Trends in the Burden for Patients Participating in Industry-Funded Clinical Trials.
Background: During the past five years, there has been growing interest among pharmaceutical companies in incorporating patient needs and preferences early in the protocol design process. Through individual and larger group studies, the Tufts Center for the Study of Drug Development (Tufts CSDD) has...
| Publicado en: | Therapeutic Innovation & Regulatory Science Vol. 59; no. 5; pp. 893 - 901 |
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| Autores principales: | , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Springer Nature
Sep2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=188049078&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 188049078 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 21684790 FUHO jtl: Therapeutic Innovation & Regulatory Science issn: 21684790 maglogo: N pubinfo: dt: Sep2025 vid: 59 iid: 5 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 188049078 185769752 188049078 188049078 10.1007/s43441-025-00805-y 188049078 ppf: 893 ppct: 8 formats: tig: atl: Trends in the Burden for Patients Participating in Industry-Funded Clinical Trials. aug: au: Dirks, Abigail Botto, Emily Smith, Zachary Getz, Kenneth affil: https://ror.org/05wvpxv85 Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, MA, USA sug: subj: Protocols Research Subject Recruitment Trends Clinical Trials Needs Assessment Patient Preference Treatment Outcomes Pharmaceutical Companies Human Collaboration Questionnaires Diagnostic Tests, Routine Algorithms Research Dropouts Surveys Software Research Subject Retention Diagnostic Imaging T-Tests Analysis of Variance Post Hoc Analysis ab: Background: During the past five years, there has been growing interest among pharmaceutical companies in incorporating patient needs and preferences early in the protocol design process. Through individual and larger group studies, the Tufts Center for the Study of Drug Development (Tufts CSDD) has collaborated with 14 pharmaceutical companies in applying a validated approach early in the protocol design process to assess patient participation burden. Data from these assessments has been aggregated to analyze trends in participation burden between 2011 and 2022. Methods: 156 phase II and III protocols were analyzed. Results: Overall burden for patients to participate in phase II and III clinical trials has been rising steadily since 2011. Procedures contributing most to participation burden include patient questionnaires, lab and blood work and routine procedures conducted at each planned visit. A notable increase in the average duration of each visit per protocol was observed in large part due to the volume of procedures performed per visit. A growing proportion of procedures contributing to participation burden are those supporting supplementary, tertiary and exploration endpoints. The results of this aggregate analysis demonstrate the value of assessing patient participation burden to inform protocol design optimization. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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