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      Curricular adequacy on basics of clinical trials

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          Abstract

          INTRODUCTION:

          Clinical trials are integral to innovation in the treatment modalities and are conducted to assess the safety and efficacy of novel drugs. Clinical trials of modern era have evolved through stern consequences and tragedies in the past. This study was designed to know knowledge on ethics, adverse drug reactions (ADRs), and tragedies in clinical trials among interns and postgraduates (PGs).

          METHODOLOGY:

          A cross-sectional study was carried out on graduates undergoing internship (interns) and PG residents of a medical college and a dental college from Punjab. This descriptive cross-sectional study was conducted on 151 professionals of medical college and 100 professionals of dental colleges in Punjab with the help of a prevalidated questionnaire. The data were then analyzed using descriptive statistics.

          RESULTS:

          There was no significant difference between dental and medical doctors regarding ethics and ADRs, but a significant difference was observed among interns and PG residents, with interns having higher awareness regarding ethics and ADRs. There was no significant difference ( P = 0.941) in knowledge among dental and medical doctors as well as among interns and PG residents, with P = 0.264 about tragedies in clinical trials.

          CONCLUSION:

          From the study, it can be concluded that interns and PGs do not get enough exposure to basics in clinic research such as research ethics, ADRs, and tragedies in clinical trials. It is suggested that there is a requirement for suitable modifications in the teaching curriculum at undergraduate level and regular training must be provided to professionals.

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          Most cited references29

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          Informed consent process: A step further towards making it meaningful!

          Informed consent process is the cornerstone of ethics in clinical research. Obtaining informed consent from patients participating in clinical research is an important legal and ethical imperative for clinical trial researchers. Although informed consent is an important process in clinical research, its effectiveness and validity are always a concern. Issues related to understanding, comprehension, competence, and voluntariness of clinical trial participants may adversely affect the informed consent process. Communication of highly technical, complex, and specialized clinical trial information to participants with limited literacy, diverse sociocultural background, diminished autonomy, and debilitating diseases is a difficult task for clinical researchers. It is therefore essential to investigate and adopt innovative communication strategies to enhance understanding of clinical trial information among participants. This review article visits the challenges that affect the informed consent process and explores various innovative strategies to enhance the consent process.
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            Knowledge, attitudes and practice of healthcare ethics and law among doctors and nurses in Barbados

            Background The aim of the study is to assess the knowledge, attitudes and practices among healthcare professionals in Barbados in relation to healthcare ethics and law in an attempt to assist in guiding their professional conduct and aid in curriculum development. Methods A self-administered structured questionnaire about knowledge of healthcare ethics, law and the role of an Ethics Committee in the healthcare system was devised, tested and distributed to all levels of staff at the Queen Elizabeth Hospital in Barbados (a tertiary care teaching hospital) during April and May 2003. Results The paper analyses 159 responses from doctors and nurses comprising junior doctors, consultants, staff nurses and sisters-in-charge. The frequency with which the respondents encountered ethical or legal problems varied widely from 'daily' to 'yearly'. 52% of senior medical staff and 20% of senior nursing staff knew little of the law pertinent to their work. 11% of the doctors did not know the contents of the Hippocratic Oath whilst a quarter of nurses did not know the Nurses Code. Nuremberg Code and Helsinki Code were known only to a few individuals. 29% of doctors and 37% of nurses had no knowledge of an existing hospital ethics committee. Physicians had a stronger opinion than nurses regarding practice of ethics such as adherence to patients' wishes, confidentiality, paternalism, consent for procedures and treating violent/non-compliant patients (p = 0.01) Conclusion The study highlights the need to identify professionals in the workforce who appear to be indifferent to ethical and legal issues, to devise means to sensitize them to these issues and appropriately training them.
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              Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act.

              Paul M Wax (1995)
              The Elixir Sulfanilamide disaster of 1937 was one of the most consequential mass poisonings of the 20th century. This tragedy occurred shortly after the introduction of sulfanilamide, the first sulfa antimicrobial drug, when diethylene glycol was used as the diluent in the formulation of a liquid preparation of sulfanilamide known as Elixir Sulfanilamide. One hundred five patients died from its therapeutic use. Under the existing drug regulations, premarketing toxicity testing was not required. In reaction to this calamity, the U.S. Congress passed the 1938 Federal Food, Drug and Cosmetic Act, which required proof of safety before the release of a new drug. The 1938 law changed the drug focus of the Food and Drug Administration from that of a policing agency primarily concerned with the confiscation of adulterated drugs to a regulatory agency increasingly involved with overseeing the evaluation of new drugs. The Elixir Sulfanilamide tragedy, its effect on drug regulations, and the history of other diethylene glycol and diluent mass poisonings are discussed.
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                Author and article information

                Journal
                Indian J Pharmacol
                Indian J Pharmacol
                IJPharm
                Indian Journal of Pharmacology
                Wolters Kluwer - Medknow (India )
                0253-7613
                1998-3751
                Mar-Apr 2019
                : 51
                : 2
                : 109-115
                Affiliations
                [1] Department of Clinical Research, Dasmesh Institute of Research and Dental Sciences, Faridkot, Punjab, India
                [1 ] Department of Hospital Management, Guru Gobind Singh Medical Hospital, Faridkot, Punjab, India
                Author notes
                Address for correspondence: Dr. Ravinder Nath Bansal, Department of Hospital Management, Guru Gobind Singh Medical Hospital, Faridkot - 151 203, Punjab, India. E-mail: rnbansal@ 123456gmail.com
                Article
                IJPharm-51-109
                10.4103/ijp.IJP_184_18
                6533931
                a946e494-8fd0-4ee0-badc-d598f0367283
                Copyright: © 2019 Indian Journal of Pharmacology

                This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.

                History
                : 07 April 2018
                : 30 April 2019
                Categories
                Research Article

                Pharmacology & Pharmaceutical medicine
                adverse drug reaction,clinical trials,ethics,tragedies
                Pharmacology & Pharmaceutical medicine
                adverse drug reaction, clinical trials, ethics, tragedies

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