2 results
4 - Clinical trials in lymphoma
-
- By Thomas M. Habermann, Mayo Clinic College of Medicine, Matthew Maurer, Mayo Clinic College of Medicine
- Edited by Robert Marcus, King's College London, John W. Sweetenham, University of Utah, Michael E. Williams
-
- Book:
- Lymphoma
- Published online:
- 18 December 2013
- Print publication:
- 05 December 2013, pp 45-60
-
- Chapter
- Export citation
-
Summary
Introduction
Clinical trials are the backbone of the development and advancement of therapeutic approaches. The pace of development of new agents, the regulatory overhead, the costs of data management, inclusion of quality-of-life assessments, radiologic assessments and central review, central pathology review, biospecimen acquisition, symptom-control assessments, and the evaluation of biologic correlates all present significant challenges for the future development of new therapeutic agents and regimens. As these therapeutic agents and approaches become increasingly targeted and the basic science, clinical risk factors, toxicities, and natural history of lymphomas broadens, the identification and assessment of relevant endpoints, be they clinical (e.g. physical examination, radiologic) or biologic (e.g. immunologic, genetic, metabolic, etc.), also becomes increasingly complex. In turn, the more complex the endpoints and the more targeted the regimens, the more challenges are presented when designing and conducting clinical trials and analyzing and interpreting the results. While this field of clinical trial design is too broad to give full discussion adequately in this chapter, the reader is referred to more extensive references on this area. Given the complexity of issues when designing, monitoring, interpreting, and analyzing data for a clinical trial, statistician input and collaboration is of paramount importance. This chapter will focus on the principles and details of clinical trials from the clinician perspective. As such, the fundamental considerations of clinical trial design as well as the types of trials conducted in clinical research will be reviewed.
5 - Clinical trials in lymphoma
- from Part I - LYMPHOMA OVERVIEW
-
- By Thomas M. Habermann, Division of Hematology, Mayo Clinic College of Medicine, Rochester, MN 55901, USA, Susan M. Geyer, Division of Hematology, Mayo Clinic College of Medicine, Rochester, MN 55901, USA
- Edited by Robert Marcus, John W. Sweetenham, Case Western Reserve University, Ohio, Michael E. Williams, University of Virginia
-
- Book:
- Lymphoma: Pathology, Diagnosis and Treatment
- Published online:
- 05 March 2010
- Print publication:
- 21 June 2007, pp 55-67
-
- Chapter
- Export citation
-
Summary
INTRODUCTION
Clinical trials are the backbone of the development and advancement of therapeutic interventions. The pace of development of new agents, the costs of data management, inclusion of quality-of-life assessments, symptom-control assessments and the evaluation of biologic correlates all present significant challenges for the future development of new therapeutic regimens. As these therapeutic regimens become increasingly targeted and our understanding of lymphoma deepens, the identification and assessment of relevant endpoints, be they clinical (e.g. physical examination, radiologic) or biologic (e.g. immunologic, genetic, metabolic etc.), also becomes increasingly complex. In turn, the more complex our endpoints and the more targeted our regimens, the more challenges are presented when designing and conducting clinical trials and analyzing and interpreting their results. While the field of clinical trial design is too broad and widely discussed to adequately give full discussion in this chapter, the reader is referred to more general references on this area. Given the complexity of issues when designing, monitoring, interpreting and analyzing data for a clinical trial, statistician input and collaboration is of paramount importance. This chapter focuses on the principles behind and details of clinical trials from the clinician perspective. As such, we discuss the fundamental considerations when designing trials as well as outline the types of trials typically conducted in clinical research.
BACKGROUND
The practice and science of clinical trials and research is in its relative infancy. Until 1750, the thinking was that of Galen, who attained an authority that remained unchallenged.