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Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative.

Publication ,  Journal Article
Evans, SR; Paraoan, D; Perlmutter, J; Raman, SR; Sheehan, JJ; Hallinan, ZP
Published in: Ther Innov Regul Sci
May 2021

The growing availability of real-world data (RWD) creates opportunities for new evidence generation and improved efficiency across the research enterprise. To varying degrees, sponsors now regularly use RWD to make data-driven decisions about trial feasibility, based on assessment of eligibility criteria for planned clinical trials. Increasingly, RWD are being used to support targeted, timely, and personalized outreach to potential trial participants that may improve the efficiency and effectiveness of the recruitment process. This paper highlights recommendations and resources, including specific case studies, developed by the Clinical Trials Transformation Initiative (CTTI) for applying RWD to planning eligibility criteria and recruiting for clinical trials. Developed through a multi-stakeholder, consensus- and evidence-driven process, these actionable tools support researchers in (1) determining whether RWD are fit for purpose with respect to study planning and recruitment, (2) engaging cross-functional teams in the use of RWD for study planning and recruitment, and (3) understanding patient and site needs to develop successful and patient-centric approaches to RWD-supported recruitment. Future considerations for the use of RWD are explored, including ensuring full patient understanding of data use and developing global datasets.

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Published In

Ther Innov Regul Sci

DOI

EISSN

2168-4804

Publication Date

May 2021

Volume

55

Issue

3

Start / End Page

545 / 552

Location

Switzerland

Related Subject Headings

  • Statistics & Probability
  • Research Design
  • Humans
  • Eligibility Determination
  • Clinical Trials as Topic
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
  • 1117 Public Health and Health Services
  • 0104 Statistics
 

Citation

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ICMJE
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Evans, S. R., Paraoan, D., Perlmutter, J., Raman, S. R., Sheehan, J. J., & Hallinan, Z. P. (2021). Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative. Ther Innov Regul Sci, 55(3), 545–552. https://doi.org/10.1007/s43441-020-00248-7
Evans, Scott R., Dianne Paraoan, Jane Perlmutter, Sudha R. Raman, John J. Sheehan, and Zachary P. Hallinan. “Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative.Ther Innov Regul Sci 55, no. 3 (May 2021): 545–52. https://doi.org/10.1007/s43441-020-00248-7.
Evans SR, Paraoan D, Perlmutter J, Raman SR, Sheehan JJ, Hallinan ZP. Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative. Ther Innov Regul Sci. 2021 May;55(3):545–52.
Evans, Scott R., et al. “Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative.Ther Innov Regul Sci, vol. 55, no. 3, May 2021, pp. 545–52. Pubmed, doi:10.1007/s43441-020-00248-7.
Evans SR, Paraoan D, Perlmutter J, Raman SR, Sheehan JJ, Hallinan ZP. Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative. Ther Innov Regul Sci. 2021 May;55(3):545–552.
Journal cover image

Published In

Ther Innov Regul Sci

DOI

EISSN

2168-4804

Publication Date

May 2021

Volume

55

Issue

3

Start / End Page

545 / 552

Location

Switzerland

Related Subject Headings

  • Statistics & Probability
  • Research Design
  • Humans
  • Eligibility Determination
  • Clinical Trials as Topic
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
  • 1117 Public Health and Health Services
  • 0104 Statistics