{"doi":"10.1093/reseval/rvac003","title":"Evaluating the Revised National Institutes of Health clinical trial definition impact on recruitment progress","abstract":"Background: The National Institutes of Health (NIH) announced a revised, expanded definition of \"clinical trial\" in 2014 to improve trial identification and administrative compliance. Some stakeholders voiced concerns that the policy added administrative burden potentially slowing research progress. Methods: This quasi-experimental study examined the difference-in-differences impact of the new NIH clinical trial definition policy on participant recruitment progress in grants funded by the National Institute of Mental Health (NIMH). Results: 132 funded clinical trial grants were identified. While more grants were identified as clinical trials under the revised definition, the difference-in-differences in recruitment progress before and after the policy change was not statistically significant. Conclusions: The revised NIH clinical trial definition had no clear effect on recruitment progress in newly-identified NIMH-funded clinical trials as compared to traditionally-identified clinical trials. Concerns that administrative delays and burden could impact study progress may be alleviated by these initial results.","journal":"Research Evaluation","year":2022,"id":292410,"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":3,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.948,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":287897,"name":"Gail L. Daumit","orcid":"0000-0003-0717-0216","position":1,"is_corresponding":false},{"id":307293,"name":"Kevin M. Fain","orcid":"0000-0001-7839-7149","position":2,"is_corresponding":false},{"id":52749,"name":"Roberta W. Scherer","orcid":"0000-0003-2493-1769","position":3,"is_corresponding":false},{"id":287907,"name":"Emma E. McGinty","orcid":"0009-0003-5095-9308","position":4,"is_corresponding":false},{"id":801106,"name":"Eugene I. Kane","orcid":"0000-0001-9522-3933","position":0,"is_corresponding":true}],"reference_count":9,"raw_metadata":null,"created_at":"2026-07-19T00:30:46.209549Z","pmid":"36248212","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":[]}