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Effectiveness Guidance Documents resources

Best Practices for the Design, Implementation, Analysis, and Reporting of Oncology Trials with High Rates of Treatment Switching
GPC released a report that provides guidance for researchers who lead oncology drug trials that may involve substantial treatment switching. Treatment switching most often occurs when a patient moves from the control to the experimental group during a clinical trial ' for example, because the patient 's disease has progressed and they want to try the experimental treatment.
Recommendations for Comparing Therapeutic Sequences for Patients with Breast, Kidney, and Other Advanced and Metastatic Cancers (Aug 2015)
This EGD provides recommendations to use real-world data sources in studies to compare sequences of therapies in areas of advanced and metastatic cancer where a range of therapeutic options exist but evidence is lacking on the optimal choices for sequential or combination therapy. The focus is on settings where the expected outcome of therapy is not a cure since patient decisions in these settings often involve negotiation of more complex tradeoffs than in curative settings 'tradeoffs in which factors other than overall survival may have heightened importance. Metastatic breast cancer and renal cell carcinoma served as example disease areas for developing this EGD, but this approach may be relevant for other incurable cancers as well. The EGD recommends the analysis of novel outcomes and suggests ways that existing data sources should be enhanced for more robust research studies of this type.
Recommendations for Late Phase Drug Studies in Type 2 Diabetes (July 2014)
The EGD provides guidance for improving the design, conduct, and reporting of late phase (approval and post-approval) drug studies for patients with type 2 diabetes. It includes specific recommendations for the design of prospective clinical studies that reflect the evidence expectations of payers, informed by the perspectives of patients, clinicians, and other decision makers. The recommendations are made in four major areas: population, outcomes, methods, and reporting for patient stakeholders.
Evaluation of Clinical Validity and Utility of Actionable Molecular Diagnostic Tests in Adult Oncology (May 2013)
While molecular diagnostics offer tremendous promise for improving health and offsetting costs in the oncology setting, the benefits and harms of testing are often not well known in terms that are meaningful to stakeholders. This EGD serves to close the gap between the presumed benefits of tests undergoing technology assessments and the information needs of payers, clinicians and patients. We provide specific recommendations for designing studies to evaluate the clinical validity and utility of 'actionable ' MDx tests, meaning those tests intended to guide clinical decision-making for patients with a known diagnosis of cancer.
Design of Clinical Studies of Pharmacologic Therapies for Alzheimer 's Disease (April 2013)
This EGD on Alzheimer's disease tests a process for developing disease-specific guidance for clinical studies that meet the needs of both payers and health technology assessment bodies.
Methodological Recommendations for Comparative Effectiveness Research on the Treatment of Chronic Wounds (October 2012)
This EGD provides specific recommendations to product developers and clinical researchers on the design of comparative effectiveness studies for the treatment of chronic wounds, specifically those pertaining to arterial and venous disease-related ulcers, diabetic foot ulcers, pressure ulcers, and burn wounds
Proposed Recommendations for Designing Clinical Trials for 'New Indications ' of Approved Oncology Drugs for Treatment of Late Stage Disease (September 2012)
This EGD provides a framework to guide the design and implementation of prospective clinical trials for FDA-approved oncology drugs used outside their current labeled indications to treat late stage cancer.
Research on the Treatment of Atrial Fibrillation (July 2012)
This EGD outlines how future studies can improve our knowledge of atrial fibrillation by addressing certain critical aspects of study design. It also provides a set of priorities, which are intended to address our lack of understanding of disease progression, optimal timing of treatments, and/or the history of disease.
Recommendations for Incorporating Patient-Reported Outcomes into Clinical Comparative Effectiveness Research in Adult Oncology (May 2012)
This EGD provides recommendations to set a minimum standard that will ensure that data collection allows for examination of patients ' directly reported experiences in diverse studies of treatment effectiveness and outcomes in oncology.
Pragmatic Phase 3 Pharmaceutical Trials: Recommendations for the Design of Clinical Trials that Are More Informative for Patients, Clinicians, and Payers (September 2010)
This EGD provides recommendations to guide the implementation of pragmatic study designs for phase 3 pharmaceutical trials. Pragmatic Clinical Trials (PCTs) are designed to assist patients, clinicians, and payers in making informed decisions about alternative drug therapies.
Gene Expression Profile Tests for Early Stage Breast Cancer (released June 2009)
This Evidence Guidance Document provides clinical researchers and product developers with guidelines for the design of studies that meet the evidence requirements of health care decision-makers on gene expression profile tests.

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Effectiveness Guidance Documents resources

Best Practices for the Design, Implementation, Analysis, and Reporting of Oncology Trials with High Rates of Treatment Switching

Recommendations for Comparing Therapeutic Sequences for Patients with Breast, Kidney, and Other Advanced and Metastatic Cancers (Aug 2015)

Recommendations for Late Phase Drug Studies in Type 2 Diabetes (July 2014)

Evaluation of Clinical Validity and Utility of Actionable Molecular Diagnostic Tests in Adult Oncology (May 2013)

Design of Clinical Studies of Pharmacologic Therapies for Alzheimer 's Disease (April 2013)

Methodological Recommendations for Comparative Effectiveness Research on the Treatment of Chronic Wounds (October 2012)

Proposed Recommendations for Designing Clinical Trials for 'New Indications ' of Approved Oncology Drugs for Treatment of Late Stage Disease (September 2012)

Research on the Treatment of Atrial Fibrillation (July 2012)

Recommendations for Incorporating Patient-Reported Outcomes into Clinical Comparative Effectiveness Research in Adult Oncology (May 2012)

Pragmatic Phase 3 Pharmaceutical Trials: Recommendations for the Design of Clinical Trials that Are More Informative for Patients, Clinicians, and Payers (September 2010)

Gene Expression Profile Tests for Early Stage Breast Cancer (released June 2009)