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Improving the quality conduct and efficiency of clinical trials with training: Recommendations for preparedness and qualification of investigators and delegates.
Contemp Clin Trials. 2020 02; 89:105918.CC

Abstract

The Clinical Trials Transformation Initiative (CTTI) Investigator Qualification Project addresses the need for a more efficient and effective means of identifying qualified clinical investigators and delegates. Selection of investigators and delegates who are qualified by training and experience to conduct clinical trials is essential to safeguarding protections for study participants and ensuring data quality and integrity. Sponsors generally document investigator qualification through training on the principles of good clinical practice (GCP), as defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), adopted by regulatory authorities in the United States, Japan and the European Union. Although these GCP principles provide an important foundation for promoting the conduct of quality clinical trials, the industry standard "one-size-fits-all" GCP training may not fully prepare investigators and delegates for conducting quality clinical trials. Routine GCP training alone may not be sufficient to prepare an inexperienced member of a site team, while repeating such training is unlikely to enhance the qualifications of an experienced researcher. The CTTI project team used findings from qualitative research activities, as well as input from an expert meeting with multiple stakeholders, to identify gaps and redundancies in the current training of investigators and their delegates and recommend practical, action-based solutions. CTTI provides recommendations on how to implement a more efficient and effective means of preparedness and qualification of investigators and delegates, determining whether a site team is a good fit for a particular protocol, and improving the quality of clinical trial conduct.

Authors+Show Affiliations

Society for Clinical Research Sites, 7250 Parkway Dr, Suite 405, Hannover, MD 21076, United States of America. Electronic address: jimmy.bechtel@myscrs.org.The Feinstein Institutes for Medical Research, Northwell Health, 125 Community Dr, Great Neck, NY 11021, United States of America. Electronic address: tchuck@northwell.edu.Clinical Trials Transformation Initiative, PO Box 17969, Durham, NC 27714, United States of America. Electronic address: annemarie.forrest@duke.edu.Amici Clinical Research, 34 E Somerset St, Raritan, NJ 08869, United States of America. Electronic address: christine.hildebrand@amicicr.com.Population Health Research Institute, 237 Barton St E, Hamilton, ON L8L 2X2, Canada. Electronic address: janette.panhuis@phri.ca.US Food and Drug Administration, 10903 New Hampshire Ave, White Oak, Bldg. 51, Rm. 3328, Silver Spring, MD 20993, United States of America. Electronic address: suzanne.pattee@fda.hhs.gov.The Medicines Company, 8 Sylvan Way, Parsippany, NJ 07054, United States of America. Electronic address: sabrina.comic-savic@themedco.com.Clinical Trials Transformation Initiative, PO Box 17969, Durham, NC 27714, United States of America; Department of Population Health Sciences, School of Medicine, Duke University, 215 Morris St, Durham, NC 27701, United States of America. Electronic address: teresa.swezey@duke.edu.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

31881391

Citation

Bechtel, Jimmy, et al. "Improving the Quality Conduct and Efficiency of Clinical Trials With Training: Recommendations for Preparedness and Qualification of Investigators and Delegates." Contemporary Clinical Trials, vol. 89, 2020, p. 105918.
Bechtel J, Chuck T, Forrest A, et al. Improving the quality conduct and efficiency of clinical trials with training: Recommendations for preparedness and qualification of investigators and delegates. Contemp Clin Trials. 2020;89:105918.
Bechtel, J., Chuck, T., Forrest, A., Hildebrand, C., Panhuis, J., Pattee, S. R., Comic-Savic, S., & Swezey, T. (2020). Improving the quality conduct and efficiency of clinical trials with training: Recommendations for preparedness and qualification of investigators and delegates. Contemporary Clinical Trials, 89, 105918. https://doi.org/10.1016/j.cct.2019.105918
Bechtel J, et al. Improving the Quality Conduct and Efficiency of Clinical Trials With Training: Recommendations for Preparedness and Qualification of Investigators and Delegates. Contemp Clin Trials. 2020;89:105918. PubMed PMID: 31881391.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Improving the quality conduct and efficiency of clinical trials with training: Recommendations for preparedness and qualification of investigators and delegates. AU - Bechtel,Jimmy, AU - Chuck,Tina, AU - Forrest,Annemarie, AU - Hildebrand,Christine, AU - Panhuis,Janette, AU - Pattee,Suzanne R, AU - Comic-Savic,Sabrina, AU - Swezey,Teresa, Y1 - 2019/12/24/ PY - 2019/09/18/received PY - 2019/12/16/revised PY - 2019/12/23/accepted PY - 2019/12/28/pubmed PY - 2019/12/28/medline PY - 2019/12/28/entrez KW - Clinical trials KW - Good clinical practice KW - Investigator qualification KW - Investigator training SP - 105918 EP - 105918 JF - Contemporary clinical trials JO - Contemp Clin Trials VL - 89 N2 - The Clinical Trials Transformation Initiative (CTTI) Investigator Qualification Project addresses the need for a more efficient and effective means of identifying qualified clinical investigators and delegates. Selection of investigators and delegates who are qualified by training and experience to conduct clinical trials is essential to safeguarding protections for study participants and ensuring data quality and integrity. Sponsors generally document investigator qualification through training on the principles of good clinical practice (GCP), as defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), adopted by regulatory authorities in the United States, Japan and the European Union. Although these GCP principles provide an important foundation for promoting the conduct of quality clinical trials, the industry standard "one-size-fits-all" GCP training may not fully prepare investigators and delegates for conducting quality clinical trials. Routine GCP training alone may not be sufficient to prepare an inexperienced member of a site team, while repeating such training is unlikely to enhance the qualifications of an experienced researcher. The CTTI project team used findings from qualitative research activities, as well as input from an expert meeting with multiple stakeholders, to identify gaps and redundancies in the current training of investigators and their delegates and recommend practical, action-based solutions. CTTI provides recommendations on how to implement a more efficient and effective means of preparedness and qualification of investigators and delegates, determining whether a site team is a good fit for a particular protocol, and improving the quality of clinical trial conduct. SN - 1559-2030 UR - https://www.unboundmedicine.com/medline/citation/31881391/Improving_the_quality_conduct_and_efficiency_of_clinical_trials_with_training:_Recommendations_for_preparedness_and_qualification_of_investigators_and_delegates_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1551-7144(19)30634-2 DB - PRIME DP - Unbound Medicine ER -
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