Current perspectives on monitoring in clinical trials: Clinical Trials Transformation Initiative update and recommendations Dr Martin Landray Reader in Epidemiology & Honorary Consultant Physician Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU) University of Oxford
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Current perspectives on monitoring in clinical trials:
Clinical Trials Transformation Initiative update and recommendations
Dr Martin Landray Reader in Epidemiology & Honorary Consultant Physician
Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU)
University of Oxford
Need for reliable evidence from clinical trials
• Essential for appropriate decision making concerning the benefits and risks associated with clinical interventions.
• Decisions made in the absence of reliable evidence (either because relevant trials have never been performed or because those that have been performed were poorly designed or conducted) may harm individual patients and public health.
FDA Clinical Trials Transformation Initiative
Mission
• To identify practices that through broad adoption will increase the quality and efficiency of clinical trials
• Seek incremental improvements to current system
• Identify and shape potential transformational changes to the system
Strategy
Encouraging Incremental Change
• Develop evidence that may generate recommendations for improvement and inform regulatory guidance
• Involve all sectors in selection, conduct, and interpretation of projects
• Identify and eliminate activities in the conduct of trials that do not add value
• Understand incentives to maintain non-value-added activities
• Maintain an open and respectful dialogue across sectors
• Develop solutions that are mindful of the needs of patients and all sectors in the clinical research enterprise
• Objectives 1. Describe the range of current monitoring practices and
examine factors that drive their adoption (What’s happening?)
2. Define key quality objectives for monitoring clinical trials (What’s the aim?)
3. Examine ways to build quality into trials to enable more focused and efficient monitoring (How can we improve?)
– Collaboration between academia, industry, and regulators to share methodologies and data
• Encourage appropriate regulatory guidance
– Emphasize key principles of quality trials (i.e. human subjects protection, reliable results, protocol adherence)
– Encourage risk-focused oversight of trials
• Promote education and awareness
– Audience: those involved in design, implementation, analysis, interpretation, regulation, inspection, and publication of clinical trials
– Include users of results (e.g. health care providers, doctors, patients)
• Seek international adoption and harmonization
– Facilitate global adoption of proposed changes
Draft US FDA Guidance on a risk-based approach to monitoring (August 2011)
“There is a growing consensus that risk-based approaches to monitoring, such as focussing on the most critical data elements, are more likely to ensure subject protection and overall study quality, and will permit sponsors to monitor the conduct of clinical investigations more effectively than routine visits to all clinical sites and 100% data verification.”
Quality by Design (QbD)
Protocol
(Plan)
- assess key risks
(likelihood, impact)
- plan mitigation
- plan evaluation
Operations
(Do)
- organization, training,
systems and procedures
tailored to the protocol
Monitoring
(Check)
- measure and evaluate
performance
Make improvements
(Act)
- re-assess risks
- make appropriate changes
to protocol, operations or
monitoring
Landray 2011
• Objectives – Develop principles
– Review case-studies
– Develop skills
– Explore evaluation methods
– Dissemination of results
• Leaders – Martin Landray (University of Oxford)
– Briggs Morrison (Astra-Zeneca)
– Ann Meeker-O’Connell (OSI, CDER, FDA)
Quality by Design Project
References
• Academy of Medical Sciences: A new pathway for the regulation and governance of health research. http://www.acmedsci.ac.uk/p99puid209.html
• Morrison BW, Cochran CJ, White JG et al. Monitoring the quality of conduct of clinical trials: a survey of current practices. Clin Trials 2011;8(3):342-349.
• FDA Draft Guidance: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring htttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf
• EMA Reflection Paper on risk based quality management in clinical trials. Draft for consultation. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500110059.pdf
• MRC/DH/MHRA Joint Project report on risk-adapted approaches to the management of clinical trials of investigational medicinal products http://www.mhra.gov.uk/home/groups/l-ctu/documents/websiteresources/con111784.pdf