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Perez RP, Finnigan S, Patel K, et al. Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project. JMIR Cancer. 2016;2(2):e16doi: 10.2196/cancer.6701.
Perez, R. P., Finnigan, S., Patel, K., Whitney, S., & Forrest, A. (2016). Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project. JMIR cancer, 2(2), e16. https://doi.org/10.2196/cancer.6701
Perez, Raymond P, et al. "Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project." JMIR cancer vol. 2,2 (2016): e16. doi: https://doi.org/10.2196/cancer.6701
Perez RP, Finnigan S, Patel K, Whitney S, Forrest A. Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project. JMIR Cancer. 2016 Dec 15;2(2):e16. doi: 10.2196/cancer.6701. PMID: 28410179; PMCID: PMC5367842.
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JMIR Cancer. 2016 Dec 15;2(2):e16. doi: 10.2196/cancer.6701.

Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project.

JMIR cancer

Raymond P Perez, Shanda Finnigan, Krupa Patel, Shanell Whitney, Annemarie Forrest

Affiliations

  1. The University of Kansas Cancer Center, Kansas City, KS, United States.
  2. National Cancer Institute, National Institutes of Health, Bethesda, MD, United States.
  3. Merck Research Laboratories, Sudbury, MA, United States.
  4. Eli Lilly and Company, Indianapolis, IN, United States.
  5. Clinical Trials Transformation Initiative, Durham, NC, United States.

PMID: 28410179 PMCID: PMC5367842 DOI: 10.2196/cancer.6701

Abstract

BACKGROUND: Use of electronic clinical trial portals has increased in recent years to assist with sponsor-investigator communication, safety reporting, and clinical trial management. Electronic portals can help reduce time and costs associated with processing paperwork and add security measures; however, there is a lack of information on clinical trial investigative staff's perceived challenges and benefits of using portals.

OBJECTIVE: The Clinical Trials Transformation Initiative (CTTI) sought to (1) identify challenges to investigator receipt and management of investigational new drug (IND) safety reports at oncologic investigative sites and coordinating centers and (2) facilitate adoption of best practices for communicating and managing IND safety reports using electronic portals.

METHODS: CTTI, a public-private partnership to improve the conduct of clinical trials, distributed surveys and conducted interviews in an opinion-gathering effort to record investigator and research staff views on electronic portals in the context of the new safety reporting requirements described in the US Food and Drug Administration's final rule (Code of Federal Regulations Title 21 Section 312). The project focused on receipt, management, and review of safety reports as opposed to the reporting of adverse events.

RESULTS: The top challenge investigators and staff identified in using individual sponsor portals was remembering several complex individual passwords to access each site. Also, certain tasks are time-consuming (eg, downloading reports) due to slow sites or difficulties associated with particular operating systems or software. To improve user experiences, respondents suggested that portals function independently of browsers and operating systems, have intuitive interfaces with easy navigation, and incorporate additional features that would allow users to filter, search, and batch safety reports.

CONCLUSIONS: Results indicate that an ideal system for sharing expedited IND safety information is through a central portal used by all sponsors. Until this is feasible, electronic reporting portals should at least have consistent functionality. CTTI has issued recommendations to improve the quality and use of electronic portals.

©Raymond P Perez, Shanda Finnigan, Krupa Patel, Shanell Whitney, Annemarie Forrest. Originally published in JMIR Cancer (http://cancer.jmir.org), 15.12.2016.

Keywords: clinical trials; investigational new drug application; risk management

References

  1. Clin Trials. 2017 Mar 1;:1740774517700640 - PubMed

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