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2013 | OriginalPaper | Buchkapitel

On the Use of Biomarkers to Elucidate Clinical Trial Results: Examples from the Women’s Health Initiative

verfasst von : Ross L. Prentice, Shanshan Zhao

Erschienen in: Proceedings of the Fourth Seattle Symposium in Biostatistics: Clinical Trials

Verlag: Springer New York

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Abstract

Biomarkers provide opportunities to maximize the knowledge gained from randomized controlled trials. Applications may include the identification of subpopulations that experience differential treatment effects; the assessment of adherence to treatment or intervention goals; and the elucidation of key biological pathways through which the treatments affect clinical outcomes. This last biomarker role also has implications for the development and initial testing of potential treatments. These types of applications are illustrated using biomarker studies in the Women’s Health Initiative postmenopausal hormone therapy and low-fat dietary pattern trials. Related topics are also described where further methodology developments would be helpful.

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Literatur
1.
Zurück zum Zitat The Women’s Health Initiative Study Group (1998) Design of the Women’s Health Initiative clinical trial and observational study. Control Clin Trials 19(1):61–109CrossRef The Women’s Health Initiative Study Group (1998) Design of the Women’s Health Initiative clinical trial and observational study. Control Clin Trials 19(1):61–109CrossRef
2.
Zurück zum Zitat Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J, Writing Group for the Women’s Health Initiative Investigators (2002) Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA 288(3):321–333CrossRef Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J, Writing Group for the Women’s Health Initiative Investigators (2002) Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA 288(3):321–333CrossRef
3.
Zurück zum Zitat Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, Bonds D, Brunner R, Brzyski R, Caan B, Chlebowski R, Curb D, Gass M, Hays J, Heiss G, Hendrix S, Howard BV, Hsia J, Hubbell A, Jackson R, Johnson KC, Judd H, Kotchen JM, Kuller L, LaCroix AZ, Lane D, Langer RD, Lasser N, Lewis CE, Manson J, Margolis K, Ockene J, O’Sullivan MJ, Phillips L, Prentice RL, Ritenbaugh C, Robbins J, Rossouw JE, Sarto G, Stefanick ML, Van Horn L, Wactawski-Wende J, Wallace R, Wassertheil-Smoller S, Women’s Health Initiative Steering Committee (2004) Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: The Women’s Health Initiative randomized controlled trial. JAMA 291(14):1701–1712CrossRef Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, Bonds D, Brunner R, Brzyski R, Caan B, Chlebowski R, Curb D, Gass M, Hays J, Heiss G, Hendrix S, Howard BV, Hsia J, Hubbell A, Jackson R, Johnson KC, Judd H, Kotchen JM, Kuller L, LaCroix AZ, Lane D, Langer RD, Lasser N, Lewis CE, Manson J, Margolis K, Ockene J, O’Sullivan MJ, Phillips L, Prentice RL, Ritenbaugh C, Robbins J, Rossouw JE, Sarto G, Stefanick ML, Van Horn L, Wactawski-Wende J, Wallace R, Wassertheil-Smoller S, Women’s Health Initiative Steering Committee (2004) Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: The Women’s Health Initiative randomized controlled trial. JAMA 291(14):1701–1712CrossRef
4.
Zurück zum Zitat Heiss G, Wallace R, Anderson GL, Aragaki A, Beresford SA, Brzyski R, Chlebowski RT, Gass M, LaCroix A, Manson JE, Prentice RL, Rossouw J, Stefanick ML, WHI Investigators (2008) Health risks and benefits 3 years after stopping randomized treatment with estrogen and progestin. JAMA 299(9):1036–1045CrossRef Heiss G, Wallace R, Anderson GL, Aragaki A, Beresford SA, Brzyski R, Chlebowski RT, Gass M, LaCroix A, Manson JE, Prentice RL, Rossouw J, Stefanick ML, WHI Investigators (2008) Health risks and benefits 3 years after stopping randomized treatment with estrogen and progestin. JAMA 299(9):1036–1045CrossRef
5.
Zurück zum Zitat LaCroix AZ, Chlebowski RT, Manson JE, Aragaki AK, Johnson KC, Martin L, Margolis KL, Stefanick ML, Brzyski R, Curb JD, Howard BV, Lewis CE, Wactawski-Wende J, WHI Investigators (2011) Health outcomes after stopping conjugated equine estrogens among postmenopausal women with prior hysterectomy: a randomized controlled trial. JAMA 305(13):1305–1314CrossRef LaCroix AZ, Chlebowski RT, Manson JE, Aragaki AK, Johnson KC, Martin L, Margolis KL, Stefanick ML, Brzyski R, Curb JD, Howard BV, Lewis CE, Wactawski-Wende J, WHI Investigators (2011) Health outcomes after stopping conjugated equine estrogens among postmenopausal women with prior hysterectomy: a randomized controlled trial. JAMA 305(13):1305–1314CrossRef
6.
Zurück zum Zitat Chlebowski RT, Kuller LH, Prentice RL, Stefanick ML, Manson JE, Gass M, Aragaki AK, Ockene JK, Lane DS, Sarto GE, Rajkovic A, Schenken R, Hendrix SL, Ravdin PM, Rohan TE, Yasmeen S, Anderson G, WHI Investigators (2009) Breast cancer after use of estrogen plus progestin in postmenopausal women. N Engl J Med 360(6):573–587CrossRef Chlebowski RT, Kuller LH, Prentice RL, Stefanick ML, Manson JE, Gass M, Aragaki AK, Ockene JK, Lane DS, Sarto GE, Rajkovic A, Schenken R, Hendrix SL, Ravdin PM, Rohan TE, Yasmeen S, Anderson G, WHI Investigators (2009) Breast cancer after use of estrogen plus progestin in postmenopausal women. N Engl J Med 360(6):573–587CrossRef
7.
Zurück zum Zitat Ravdin PM, Cronin KA, Howlader N, Berg CD, Chlebowski RT, Feuer EJ, Edwards BK, Berry DA (2007) The decrease in breast-cancer incidence in 2003 in the United States. N Engl J Med 356(16):1670–1674CrossRef Ravdin PM, Cronin KA, Howlader N, Berg CD, Chlebowski RT, Feuer EJ, Edwards BK, Berry DA (2007) The decrease in breast-cancer incidence in 2003 in the United States. N Engl J Med 356(16):1670–1674CrossRef
8.
Zurück zum Zitat Prentice RL, Caan B, Chlebowski RT, Patterson R, Kuller LH, Ockene JK, Margolis KL, Limacher MC, Manson JE, Parker LM, Paskett E, Phillips L, Robbins J, Rossouw JE, Sarto GE, Shikany JM, Stefanick ML, Thomson CA, Van Horn L, Vitolins MZ, Wactawski-Wende J, Wallace RB, Wassertheil-Smoller S, Whitlock E, Yano K, Adams-Campbell L, Anderson GL, Assaf AR, Beresford SA, Black HR, Brunner RL, Brzyski RG, Ford L, Gass M, Hays J, Heber D, Heiss G, Hendrix SL, Hsia J, Hubbell FA, Jackson RD, Johnson KC, Kotchen JM, LaCroix AZ, Lane DS, Langer RD, Lasser NL, Henderson MM (2006) Low-fat dietary pattern and risk of invasive breast cancer: The Women’s Health Initiative Randomized Controlled Dietary Modification Trial. JAMA 295(6):629–642CrossRef Prentice RL, Caan B, Chlebowski RT, Patterson R, Kuller LH, Ockene JK, Margolis KL, Limacher MC, Manson JE, Parker LM, Paskett E, Phillips L, Robbins J, Rossouw JE, Sarto GE, Shikany JM, Stefanick ML, Thomson CA, Van Horn L, Vitolins MZ, Wactawski-Wende J, Wallace RB, Wassertheil-Smoller S, Whitlock E, Yano K, Adams-Campbell L, Anderson GL, Assaf AR, Beresford SA, Black HR, Brunner RL, Brzyski RG, Ford L, Gass M, Hays J, Heber D, Heiss G, Hendrix SL, Hsia J, Hubbell FA, Jackson RD, Johnson KC, Kotchen JM, LaCroix AZ, Lane DS, Langer RD, Lasser NL, Henderson MM (2006) Low-fat dietary pattern and risk of invasive breast cancer: The Women’s Health Initiative Randomized Controlled Dietary Modification Trial. JAMA 295(6):629–642CrossRef
9.
Zurück zum Zitat Prentice RL, Thomson CA, Caan B, Hubbell FA, Anderson GL, Beresford SAA, Pettinger M, Lane DS, Lessin L, Yasmeen S, Singh B, Khandekar J, Shikany JM, Satterfield S, Chlebowski RT (2007) Low-fat dietary pattern and cancer incidence in the Women’s Health Initiative Dietary Modification Randomized Controlled Trial. J Natl Cancer Inst 99(20):1534–1543CrossRef Prentice RL, Thomson CA, Caan B, Hubbell FA, Anderson GL, Beresford SAA, Pettinger M, Lane DS, Lessin L, Yasmeen S, Singh B, Khandekar J, Shikany JM, Satterfield S, Chlebowski RT (2007) Low-fat dietary pattern and cancer incidence in the Women’s Health Initiative Dietary Modification Randomized Controlled Trial. J Natl Cancer Inst 99(20):1534–1543CrossRef
10.
Zurück zum Zitat Jackson RD, LaCroix AZ, Gass M, Wallace RB, Robbins J, Lewis CE, Bassford T, Beresford SA, Black HR, Blanchette P, Bonds DE, Brunner RL, Brzyski RG, Caan B, Cauley JA, Chlebowski RT, Cummings SR, Granek I, Hays J, Heiss G, Hendrix SL, Howard BV, Hsia J, Hubbell FA, Johnson KC, Judd H, Kotchen JM, Kuller LH, Langer RD, Lasser NL, Limacher MC, Ludlam S, Manson JE, Margolis KL, McGowan J, Ockene JK, O’Sullivan MJ, Phillips L, Prentice RL, Sarto GE, Stefanick ML, Van Horn L, Wactawski-Wende J, Whitlock E, Anderson GL, Assaf AR, Barad D, Women’s Health Initiative Investigators (2006) Calcium plus vitamin D supplementation and the risk of fractures. N Engl J Med 354(7):669–683CrossRef Jackson RD, LaCroix AZ, Gass M, Wallace RB, Robbins J, Lewis CE, Bassford T, Beresford SA, Black HR, Blanchette P, Bonds DE, Brunner RL, Brzyski RG, Caan B, Cauley JA, Chlebowski RT, Cummings SR, Granek I, Hays J, Heiss G, Hendrix SL, Howard BV, Hsia J, Hubbell FA, Johnson KC, Judd H, Kotchen JM, Kuller LH, Langer RD, Lasser NL, Limacher MC, Ludlam S, Manson JE, Margolis KL, McGowan J, Ockene JK, O’Sullivan MJ, Phillips L, Prentice RL, Sarto GE, Stefanick ML, Van Horn L, Wactawski-Wende J, Whitlock E, Anderson GL, Assaf AR, Barad D, Women’s Health Initiative Investigators (2006) Calcium plus vitamin D supplementation and the risk of fractures. N Engl J Med 354(7):669–683CrossRef
11.
Zurück zum Zitat Chlebowski RT, Hendrix SL, Langer RD, Stefanick ML, Gass M, Lane D, Rodabough RJ, Gilligan MA, Cyr MG, Thomson CA, Khandekar J, Petrovitch H, McTiernan A, WHI Investigators (2003) Influence of estrogen plus progestin on breast cancer and mammography in healthy postmenopausal women: the Women’s Health Initiative Randomized Trial. JAMA 289(24):3243–3253CrossRef Chlebowski RT, Hendrix SL, Langer RD, Stefanick ML, Gass M, Lane D, Rodabough RJ, Gilligan MA, Cyr MG, Thomson CA, Khandekar J, Petrovitch H, McTiernan A, WHI Investigators (2003) Influence of estrogen plus progestin on breast cancer and mammography in healthy postmenopausal women: the Women’s Health Initiative Randomized Trial. JAMA 289(24):3243–3253CrossRef
12.
Zurück zum Zitat Stefanick ML, Anderson GL, Margolis KL, Hendrix SL, Rodabough RJ, Paskett ED, Lane DS, Hubbell FA, Assaf AR, Sarto GE, Schenken RS, Yasmeen S, Lessin L, Chlebowski RT, WHI Investigators (2006) Effects of conjugated equine estrogens on breast cancer and mammography screening in postmenopausal women with hysterectomy. JAMA 295(14): 1647–1657CrossRef Stefanick ML, Anderson GL, Margolis KL, Hendrix SL, Rodabough RJ, Paskett ED, Lane DS, Hubbell FA, Assaf AR, Sarto GE, Schenken RS, Yasmeen S, Lessin L, Chlebowski RT, WHI Investigators (2006) Effects of conjugated equine estrogens on breast cancer and mammography screening in postmenopausal women with hysterectomy. JAMA 295(14): 1647–1657CrossRef
13.
Zurück zum Zitat Rossouw JE, Cushman M, Greenland P, Lloyd-Jones DM, Bray P, Kooperberg C, Pettinger M, Robinson J, Hendrix S, Hsia J (2008) Inflammatory, lipid, thrombotic, and genetic markers of coronary heart disease risk in the Women’s Health Initiative trials of hormone therapy. Arch Intern Med 168(20):2245–2253CrossRef Rossouw JE, Cushman M, Greenland P, Lloyd-Jones DM, Bray P, Kooperberg C, Pettinger M, Robinson J, Hendrix S, Hsia J (2008) Inflammatory, lipid, thrombotic, and genetic markers of coronary heart disease risk in the Women’s Health Initiative trials of hormone therapy. Arch Intern Med 168(20):2245–2253CrossRef
14.
Zurück zum Zitat Kooperberg C, Cushman M, Hsia J, Robinson J, Aragaki A, Lynch J, Baird A, Johnson K, Kuller L, Beresford S, Rodriguez B (2007) Can biomarkers identify women at increased stroke risk? The Women’s Health Initiative hormone trials. PLoS Clin Trials 2(6):e28CrossRef Kooperberg C, Cushman M, Hsia J, Robinson J, Aragaki A, Lynch J, Baird A, Johnson K, Kuller L, Beresford S, Rodriguez B (2007) Can biomarkers identify women at increased stroke risk? The Women’s Health Initiative hormone trials. PLoS Clin Trials 2(6):e28CrossRef
15.
Zurück zum Zitat Prentice RL, Huang Y, Hinds DA, Peters U, Pettinger M, Cox DR, Beilharz E, Chlebowski RT, Rossouw JE, Caan B, Ballinger DG (2009) Variation in the FGFR2 gene and the effects of postmenopausal hormone therapy on invasive breast cancer. Cancer Epidemiol Biomarker Prev 18(11):3079–3085CrossRef Prentice RL, Huang Y, Hinds DA, Peters U, Pettinger M, Cox DR, Beilharz E, Chlebowski RT, Rossouw JE, Caan B, Ballinger DG (2009) Variation in the FGFR2 gene and the effects of postmenopausal hormone therapy on invasive breast cancer. Cancer Epidemiol Biomarker Prev 18(11):3079–3085CrossRef
16.
Zurück zum Zitat Prentice RL, Huang Y, Hinds DA, Peters U, Cox DR, Beilharz E, Chlebowski RT, Rossouw JE, Caan B, Ballinger DG (2010) Variation in the FGFR2 gene and the effect of a low-fat dietary pattern on invasive breast cancer. Cancer Epidemiol Biomarker Prev 19:74–79CrossRef Prentice RL, Huang Y, Hinds DA, Peters U, Cox DR, Beilharz E, Chlebowski RT, Rossouw JE, Caan B, Ballinger DG (2010) Variation in the FGFR2 gene and the effect of a low-fat dietary pattern on invasive breast cancer. Cancer Epidemiol Biomarker Prev 19:74–79CrossRef
17.
Zurück zum Zitat Huang Y, Ballinger DG, Dai J, Peters U, Hinds DA, Cox DR, Beilharz E, Chlebowski RT, Rossouw JE, McTiernan A, Rohan T, Prentice RL (2011) Genetic variants in the MRPS30 region and postmenopausal breast cancer risk. Genome Med 3:42CrossRef Huang Y, Ballinger DG, Dai J, Peters U, Hinds DA, Cox DR, Beilharz E, Chlebowski RT, Rossouw JE, McTiernan A, Rohan T, Prentice RL (2011) Genetic variants in the MRPS30 region and postmenopausal breast cancer risk. Genome Med 3:42CrossRef
18.
Zurück zum Zitat Schoeller DA (1999) Recent advances from application of doubly labeled water to measurement of human energy expenditure. J Nutr 129(10):1765–1768 Schoeller DA (1999) Recent advances from application of doubly labeled water to measurement of human energy expenditure. J Nutr 129(10):1765–1768
19.
Zurück zum Zitat Bingham S (1994) The use of 24-h urine samples and energy expenditure to validate dietary assessments. Am J Clin Nutr 59(1):2275–2315 Bingham S (1994) The use of 24-h urine samples and energy expenditure to validate dietary assessments. Am J Clin Nutr 59(1):2275–2315
20.
Zurück zum Zitat Prentice RL, Mossavar-Rahmani Y, Huang Y, Van Horn L, Beresford SAA, Caan B, Tinker LF, Schoeller D, Bingham S, Eaton CB, Thomson C, Johnson KC, Ockene J, Sarto G, Heiss G, Neuhouser ML (2011) Evaluation and comparison of food records, recalls and frequencies for energy and protein assessment using recovery biomarkers. Am J Epidemiol 174(5):591–603CrossRef Prentice RL, Mossavar-Rahmani Y, Huang Y, Van Horn L, Beresford SAA, Caan B, Tinker LF, Schoeller D, Bingham S, Eaton CB, Thomson C, Johnson KC, Ockene J, Sarto G, Heiss G, Neuhouser ML (2011) Evaluation and comparison of food records, recalls and frequencies for energy and protein assessment using recovery biomarkers. Am J Epidemiol 174(5):591–603CrossRef
21.
Zurück zum Zitat Prentice RL, Shaw PA, Bingham SA, Beresford SA, Caan B, Neuhouser ML, Patterson RE, Stefanick ML, Satterfield S, Thomson CA, Snetselaar L, Thomas A, Tinker LF (2009) Biomarker-calibrated energy and protein consumption and increased cancer risk among postmenopausal women. Am J Epidemiol 169(8):977–989CrossRef Prentice RL, Shaw PA, Bingham SA, Beresford SA, Caan B, Neuhouser ML, Patterson RE, Stefanick ML, Satterfield S, Thomson CA, Snetselaar L, Thomas A, Tinker LF (2009) Biomarker-calibrated energy and protein consumption and increased cancer risk among postmenopausal women. Am J Epidemiol 169(8):977–989CrossRef
22.
Zurück zum Zitat Prentice RL, Huang Y, Kuller LH, Tinker LF, Van Horn L, Stefanick ML, Sarto G, Ockene J, Johnson KJ (2011) Biomarker-calibrated energy and protein consumption and cardiovascular disease risk among postmenopausal women. Epidemiology 22(2):170–179CrossRef Prentice RL, Huang Y, Kuller LH, Tinker LF, Van Horn L, Stefanick ML, Sarto G, Ockene J, Johnson KJ (2011) Biomarker-calibrated energy and protein consumption and cardiovascular disease risk among postmenopausal women. Epidemiology 22(2):170–179CrossRef
23.
Zurück zum Zitat Tinker LF, Sarto GE, Howard BV, Huang Y, Neuhouser ML, Mossavar-Rahmani Y, Beasley JM, Margolis KL, Eaton CB, Phillips LS, Prentice RL (2011) Biomarker-calibrated dietary energy and protein intake association with diabetes risk among postmenopausal women from the WHI. Am J Clin Nutr 94(6):1600–1606, Epub 2011 Nov 9CrossRef Tinker LF, Sarto GE, Howard BV, Huang Y, Neuhouser ML, Mossavar-Rahmani Y, Beasley JM, Margolis KL, Eaton CB, Phillips LS, Prentice RL (2011) Biomarker-calibrated dietary energy and protein intake association with diabetes risk among postmenopausal women from the WHI. Am J Clin Nutr 94(6):1600–1606, Epub 2011 Nov 9CrossRef
24.
25.
Zurück zum Zitat Faca V, Coram M, Phanstiel D, Glukhova V, Zhang Q, Fitzgibbon M, McIntosh M, Hanash S (2006) Quantitative analysis of acrylamide labeled serum proteins by LC-MS/MS. J Proteome Res 5(8):2009–2018CrossRef Faca V, Coram M, Phanstiel D, Glukhova V, Zhang Q, Fitzgibbon M, McIntosh M, Hanash S (2006) Quantitative analysis of acrylamide labeled serum proteins by LC-MS/MS. J Proteome Res 5(8):2009–2018CrossRef
26.
Zurück zum Zitat Katayama H, Pacznesny S, Prentice RL, Aragaki A, Faca VM, Pitteri SJ, Zhang Q, Wang H, Silva M, Kennedy J, Rossouw J, Jackson R, Hsia J, Chlebowski R, Manson J, Hanash S (2009) Application of serum proteomics to the Women’s Health Initiative conjugated equine estrogens trial reveals a multitude of effects relevant to clinical findings. Genome Med 1(4):47.1–47.16CrossRef Katayama H, Pacznesny S, Prentice RL, Aragaki A, Faca VM, Pitteri SJ, Zhang Q, Wang H, Silva M, Kennedy J, Rossouw J, Jackson R, Hsia J, Chlebowski R, Manson J, Hanash S (2009) Application of serum proteomics to the Women’s Health Initiative conjugated equine estrogens trial reveals a multitude of effects relevant to clinical findings. Genome Med 1(4):47.1–47.16CrossRef
27.
Zurück zum Zitat Pitteri SJ, Hanash SM, Aragaki A, Amon L, Chen L, Busald Buson T, Paczesny S, Katayama H, Wang H, Johnson MM, Zhang Q, McIntosh M, Wang P, Kooperberg C, Rossouw JE, Jackson R, Manson JE, Hsia J, Liu S, Martin L, Prentice RL (2009) Postmenopausal estrogen and progestin effects on the serum proteome. Genome Med 1(12):121.1–121.14CrossRef Pitteri SJ, Hanash SM, Aragaki A, Amon L, Chen L, Busald Buson T, Paczesny S, Katayama H, Wang H, Johnson MM, Zhang Q, McIntosh M, Wang P, Kooperberg C, Rossouw JE, Jackson R, Manson JE, Hsia J, Liu S, Martin L, Prentice RL (2009) Postmenopausal estrogen and progestin effects on the serum proteome. Genome Med 1(12):121.1–121.14CrossRef
28.
Zurück zum Zitat Prentice RL, Paczesny SJ, Aragaki A, Amon LM, Chen L, Pitteri SJ, McIntosh M, Wang P, Busald Buson T, Hsia J, Jackson RD, Rossouw JE, Manson JE, Johnson K, Eaton C, Hanash SM (2010) Novel proteins associated with risk for coronary heart disease or stroke among postmenopausal women identified by in-depth plasma proteome profiling. Genome Med 2(7):48–60CrossRef Prentice RL, Paczesny SJ, Aragaki A, Amon LM, Chen L, Pitteri SJ, McIntosh M, Wang P, Busald Buson T, Hsia J, Jackson RD, Rossouw JE, Manson JE, Johnson K, Eaton C, Hanash SM (2010) Novel proteins associated with risk for coronary heart disease or stroke among postmenopausal women identified by in-depth plasma proteome profiling. Genome Med 2(7):48–60CrossRef
29.
Zurück zum Zitat PEPI Trial Writing Group (1995) Effects of estrogen or estrogen/progestin regimes on heart disease risk factors in postmenopausal women: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. JAMA 273(3):199–208CrossRef PEPI Trial Writing Group (1995) Effects of estrogen or estrogen/progestin regimes on heart disease risk factors in postmenopausal women: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. JAMA 273(3):199–208CrossRef
30.
Zurück zum Zitat PEPI Trial Writing Group (1996) Effects of hormone replacement therapy on endometrial histology in postmenopausal women: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. JAMA 275(5):370–375CrossRef PEPI Trial Writing Group (1996) Effects of hormone replacement therapy on endometrial histology in postmenopausal women: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. JAMA 275(5):370–375CrossRef
32.
Zurück zum Zitat Pearl J (2011) Principal stratification – a goal or a tool? Int J Biostat 7(1). pii: Article 20 Pearl J (2011) Principal stratification – a goal or a tool? Int J Biostat 7(1). pii: Article 20
33.
Zurück zum Zitat Prentice RL (2011) Invited commentary on pearl and principal stratification. Int J Biostat 7(1):Article 30 Prentice RL (2011) Invited commentary on pearl and principal stratification. Int J Biostat 7(1):Article 30
34.
Zurück zum Zitat Neuhouser ML, Tinker L, Shaw PA, Schoeller D, Bingham SA, Van Horn L, Beresford SAA, Caan B, Thompson C, Satterfield S, Kuller L, Heiss G, Smit E, Sarto G, Ockene J, Stefanick ML, Assaf A, Runswick S, Prentice RL (2008) Use of recovery biomarkers to calibrate nutrient consumption self-reports in the Women’s Health Initiative. Am J Epidemiol 167(10):1247–1259CrossRef Neuhouser ML, Tinker L, Shaw PA, Schoeller D, Bingham SA, Van Horn L, Beresford SAA, Caan B, Thompson C, Satterfield S, Kuller L, Heiss G, Smit E, Sarto G, Ockene J, Stefanick ML, Assaf A, Runswick S, Prentice RL (2008) Use of recovery biomarkers to calibrate nutrient consumption self-reports in the Women’s Health Initiative. Am J Epidemiol 167(10):1247–1259CrossRef
Metadaten
Titel
On the Use of Biomarkers to Elucidate Clinical Trial Results: Examples from the Women’s Health Initiative
verfasst von
Ross L. Prentice
Shanshan Zhao
Copyright-Jahr
2013
Verlag
Springer New York
DOI
https://doi.org/10.1007/978-1-4614-5245-4_2