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Patient Reported Outcomes (PROs): Overview and Guidance for clinical trials and medical product labeling
Thursday, December 13, 2012 from 10:00 AM to 11:00 AM (PST)
This webinar on patient-reported outcomes (PRO) will discuss the conceptual framework of PRO, its reliability, validity, and sensitivity when used in clinical trials. The current guidelines released to standardize PRO usage and interpretation in clinical trials will also be discussed.
Why Should You Attend:
A patient-reported outcome (PRO) is “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.” Use of such outcome measures has recently increased as PROs have gained greater credibility and can play an important role in drug approval. Regulatory bodies in the US and EU have released guidelines aiming to standardize PRO use and interpretation in clinical trials supporting medicinal product submissions. This webinar provides an overview of the philosophy and assumptions underlying the use of PROs, current perspectives and guidance for their use in clinical trials.
Areas Covered in the Webinar:
- PRO instruments: Conceptual framework, endpoint models.
- Reliability, Validity, and Sensitivity.
- Existing instruments, modified instruments, and newly created instruments. Types of evidence needed for FDA review.
- Protocol Considerations.
- Electronic Data Capture.
- Multiple and Composite Endpoints.
- Statistical Considerations: SAPs
- Interpretation of Clinical Trial Results.
Who will Benefit:
Professionals who will benefit from this webinar include:
- Pharmaceutical and Medical Device Company Representatives and Decision-Makers
- Clinical Research Professionals
- Clinical Protocol Developers
- Clinical Study Managers
- Regulatory Managers
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.