthcare systems, and across other PMC3 WGs","journal":"Pain Medicine","year":2024,"id":483805,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.946,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":263472,"name":"Cynthia Brandt","orcid":"0000-0001-8179-1796","position":1,"is_corresponding":false},{"id":794498,"name":"Norman Silliker","orcid":null,"position":2,"is_corresponding":false},{"id":1325277,"name":"Bolatito Adepoju","orcid":null,"position":3,"is_corresponding":false},{"id":794497,"name":"Michael Raffanello","orcid":null,"position":4,"is_corresponding":false},{"id":11398,"name":"Michael E. Matheny","orcid":"0000-0003-3217-4147","position":5,"is_corresponding":false},{"id":537191,"name":"William T. Roddy","orcid":null,"position":6,"is_corresponding":false},{"id":1324792,"name":"Joseph Erdos","orcid":"0000-0003-4442-0683","position":7,"is_corresponding":false},{"id":1324791,"name":"Kalyn C Jannace","orcid":"0000-0001-8119-6962","position":0,"is_corresponding":true}],"reference_count":3,"raw_metadata":null,"created_at":"2026-07-19T02:07:33.718973Z","pmid":"39514872","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}