New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance.
The Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a follow-up study in 2022 to assess trends in protocol amendment experiences and the impact amendments have had on clinical trial performance, particularly during the COVID-19 pandemic. Sixteen pharmaceutical companies and con...
| Publicado en: | Therapeutic Innovation & Regulatory Science Vol. 58; no. 3; pp. 539 - 549 |
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| Autores principales: | , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Springer Nature
May2024
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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=176842507&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 176842507 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 21684790 FUHO jtl: Therapeutic Innovation & Regulatory Science issn: 21684790 maglogo: N pubinfo: dt: May2024 vid: 58 iid: 3 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 176842507 175817608 176842507 176842507 10.1007/s43441-024-00622-9 176842507 ppf: 539 ppct: 10 formats: tig: atl: New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance. aug: au: Getz, Kenneth Smith, Zachary Botto, Emily Murphy, Elisabeth Dauchy, Arnaud affil: https://ror.org/05wvpxv85 Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, USA sug: subj: Clinical Trials Task Performance and Analysis Practice Guidelines Human Pharmaceutical Companies COVID-19 Pandemic Prospective Studies Drug Development ab: The Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a follow-up study in 2022 to assess trends in protocol amendment experiences and the impact amendments have had on clinical trial performance, particularly during the COVID-19 pandemic. Sixteen pharmaceutical companies and contract research organizations provided data on 950 protocols and 2188 amendments. The results show that, since 2015, the prevalence of protocols with at least one amendment in phases I–IV has increased substantially (from 57 to 76%) and the mean number of amendments per protocol has increased 60% to 3.3, up from 2.1. Phase I and III protocols saw the highest increases in the mean number of amendments implemented per protocol. A much higher percentage of amendments—77%—were deemed unavoidable with regulatory agency requests and changes to the study strategy as the top reasons cited for amending a protocol. The total average duration to implement an amendment has nearly tripled during the past decade. The time from identifying the need-to-amend to last oversight approval now takes an average of 260 days and the mean duration during which investigative sites operate with different versions of the clinical trial protocol spans 215 days. Protocols that implemented at least one amendment were more effective at increasing patient screening volume and reducing the actual number of patients enrolled relative to plan. Lastly, the prevalence of protocols with at least one amendment and mean number of amendments was significantly higher for protocols conducted during the pandemic. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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