title: Factors influencing inclusion of patients with malignancies in clinical trials.
abstract: Participation in clinical trials remains low and is a central issue in oncology. The authors identified, through a systematic review, 75 papers published up to August 2004 that report barriers to recruitment of patients in clinical trials. These barriers range from patient preference and concern about information/consent to clinical problems with protocols. Strategies to overcome barriers on the part of patients and clinicians are needed and should be carefully evaluated. Thirty-three (44%) papers reported factors related to patients as influencing the inclusion of patients, 28 (37%) reported clinician's related factors, and 37 (49%) other factors from either specific groups of patients (30 papers, 40%) and/or other scopes (13 papers, 17%). No differences in prevalence were found between papers dedicated to hematologic malignancies and solid tumors. Factors related to clinicians as influential were more frequently reported before 1995 (70%) than thereafter (25%; P = 0.0009). Reporting specific groups of patients as influential was more frequent in North American articles (50%) than in others (14%, P = 0.008). Patients' barriers included mostly patient preference (12 papers), concern about information and/or consent (11 papers), worry about uncertainty (7 papers), and/or relationship with medical team (7 papers). Concerning clinicians, incompatibility of protocol with normal practice (nine papers), problems in complying with the protocol (eight papers), and/or consent procedure (eight papers) were the most reported factors. The remaining factors mostly relied on specific groups of patients (30 papers), notably age of patients (18 papers) and/or minority population (11 papers, all from the USA). Strategies to overcome these barriers are needed and should be carefully evaluated.
authors.affiliation: Department of Biostatistics, Hospital Saint Louis, APHP, Paris, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Tournoux
authors.forename: Sandrine
authors.initials: S
authors.lastname: Katsahian
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
authors.forename: Vincent
authors.initials: V
authors.lastname: Levy
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D006402:Hematologic Diseases / Q000628:therapy*; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D018579:Patient Selection