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   2011| October-December  | Volume 2 | Issue 4  
    Online since October 31, 2011

 
 
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STATISTICS
Survival analysis in clinical trials: Basics and must know areas
Ritesh Singh, Keshab Mukhopadhyay
October-December 2011, 2(4):145-148
DOI:10.4103/2229-3485.86872  
Many clinical trials involve following patients for a long time. The primary event of interest in those studies is death, relapse, adverse drug reaction or development of a new disease. The follow-up time for the study may range from few weeks to many years. A different set of statistical procedures are employed to analyze the data, which involves time to event an analysis. It is a very useful tool in clinical research and provides invaluable information about an intervention. This article introduces the researcher to the different tools of survival analysis.
  14,082 2,728 44
RESEARCH METHODOLOGY
Patient-reported outcomes: A new era in clinical research
Prasanna R Deshpande, Surulivel Rajan, B Lakshmi Sudeepthi, CP Abdul Nazir
October-December 2011, 2(4):137-144
DOI:10.4103/2229-3485.86879  
Now-a-days there is significant discussion about patient-reported outcomes (PRO) in medical world. The following article covers almost all the areas of PRO including-their importance, important concepts for understanding of PRO, significance, ideal properties, types, development and evaluation of PRO instruments. It is useful for physicians, pharmacists and patients for the assessment and improvement of the therapy.
  13,298 3,072 272
EDITORIAL
Non-inferiority and equivalence trials: Need for a standardized process
Suresh Keshav Bowalekar
October-December 2011, 2(4):115-118
DOI:10.4103/2229-3485.86868  
  3,413 5,929 2
ORIGINAL ARTICLE
An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting among prescribers at a tertiary care hospital
Chetna K Desai, Geetha Iyer, Jigar Panchal, Samidh Shah, RK Dikshit
October-December 2011, 2(4):129-136
DOI:10.4103/2229-3485.86883  
Objectives: Spontaneous reporting is an important tool in pharmacovigilance. However, its success depends on cooperative and motivated prescribers. Under-reporting of adverse drug reactions (ADRs) by prescribers is a common problem. The present study was undertaken to evaluate the knowledge, attitude, and practices (KAP) regarding ADR reporting among prescribers at the Civil Hospital, Ahmedabad, to get an insight into the causes of under-reporting of ADRs. Materials and Methods: A pretested KAP questionnaire comprising of 15 questions (knowledge 6, attitude 5, and practice 4) was administered to 436 prescribers. The questionnaires were assessed for their completeness (maximum score 20) and the type of responses regarding ADR reporting. Microsoft Excel worksheet (Microsoft Office 2007) and Chi-Square test were used for statistical analysis. Results: A total of 260 (61%) prescribers completed the questionnaire (mean score of completion 18.04). The response rate of resident doctors (70.7%) was better than consultants (34.5%) (P < 0.001). ADR reporting was considered important by 97.3% of the respondents; primarily for improving patient safety (28.8%) and identifying new ADRs (24.6%). A majority of the respondents opined that they would like to report serious ADRs (56%). However, only 15% of the prescribers had reported ADRs previously. The reasons cited for this were lack of information on where (70%) and how (68%) to report and the lack of access to reporting forms (49.2%). Preferred methods for reporting were e-mail (56%) and personal communication (42%). Conclusion: The prescribers are aware of the ADRs and the importance of their reporting. However, under reporting and lack of knowledge about the reporting system are clearly evident. Creating awareness about ADR reporting and devising means to make it easy and convenient may aid in improving spontaneous reporting.
  6,520 1,424 24
QUALITY
Quality of clinical trials: A moving target
Arun Bhatt
October-December 2011, 2(4):124-128
DOI:10.4103/2229-3485.86880  
Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.
  6,193 1,444 20
OPINION
Industry commitment to the science of safety
Viraj Suvarna
October-December 2011, 2(4):119-120
DOI:10.4103/2229-3485.86870  
  2,452 2,172 -
REGULATORY
Implications of ICH-E5: Assessment of drug's sensitivity to ethnic factors and necessity of a bridging study for global drug development
Sandeep Kumar Gupta
October-December 2011, 2(4):121-123
DOI:10.4103/2229-3485.86874  
The ICH-E5 guideline provides a general framework for evaluating the potential impact of ethnic factors on the acceptability of foreign clinical data, with the underlying objective of minimizing duplication of clinical data, and it also describes the requirement of bridging studies for extrapolation of foreign clinical data to a new region. The ICH-E5 guideline brought great change in concept and strategy of global drug development for pharmaceutical companies. The procedures described in the ICH-E5 guideline have proved useful in the assessment of the ethnic sensitivity of a medicinal product that is to be introduced to a foreign region for registration purpose. Many companies are now developing various products based on ICH-E5 strategies and many successful cases will continuously appear within coming years.
  3,229 1,339 3
LETTER TO EDITOR
Documents versus facts
Rakesh Parikh
October-December 2011, 2(4):149-149
DOI:10.4103/2229-3485.86867  
  2,321 278 -
Plagiarism: Pre-submission screening
Viroj Wiwanitkit
October-December 2011, 2(4):149-150
DOI:10.4103/2229-3485.86869  
  1,879 418 2
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