Considerations in the Evaluation of Surrogate Endpoints in Clinical Trials

Gruttola, Victor G De; Clax, P.; DeMets, David L.; Downing, Gregory J.; Ellenberg, Susan S.; Friedman, Lawrence M.; Gail, Mitchell H.; Prentice, Ross L.; Wittes, Janet; Zeger, Scott L.

doi:10.1016/s0197-2456(01)00153-2

Cited by 381 publications

(233 citation statements)

References 17 publications

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“…Various meta-analytical models are used to validate CoP for this purpose. 9,26,27 Of note, it is generally recommended that before performing the meta-analysis the candidate CoP be recognized as such at the individual trial level. 10 …”

Section: Methods For Investigating Vaccine Copmentioning

confidence: 99%

“…However, some authors are skeptical about this type of analysis. 9,20 Statistical analyses for individual VE trials In numerous vaccine studies, a threshold level of an immune assay above which subjects do not develop disease have been identified. 15 Individuals who achieve the threshold after vaccination are considered protected.…”

Section: Methods For Investigating Vaccine Copmentioning

confidence: 99%

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Correlates of protection for rotavirus vaccines: Possible alternative trial endpoints, opportunities, and challenges

Ángel

Steele

Franco

2014

Human Vaccines & Immunotherapeutics

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Rotavirus (RV) is a major vaccine-preventable killer of young children worldwide. Two RV vaccines are globally commercially available and other vaccines are in different stages of development. Due to the absence of a suitable correlate of protection (CoP), all RV vaccine efficacy trials have had clinical endpoints. These trials represent an important challenge since RV vaccines have to be introduced in many different settings, placebo-controlled studies are unethical due to the availability of licensed vaccines, and comparator assessments for new vaccines with clinical endpoints are very large, complex, and expensive to conduct. A CoP as a surrogate endpoint would allow predictions of vaccine efficacy for new RV vaccines and enable a regulatory pathway, contributing to the more rapid development of new RV vaccines. The goal of this review is to summarize experiences from RV natural infection and vaccine studies to evaluate potential CoP for use as surrogate endpoints for assessment of new RV vaccines, and to explore challenges and opportunities in the field.

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Section: Methods For Investigating Vaccine Copmentioning

confidence: 99%

Section: Methods For Investigating Vaccine Copmentioning

confidence: 99%

Correlates of protection for rotavirus vaccines: Possible alternative trial endpoints, opportunities, and challenges

Ángel

Steele

Franco

2014

Human Vaccines & Immunotherapeutics

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“…Simultaneously, there is a growing awareness of the importance of rigorous analysis and testing of these markers, leading to more sophisticated nomenclature and biostatistical approaches related to evaluation of biomarkers and surrogate end points. Table 1 shows a glossary of terms for end points in clinical trials (1,2).…”

Section: Surrogate End Pointsmentioning

confidence: 99%

Surrogate End Points for Clinical Trials of Kidney Disease Progression

Stevens

Greene

Levey

2006

Clinical Journal of the American Society of Nephrology

120

123

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“…A biomarker is a biologic characteristic that is measured and evaluated objectively as an indicator of normal biologic processes, pathogenic processes, or pharmacologic response to therapeutic intervention (Table 1) (9,10). Biomarkers may be any parameter of a patient that can be measured, for example, mRNA expression profiles, proteins, proteomic patterns, lipids, imaging methods, or electrical signals.…”

Section: Definitionsmentioning

confidence: 99%

Discovery of Protein Biomarkers for Renal Diseases

Hewitt¹,

Dear²,

Star³

2004

Journal of the American Society of Nephrology

271

150

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Abstract. Animal models and human studies have been useful in dissecting the molecular mechanisms of renal disease and finding new disease targets; however, translation of these findings to new clinical therapeutics remains challenging. Difficulties with detecting early disease, measuring drug effectiveness, and the daunting cost of clinical trials hampers the development of new therapeutics for renal diseases. Many existing laboratory tests were discovered because of inspired recognition that a particular protein might prove useful in clinical practice. New unbiased genomic and proteomic techniques identify many constituents present in biologic samples and thus may greatly accelerate biomarker research. This review focuses on the steps needed to develop new biomarkers that are useful in laboratory and clinical investigations, with particular focus on new proteomic screening technologies. New biomarkers will speed the laboratory and clinical development of new treatments for renal diseases through mechanistic insights, diagnoses that are more refined, early detection, and enhanced proof of concept testing.

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Considerations in the Evaluation of Surrogate Endpoints in Clinical Trials

Cited by 381 publications

References 17 publications

Correlates of protection for rotavirus vaccines: Possible alternative trial endpoints, opportunities, and challenges

Correlates of protection for rotavirus vaccines: Possible alternative trial endpoints, opportunities, and challenges

Surrogate End Points for Clinical Trials of Kidney Disease Progression

Discovery of Protein Biomarkers for Renal Diseases

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