Fromajoux A, Julien C, Piegay C, Setbon M, Thivolet C, Colin C; International Society of Technology Assessment in Health Care. Meeting.
Annu Meet Int Soc Technol Assess Health Care Int Soc Technol Assess Health Care Meet. 2000; 16: 243.
Departement d'Information Medicale des Hospices Civils de Lyon 162, Avenue Lacassagne - 69424 Lyon Cedex 03 - France
Introduction : The Experimental Innovative Therapy (EIT) of human and substitutive products is defined as all products which are derived from blood, cells, tissues or organs, and which are modified for a therapeutic utilisation, without intervention on the genetic patrimony. Our study aimed to build a methodological design of evaluation of EIT. Method: From all available sources, our study has analysed the legal, ethical and methodological documents about therapeutic use of human and substitutive products. A model of evaluation was built from the example of Langerhans islets transplantation. This model, composed of four steps, was inspired from the model utilised for drug and health technology in France and has been discussed with clinicians, researchers and social security experts in the Intercommission 2 INSERM. Results: This model considered the measure of biological or clinical endpoints, and also endpoints as quality of life, cost and social acceptability. The first step is a pre-clinical phase with animal experimentation, the second step is an observational clinical study based on a phase I-II design including a benefit-risk approach with a measure of biological and clinical endpoints, side effects and the predictive factors of success. The third step is a randomised clinical-economic trial including a measure of clinical and economical benefit based on a phase III design. The last step is made of bio-vigilance with record of undesirable incidents and measure of social acceptability. Conclusion : A new design for the evaluation of experimental innovative therapy is necessary for an efficient co-ordination of research in this field, an appropriate level of biosecurity of practice and a rational use of health care resources.
Publication Types:
Keywords:
- Animal Experimentation
- Animals
- Costs and Cost Analysis
- France
- Humans
- Research Design
- Social Control, Formal
- Social Work
- Therapies, Investigational
- Treatment Outcome
- economics
- methods
- transplantation
- hsrmtgs
Other ID:
UI: 102271793
From Meeting Abstracts