{"doi":"10.1001/jamanetworkopen.2025.18510","title":"Enhancing Randomized Clinical Trial Readiness for Public Health Emergencies","abstract":"Rapid and efficient implementation of randomized clinical trials (RCTs) during a public health emergency is crucial in the discovery and development of vaccines and therapies.By use of the Randomized Embedded Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP), van Hout and colleagues 1 identified hurdles for the delivery of multinational RCTs, specifically in the areas of ethical, administrative, regulatory, and logistical procedures.Using this empirical example, the authors focused on site contract completion times, time to regulatory and ethical approval (TTA), and time to first patient in (FPI) to compare the UK to non-UK European countries before and during the pandemic.The UK and other European countries did not have any significant differences in any of the above time processes before the pandemic.Conversely, significant differences were present between the UK and non-UK European countries during the pandemic, with the UK's median contract completion time decreasing from 196 to 5 days, TTA decreasing from 19 to 8 days, and median time of 26 days from regulatory approval to FPI.Conversely, non-UK countries maintained lengthy durations, with median contract completion of 183 days, TTA of 115 days, and 116 days from regulatory approval to FPI.These results were, in part, the product of the UK implementing robust policies that drastically reduced contract completion and approval times, while non-UK countries saw no such improvements, highlighting valuable insights into the challenges and potential solutions for improving delivery of RCTs during public health emergencies. 1 prepare for future public health emergencies, it is crucial to develop mechanisms that enable countries to swiftly and effectively implement RCTs.One such mechanism is the expediting of approvals.For instance, during the H1N1 pandemic of 2009, Annane et al 2 analyzed the hurdles in implementing a RCT of corticosteroids for severe H1N1 influenza infections.They found that parallel approvals, rather than sequential, could have allowed the trial to start 1 month earlier, before the peak of the influenza season. 2 Expedited reviews must be balanced against the risk to patients.Ethics committee staff with experience in epidemic research and joint research ethics committees with representatives from all affected countries are recommended to facilitate approvals and protect patient safety.These committees should ensure that protocols are collaborative and consistent with community values.For example, expedited ethical review time frames for Ebola averaged 6 days, and for H1N1 in the UK, 18 days. 3Despite recommendations to mitigate challenges during the response to the H1N1 pandemic in 2009, these were not globally implemented, and similar issues occurred during the Ebola response. 3en when fast-tracked processes are implemented, bureaucratic workload can still result in substantial delays in implementing a RCT.For example, Pollard et al 4 reported several bureaucratic delays in spite of having an expedited process, highlighting the importance of support for clinical trials infrastructure and the need to improve trial setup timelines beyond pandemic situations. 4rthermore, the implementation of RCTs, as well as the continuation of other trials in clinical research units during a public health emergency, can result in delays in the enrollment of participants, as explored by Subramain et al 5 in the clinical research units across the US during the COVID-19 pandemic.Even with preapproved and prepositioned study protocols, conducting international RCTs faces other challenges.These include issues related to researchers, participants, and specific ethical and administrative concerns in each country.For instance, variations in insurance and indemnity","journal":"JAMA Network Open","year":2025,"id":569554,"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":0.9541,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":250081,"name":"Alejandro P. Comellas","orcid":"0000-0003-1521-7520","position":0,"is_corresponding":true}],"reference_count":6,"raw_metadata":null,"created_at":"2026-07-19T02:56:59.652443Z","pmid":"40601324","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":[]}