Background This pilot study evaluated the speaking book ‘What it means to be part of a clinical trial’. The book aims at empowering populations with information on their rights and responsibilities when enrolled in clinical research. Wide publication of the book—at significant cost—is anticipated. It is important that the book is evaluated within the communities for whom it is intended, and the necessary changes (if any) are made, before translation and large-scale publication takes place.
Objective The objective of the study was to measure the efficacy and ease of use of the book.
Methods Participants were recruited from a catering company. Participants were questioned on their knowledge of clinical trials and were then given the book. Instructions for use of the book were given to one group (‘experimental’ group). The other group (‘control’ group) was not given any instructions. A week later, the investigators returned, repeated the knowledge questions and asked ‘ease of use’ questions.
Results A two-way repeated measure of covariants showed a statistically significant positive increase in knowledge of clinical trials among the intervention group (p=0.02). Results for the control group displayed trends that were not statistically significant. Percentage analysis of ‘ease of use’ questions proved that the book is easy to use, although some changes would be beneficial.
Conclusion This study revealed that the speaking book is easy to use. It significantly increased knowledge of clinical trials among the study sample if instructions on use of the book were provided.
- Clinical trials
- developing world
- drugs and drug industry
- enhancing informed consent
- informed consent
- philosophy of medicine
- scientific research
- speaking book
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Competing interests One teaching post at the Steve Biko Centre for Bioethics (the occupant of this past was not involved in this research) and some activities of the Centre have been sponsored by Pfizer.
Ethics approval This study was conducted with the approval of the University of the Witwatersrand, Johannesburg, Human Research Ethics Committee (Medical).
Patient consent Obtained.
Provenance and peer review Not commissioned; externally peer reviewed.
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