{"doi":"10.3389/fphar.2024.1446908","title":"Editorial: Building the clinical research workforce: challenges, capacities and competencies","abstract":"In this editorial, we summarize identified headwinds evident in the clinical research professional workforce, spanning capacity constraints and aligning competencies to meet the complexity of modern clinical research. This editorial is part of the research topic: \"Building the Clinical Research Workforce: Challenges, Capacities and Competencies\". To progress beyond common challenges, we outline opportunities for innovation in medicinal and pharmacological advancement from the collection.In the past decade and more considerably in the past five years, there has been heightened attention to the available resources and training within the clinical research workforce. With pharmaceutical research sponsors spending 50% more on average in research and development since 2018, and much of this spending and investment in novel therapies coming from emerging biopharma companies, the criticality of a workforce pipeline cannot be overstated during periods of intensive growth and market fluctuations in new drug and device development (Mullard, 2024).The foundation for core clinical research workforce competencies was established in 2014 with the initial publication of the harmonized Joint Task Force Clinical Trial Competency Framework (JTF Framework) as a means of establishing a common lexicon of critical functional abilities of personnel in order to adapt to innovative trial designs, complex trial conduct, and novel technologies (Sonstein et al., 2014). By 2024, the framework, with translations in 11 languages, had been applied both in the United States and internationally to educate, train, and support the clinical research workforce (Joint Task Force for Clinical Trial Competency, 2017;Sonstein et al., 2024). In the post-COVID-19 era, the aftershocks of increasing staff turnover rates and overall workforce contraction necessitated a harmonized response across a broad spectrum of employers: academic medical center research sites, cooperative groups, contract research organizations, and pharmaceutical companies, among others (Freel et al., 2023). The archetype of the clinical research professional (CRP) has become broadened to include all individuals who support the operationalization of clinical research, including not only clinical research coordinators, clinical research nurses and midwives, but also advanced practice providers, pharmaceutical industry research physicians (e.g., medical monitors), regulatory affairs professionals, data management professionals, grant and contract administrators, ethics committee members, clinical laboratory personnel and managers, quality assurance monitors and assistants (Mendell et al., 2024). This broad professional group continues to evolve but competency standards are necessary to meet the needs of a dynamic and constantly changing clinical research enterprise.Besides increasing staff turnover rates, additional challenges and gaps exist that affect institutions, researchers, and the CRP workforce. One gap is a generalized lack of public understanding of clinical research, which contributes to the lack of awareness that clinical research offers a career track for future employees. Most enter the profession \"by accident\" rather than having an intentional plan to enter the clinical research workforce at the end of secondary school (Freel et al., 2023) or higher education. As the general retirement cliff approaches for the current CRP workforce, attention is appropriately shifting to cultivating interest and inquiry among the next generation of research-engaged graduates. This includes the opportunity to recruit and retain CRPs from diverse backgrounds and communities which in turn may facilitate a higher degree of relatability among members of the public to feel welcome to participate in research.As part of an initiative to increase higher education integration of careers in clinical research, a competency-based curricula for training certificates, academic degrees, internships, and apprenticeships h","journal":"Frontiers in Pharmacology","year":2024,"id":500990,"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":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9599,"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":1350406,"name":"Elizabeth A. Johnson","orcid":"0000-0001-6628-4083","position":1,"is_corresponding":false},{"id":51663,"name":"Barbara E. Bierer","orcid":"0000-0001-6448-8170","position":2,"is_corresponding":false},{"id":502625,"name":"Denise C. Snyder","orcid":"0000-0003-1160-7433","position":3,"is_corresponding":false},{"id":1350407,"name":"Hazel Smith","orcid":"0000-0001-5538-0897","position":4,"is_corresponding":false},{"id":1350655,"name":"Emma Akuffo","orcid":null,"position":5,"is_corresponding":false},{"id":1031035,"name":"Stephen A. Sonstein","orcid":"0000-0003-1888-5516","position":6,"is_corresponding":false},{"id":528257,"name":"Carolynn Thomas Jones","orcid":"0000-0002-0669-7860","position":0,"is_corresponding":true}],"reference_count":5,"raw_metadata":null,"created_at":"2026-07-19T02:10:12.068207Z","pmid":"39081959","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":[]}