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Therapeutic misconception in early phase gene transfer trials
Gail E Henderson1, Michele M Easter, Catherine Zimmer
1School of Medicine, University of NC at Chapel Hill, CB# 7240, Chapel Hill, NC 27599-7240, USA. ghenders@med.unc.edu
Social Science & Medicine (1982)
|July 8, 2005
Summary
Many early phase clinical trial participants have unrealistic expectations of direct medical benefit. Factors like education and communication influence this therapeutic misconception, highlighting informed consent challenges in gene therapy research.
Area of Science:
- Clinical Trials
- Gene Therapy Research
- Informed Consent
Background:
- Participants in early phase clinical trials often expect direct medical benefit.
- Unrealistic expectations can stem from issues in the informed consent process.
- Distinguishing between research and clinical treatment can be challenging for subjects.
Purpose of the Study:
- To investigate and measure therapeutic misconception (TM) in early phase gene transfer trials.
- To identify subject- and study-level factors predicting therapeutic misconception.
- To refine the understanding and measurement of TM in clinical research.
Main Methods:
- Analysis of consent forms from early phase gene transfer research.
- Interviews with researchers and subjects involved in gene therapy trials.
- Development of a composite measure for therapeutic misconception using three variables.
Main Results:
- Multivariate modeling identified key predictors of therapeutic misconception.
- Subject-level factors such as education and disease type were significant.
- Communication from study personnel regarding the likelihood of benefit also influenced TM.
Conclusions:
- Therapeutic misconception is influenced by a combination of participant characteristics and study-specific elements.
- Clearer communication about the research purpose and potential benefits is crucial.
- Further refinement in defining and measuring TM is needed for improved informed consent in gene therapy research.