{"doi":"10.1177/17407745231203330","title":"Recommendations for the collection and annotation of biosamples for analysis of biomarkers in neurofibromatosis and schwannomatosis clinical trials","abstract":"INTRODUCTION: Neurofibromatosis 1 and schwannomatosis are characterized by potential lifelong morbidity and life-threatening complications. To date, however, diagnostic and predictive biomarkers are an unmet need in this patient population. The inclusion of biomarker discovery correlatives in neurofibromatosis 1/schwannomatosis clinical trials enables study of low-incidence disease. The implementation of a common data model would further enhance biomarker discovery by enabling effective concatenation of data from multiple studies. METHODS: The Response Evaluation in Neurofibromatosis and Schwannomatosis biomarker working group reviewed published data on emerging trends in neurofibromatosis 1 and schwannomatosis biomarker research and developed recommendations in a series of consensus meetings. RESULTS: Liquid biopsy has emerged as a promising assay for neurofibromatosis 1/schwannomatosis biomarker discovery and validation. In addition, we review recommendations for a range of biomarkers in clinical trials, neurofibromatosis 1/schwannomatosis-specific data annotations, and common data models for data integration. CONCLUSION: These Response Evaluation in Neurofibromatosis and Schwannomatosis consensus guidelines are intended to provide best practices for the inclusion of biomarker studies in neurofibromatosis 1/schwannomatosis clinical trials, data, and sample annotation and to lay a framework for data harmonization and concatenation between trials.","journal":"Clinical Trials","year":2023,"id":377877,"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":0.9443,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":517985,"name":"Steven D. Rhodes","orcid":"0000-0002-6551-8631","position":1,"is_corresponding":false},{"id":959637,"name":"Edina Komlódi-Pásztor","orcid":"0000-0002-4749-607X","position":2,"is_corresponding":false},{"id":1141479,"name":"Herb Sarnoff","orcid":"0000-0002-3219-3113","position":3,"is_corresponding":false},{"id":1141834,"name":"Vito Grasso","orcid":null,"position":4,"is_corresponding":false},{"id":841422,"name":"Meena Upadhyaya","orcid":"0000-0002-4881-0235","position":5,"is_corresponding":false},{"id":109186,"name":"AeRang Kim","orcid":"0000-0002-7813-5568","position":6,"is_corresponding":false},{"id":52732,"name":"D. Gareth Evans","orcid":"0000-0002-8482-5784","position":7,"is_corresponding":false},{"id":80025,"name":"Jaishri O. Blakeley","orcid":"0000-0002-1049-0993","position":8,"is_corresponding":false},{"id":345865,"name":"C. Oliver Hanemann","orcid":"0000-0002-1951-1025","position":9,"is_corresponding":false},{"id":24634,"name":"Chetan Bettegowda","orcid":"0000-0001-9991-7123","position":10,"is_corresponding":false},{"id":644046,"name":"R. Taylor Sundby","orcid":"0000-0001-8485-0026","position":0,"is_corresponding":true}],"reference_count":78,"raw_metadata":null,"created_at":"2026-07-19T01:16:40.346877Z","pmid":"37904489","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":[]}