Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making Workshop Report (1999) / Chapter Skim
Currently Skimming:
Pages 26-41
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 26... ...
26 FDA Regulatory Review PAPER AUDITING Presented by Jay P Siegel, M.D.
|
From page 27... ...
FDA REGULATORY REVIEW 27 (QA) efforts can be powerful and effective.
|
From page 28... ...
ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS28 years and that focus on five groups: Institutional Review Boards (IRBs) , clinical investigators, sponsors, contract research organizations, and monitors.
|
From page 29... ...
FDA REGULATORY REVIEW 29 TABLE 1 Time and Costs of Each Clinical Investigator or IRB Inspection Type of Inspection Time (hours)
|
From page 30... ...
ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS30 More than 50 percent of domestic clinical investigator inspections revealed at least minor deficiencies. In most cases, these deficiencies were of a nature that should have been detectable, correctable, and preventable with effective monitoring.
|
From page 31... ...
FDA REGULATORY REVIEW 31 only 4 percent of domestic sites received this classification (see Figure 2)
|
From page 32... ...
ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS32 (1) clinical investigators, (2)
|
From page 33... ...
FDA REGULATORY REVIEW 33 ASSESSMENT OF DRUGS Presented by Murray Lumpkin, M.D. Deputy Director for Review Management Center for Drug Evaluation and Research, Food and Drug Administration When the results of paper audit and on-site review are completed, two fundamental questions may determine their impact on decision making: 1.
|
From page 34... ...
ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS34 Of the five applications with a more serious rating of voluntary action indicated, the number and nature of the discrepancies were less egregious than those at sites with a rating of official action indicated, such as admission of a subject before collection of a signed consent, no record of institutional review board approval for protocol amendments, failure to randomize all subjects, and inability to produce original documents. These problems appeared to occur randomly and were deemed administrative rather than analytic.
|
From page 35... ...
FDA REGULATORY REVIEW 35 plication. These findings suggest that the majority of investigators are conducting clinical trials correctly.
|
From page 36... ...
ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS36 • In one case, informed-consent documents for some of the subjects at several sites were absent, and failure to follow the protocol was determined at another site. These discrepancies, however, did not have a significant negative impact on data quality.
|
From page 37... ...
FDA REGULATORY REVIEW 37 terminate the study. The case studies provided here demonstrate that audits increase the quality of the data across the board.
|
From page 38... ...
ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS38 need to modify medical education and to certify clinical investigators, as is already done for other subspecialties. Although certification of clinical investigators may also be desirable for research coordinators, there is a need to explore alternative incentives (and reimbursement patterns)
|
From page 39... ...
FDA REGULATORY REVIEW 39 panies in designing programs that permit expanded access to clinical trials (see the box on The National Breast Cancer Coalition)
|
From page 40... ...
ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS40 be invited to address data sets and data quality measures as early as possible in the process. Other panelists expressed reservations about having FDA work closely with sponsors in planning the design of a trial.
|
From page 41... ...
FDA REGULATORY REVIEW 41 National Breast Cancer Coalition Continued • developed a science course designed to educate advocates in the basic science, medical language, and concepts of breast cancer, as well as in the breast cancer research decision-making structure; • developed a program to educate members of Congress and their staffs on the science, health care, and medical practices that are important for implementation of policies related to breast cancer; • launched a breast cancer political campaign; • brought together more than 250 breast cancer activists from 43 countries to help create or expand networks and collaboration, as well as to share information, ideas, and strategies in the fight against the disease; • developed a program to educate and train the media in the tools essential for critical analysis of information on breast cancer before relaying that information to the public; and • initiated the Clinical Trials Project, which educates NBCC members on the importance of clinical trials and trains them to work in partnership with industry and the scientific community to expedite the conduct of clinical trials. Such trials provide an opportunity to involve consumers in the search for answers to research questions that may subsequently result in important new advances in the field.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.