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Surrogate Markers - American Statistical Association

Surrogate Markers and its role in the. Drug Development Process. Aloka G. Chakravarty, Ph.D. Director,. Biologics Therapeutics Statistical Staff .
http://www.amstat.org/meetings/fdaworkshop/presentations/2004/ParallelSession6/ParallelSession6B.ppt


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Surrogate Endpoints And FDA's Accelerated Approval Process

This paper considers issues related to validating surrogate endpoints—that is, identifying when effects on biological markers would accurately predict when .
http://content.healthaffairs.org/content/24/1/67.full


One of the first questions most people usually ask is "what is a surrogate marker much does a

Surrogate marker - definition from Biology-Online.org

Definition and other additional information on Surrogate marker from Biology- Online.org dictionary.
http://www.biology-online.org/dictionary/Surrogate_marker


Appropriate Endpoints in Clinical Trials and Markers for Long-Term ...

robust surrogate markers for the outcome of interest. ?Smaller . surrogate marker has been standardized. – Including . What is a Surrogate Marker? • Defining .
http://ctep.cancer.gov/highlights/docs/wolff.pdf


Biomarkers and Surrogate Markers: An FDA Perspective

Summary: Interest is increasing rapidly in the use of surrogate markers as primary measures of the effectiveness of investigational drugs in definitive drug trials.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC534924/


Surrogate Markers in AIDS Clinical Trials - Clinical Infectious Diseases

The identification of surrogate markers for clinical end points has important . concept of a surrogate marker and the properties of an ideal marker are discussed.
http://cid.oxfordjournals.org/content/16/Supplement_1/S22.full.pdf



Workshop Presentation: Use of Surrogate Markers of Efficacy

2. Current State of Efficacy Evaluation of. Pandemic Influenza Vaccines. • Evaluation of pandemic influenza vaccines will depend upon surrogate measures of .
http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm090498.pdf


Beware surrogate markers: colon polyps, arterial plaque, cholesterol ...

Aug 3, 2010 . Michael Kirsch, M.D, who blogs as MD Whistleblower, offers an educational insight about surrogate markers – especially helpful if you don't .
http://www.healthnewsreview.org/2010/08/beware-surrogate-markers-colon-polyps-arterial-plaque-cholesterol-tumor-markers/

"Interested in Breeding your

Surrogate markers - Aidsmap

A surrogate marker is an indirect measure. In HIV disease, morbidity and mortality are direct markers of disease progression; laboratory tests are surrogate .
http://www.aidsmap.com/Surrogate-markers/page/1391214/



Introduction to Surrogate Markers

The clinical complications of atherosclerosis and atherothrombotic disease represent the major causes of morbidity and mortality in the United States and .
http://circ.ahajournals.org/content/109/25_suppl_1/IV-20.full


1.7 CD4 count as a surrogate marker | Treatment training manual

Jul 23, 2011 . The CD4 count is a good surrogate marker for how much HIV has damaged your immune system. It can tell you your risk of infections and when .
http://i-base.info/ttfa/section-1/17-cd4-count-as-a-surrogate-marker/


Surrogate endpoint - Wikipedia, the free encyclopedia

Surrogate markers are used when the primary endpoint is undesired (e.g., death) , . from clinical trials that show a direct clinical benefit to surrogate markers.
http://en.wikipedia.org/wiki/Surrogate_endpoint


listings on the internet and in newspapers where Labradoodle and

The Difference Between a Surrogate Marker and a Risk Factor.

May 18, 2011 . A surrogate marker on the other hand should be considered a clue that the person is at risk for health problems in the future. Microalbuminuria .
http://www.michaelaaronsonmd.com/backintheday/indexd7d8.html?p=153


Surrogate Markers - Rethinking AIDS

The commonest surrogate markers used in HIV/AIDS research are CD4/CD8 cell counts/ratios and Viral Load. Decisions made on the basis of these lab counts .
http://rethinkingaids.com/quotes/test-surrogate.html


Surrogate marker - Medical Dictionary - The Free Dictionary

Lab medicine A parameter or measured to detect a pathologic condition when a more specific test doesn't exist, is impractical or not cost-effective; surrogate .
http://medical-dictionary.thefreedictionary.com/surrogate+marker



Surrogate outcome markers in research and clinical practice ...

Dec 11, 2010 . A surrogate measure or marker aims to predict a clinical outcome or prognosis. Surrogates are often used in drug or therapeutic intervention .
http://www.australianprescriber.com/magazine/32/2/47/50


Player Surrogate Marker "USED?" | Swing States 2012 | BoardGameGeek

I have a quick rules question about the player surrogate marker. My interpretation of the effect of the player surrogate marker is as follows: 1.
http://boardgamegeek.com/thread/838572/player-surrogate-marker-used


Full text | Interferon-gamma, a valuable surrogate marker of ...

Immunity against the pre-erythrocytic stages of malaria is the most promising, as it is strong and fully sterilizing. Yet, the underlying immune effectors against the .
http://www.malariajournal.com/content/10/1/27


Pros and cons of surrogate markers, part 1 | Parkhurst Exchange

As physicians, we often rely on surrogate markers to determine the best course of treatment for a given patient. Indicators such as blood glucose, low-density .
http://www.parkhurstexchange.com/columns/sept08-p13


Surrogate endpoints: a regulatory review

Jun 11, 2010 . “selection of a surrogate marker as study endpoint requires it to be reasonably likely – based on epidemiologic, pathophysiologic, or other .
http://www.slideshare.net/timfelgate/surrogate-endpoints-a-regulatory-review


Abstract | Total Lymphocyte Count as surrogate marker for CD4 Cell ...

Jul 15, 2012 . The high cost of CD4 count estimation in resource-limited countries is a major challenge in.
http://www.aidsrestherapy.com/content/9/1/21


Biochemical Surrogate Markers of Liver Fibrosis ... - Hepatitis Central

Biochemical Surrogate Markers of Liver Fibrosis and. Activity in a Randomized Trial of Peginterferon Alfa-2b and Ribavirin. Thierry Poynard,1 John McHutchison .
http://www.hepatitiscentral.net/hcv/info/2003/aug/hepcinfo481.pdf


Surrogate Markers for Cardiovascular Disease - Circulation

Although there is convincing evidence that endothelial function predicts future outcome, evidence that such a measure can be a surrogate marker for assessing .
http://circ.ahajournals.org/content/109/25_suppl_1/IV-31.full


they are not intended to provide the same advantages that the more
expensive cars do.

Total lymphocyte count as a surrogate marker for ... - BioMed Central

CD4 testing is the recognized gold standard used to stage HIV/AIDS, guide treatment decisions for HIV-infected persons and evaluate effectiveness of therapy.
http://www.biomedcentral.com/1471-2334/12/128


GKA Online Academy | Surrogate Markers: False Prophets!?

Sep 6, 2012 . An interesting article in the BMJ by Prof Yudkin and colleagues in London is entitled:
http://www.gkaonlineacademy.com/blog/4017-surrogate-markers-false-prophets


Surrogate Markers for Cardiovascular Disease - Circulation

Careful carotid ultrasound examination and IMT measurement performed by an experienced laboratory can provide a useful surrogate marker for atherosclerotic .
http://circ.ahajournals.org/content/109/25_suppl_1/IV-22.full


Statistical Methods in Surrogate Marker Research for Clinical Trials

Predicting Treatment Effects Using Surrogate Markers in Clinical Trials. 6. 2.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8. 2.2 Single Trial Setting .
http://deepblue.lib.umich.edu/bitstream/2027.42/61692/1/yunlisph_1.pdf


Full text | Prognostic implications of surrogate markers of ...

Type 2 diabetes mellitus (T2DM) patients are at increased risk of developing cardiovascular events. Unfortunately traditional risk assessment scores, including .
http://www.cardiab.com/content/11/1/101


Determining best cholesterol-based surrogate marker for lowering ...

Cardiology Today | Current treatment of hyperlipidemia is focused on decreasing LDL cholesterol to predetermined treatment goals using various .
http://www.healio.com/cardiology/vascular-medicine/news/print/cardiology-today/%7B8cf74dd0-a7f3-48ac-8ff2-7583e750f820%7D/determining-best-cholesterol-based-surrogate-marker-for-lowering-chd


SURROGATE MARKERS OF CLINICAL DISEASE IN MS

Surrogate markers are invaluable in the study of chronic disease. With respect to multiple sclerosis. (MS), ideally surrogate markers should predict the long-term .
http://www.msforum.net/site/ViewPDF/ViewPDF.aspx?ArticleID=945D66736EBD4EF68FBBB3D70CFE2403;&doctype=Article


breeding does not guarantee genetic problems like hip dysplasia will

PLOS ONE: CD133 Is a Useful Surrogate Marker for Predicting ...

We hypothesized that a cancer stem cell marker may identify NAC-resistant patients, and evaluated CD133 and ALDH1 as a potential surrogate marker for .
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0045865



So one big difference between an inexpensive dog and a more

Surrogate markers in HIV disease - Journal of Antimicrobial ...

The use of surrogate markers in HIV disease is an attractive method of assessing . characteristics of an ideal surrogate marker and the theoretical dangers of .
http://jac.oxfordjournals.org/content/37/suppl_B/161.full.pdf


Surrogate Markers of Intestinal Inflammation Are Predictive of ...

Prediction of relapse of inflammatory bowel disease has important implications for therapeutic stategies. We assessed whether measurement of intestinal .
http://www.sciencedirect.com/science/article/pii/S001650850064458X


Evaluating Surrogate Markers of Clinical Outcome When ... - JStor

The potential value of surrogate markers in new drug development is enormous as . A number of requirements must be satisfied by a good surrogate marker.
http://www.jstor.org/stable/2533670


A surrogate marker to monitor angiogenesis at last.

A surrogate marker to monitor angiogenesis at last. Schneider M, Tjwa M, Carmeliet P. The Flanders Interuniversity Institute for Biotechnology, the Center for .
http://www.ncbi.nlm.nih.gov/pubmed/15652744


Evaluating surrogate markers.

We discuss approaches for efficiently evaluating potential surrogate markers; in particular, we focus on case-cohort designs in which marker evaluation is .
http://www.ncbi.nlm.nih.gov/pubmed/7552506


Role of surrogate markers in assessing patients with ... - ScienceDirect

Diabetes mellitus and the metabolic syndrome (MS) are reaching epidemic proportions in the United States, and cardiovascular disease continues to be the .
http://www.sciencedirect.com/science/article/pii/S0002914904001201


Mammographic density as a surrogate marker for the effects of ...

Mammographic density as a surrogate marker for the effects of hormone therapy on risk of breast cancer. Boyd NF, Martin LJ, Li Q, Sun L, Chiarelli AM, Hislop G, .
http://www.ncbi.nlm.nih.gov/pubmed/16702377


Lipopolysaccharide-Binding Protein, a Surrogate Marker of Microbial

Sep 7, 2012 . Lipopolysaccharide-Binding Protein, a Surrogate Marker of Microbial Translocation, Is Associated With Physical Function in Healthy Older .
http://www.ncbi.nlm.nih.gov/pubmed/22960476


MRI--the perfect surrogate marker for multiple sclerosis?

MRI--the perfect surrogate marker for multiple sclerosis? Barkhof F, Filippi M. MS Center Amsterdam and Department of Radiology, Vrije Universiteit Medical .
http://www.ncbi.nlm.nih.gov/pubmed/19347020



Homeobox B9: A potential surrogate marker for bevacizumab in ...

Homeobox B9: A potential surrogate marker for bevacizumab in combination . Therefore, HOXB9 may work as a potential surrogate marker of bevacizumab .
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=114&abstractID=94472


What matters in healthcare? Surrogate markers or patients? | Croakey

Jan 20, 2012 . Furthermore, as the surrogate markers are generally more responsive to interventions than such 'hard' end points as renal failure, the authors .
http://blogs.crikey.com.au/croakey/2012/01/20/what-matters-in-healthcare-surrogate-markers-or-patients/


to size considerations a female will need to be inseminated rather than

What is a surrogate marker for optimal dialysis?

To find a surrogate marker to obtain optimal dialysis delivery from the viewpoint of nutrition, 180 maintenance hemodialysis patients (109 males/71 females) .
http://www.ncbi.nlm.nih.gov/pubmed/17922747


Surrogate markers for atherosclerotic disease.

Surrogate markers for atherosclerotic disease. Sankatsing RR, de Groot E, Jukema JW, de Feyter PJ, Pennell DJ, Schoenhagen P, Nissen SE, Stroes ES, .
http://www.ncbi.nlm.nih.gov/pubmed/15990593


required genetic diversity by using dogs only within their own breeding

Surrogate markers in HIV disease

The use of surrogate markers in HIV disease is an attractive method of assessing the efficacy of new treatments more quickly than by using clinical end-points.
http://jac.oxfordjournals.org/content/37/suppl_B/161.short


Cardiovascular and renal surrogate markers in the clinical ...

INTRODUCTION: Surrogate markers represent a significant contribution to early diagnosis, longitudinal prognoses, and outcome prediction in cases of .
http://www.ncbi.nlm.nih.gov/pubmed/19572190


Circulating microRNAs as Surrogate Markers for Circulating Tumour ...

Clin Cancer Res. 2012 Sep 4. [Epub ahead of print]. Circulating microRNAs as Surrogate Markers for Circulating Tumour Cells and Prognostic Markers in .
http://www.ncbi.nlm.nih.gov/pubmed/22952344


Diffusion Magnetic Resonance Imaging: an Early Surrogate Marker of

Jun 20, 2012 . Background: A surrogate marker for treatment response that can be observed earlier than comparison of sequential magnetic resonance .
http://jnci.oxfordjournals.org/content/92/24/2029.long


Fecal calprotectin is a surrogate marker for endoscopic lesions in ...

Feb 16, 2012 . Fecal calprotectin is a surrogate marker for endoscopic lesions in inflammatory bowel disease. D'Haens G, Ferrante M, Vermeire S, Baert F, .
http://www.ncbi.nlm.nih.gov/pubmed/22344983


Using sexually transmitted disease incidence as a surrogate marker ...

Using sexually transmitted disease incidence as a surrogate marker for HIV incidence in prevention trials: a modeling study. Pinkerton SD, Layde PM; for the .
http://www.ncbi.nlm.nih.gov/pubmed/11984448



I guarantee that the dogs that are being sold for under $1000 are not

Transient elastography: a new surrogate marker of liver fibrosis ...

Transient elastography: a new surrogate marker of liver fibrosis influenced by major changes of transaminases. Coco B, Oliveri F, Maina AM, Ciccorossi P, .
http://www.ncbi.nlm.nih.gov/pubmed/17439526


Total lymphocyte count as a surrogate marker to predict CD4 count ...

Total lymphocyte count as a surrogate marker to predict CD4 count in human immunodeficiency virus-infected children: a retrospective evaluation. Wang Y, Li Y, .
http://www.ncbi.nlm.nih.gov/pubmed/22217967


Identifying predictive and surrogate markers of erlotinib antitumor ...

The identification of predictive or surrogate markers of response to HER1/ epidermal growth factor receptor (EGFR) inhibitor treatment would permit selection of .
http://www.ncbi.nlm.nih.gov/pubmed/14682121


Cefoxitin resistance as a surrogate marker for the detection of ...

Objectives: To evaluate the usefulness of cefoxitin when used as a surrogate marker for the detection of methicillin resistance. Patients and methods: Eight .
http://jac.oxfordjournals.org/content/55/4/506.full


Amyloid imaging as a surrogate marker in clinical trials in Alzheimer's

Amyloid imaging as a surrogate marker in clinical trials in Alzheimer's disease. Scheinin NM, Scheinin M, Rinne JO. Turku PET Centre, University of Turku, Turku .
http://www.ncbi.nlm.nih.gov/pubmed/21532540


Surrogate markers of transport distance for out-of-hospital cardiac ...

Sep 27, 2011 . Surrogate markers of transport distance for out-of-hospital cardiac arrest patients. Cudnik MT, Yao J, Zive D, Newgard C, Murray AT.
http://www.ncbi.nlm.nih.gov/pubmed/21950551


Surrogate markers may not tell the whole story - Health News Review

A surrogate marker is an event or a laboratory value that researchers hope can serve as a reliable substitute for an actual disease. A common example of this is .
http://www.healthnewsreview.org/toolkit/tips-for-understanding-studies/surrogate-markers-may-not-tell-the-whole-story/

"What's it Like to Whelp
what is acute gastroenteritisAnd many people find that it sucks them dry financially

Measurement of Arterial Wall Thickness as a Surrogate Marker for ...

Measurement of Arterial Wall Thickness as a Surrogate Marker for Atherosclerosis . is a valid surrogate marker for the progression of atherosclerotic disease.
http://circ.ahajournals.org/content/109/23_suppl_1/III-33.abstract



Surrogate marker for predicting the virus binding of urogenital ...

Surrogate marker for predicting the virus binding of urogenital cancer cells during adenovirus-based gene therapy. Lai YJ, Pong RC, McConnell JD, Hsieh JT.
http://www.ncbi.nlm.nih.gov/pubmed/12866420


A surrogate marker for A?42 production in the CNS

The authors therefore propose that relative levels of APLP1?28 in CSF act as a surrogate marker for the level and relative production of A?42 in the CNS.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3378130/


know of breeders who charge very high prices for dogs but have not

Carotid intima-media thickness as a surrogate marker for ...

Carotid intima-media thickness as a surrogate marker for cardiovascular disease in intervention studies. Bots ML. Julius Center for Health Sciences and Primary .
http://www.ncbi.nlm.nih.gov/pubmed/17076979


ASC/SIL Ratio for Cytotechnologists: A surrogate marker of ...

ASC/SIL Ratio for Cytotechnologists: A surrogate marker of screening sensitivity. Renshaw AA, Deschênes M, Auger M. Dept of Pathology, McGill University, .
http://www.ncbi.nlm.nih.gov/pubmed/19461082


Circulating tumor cells (CTCs) as a surrogate marker for determining ...

Circulating tumor cells (CTCs) as a surrogate marker for determining response to chemotherapy in advanced gastric cancer (AGC). Print this page .
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=65&abstractID=33825


Absolute CD4+ T-lymphocyte count as a surrogate marker of pediatric

Absolute CD4+ T-lymphocyte count as a surrogate marker of pediatric human immunodeficiency virus disease progression. Paintsil E, Ghebremichael M, .
http://www.ncbi.nlm.nih.gov/pubmed/18520446


look for in a breeder when does implantation bleeding occurand The

Use of fluconazole as a surrogate marker to predict susceptibility ...

Use of fluconazole as a surrogate marker to predict susceptibility and resistance to voriconazole among 13,338 clinical isolates of Candida spp. Tested by .
http://www.ncbi.nlm.nih.gov/pubmed/17079501


Statistical Issues in Clinical Studies Using Laboratory Endpoints

Use of a marker as surrogate for outcome requires that you first identify one. . the clinical outcome. Surrogate Markers. marker. Clinical. outcome. treatment .
http://people.musc.edu/~elg26/talks/statsforlabstudies.ppt



Relationship of asthma control to asthma exacerbations using ...

OBJECTIVE: To compare the relationship of surrogate markers of asthma control to subsequent asthma exacerbations. STUDY DESIGN: Retrospective cohort.
http://www.ncbi.nlm.nih.gov/pubmed/20469953


HIV & AIDS - HIV as a surrogate marker for drug use: a re-analysis of ...

VIRUSMYTH HOMEPAGE. Genetica 95: 165-171, 1995. HIV AS SURROGATE MARKER FOR DRUG USE: A RE-ANALYSIS OF THE SAN FRANCISCO MEN'S .
http://www.virusmyth.com/aids/hiv/pdaztsfstudy.htm


Doppler measurements: a surrogate marker of liver fibrosis?

Doppler measurements: a surrogate marker of liver fibrosis? Bernatik T, Strobel D , Hahn EG, Becker D. Department of Internal Medicine I, .
http://www.ncbi.nlm.nih.gov/pubmed/11943950


what you pay for.