|Year : 2011 | Volume
| Issue : 3 | Page : 83
The Year Ahead: An initiative to assess the impact of an intervention "Speaking Book" on awareness among the potential participants about clinical trials in India
Urmila Thatte1, Santosh Taur2
1 Secretary, Forum for Ethics Review Committees in India; Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Parel, Mumbai, India
2 Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Parel, Mumbai, India
|Date of Web Publication||27-Jul-2011|
Prof & Head, Department of Clinical Pharmacology, Seth GS Medical College & KEM Hospital, Acharya Donde Marg, Parel, Mumbai- 400012
|How to cite this article:|
Thatte U, Taur S. The Year Ahead: An initiative to assess the impact of an intervention "Speaking Book" on awareness among the potential participants about clinical trials in India. Perspect Clin Res 2011;2:83
|How to cite this URL:|
Thatte U, Taur S. The Year Ahead: An initiative to assess the impact of an intervention "Speaking Book" on awareness among the potential participants about clinical trials in India. Perspect Clin Res [serial online] 2011 [cited 2013 May 25];2:83. Available from: http://www.picronline.org/text.asp?2011/2/3/83/83222
Ethical issues remain major challenges in the clinical research space in India.  The Forum for Ethics Review Committees in India (FERCI) is a registered society set up under the umbrella of FERCAP (Forum for Ethics Review Committees in Asia-Pacific) and has been engaged over the last few years in activities of fostering an improved ethical review of biomedical research studies in India, and empowerment of investigators and patients in the ethical conduct of research. Conduct of training programmes on ethics review processes, assisting in the development and implementation of standard operating procedures for ethical review, and making an educational video on the Informed Consent Process as a training tool for investigators have been some of the activities undertaken in the past.
In an effort to assist people of low literacy to understand what it means to take part in a clinical trial, a "Speaking Book" (English, Hindi and Telugu) has been developed by Pfizer India. The book is expected to improve understanding of clinical research in the community. A study will be conducted across 5 different centres in India after obtaining approval from Institutional Ethics Committees. The impact of the Speaking Book on the knowledge of the individuals participating in the study will be assessed using a structured, validated questionnaire which will help to assess the baseline knowledge and attitude about clinical trials. Assessment will also include the 'ease of use' of the Speaking Book and will be done immediately after listening, and 8 days later to evaluate recall. The study would bring forth more detailed information about the prevailing knowledge, attitude and practice about Clinical Trials in different geographical regions in India, and give valuable insight into the ability of an innovative intervention like the "Speaking Book" in enhancing the understanding of the clinical trial protocols and ethics amongst the potential participants in the country.
It is important that more such interventions that empower the potential research participant regarding his/her rights and responsibilities of clinical trials are developed, and their impact studied. It is also important in the near future to have "evidence" based innovations in the research ethics arena.
| References|| |
|1.||Thatte UM, Bavdekar SB. Clinical research in India: Great expectations? J Postgrad Med 2008;54:318-23. |