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Investigators' Experience With Expedited Safety Reports Prior to the FDA's Final IND Safety Reporting Rule.

Kramer JM, Vock D, Greenberg HE, Janning C, Szczech L, Salgo M, Gagnon S, Ellenberg S - Ther Innov Regul Sci (2014)

Bottom Line: Few expedited safety reports were retrospectively said to have changed study conduct or informed consent.However, a low response rate and the concentration of clinical sites in a single therapeutic area preclude generalizing these results.The authors discuss the challenges in gaining investigators' cooperation to evaluate the impact of regulatory requirements.

View Article: PubMed Central - PubMed

Affiliation: Duke Translational Medicine Institute, Duke University School of Medicine, Durham, NC, USA ; Department of Medicine, Duke University School of Medicine, Durham, NC, USA ; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.

ABSTRACT
Prior to enactment of the final investigational new drug application (IND) safety reporting rule, an attempt was made to document the effort expended at investigative sites in processing IND safety reports from sponsors and to assess the effect of these expedited reports on trial conduct. Investigators were asked to (1) prospectively document time to process IND safety reports and (2) retrospectively review safety reports from a previous 3-month period, documenting resultant actions. In this limited sample, sites spent a median of 0.25 hours per report at a median cost of US$22. Few expedited safety reports were retrospectively said to have changed study conduct or informed consent. However, a low response rate and the concentration of clinical sites in a single therapeutic area preclude generalizing these results. The authors discuss the challenges in gaining investigators' cooperation to evaluate the impact of regulatory requirements. Better methods to facilitate this type of research will enrich the scientific basis of future clinical trial regulation and guidance.

No MeSH data available.


Prospective data form—resource requirements.
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fig1-2168479013520160: Prospective data form—resource requirements.

Mentions: To avoid recall bias, we asked investigators to prospectively record the time that they and their staff spent in receiving, interpreting, and communicating expedited safety reports from IND sponsors. Participants were provided with a single-page paper form (Figure 1) to be kept at the workstation of the person (or persons) responsible for processing expedited safety reports. Using this form, investigators were asked to document over a period of 8 weeks the number of individual expedited safety reports received, the time required for managing the reports, and the type of personnel involved in interpreting and communicating relevant information to other staff and to the IRB.


Investigators' Experience With Expedited Safety Reports Prior to the FDA's Final IND Safety Reporting Rule.

Kramer JM, Vock D, Greenberg HE, Janning C, Szczech L, Salgo M, Gagnon S, Ellenberg S - Ther Innov Regul Sci (2014)

Prospective data form—resource requirements.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2 - License 3
Show All Figures
getmorefigures.php?uid=PMC4230957&req=5

fig1-2168479013520160: Prospective data form—resource requirements.
Mentions: To avoid recall bias, we asked investigators to prospectively record the time that they and their staff spent in receiving, interpreting, and communicating expedited safety reports from IND sponsors. Participants were provided with a single-page paper form (Figure 1) to be kept at the workstation of the person (or persons) responsible for processing expedited safety reports. Using this form, investigators were asked to document over a period of 8 weeks the number of individual expedited safety reports received, the time required for managing the reports, and the type of personnel involved in interpreting and communicating relevant information to other staff and to the IRB.

Bottom Line: Few expedited safety reports were retrospectively said to have changed study conduct or informed consent.However, a low response rate and the concentration of clinical sites in a single therapeutic area preclude generalizing these results.The authors discuss the challenges in gaining investigators' cooperation to evaluate the impact of regulatory requirements.

View Article: PubMed Central - PubMed

Affiliation: Duke Translational Medicine Institute, Duke University School of Medicine, Durham, NC, USA ; Department of Medicine, Duke University School of Medicine, Durham, NC, USA ; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.

ABSTRACT
Prior to enactment of the final investigational new drug application (IND) safety reporting rule, an attempt was made to document the effort expended at investigative sites in processing IND safety reports from sponsors and to assess the effect of these expedited reports on trial conduct. Investigators were asked to (1) prospectively document time to process IND safety reports and (2) retrospectively review safety reports from a previous 3-month period, documenting resultant actions. In this limited sample, sites spent a median of 0.25 hours per report at a median cost of US$22. Few expedited safety reports were retrospectively said to have changed study conduct or informed consent. However, a low response rate and the concentration of clinical sites in a single therapeutic area preclude generalizing these results. The authors discuss the challenges in gaining investigators' cooperation to evaluate the impact of regulatory requirements. Better methods to facilitate this type of research will enrich the scientific basis of future clinical trial regulation and guidance.

No MeSH data available.