Tag Archives: ethics

Ethics and equity in research priority-setting: stakeholder engagement and the needs of disadvantaged groups

A transparent and evidence-based priority-setting process promotes the optimal use of resources to improve health outcomes. Decision-makers and funders have begun to increasingly engage representatives of patients and healthcare consumers to ensure that research becomes more relevant. However, disadvantaged groups and their needs may not be integrated into the priority-setting process since they do not have a “political voice” or are unable to organise into interest groups. Equitable priority-setting methods need to balance patient needs, values, experiences with population-level issues and issues related to the health system.
Read the full paper published by Dr. Soumyadeep B et al at Indian Journal of Medical Ethics here (Click: Open Access)

Indian journals fair poorly with respect to clinical trial registration details for publication.

CaptureProspective registration of clinical trials has been made mandatory by various government regulations. The ICMJE guidelines require a clinical trial to be registered as a prerequisite for publication while the revised CONSORT Statement requires the authors to submit the trial registration number and name of registry while reporting of clinical trials.

A short study of ‘instructions for authors’ of MEDLINE indexed Indian medical and dental journals publishing clinical trials to assess their editorial policies on trial registration was done by Dr. Soumyadeep B and his colleague .

They identified 30 journals from the National Library of Medicine Catalog meeting our study criteria. From the websites of these journals, they accessed the ‘instructions for authors’ and extracted information on requirement of trial registration number during submission of clinical trials, mention about any eligible trial registry, endorsement of CONSORT Statement in reporting of trials and mention about the ICMJE Guidelines.
Results :Trial registration number was required in only 30 % journals (9/30, 30%). Only 16 journals (16/30, 53.33%) encouraged adherence to the CONSORT Statement in reporting of trials, while 22 journals (22/30, 73.33%) mentioned about ICMJE Guidelines in their instructions.

The study shows an urgent need of uniform endorsement of international standards in registration and reporting of clinical trials by the journals and identifies a major issue in the medical publishing arena in India. Read the full study titled ” Editorial Policies of MEDLINE Indexed Indian Journals on Clinical Trial Registration  ” published in the esteemed medical journal Indian Pediatrics here. (OPEN ACCESS)

Clinical Trial Data and the “Do no harm” principle

In an era of evidence based medicine clinical trials hold the key to validate or negate a medical intervention, whatsoever is its nature. However, clinical trials have been under increased scrutiny in the recent past due to concerns over violations of ethical concerns and research related injury. Thus it has become imperative on the part of those at the helm of affairs of clinical trials (drug makers as well as non-governmental organisations and governments which funds such studies) to make available the full and complete information of clinical trial available in public domain.

Making clinical trial data available right from the initial phase’s right till its end in the public domain not only enhances the transparency and validity of the trial it is also beneficial to those running the trial itself. It helps to improve the quality of clinical trials by making it possible to identify potential problems as well as allow health care practitioners to identify researchers related to their field.

Read Dr. Soumyadeep B’s response to the BMJ Open Data Campaign at the British Medical Journal (Open Access)

From a Doctor to a Soldier

May  2010, Bankura, India –A head injury patient lay in the emergency room  just on intravenous fluids for the second day. He did not even have the pension money to do CT scan at government subsidised rates (INR 800-US$16). I lay down in my hostel bed listening to the legendary Floyd’s “ we dont..  need.. now no education…” in my iPod and wondering whether “I should have reached the purse and given him the 800 rupees required for the CT scan?Continue reading “From a Doctor to a Soldier”

Data used to justify Indian HPV vaccination trial questioned

A trial of human papillomavirus (HPV) vaccines in India, halted by the Indian Government in 2010, ran into fresh controversy with the publication of a study suggesting that the trial should not have been started in the first place.
The HPV vaccine trial of more than 23 000 girls from Gujarat and Andhra Pradesh, run by the Program for Appropriate Technology in Health (PATH), an international charity, was suspended by the Indian Government after reports of deaths of four girls in the trial and subs …
 
Read the full article by Dr. Soumyadeep B at : The Lancet Oncology