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Data Handling and Computational Methods in Clinical Trials

  • Conference paper
COMPSTAT

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Summary

After outlining the complexity of the chronic diseases and commenting briefly upon the levels of strength of evicence of different studies commonly adopted in bio-medical research, the paper focuses on the problem of using data-bases fcr the assessment of therapies and some tipical subjects arising in analyzing data collected in cancer randomized clinical trials and in combining findings from trials carried out in different situations.

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References

  • Armitage P. (1982), The role of randomization in clinical trials, Stat.Med., 1, 345–352.

    Article  Google Scholar 

  • Armitage P., Gehan E.A. (1974), Statistical method for the identification and use of prognostic factors, Inter. J. Cancer, 13, 16–36.

    Google Scholar 

  • Azzalini A., Cox D.R. (1984), Two new tests associated with analysis of variance, J.Roy.Stat.Soc. B, 46, 335–343.

    Google Scholar 

  • Budzar A.M., Gutterman J.U., Blumenscein G.R., Hortobagji G.N., Toshima C.K., Smith T.L., Hersh E.M., Freireich E.J., Gehan E.A. (1978), Intensive postoperative chemoimmunotherapy for patients with stage II and stage III breast cancer. Cancer, 41, 1064–1075.

    Article  Google Scholar 

  • Byar D.P. (1980), Why data bases should not replace randomized clinical trials?, Biometrics, 36, 337–342.

    Article  Google Scholar 

  • Byar D.P., Simon R.M., Friedewald W.T., Schlesselman J.J., De Mets D.L., Ellenberg J.H., Gail M.H., Ware J.H. (1976), Randomized clinical trials: prospectives on some recent ideas, New Engl.J.Med., 295, 74–80.

    Article  Google Scholar 

  • Cascinelli N., Marubini E., Morabito A., Bufalino R. (1985), Prognostic factors for stage I melanoma of the skin: a review, Stat.Med., 4, 265–278.

    Article  Google Scholar 

  • Chalmers T.C., Schroeder B. (1979), Controls in journal articles, New Engl.J.Med., 301, 1293.

    Google Scholar 

  • Cochran W.G. (1954), The combination of estimates from different experiments, Biometrics, 10, 101–129.

    Article  Google Scholar 

  • Cox D.R. (1972), Regression models and life tables (with discussion), J. Roy.Stat.Soc. B, 34, 187–220.

    Google Scholar 

  • Dambrosia J.M., Ellenberg J. II (1980), Statistical considerations for a medical data-base, Biometrics, 36, 323–332.

    Article  Google Scholar 

  • Drzewiecki K.T., Andersen K.P. (1982), Survival with malignant melanoma. A regression analysis of prognostic factors, Cancer, 49, 2414–2419.

    Article  Google Scholar 

  • Fries J.F. (1976), A data bank for the clinician? New Engl.J.Med., 294, 1400–1402.

    Article  Google Scholar 

  • Gail M., Simon R. (1985), Testing for qualitative interactions between treatment effects and patient subsets, Biometrics, 41, 361–372.

    Article  Google Scholar 

  • Gehan E.A. (1982), Design of controlled clinical trials: use of historical controls. Canc. Treat. Rep., 66, 1089–1093.

    Google Scholar 

  • Gehan E.A., Freireich E.J. (1974), Non-randomized controls in cancer clinical trials, New Eng.J.Med., 290, 198–203.

    Article  Google Scholar 

  • Green S.B., Byar D.P. (1984), Using observational data from registries to compare treatments: the fallacy of omnimetrics, Stat.Med., 3, 361–370.

    Article  Google Scholar 

  • Harrell F.E., Lee K.L., Matchar D.B., Reichert T.A. (1985), Regression models for prognostic prediction: advantages, problems, and suggested solutions, Cane. Treat.Rep., 69, 1071–1077.

    Google Scholar 

  • Hedges L.V., Olkin I. (1985), Statistical methods for meta-analysis, Academic Press., New York.

    Google Scholar 

  • Hlatky M.A., Lee K.L., Harrell F.E., Califf R.M., Pryor D.B., Mark D.B., Rosati R.A. (1982), Tying clinical research to patient care by use of an observational data-base, Stat.Med., 3, 375–384.

    Article  Google Scholar 

  • Laird N.N., Dersimonian R. (1982), Issues in combining evidence from several comparative trials of clinical therapy, Proceedings of the Xlth International Biometrie Conference, Toulouse, 6–11 September.

    Google Scholar 

  • Lamberg S.I., Green S.B., Byar D.P., Block J.B., Clendenning W.E., Douglass M.C., Epstein E.H. Jr., Fuks, Z.Y., Golitz L.E., Lorinez A.L., McBurney E.I., Michel B., Roenigk H.H. Jr., Van Scott E.J., Yonderheid E.C. (1984), Clinical staging for cutaneous T-cell lymphoma, Ann.Inter. Med., 100, 187–192.

    Google Scholar 

  • Louis T.A., Fineberg H.V., Mosteller F. (1985), Findings for public health from meta-analyses, Am.Rev.Pub.Hlth., 6, 1–20.

    Article  Google Scholar 

  • Mantel N. (1983), Cautions on the use of medical data-bases, Stat. Med., 2, 355–362.

    Article  Google Scholar 

  • Marubini E., Morabito A., Valsecchi M.G. (1983), Prognostic factors and risk groups: some results given by using an algorithm suitable for censored survival data, Stat.Med., 2, 295–303.

    Article  Google Scholar 

  • Micciolo R., Valagussa P., Marubini E. (1985), The use of historical controls in breast cancer. An assessment in three consecutive trials, Con. Clin. Trials, 6, 259–270.

    Article  Google Scholar 

  • Moon T.E., Jones S.E., Bonadonna G., Powles T.J., Rivkin S., Budzar A., Montagne E. (1984), Using a data-base of protocol studies to evaluate therapy: a breast cancer example, Biometrics, 3, 333–339.

    Google Scholar 

  • Peto R. (1982), Statistical aspects of cancer trials. In “Treatment of cancer”, Chapman and Hall, London.

    Google Scholar 

  • Rosati R.A., McNeer J.F., Starmer C.F., Mittler B.S., Morris J.J., Wallace A.G (1975), A new information system for medical practice, Arch. Intern.Med., 135, 1017–1024.

    Google Scholar 

  • Sacks H., Chalmers T.C., Smith H. (1982), Randomized versus historical controls for clinical trials, Am.J.Med., 72, 233–240.

    Article  Google Scholar 

  • Shuster J., van Eys J. (1983), Interaction between prognostic factors and treatment, Contr.Clin.Trials, 4, 209–214.

    Google Scholar 

  • Simon R. (1982), Randomized clinical trials and research strategy, Canc. Treat.Rep., 66, 1083–1087.

    Google Scholar 

  • Starmer C.F., Lee K.L. (1982), A data-based approach to assessing clinical interventions in the setting of chronic disease, Canc.Treat.Rep., 66, 1077–1082.

    Google Scholar 

  • Starmer C.F., Rosati R.A., McNeer J.F. (1974), Data-bank use in management of chronic disease, Comp.Biom.Res., 7, 11–116.

    Google Scholar 

  • WHO Collaborating Centres for the evaluation of methods of diagnosis and treatment of melanoma (1980), Prognosis of stage I melanoma of the skin, Int.J.Canc., 26, 733–739.

    Article  Google Scholar 

  • Zelen M. (1985), The role of statistics in the design and evaluation of trials in cancer medicine. In “Clinical trials in cancer medicine”, Academic Press, New York.

    Google Scholar 

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Author information

Authors and Affiliations

  1. Milano, Italy

    E. Marubini

Authors
  1. E. Marubini
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Editor information

Editors and Affiliations

  1. Dipartimento di Statistica, Probabilità e Statistiche applicate, Università degli Studi di Roma „La Sapienza“, Piazzale Aldo Moro, 5, I-00185, Roma, Italy

    F. De Antoni  & A. Rizzi  & 

  2. Dipartimento di Matematica e Statistica, Università degli Studi di Napoli, Via Partenope, 36, I-80121, Napoli, Italy

    N. Lauro

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© 1986 Physica-Verlag, Heidelberg for IASC (International Association for Statistical Computing)

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Marubini, E. (1986). Data Handling and Computational Methods in Clinical Trials. In: De Antoni, F., Lauro, N., Rizzi, A. (eds) COMPSTAT. Physica-Verlag HD. https://doi.org/10.1007/978-3-642-46890-2_53

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  • DOI: https://doi.org/10.1007/978-3-642-46890-2_53

  • Publisher Name: Physica-Verlag HD

  • Print ISBN: 978-3-7908-0355-6

  • Online ISBN: 978-3-642-46890-2

  • eBook Packages: Springer Book Archive

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