Abstract:

Objective:

The main project is about finding perspective of Indian population (segregated into 3 categories: Patients, Healthy Volunteers, and Parents) on Clinical Research.

Design

A survey in the question-answer form was carried out including the Volunteers/Participants of Clinical research all over different regions of India. Questionnaires were filled with the help of investigators, physicians, social workers, freelancers, and research professionals, etc.

Methods

Clinical research is an important factor but it is only possible when Healthy Volunteers are participating in the clinical research. Physiological and anatomical conditions of a participant are taken in to consideration. Therefore diseases & conditions and their treatments also vary among each individual. This study has major focus on the awareness and perspective of Indian participants and their views towards clinical research. Also, participants are provided with proper treatment, confidentiality, compensation, proper treatment and knowledge as well as safety which always remain the top priority.

Results

There were 28 different parameters/data points based on which the data was collected from 1114volunteers/participants across the country. As the available data is dichotomous, a dynamic analysis was done using a percentile method.

Conclusion

In India, regulatory health authority such as the Central Drugs Standard Control Organization (CDSCO) – the office of the Drug Controller General (India), set the necessary guidelines & schedules for ethical conduction of clinical trials. This survey overall displays the analysis study all about the volunteers for clinical researches. It throws light on their understanding about ‘clinical research’, their beliefs, dis-beliefs about certain facts of clinical research. The whole survey was categorized into three types: Part of the population who agreed to a certain pattern of survey, one part which did not agree and the third one being unaware at all. It was observed that people who believed or thought that the facts involved were true or correct were at an appreciable percentage when compared to those who considered it as False. Whereas, the number of people who were un-aware couldn’t be ignored either.

Keywords: Clinical trials, Awareness, Volunteer/Participant Perspective, Safety, Confidentiality, Compensation, Harm /Benefit to the society, Participation, Financial gain, Collaboration.

References:

[1]. A.R., C. (n.d.). Clinical trials: present and future in India. Retrieved February 2015, from Pharmainfo.net: http://www.pharmainfo.net

[2]. Bhatt, A. (2006). Winds of Change - Evolution of clinical drug trials in India. Pharma Times(38:), pp. 19-20.

[3]. Bhatt, A. S. (2004, Feb 26). Indian clinical research odyssey. Pharma Biz(Chronicle specials). Retrieved January 2015, from http://saffron.pharmabiz.com/article/detnews.asp?articleid=20742&sectionid=50

[4]. Bindra, S. K. (2010). Survey on perceptions of indian investigators on research ethics. Perceptives in Clinical Research, 1:, 94-7.

[5]. Das, N. (n.d.). Outsourcing clinical trials to India. Chillibreeze Solutions Pvt. Ltd. Retrieved February 2015, from http://www.chillibreeze.com

[6]. De, M. (2005). India, ideal destination for clinical trials. CurrSci, 89:597.

[7]. Fenn, C. W. (2001). The contemporary situation for the conduct of clinical trials in Asia. Int J Pharm Med(15:), 169-73.

[8]. Jayasheel, B. (2010). Issues regarding delay in regulatory approvals carrying out clinical trials in India. Regulatory Affairs Journal Pharma, 1-4.

[9]. Moin, D. (2013). Clinical trials and safety reporting under Schedule Y. Retrieved February 2015, from Pharmabiz: http://www.pharmabiz.com.

[10]. N., V. (2006, June 1). Conducting clinical trials in Asia. Retrieved February 2015, from http://www.actmagazine.com

[11]. Parikh RM, G. M. (2011;). Trend of clinical drug trials in type 2 DM over last decade. Percept Clin Res, 2:, 64-6.

[12]. Research and Markets. (2006). India: pharmaceutical and biotechnology opportunities. India: Pharmalicensing Ltd. Retrieved January 2015, from http://www.researchandmarkets.com

Works Cited

[1]. A.R., C. (n.d.). Clinical trials: present and future in India. Retrieved February 2015, from Pharmainfo.net: http://www.pharmainfo.net

[2]. Bhatt, A. (2006). Winds of Change - Evolution of clinical drug trials in India. Pharma Times(38:), pp. 19-20.

[3]. Bhatt, A. S. (2004, Feb 26). Indian clinical research odyssey. Pharma Biz(Chronicle specials). Retrieved January 2015, from http://saffron.pharmabiz.com/article/detnews.asp?articleid=20742&sectionid=50

[4]. Bindra, S. K. (2010). Survey on perceptions of indian investigators on research ethics. Perceptives in Clinical Research, 1:, 94-7.

[5]. Das, N. (n.d.). Outsourcing clinical trials to India. Chillibreeze Solutions Pvt. Ltd. Retrieved February 2015, from http://www.chillibreeze.com

[6]. De, M. (2005). India, ideal destination for clinical trials. CurrSci, 89:597.

[7]. Fenn, C. W. (2001). The contemporary situation for the conduct of clinical trials in Asia. Int J Pharm Med(15:), 169-73.

[8]. Jayasheel, B. (2010). Issues regarding delay in regulatory approvals carrying out clinical trials in India. Regulatory Affairs Journal Pharma, 1-4.

[9]. Moin, D. (2013). Clinical trials and safety reporting under Schedule Y. Retrieved February 2015, from Pharmabiz: http://www.pharmabiz.com.

[10]. N., V. (2006, June 1). Conducting clinical trials in Asia. Retrieved February 2015, from http://www.actmagazine.com

[11]. Parikh RM, G. M. (2011;). Trend of clinical drug trials in type 2 DM over last decade. Percept Clin Res, 2:, 64-6.

[12]. Research and Markets. (2006). India: pharmaceutical and biotechnology opportunities. India: Pharmalicensing Ltd. Retrieved January 2015, from http://www.researchandmarkets.com