Literature DB >> 18630235

Ethics committees and clinical trials registration in India: opportunities, obligations, challenges and solutions.

Prathap Tharyan1.   

Abstract

Registering clinical trials is considered an ethical and moral imperative. The launch of the Clinical Trials Registry-India provides opportunities to all in India to fulfil this imperative. The CTRI requires prospective registration, disclosure of all 20 items in the WHO Trial Registration Data Set and proof of ethics and regulatory clearances. Registration in the CTRI is voluntary. However, institutional research ethics committees have obligations. This article reviews these obligations and provides an example of how this can be achieved.

Mesh:

Year:  2007        PMID: 18630235     DOI: 10.20529/IJME.2007.066

Source DB:  PubMed          Journal:  Indian J Med Ethics        ISSN: 0974-8466


  9 in total

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Authors:  Nisha Venugopal; Gayatri Saberwal
Journal:  PLoS One       Date:  2021-05-11       Impact factor: 3.240

2.  Ethics committees in India: Facing the challenges!

Authors:  Rashmi Kadam; Shashikant Karandikar
Journal:  Perspect Clin Res       Date:  2012-04

3.  A study to assess completeness of project application forms submitted to Institutional Ethics Committees (IEC) of a tertiary care hospital.

Authors:  Yashashri C Shetty; Padmaja A Marathe; Gauri V Billa; C P Neelima Nambiar
Journal:  Perspect Clin Res       Date:  2012-10

4.  Ethics of sponsored research.

Authors:  Jharna Mandal; Subhash Chandra Parija
Journal:  Trop Parasitol       Date:  2014-01

Review 5.  Challenges in launching multinational oncology clinical trials in India.

Authors:  Kamal S Saini; Gaurav Agarwal; Ramesh Jagannathan; Otto Metzger-Filho; Monika L Saini; Khurshid Mistry; Raghib Ali; Sudeep Gupta
Journal:  South Asian J Cancer       Date:  2013-01

Review 6.  Ethics Committees in India: Past, present and future.

Authors:  Urmila M Thatte; Padmaja A Marathe
Journal:  Perspect Clin Res       Date:  2017 Jan-Mar

7.  An audit of studies registered retrospectively with the Clinical Trials Registry of India: A one year analysis.

Authors:  Amit R Birajdar; Debdipta Bose; Tushar B Nishandar; Anagha A Shende; Urmila M Thatte; Nithya J Gogtay
Journal:  Perspect Clin Res       Date:  2019 Jan-Mar

8.  Randomised trials relevant to mental health conducted in low and middle-income countries: a survey.

Authors:  Rebecca J Syed Sheriff; Clive E Adams; Prathap Tharyan; Mahesh Jayaram; Lelia Duley
Journal:  BMC Psychiatry       Date:  2008-08-14       Impact factor: 3.630

9.  The quality of registration of clinical trials: still a problem.

Authors:  Roderik F Viergever; Ghassan Karam; Andreas Reis; Davina Ghersi
Journal:  PLoS One       Date:  2014-01-10       Impact factor: 3.240

  9 in total

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