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   2011| April-June  | Volume 2 | Issue 2  
    Online since May 2, 2011

 
 
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MEDICAL WRITING
Plagiarism: Why is it such a big issue for medical writers?
Natasha Das, Monica Panjabi
April-June 2011, 2(2):67-71
DOI:10.4103/2229-3485.80370  PMID:21731858
Plagiarism is the wrongful presentation of somebody else's work or idea as one's own without adequately attributing it to the source. Most authors know that plagiarism is an unethical publication practice. Yet, it is a serious problem in the medical writing arena. Plagiarism is perhaps the commonest ethical issue plaguing medical writing. In this article, we highlight the different types of plagiarism and address the issues of plagiarism of text, plagiarism of ideas, mosaic plagiarism, self-plagiarism, and duplicate publication. An act of plagiarism can have several repercussions for the author, the journal in question and the publication house as a whole. Sometimes, strict disciplinary action is also taken against the plagiarist. The article cites examples of retraction of articles, suspension of authors, apology letters from journal editors, and other such actions against plagiarism.
  10,131 1,738 18
QUALITY
Good documentation practice in clinical research
Chitra Bargaje
April-June 2011, 2(2):59-63
DOI:10.4103/2229-3485.80368  PMID:21731856
One of the most common inspection findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data. This article focuses on the key principles of good documentation practice and offers suggestions for improvement.
  9,254 1,842 11
PHARMACOVIGILANCE
Pharmacovigilance for clinical trials in India: Current practice and areas for reform
Ballari Brahmachari, Melanie Fernandes, Arun Bhatt
April-June 2011, 2(2):49-53
DOI:10.4103/2229-3485.80366  PMID:21731854
Keeping in mind India's increasing participation in multinational trials, this article explores potential areas of Indian pharmacovigilance, requiring reform and provides recommendations for building a robust safety reporting system. Internal discrepancies exist between Schedule Y and Central Drugs Standard Control Organisation approval letter regarding what to report. Schedule Y's silence on expedited reporting requirements creates confusion for Indian sites that are part of multinational trial. Not allowing waiver for serious adverse events that are protocol specified or are study endpoints, along with lack of emphasis on causality as reporting criteria, adds substantial burden of uninformative cases for regulatory review. Despite global focus on Development Safety Update Report, Indian regulators are not yet insistent on real-time update of a drug's cumulative safety profile. Issues like reporting requirements for generic trials, pregnancy reporting and lenient timeline for death/life-threatening events need attention. Finally, the need to formulate an all-encompassing pharmacovigilance guideline for India, in sync with global practice cannot be overemphasized.
  8,516 1,633 3
ETHICS
The Nuremberg Code-A critique
Ravindra B Ghooi
April-June 2011, 2(2):72-76
DOI:10.4103/2229-3485.80371  PMID:21731859
The Nuremberg Code drafted at the end of the Doctor's trial in Nuremberg 1947 has been hailed as a landmark document in medical and research ethics. Close examination of this code reveals that it was based on the Guidelines for Human Experimentation of 1931. The resemblance between these documents is uncanny. It is unfortunate that the authors of the Nuremberg Code passed it off as their original work. There is evidence that the defendants at the trial did request that their actions be judged on the basis of the 1931 Guidelines, in force in Germany. The prosecutors, however, ignored the request and tried the defendants for crimes against humanity, and the judges included the Nuremberg Code as a part of the judgment. Six of ten principles in Nuremberg Code are derived from the 1931 Guidelines, and two of four newly inserted principles are open to misinterpretation. There is little doubt that the Code was prepared after studying the Guidelines, but no reference was made to the Guidelines, for reasons that are not known. Using the Guidelines as a base document without giving due credit is plagiarism; as per our understanding of ethics today, this would be considered unethical. The Nuremberg Code has fallen by the wayside; since unlike the Declaration of Helsinki, it is not regularly reviewed and updated. The regular updating of some ethics codes is evidence of the evolving nature of human ethics.
  7,772 1,295 14
ORIGINAL ARTICLE
Trend of clinical drug trials in type 2 diabetes mellitus over last decade
Rakesh Parikh, Kirti Pandia, Mahesh Goyal, Meenakshi Sharma, MS Dolima
April-June 2011, 2(2):64-66
DOI:10.4103/2229-3485.80369  PMID:21731857
Background: Type 2 diabetes mellitus (Type 2 DM) has been recognized as the recent pandemic; India and China competing each other for the title--"Diabetes Capital of the World." A number of new drugs have been recently available and has lead to a boom in the clinical drug trial industry. We intend to evaluate the trend of clinical drug trials in Type 2 DM over last one decade. Materials and Methods: Clinical drug trial registry of USA was used for getting the data regarding number of drug trials conducted in each country over last decade. India, China, and USA being the countries with highest prevalence of diabetes were included in the analysis. The percentage share of each country in clinical drug trials in Type 2 DM was compared with their percentage share in prevalence of Type 2 DM. Discussion: A significant growth in the drug trials in Type 2 DM was observed during 2005 to 2008, after which there has been a plateau. It was also recognized that India and China which contribute to around 30% of diabetic population of the world contributed in only 9.73% and 5.15% of drug trials in Type 2 DM during 2010, respectively. USA comprising of 15.15% of diabetic population of world was seen to have contributed in 38.36% of clinical drug trials in Type 2 DM. This raises a question of skewing in the data generated from various drug trials conducted in Type 2 DM.
  4,437 511 3
EDITORIAL
Quality of independent review board/ethics committee oversight in clinical trials in India
Anvita Pandiya
April-June 2011, 2(2):45-47
DOI:10.4103/2229-3485.80364  PMID:21731852
  3,062 516 3
QUALITY
Strategies for ensuring quality data from Indian investigational sites
Antal K Hajos, Sujal K Kamble
April-June 2011, 2(2):54-58
DOI:10.4103/2229-3485.80367  PMID:21731855
The topic of ensuring quality and compliance is and must be a top priority in the conduct of clinical trials, as warranted by regulatory guidelines as well as the inherent responsibility of the professionals conducting such research. Fast-growing emerging clinical geographies such as India demand special attention due to rapid growth and associated factors that may put study quality at risk. In this paper, we used the basic principle of PDCA (Plan, Do, Check, and Adjust) to structure the processes of a clinical trial from protocol to final analysis in order to highlight the interactive nature of involved people and processes required to ensure quality of data and site functioning.
  2,593 418 -
LEADERSHIP INITIATIVE
Comparative effectiveness research
Chitra Lele
April-June 2011, 2(2):48-48
DOI:10.4103/2229-3485.80365  PMID:21731853
  2,055 422 -
LETTER TO EDITOR
Not only documentation
Viroj Wiwanitkit
April-June 2011, 2(2):77-77
DOI:10.4103/2229-3485.80372  PMID:21731860
  1,786 261 -
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