Skip to main content Accessibility help
×
Home

The Importance of Non-biological Factors in Influencing the Outcome of Clinical Trials

  • W. Gaebel (a1)

Abstract

The outcome of clinical drug trials is influenced both by biological and by non-biological factors. Non-biological factors can be subdivided into methodological factors and non-drug factors. The former are related to the definition and measurement of treatment course, response, and outcome itself; the latter cover characteristics of the patient, the treatment milieu, the patient's milieu apart from treatment, and (planned) psychosocial interventions. Although their mechanism of interaction with treatment outcome is not yet fully understood, these non-drug factors should be routinely monitored in clinical trials for three practical reasons: (a) to control for the heterogeneity of outcome; (b) to develop individualised outcome predictors; and (c) to promote the development of individualised guidelines for treatment indication.

Copyright

References

Hide All
Alpert, M. (1985) The signs and symptoms of schizophrenia. Comprehensive Psychiatry, 26, 103112.
Awad, A. (1992) Quality of life of schizophrenic patients on medications and implications for new drug trials. Hospital and Community Psychiatry, 43, 262265.
Barrowclough, C. & Tarrier, N. (1992) Interventions with families. In Innovations in the Psychological Management of Schizophrenia (eds Birchwood, M. & Tarrier, N.), pp. 79101. Chichester: Wiley.
Birchwood, M., Macmillan, R. & Smith, J. (1992) Early intervention. In Innovations in the Psychological Management of Schizophrenia (eds Birchwood, M. & Tarrier, N.), pp. 115145. Chichester: Wiley.
Carpenter, W. T., McGlashan, T. & Strauss, J. S. (1977) The treatment of acute schizophrenia without drugs: an investigation of some current assumptions. American Journal of Psychiatry, 134, 1420.
Carpenter, W. T., Heinrichs, D. W. & Hanlon, T. E. (1981) Methodologic standards for treatment outcome research in schizophrenia. American Journal of Psychiatry, 138, 465471.
Clarkin, J. F., Glick, I. D., Haas, G., et al (1991) The effects of inpatient family intervention on treatment outcome. In Psychiatric Treatment. Advances in Outcome Research (eds Mirin, S., Gossett, J. T. & Grob, M. C.), pp. 4759. Washington: American Psychiatric Press.
Clements, K. & Turpin, G. (1992) Vulnerability models and schizophrenia: the assessment and prediction of relapse. In Innovations in the Psychological Management of Schizophrenia (eds Birchwood, M. & Tarrier, N.), pp. 2147. Chichester: Wiley.
Engel, G. L. (1980) The clinical application of the biopsychosocial model. American Journal of Psychiatry, 137, 535544.
Friis, S. (1986) Characteristics of a good ward atmosphere. Acta Psychiatrica Scandinavica, 74, 469473.
Gaebel, W. & Linden, M. (1984) Kombination von Pharmakotherapie und Psychotherapie in der Behandlung depressiver Störungen. In Klinische Psychologic Trends in Forschung und Praxis (eds Baumann, U., Berbalk, H. & Seidenstücker, G.), Vol. 6, pp. 186210. Bern: Huber.
Gaebel, W., Pietzcker, A. & Baumgartner, A. (1986) 3 year follow-up of schizophrenic patients – outcome dimensions and neuroleptic treatment. Pharmacopsychiatry, 19, 208209.
Gaebel, W., Pietzcker, A. & Baumgartner, A. (1987) A prospective study of the course of illness in schizophrenic patients. Part III: Catamnestic treatment and outcome one year after clinic discharge. Schizophrenia Bulletin, 13, 307316.
Gaebel, W., Pietzcker, A., Ulrich, G., et al (1988) Predictors of neuroleptic treatment response in acute schizophrenia. Pharmacopsychiatry, 21, 384386.
Gaebel, W. & Renfordt, E. (1989) Objective methods for behavioral analysis in psychiatry and psychopharmacology – examples and concepts. Pharmacopsychiatry, 22 (suppl.), 150.
Goldberg, S. C., Schooler, N. R., Hogarty, G. E., et al (1977) Prediction of relapse in schizophrenic outpatients treated by drug and sociotherapy. Archives of General Psychiatry, 34, 171184.
Goodman, A. (1991) Organic unity theory: the mind–body problem revisited. American Journal of Psychiatry, 148, 553563.
Helmchen & Gaebel, W. (1987) Strategies of clinical research on neurobiological determinants of psychosis. Psychiatric Developments, 5, 5162.
Hirsch, S. R., Bowen, J. T., Emami, J., et al (1993) The effect of life events and medication in the aetiology of schizophrenic relapse. Schizophrenia Research, 9, 266.
Hogan, T. & Awad, G. (1983) A self-report scale predictive of drug compliance in schizophrenics: reliability and discriminative ability. Psychological Medicine, 13, 177183.
Hogarty, G. E., Goldberg, S. C., Schooler, N. R., et al (1974) Drug and sociotherapy in the aftercare of schizophrenic patients: two year relapse rates. Archives of General Psychiatry, 31, 603608.
Hogarty, G. E., McEvoy, J. P., Munetz, M., et al (1988) Dose of fluphenazine, familial expressed emotion, and outcome in schizophrenia. Archives of General Psychiatry, 45, 797805.
Hsiao, J. K., Bartko, J. J. & Potter, W. Z. (1989) Diagnosing diagnoses: receiver operating characteristic methods and psychiatry. Archives of General Psychiatry, 46, 664667.
Johnson, D. A. W. (1984) Observations on the use of long-acting depot neuroleptic injections in the maintenance therapy of schizophrenia. Journal of Clinical Psychiatry, 45, 1321.
Koenigsberg, H. W. & Handley, R. (1986) Expressed emotion: from predictive index to clinical construct. American Journal of Psychiatry, 143, 13611373.
Leff, J. P. (1985) Social factors and maintenance neuroleptics in schizophrenic relapse: an integrative model. Integrative Psychiatry, 3, 7288.
Leff, J. P. & Vaughn, C. (1981) The role of maintenance therapy and relatives’ expressed emotion in relapse of schizophrenia: a two-year follow-up. British Journal of Psychiatry, 139, 102104.
MacMillan, J. F., Gold, T. J., Crow, T. J., et al (1986) IV. Expressed emotion and relapse. British Journal of Psychiatry, 148, 133143.
May, P. R. A. & Goldberg, S. C. (1978) Prediction of schizophrenic patients’ response to pharmacotherapy. In Psychopharmacology: a Generation of Progress (eds Lipton, M. A., Dimascio, A. & Killam, K. F.). New York: Raven Press.
Moos, R. & Schwartz, J. (1972) Treatment environment and treatment outcome. Journal of Nervous and Mental Disease, 154, 264275.
Moos, R., Shelton, R. & Petty, C. H. (1973) Perceived ward climate and treatment outcome. Journal of Abnormal Psychology, 82, 291298.
Pietzcker, A. & Gaebel, W. (1983) Prediction of ‘natural’ course, relapse, and prophylactic response in schizophrenic patients. Pharmacopsychiatry, 16, 206211.
Shapiro, A. K. (1969) Iatroplacebogenics. International Pharmacopsychiatry, 2, 215248.
Spadoni, A. J. & Smith, J. A. (1969) Milieu therapy in schizophrenia. Archives of General Psychiatry, 20, 547551.
Strauss, J. S. & Carpenter, W. T. (1974) The prediction of outcome in schizophrenia – II. Relationships between predictor and outcome variables. Archives of General Psychiatry, 31, 3742.
Tuma, H., May, P. R. A., Yale, C., et al (1978) Therapist characteristics and the outcome of treatment in schizophrenia. Archives of General Psychiatry, 35, 81985.
Vaccaro, J. V. & Roberts, L. (1992) Teaching social and coping skills. In Innovations in the Psychological Management of Schizophrenia (eds Birchwood, M. & Tarrier, N.), pp. 103114. Chichester: Wiley.
Van Praag, H. M., Kahn, R. S., Asnis, G. M., et al (1987) Denosologization of biological psychiatry or the specificity of 5-HT disturbances in psychiatric disorders. Journal of Affective Disorders, 13, 18.
Van Putten, T. & May, P. R. A. (1978) Subjective response as a predictor of outcome in pharmacotherapy. Archives of General Psychiatry, 35, 477480.
Vaughn, C. E. & Leff, J. P. (1976) The influence of family and social factors on the course of psychiatric illness. British Journal of Psychiatry, 129, 125137.
Vaughn, C. E., Snyder, K. S., Freeman, W., et al (1982) Family factors in schizophrenic relapse: a replication. Schizophrenia Bulletin, 8, 425426.
Wing, J. K. (1978) The social context of schizophrenia. American Journal of Psychiatry, 135, 13331339.
World Health Organization (1979) Schizophrenia: an International Follow-up Study. WHO/Geneva: Wiley & Sons.

The Importance of Non-biological Factors in Influencing the Outcome of Clinical Trials

  • W. Gaebel (a1)

Metrics

Full text views

Total number of HTML views: 0
Total number of PDF views: 0 *
Loading metrics...

Abstract views

Total abstract views: 0 *
Loading metrics...

* Views captured on Cambridge Core between <date>. This data will be updated every 24 hours.

Usage data cannot currently be displayed

The Importance of Non-biological Factors in Influencing the Outcome of Clinical Trials

  • W. Gaebel (a1)
Submit a response

eLetters

No eLetters have been published for this article.

×

Reply to: Submit a response


Your details


Conflicting interests

Do you have any conflicting interests? *