Observational Research/Registries
PPT Presentation by Gemmen et al reporting on the Patient Registry SIG from ISPOR.
Podcast from Criterium, a CRO, featuring John Hudak, MBA.
Comments on the draft handbook from from Bryan Luce, of United BioSource Corp.
PPT Presentation from Patient Registry SIG, 2009.
Presentation at ISPOR Europe, Nov. 2011, by Donna Messner, PhD, Senior Project Manager, Center for Medical Technology Policy, Baltimore, MD, USA
One of the major criticisms of observational research is 'confounding by indication', also referred to as 'treatment selection bias'. Confounding is one of the reasons that randomized controlled trials are considered by many to be the gold standard for answering questions of comparative effectiveness."
Presentation at ISPOR Europe, Nov. 2011 by Rachael Fleurence, PhD, Director, Oxford Outcomes, Bethesda, MD, USA
JMCP Supplement. Includes Ten Commandments for CER, secondary data structures, stat issues, developing collaborative study protocol, and more.
Presentation at ISPOR Europe, Nov. 2011 by Louise Parmenter, PhD, Senior Director, Late Phase Strategy and Planning, Quintiles, Inc., Bracknell, Berkshire, UK
Differences in what regulators and payers are looking for in post-approval information in Europe and the United States seem to be driving greater regional variations in the types of Phase IV clinical trials that pharmaceutical and biotech companies emphasize.
Presentation at ISPOR Europe, Nov. 2011 by Herman Pieterse, PhD, Professor, Clinical Pharmacology, University of Ghent, Heerhugowaard, The Netherlands
Real-world evidence from scientifically valid and innovative observational studies is being required, increasingly, by governmental and commercial payers globally. The findings of these studies are also important input into the decisions of regulators and health system managers responsible for protecting population health, as well as the decisions of physicians managing the health of individual patients.(Source: United BioSource Corp. “Evidence Matters” Newsletter, Oct 2010,Payne, K. et al.)
Advisory Panel Report from ISPOR, with the goal to identify key contentious methodology issues in conducting health care pharmacoeconomic evaluations clinical studies
Presentation at ISPOR Europe, Nov. 2011 by Hannah Patrick, MRCP, MFPHM, Consultant Clinical Advisor to the IP Programme, National Institute of Clinical Excellence (NICE), London, UK
Comparative effectiveness research (CER) may be defined informally as an assessment of available options for treating specific medical conditions in selected groups of patients. In this context, the most prominent features of CER are the various patient populations, medical ailments, and treatment options involved in any particular project.(Source:AJOM, Volume 123, Issue 12, Concato, J. et. al)
Research findings from PharmaNet's 3rd survey on Observational Research. The survey continues to enjoy widespread industry support, reflecting strong interest in the topic and the fundamental need for better data on “real world” outcomes. This version of the survey explored a number of provocative topics and examined trends over time. Although there remain a number of issues that merit ongoing and open discussion, there is progress in the field.
Results from survey conducted by J Trotter Research & Consulting on issues related to observational and registry research. Download PDF of preliminary results.
Goals: determine and define the most appropriate language for patient registry standardization,, a patient registry terminology (common language),
universal patient registry characteristics and a globally harmonized patient registry classification system. To establish good research practices related to choices of registry strategy and consequent design.
Late phase trials and post-marketing surveillance – once thought of simply as regulatory compliance tasks – have increasing value to biopharmaceutical companies' long-term business strategies. Today, such research is crucial for demonstrating product value to sponsors and a multitude of other stakeholders.
Patient registries are observational studies that focus on understanding how the treatments, tests, and services that are used in routine clinical care and by specialists affect patient health outcomes. A registry that is appropriately designed, conducted, and analyzed will provide unique scientific information about the effectiveness, safety, and quality of the health-care service or intervention that is being studied.
Comments from United Biosource Corp. on AHRQ draft handbook, Registries for Evaluating Patient Outcomes.
Registry of volunteers willing to learn more about research studies. Research needs both volunteers and researchers. ResearchMatch helps bring these two groups together in a secure and more convenient way.
Physicians around the nation exchange the latest medical insights with each other and improve patient outcomes - 24/7. Used for epidemiology, patient outcomes, surveys, etc.
Late Stage Clinical Development industry survey designed to shed some light on how best to demonstrate clinical benefit, manage safety and minimize product risk from Hanson Wade.
Four major content areas for which abstracts were solicited from scientists across the United States included: (1) study design, (2) data collection, (3) statistics and analytic methods, and (4) policy issues and applications. The symposium proceedings are published in a supplement to the June 2010 issue of the journal Medical Care. A printed copy of the supplement is available free of charge through the AHRQ Publications Clearinghouse.
Pharma Co's must "get a grip" on late-phase research, or other groups (e.g., payers, FDA) will do it for you, and decisions will be based on price!
Presentation at ISPOR Europe, Nov. 2011, by Patrick Keohane, MB, BS, MRCP(UK), Vice President, Payer Evidence, AstraZeneca, Södertälje, Sweden
Presentation at ISPOR Europe, Nov. 2011, byXavier Badia, PhD, MD, MPH, Global Leader, Observational COE and Senior Principal, Health Economics and Outcomes Research, IMS Health, Barcelona, Spain
Presentation at ISPOR Europe, Nov. 2011, by Leslie Levin, MB, MD(Birm), FRCP(Lon), FRCPC, Head of the Medical Advisory Secretariat, Health Quality Ontario, Toronto, ON, Canada
Insight into the reasons for choosing one type of comparative effectiveness research study design over another. (Source: 5/24, National Pharmaceutical Council: E.V.I.dently Today)
