Perspectives in Clinical Research

New clinical trial rules: Academic trials and tribulations Arun Bhatt Perspectives in Clinical Research 2019 10(3):103-105

Does India need more medical scientists? Suhasini Sharma Perspectives in Clinical Research 2019 10(3):106-107

Indian Council of Medical Research's National Ethical Guidelines for biomedical and health research involving human participants: The way forward from 2006 to 2017 Sapan Kumar Behera, Saibal Das, Alphienes Stanley Xavier, Sandhiya Selvarajan, Nishanthi Anandabaskar Perspectives in Clinical Research 2019 10(3):108-114 The Indian Council of Medical Research (ICMR) recently published the third revised guidelines “National Ethical Guidelines for Biomedical and Health-Related Research Involving Human Participants” in 2017. The changes to the guidelines were needed to acculturate the rapid advances in the research environment and advances in science and technology. The revised guidelines propose substantial changes/ modifications compared to the previous version. These include the introduction of broad consent, ethical issues related to deception, review of multi-centric research by a single ethics committee and ethical issues involved in implementation research and other issues related to public health research. The revised guidelines also incorporate modifications and minor changes to the previous version. Although most of the changes in the revised guidelines are in parallel to most of the international guidelines, we have also highlighted the minor differences compared to other international guidelines.

Assessing knowledge, attitude, and practices of health-care providers toward pharmacovigilance and adverse drug reaction reporting at a comprehensive cancer center in Jordan Abeer Ahmad Al Rabayah, Esra'a Mahmoud Hanoun, Ruba Hab Al Rumman Perspectives in Clinical Research 2019 10(3):115-120 Background and Objective: Cancer patients are more likely to experience adverse drug reactions (ADRs) than other patients, because of both the complexity of the treatment regimens and the severity of disease. The objectives of this study were to determine the knowledge, attitude, and practice of health-care providers toward pharmacovigilance and ADR reporting, barriers to ADR reporting, and the association between the demographics of health-care providers and their knowledge and attitude toward reporting. Materials and Methods: A cross-sectional survey was conducted at the King Hussein Cancer Center. A self-administered questionnaire was distributed to dispensary pharmacists, clinical pharmacists, physicians, and nurses. Descriptive analysis was used, with testing for associations between variables. Results: Of the 373 questionnaires, 306 were returned (response rate, 82%). Pharmacists and nurses were more knowledgeable than physicians; however, all participants had a highly positive attitude toward pharmacovigilance and ADR reporting, with a mean score of 3.87 out of 5. The main knowledge gaps were filling in an ADR reporting form, assessing the severity of ADRs, and differentiating between ADRs and adverse events. The main barriers to ADR reporting (37.5% of responses) were considered to be lack of training and of understanding reporting rules. No associations were found with age, gender, years of experience, attitude, or knowledge. Conclusion and Recommendations: Understanding of pharmacovigilance and ADR reporting could further be improved among health-care providers at our center.

Clinical trials in Asia: A World Health Organization database study Sheraz Ali, Oluwaseun Egunsola, Zaheer Ud Din Babar, Syed Shahzad Hasan Perspectives in Clinical Research 2019 10(3):121-124 Background and Objective: The Asian continent appears to be a growing destination for conducting cost-effective clinical trials, utilizing the available pool of treatment naïve subjects. This study aims to determine the growth rate of clinical trials in Asia. Methods: A database review was conducted. Registered clinical trials conducted in selected countries in Asia, Europe, Australia, and North America between 2008 and 2017 were searched from the International Clinical Trial Registry Platform. Compound Annual Growth Rate was determined for registered clinical trials. Results: During the 10-year period, a total of 125,918 registered clinical trials were conducted in Asia. There was a 7-fold increase in the number of registered clinical trials in Asia. More trials were registered in Japan than any other Asian country (30.8%). The average annual increase in the number of registered trials was generally higher in Asia than the United States of America, Canada, EU countries, or Australia. Iran recorded the highest average annual increase in the number of all clinical trials in Asia (41.9%). The number of pediatric clinical trials in Iran also increased annually by an average of 30.4%, more than any other country included in this study. Conclusions: Clinical trials recruitment in Asia is increasing faster than Europe, North America, and Australia. Lower trial cost and large patient pool may be contributory to this increase.

Quality of life among HIV-tuberculosis co-infected patients Dharmendra Kumar Jha, Jyotsna Jha, Anshu Kumar Jha, Basavaprabhu Achappa, Ramesh Holla Perspectives in Clinical Research 2019 10(3):125-129 Background: India is the world's third leading country in terms of people living with human deficiency virus (HIV) (2.1 million) with 0.4 million deaths due to HIV-associated tuberculosis (TB). Physical and mental stress degrades the quality of life (QOL) in these patients. Studies have been done in HIV patients but very few on HIV-TB co-infected patients. Our study aims at assessing and comparing the QOL in HIV patients with and without TB. Materials and Methods: It was a cross-sectional study done at Antiretroviral Treatment Center of KMC, Mangalore and District Wenlock Hospital, Mangalore, over 6 months. A sample size was 104. Semi-structured questionnaire to collect clinico-demographic data, World Health Organization QOL (WHOQOL)-HIV BREF to assess the QoL, and Beck's Depression Inventory Scale (Physical health, psychological well-being, social relationship, environmental health, level of independence, and spiritual health) to identify depression were used. The Cronbach's alpha was used to measure the internal consistency for each domain of the WHOQOL-HIV instrument. Results: HIV-TB co-infected patients had a lower mean score in all domains as compare to only HIV patients, suggesting that HIV-TB co-infected patients had a poor QOL (P < 0.05). Internal consistency of each domain was good (α >0.7). Conclusion: To improve the QOL in HIV patients, it is important to identify the determinants of QOL and work toward its improvement.

Utilization of antimicrobial agents in patients on ventilator in medical Intensive Care Unit at a tertiary care teaching hospital: A prospective study Raj Khirasaria, Neeta Kanani, Angelika Batta Perspectives in Clinical Research 2019 10(3):130-136 Background: The burden of bacterial infections is huge and grossly underrepresented in the current health-care system. Inappropriate use of antimicrobial agents (AMAs) poses a potential hazard to patients by causing antibiotic resistance. In addition, the field of antimicrobials is witnessing constant development and introduction of new drugs for which holistic utilization, effectiveness, and side-effects studies are the need of the hour. The current study aims at studying the prescription pattern of AMAs in patients on ventilator and focuses on their prescribing trends. Methodology: A prospective, observational study was conducted in Medical Intensive Care Unit (ICU) of a tertiary care hospital of Western India for 6 months. Prescription pattern of AMAs was analyzed using predesigned format. Statistical Analysis: Descriptive statistics was used being an observational study Results: Five-hundred and twenty patients who were on ventilator and were prescribed one or more AMAs were enrolled in the study with a mean patient age of 40.7 years. The intended purpose of the use of AMAs was prophylactic in 59% of patients. Empirical therapy was given in 92% of patients. β-lactams group of AMAs along with metronidazole were most frequently used. 73% required concurrent use of two or more AMAs. 9% of the patients required addition or substitution of one or more other AMAs on the basis of culture and sensitivity report or inadequate clinical response and expert opinion. The outcome of therapy with AMAs showed infection was effectively prevented in 34% of the patients. Conclusion: This study provides a baseline data for improving the utilization of AMAs in ICU settings by rationalizing their use and also carrying out further studies on prescribing pattern of AMAs in a tertiary care unit.

Study designs: Part 4 – Interventional studies Rakesh Aggarwal, Priya Ranganathan Perspectives in Clinical Research 2019 10(3):137-139 In the fourth piece of this series on research study designs, we look at interventional studies (clinical trials). These studies differ from observational studies in that the investigator decides whether or not a participant will receive the exposure (or intervention). In this article, we describe the key features and types of interventional studies.

Pivotal role of Pharmacovigilance Programme of India in containment of antimicrobial resistance in India Vijit Agrawal, Tarani Prakash Shrivastava, Pramod Kumar Adusumilli, Kalaiselvan Vivekanandan, Prasad Thota, Shashi Bhushan Perspectives in Clinical Research 2019 10(3):140-144 Misuse of antimicrobials has become one of the grave concerns of public health. In last two decades, this has been largely contributing in the emergence of antimicrobial resistance (AMR) among all the pathogens. A 2013 report of Centres for Disease Control and Prevention, USA figured that at least 2 million people get an antibiotic-resistant infection every year and as many as 23,000 people lost their life. A multi-country survey in Southeast Asia region conducted by World Health Organization (WHO) in 2015, identified several gaps in knowledge and awareness about the optimal use of antimicrobials and AMR. Following this, the Ministry of Health and Family Welfare (MoHFW), Government of India, developed National Action Plan in the year 2017 to combat AMR. Pharmacovigilance Programme of India (PvPI) being a flagship programme of MoHFW holds the responsibility of ensuring safety of medicines used by India population and has recently identified AMR as one of the strategic priorities. This article intends to provide insights of the recent attempts and deliberate efforts made by PvPI in the containment of AMR in India and it also intends to sensitize healthcare fraternity on restricting AMR in public interest.

Alexandros Sfakianakis
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