Quantifying the usefulness of PD biomarkers in Phase 2 screening trials of oncology drugs

Statistics in Medicine

Volumn 27, Issue 24, 2008, Pages 4928-4938

  Holmgren, Eric ^a  

^a GENENTECH INC   (United States)

Author keywords

Biomarker; Drug development; Meta analysis; Phase 2; Surrogate endpoints

Indexed keywords

ANTINEOPLASTIC AGENT; PHARMACOLOGICAL BIOMARKER;

ARTICLE; CANCER RESEARCH; CONCEPTUAL FRAMEWORK; DEATH; DISEASE MARKER; DRUG EFFICACY; DRUG RESEARCH; HAZARD RATIO; MATHEMATICAL MODEL; NORMAL DISTRIBUTION; PROBABILITY; PROPORTIONAL HAZARDS MODEL; QUANTITATIVE ANALYSIS; STATISTICAL ANALYSIS; SURVIVAL RATE; HUMAN; META ANALYSIS; PHASE 2 CLINICAL TRIAL; STATISTICAL MODEL;

ANTINEOPLASTIC AGENTS; BIOMARKERS, PHARMACOLOGICAL; CLINICAL TRIALS, PHASE II AS TOPIC; HUMANS; META-ANALYSIS AS TOPIC; MODELS, STATISTICAL;

EID: 59849090467     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.3351     Document Type: Article

References (13)

1. Prentice RL. Surrogate endpoints in clinical trials: definition and operational criteria. Statistics in Medicine 1989; 8:431-440.
2. Fleming TR, Demets DL. Surrogate end points in clinical trials: are we being misled? Annals of Internal Medicine 1996; 125:605-613.
3. Weir CJ, Walley RJ. Statistical evaluation of biomarkers as surrogate endpoints: a literature review. Statistics in Medicine 2006; 25:183-203. DOI: 10.1002/sim.2319.
4. Holmgren EB. Are Phase 2 screening trials in oncology obsolete? Statistics in Medicine 2008; 27:556-567. DOI: 10.1002/ sim.2989.
5. Daniels MJ, Hughes MD. Meta-analysis for the evaluation of potential surrogate markers. Statistics in Medicine 1997; 16:1965-1982.
6. Li Z, Meredith MP, Hoseyni MS. A method to assess the proportion of treatment effect explained by a surrogate endpoint. Statistics in Medicine 2001; 20:3175-3188. DOI: 10.1002/sim.984.
7. Burzykowski T, Molenberghs G. Validation of surrogate end points in multiple randomized clinical trials with failure time end points. Applied Statistics 2001; 50:405-422.
8. Renard D, Geys H, Molenberghs G, Burzykowski T, Buyse M. Validation of surrogate endpoints in multiple randomized clinical trials with discrete outcomes. Biometrical Journal 2002; 8:921-935.
9. Buyse M, Molenberghs G, Burzykowski T, Renard D, Geys H. The validation of surrogate endpoints in metaanalyses of randomized experiments. Biostatistics 2000; 1:49-67.
10. Burzykowski T, Molenberghs G, Buyse M. The validation of surrogate end points by using data from randomized clinical trials: a case-study in advanced colorectal cancer. Journal of the Royal Statistical Society, Series A 2004; 167:103-124.
11. Gail MH, Pfeiffer R, Van Houwelingen HC, Carroll RJ. On meta-analytic assessment of surrogate outcomes. Biostatistics 2000; 1:231-246.
12. Houwelingen HC, Arends LR, Stijnen T. Tutorial in biostatistics, advanced methods in meta-analysis: multivariate approach and meta-regression. Statistics in Medicine 2002; 21:589-624. DOI: 10.1002/sim.1040.
13. Alonso A, Molenberghs G, Burzykowski T, Renard D, Geys H, Shkedy Z, Tibaldi F, Abrahantes JC, Buyse M. Prentice's approach and the meta-analytic paradigm: a reflection on the role of statistics in the evaluation of surrogate endpoints. Biometrics 2004; 60:724-728.