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   Table of Contents - Current issue
Coverpage
January-March 2017
Volume 8 | Issue 1
Page Nos. 1-50

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PRESIDENTíS MESSAGE  

President's Message p. 1
Suneela Milind Thatte
DOI:10.4103/2229-3485.198554  
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EDITORIAL Top

Future of Indian clinical trials: Moving forward from hyped potential to human protection p. 2
Arun Bhatt
DOI:10.4103/2229-3485.198553  
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ORIGINAL ARTICLE Top

”The invisible”: Participant's experiences in clinical trials p. 5
Sarojini Nadimpally, Divya Bhagianadh
DOI:10.4103/2229-3485.198550  
Background: The paper discussing the perspectives of clinical trial participants about the various aspects of CTs is based on the primary research conducted by Sama in 2012-13. Methodology: In-depth interviews were conducted with 36 CT participants from the states of New Delhi, Gujarat, Maharashtra and Andhra Pradesh. In addition to CT participants, other key informants including investigators, representatives of Contract Research Organizations (CROs), sponsor, Ethics Committee (EC) members etc. were also interviewed to develop a comprehensive understanding of the functioning of the CT sector. Findings and Discussion: The paper describes the perspectives of participants on the relevant aspects of recruitment into CTs, reasons for participation in CTs, informed consent, adverse events and compensation. The role played by the push and pull factors in recruitment, the information asymmetry, the power imbalance between the health-care provider and seeker, the role of sociocultural factors, etc., are explored in the paper. Combined with the insights from other stakeholders, the study gives an understanding about the chasm between regulations and realities in the Indian CT sector. Further, the paper briefly explores the recent changes and amendments in the laws governing the CT sector that is aimed at improving the conduct of CTs and uphold the rights of participants. Conclusion: Participants are the most important stakeholders in a CT setting. It is imperative that their voices are heard and their rights upheld for the ethical conduct of CTs.
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REVIEW ARTICLE Top

Regulatory environment for clinical research: Recent past and expected future p. 11
Amita Bhave, Suresh Menon
DOI:10.4103/2229-3485.198551  
In the past few years, there have been numerous updates to policy and guidelines governing the conduct of clinical research in India. These measures were taken by regulators considering safety of Indian patients as the topmost priority although the overall regulatory environment became challenging. However, in the recent past, Indian regulations have evolved positively to favorably support clinical research in India while appropriately balancing patient safety as well. These regulatory changes are expected to bring newer innovative medicines to Indian patients at an earliest.
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ORIGINAL ARTICLE Top

Ethics committees and the changed clinical research environment in India in 2016: A perspective! p. 17
Sanish Davis, Poonam Sule, Murtuza Bughediwala, Vrunda Pandya, Shilpi Sinha
DOI:10.4103/2229-3485.198555  
Introduction: Institutional and Independent Ethics Committees (ECs) have as their primary mission the protection of human research subjects. The Central Drugs Standard Control Organization has in the period 2013–2016 introduced several new regulations and amendments to existing regulations overseeing the conduct of Research in India. Several of these have direct effect on the functioning of the EC from a review, approval, and oversight mechanism. Methodology: The Ethics Council of Indian Society for Clinical Research conducted a questionnaire survey among EC members to understand the impact of these changes in their functioning. The domains surveyed included awareness about recent changes/amendments and impacts, serious adverse events (SAEs) and compensation, informed consent and audio-video recording, monitoring and auditing of research, and future working of ECs. Results: Seventy-nine percent of ECs are of the opinion that the new regulations/guidelines will add to their existing burden in the process of review and approval, providing subject protection and research oversight. Even though 68% of ECs stated that they are comfortable with SAE assessment and compensation determination, they state that there is variability in calculation of compensation amount using the formulae. An overwhelming majority (80%) of ECs stated that they were not in favor of centralized EC for providing review, approval, and oversight of clinical studies. Discussion: Ethics Committees act as local regulator for clinical trials at sites providing Human Subject protection. The survey captures the contemporary issues faced by the ECs and also raises important questions on the ease of doing research, oversight of approved research, and administrative burden on the EC. Conclusion: Recent changes in regulations have on the one hand empowered Ethics committees but brought in challenges in the way that they provide oversight and monitor research carried out at the site.
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REVIEW ARTICLES Top

Ethics Committees in India: Past, present and future p. 22
Urmila M Thatte, Padmaja A Marathe
DOI:10.4103/2229-3485.198549  
Following watershed amendments in Schedule Y India's star rose rather rapidly on the clinical research (especially clinical trials) horizon. Just as dramatic was the fall of this empire. At the centre of these events has been the participant and indirectly, the Ethics Committee (EC) that is established primarily to protect this individual. This paper traces the evolution of the concept of ECs in India, examines the current state of these committees in the country and suggests the way forward. The Past: The requirement for an EC to oversee clinical research was first made in the ICMR Policy Statement for Ethics published in 1980 and then again in the Schedule Y (1988). Later, both the Amended Schedule Y (2005) assigned regulatory responsibility on the EC and the ICMR Guidelines (2006) described the functioning of ECs. Several challenges including inadequate formal training, contribution from non-technical members, administrative support as well no SOPs and a heavy workload were identified. In the absence of regulatory oversight of ECs, the introduction of the Clinical Trial Registry - India (CTRI) and self-regulation through voluntary accreditation programs brought a measure of accountability and transparency. The Present: A slew of regulatory reforms led to more than 1000 ECs to be registered with CDSCO although the actual impact on participants' protection and safety of these new regulations still remains to be seen. Way Forward: A method to oversee all ECs, improved functioning of ECs including on site monitoring, central ECs for multicentric studies, the development of metrics to assess the ability of ECs to protect the participant are other ideas for the future. Conclusions: Although ECs in India have evolved from being mere rubber stamps for approval of protocols to efficiently functioning accredited ECs, yet there is much to be done for and by Ethics Committees.
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Investigators' viewpoint of clinical trials in India: Past, present and future p. 31
Mohandas K Mallath, Tanuj Chawla
DOI:10.4103/2229-3485.198552  
India's success in producing food and milk for its population (Green Revolution and White Revolution) happened because of scientific research and field trials. Likewise improving the health of Indians needs clinical research and clinical trials. A Large proportion of the sick Indians are poor, illiterate with no access to good health care. They are highly vulnerable to inducement and exploitation in clinical trials. The past two decades saw the rise and fall of clinical trials in India. The rise happened when our regulators created a favorable environment, and Indian investigators were invited to participate in global clinical trials. The gap between the demand and supply resulted in inadequate protection of the trial participants. Reports of abuses of the vulnerable trial participants followed by public interest litigations led to strengthening of regulations by the regulators. The stringent new regulations made the conduct of clinical trials more laborious and increased the cost of clinical trials in India. There was a loss of interest in sponsored clinical trials resulting in the fall in global clinical trials in India. Following repeated appeals by the investigators, the Indian regulators have recently relaxed some of the stringent regulations, while continuing to ensure the adequate patient protection. Clinical trials that are relevant to our population and conducted by well-trained investigators and monitored by trained and registered Ethics Committees will increase in the future. We must remain vigilant, avoid previous mistakes, and strive hard to protect the trial participants in the future trials.
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Clinical research: A personal perspective p. 37
Arun S Nanivadekar
DOI:10.4103/2229-3485.198547  
Research ought to be inculcated as an attitude during the formative years of every health-care professional. The core elements of research are curiosity, observation, reasoning, and experimentation. These suggestions are supported with suitable examples. Medical advisers in the pharmaceutical industry are in a unique position to act as facilitators of such a process. The tools they can use are also suggested.
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Development of statistics as a discipline for clinical research: Past, present, and future p. 41
Chitra Lele
DOI:10.4103/2229-3485.198548  
This article traces the history and evolution of statistics in the era of evidence based medicine, and focuses on the Indian perspective of this growth of statistics as a discipline for clinical research. Statistics will assume a more inter disciplinary form. Use of software other than SAS likely to grow further. In India, innovative statistical methods will help propel the development of biosimilars. The future is exciting with statistics being used for real world evidence, development of biosimilars, mining of adverse event data and becoming a core function in medicinal product development and lifecycle maintenance.
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Development of medical writing in India: Past, present, and future p. 45
Suhasini Sharma
DOI:10.4103/2229-3485.198556  
Pharmaceutical medical writing has grown significantly in India in the last couple of decades. It includes preparing regulatory, safety, and publication documents as well as educational and communication material related to health and health-care products. Medical writing requires medical understanding, knowledge of drug development and the regulatory and safety domains, understanding of research methodologies, and awareness of relevant regulations and guidelines. It also requires the ability to analyze, interpret, and present biomedical scientific data in the required format and good writing skills. Medical writing is the fourth most commonly outsourced clinical development activity, and its global demand has steadily increased due to rising cost pressures on the pharmaceutical industry. India has the unique advantages of a large workforce of science graduates and medical professionals trained in English and lower costs, which make it a suitable destination for outsourcing medical writing services. However, the current share of India in global medical writing business is very small. This industry in India faces some real challenges, such as the lack of depth and breadth in domain expertise, inadequate technical writing skills, high attrition rates, and paucity of standardized training programs as well as quality assessment tools. Focusing our time, attention, and resources to address these challenges will help the Indian medical writing industry gain its rightful share in the global medical writing business.
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