Data Integrity in Clinical Trials: Ensuring Valid Results
The FDA has trained its laser focus on data integrity. Will you be ready when the agency scrutinizes your clinical trials?
Now is the time to examine your practices and close gaps to protect the integrity and validity of your clinical trial results. The newly updated Data Integrity in Clinical Trials: Ensuring Valid Results will show you how.
Investigators and sponsors must follow protocols and regulations to the letter to ensure the right data are captured. Enrolling the wrong subjects, administering tests incorrectly or using the wrong measures to interpret the study endpoint can all derail a trial as easily as incomplete documentation.
Gone are the days of the single-site trial managed by a physician-investigator in a hospital or academic medical center. With multisite and global trials, corporate sponsorship, electronic data collection and outsourcing of trial operations now the norm, the challenges inherent in such complex trial setups can make or break a study.
“The quality of conduct of an FDA-regulated clinical investigation is inextricably intertwined with data integrity,” says former clinical investigator and FDA advisory panel member Beverly Lorell, contributor to Data Integrity in Clinical Trials: Ensuring Valid Results.
This report details the challenges of maintaining data integrity, offering solutions for closing gaps that could lead to tainted results, including:
- How electronic records require special safeguards
- How patient-collected and stored data must be monitored
- How researchers need proper training and updates when changes in protocols occur
- … and much more.
Data Integrity in Clinical Trials provides answers to these pressing questions:
- How inadequate training of researchers can threaten data integrity
- How bioresearch monitoring (BIMO) programs monitor trials and recent inspection trends
- Common data integrity traps
- How to prioritize remediation efforts by risk; and
- How current trends in clinical trials make data security more complicated — and more important — than ever, including increased FDA scrutiny of data monitoring committees, data reporting by trial subjects themselves and corporate pressure to cull topline data for press releases.
The report also looks at how the FDA’s BIMO program inspects clinical trials and the consequences that can happen to trials with problems.
Data Integrity in Clinical Trials explains how to identify data integrity problems, prevent potential missteps and create a remediation strategy that corrects violations and builds a structure for protecting the validity of a trial’s findings — a must for anyone conducting clinical trials.
About the Contributor
Beverly Lorell, MD is the senior medical and policy adviser within King & Spalding’s FDA & Life Sciences practice group in Washington, D.C. She specializes in the clinical trial design for drug, device and biologics studies; review of premarket submissions; recalls; and assessment of matters involving a risk to health. Dr. Lorell also specializes in physician and industry relations and develops independent scientific panels to advise health industries. She was previously professor of medicine at Harvard University and has more than 25 years of experience as a practicing interventional cardiologist and heart failure specialist. While at Harvard, Dr. Lorell served the federal government in multiple roles, including as a member of the FDA’s Cardiovascular and Renal Drugs Advisory Committee. She is an internationally recognized clinical and basic science investigator with extensive experience in multicenter clinical trials and preclinical proof-of-concept translational science. Prior to joining King & Spalding, Dr. Lorell served as vice president and global chief medical and technology officer at Guidant. Her responsibilities there included evaluating emerging technologies and regulatory challenges, determining product development priorities and influencing clinical research strategies.
Who Will Benefit
- Directors of clinical operations
- Regulatory affairs professionals
- Principal investigators
- Clinical research associates (CRAs)
- Clinical research coordinators (CRCs)
- Site managers
- IT department personnel
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Beverly Lorell, MD
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