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  Citation statistics : Table of Contents
   2012| October-December  | Volume 3 | Issue 4  
    Online since November 19, 2012

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Investigator initiated trials (IITs)
Viraj Suvarna
October-December 2012, 3(4):119-121
DOI:10.4103/2229-3485.103591  PMID:23293757
  17 4,496 6,366
A study on prescribing patterns of antihypertensives in geriatric patients
Arshad H Mohd, Uday V Mateti, Venkateswarlu Konuru, Mihir Y Parmar, Buchi R Kunduru
October-December 2012, 3(4):139-142
DOI:10.4103/2229-3485.103595  PMID:23293761
Objective: Hypertension is a leading contributor to the global burden of cardiovascular morbidity and mortality. The main objective of the present study was to assess the prescribing patterns for antihypertensives in geriatric patients. Materials and Methods: A Prospective observational study was carried out for the period of six months in an out-patient department. Elderly patients who have been diagnosed with hypertension as per JNC-7 guidelines and patients receiving or prescribed with antihypertensive drugs were included. Results: A total of 100 prescriptions were analyzed during the six-month study period. 72% of the patients were in the age group of 65-67 years and this was found to be higher in men 69%. During the study period 80% of the patients were Pre-Hypertensive systolic (80-89 mmHg) and Diastolic (120-139 mmHg) followed by Stage-I Hypertension and Stage-II Hypertension. The most common drug classes involved in the study was Calcium Channel Blockers 37% followed by Angiotensin II receptor antagonists 21% and the most commonly prescribed drugs in the study population were Amlodipine 37%, Losartan 11% and Telmisartan 10%. The most common anti-hypertensive fixed dose combination therapy involved in the study was Telmisartan + Hydrochlorothiazide 15% and most common two drug combination therapy involved in the study was Amlodipine + Atenolol 7% followed by Metoprolol + Amlodipine 1%. Conclusion: Our study shows that the most commonly prescribed drug classes involved were Calcium Channel Blockers followed by Angiotensin II receptor antagonists and the anti-hypertensive drug combinations among hypertensive patients were considerable and this practice positively impacted on the overall blood pressure control.
  10 4,774 668
Public awareness of clinical trials: A qualitative pilot study in Pune
Veena Joshi, Aditi A Kulkarni
October-December 2012, 3(4):125-132
DOI:10.4103/2229-3485.103593  PMID:23293759
Context : Medical expertise combined with availability of patients with varied diseases have resulted in rapid increase in number of clinical trials (CTs) recruiting millions of patients in India. Yet, few researchers have tried to understand if the public in India is aware of CTs. Aims : To explore the awareness, perceptions of and attitude towards participating in CTs among general public in Pune. Materials and Methods : Focus group discussions (FGDs) and interviews were conducted by contacting people in the community of various age groups and socio economic status with 7 Trial participants (TPs) and 17 Non Trial Participants (NTPs). The survey tool consisted of open-ended questions that assessed the awareness and attitudes of the individuals regarding the CTs. Interview were recorded on paper and translated from (Marathi) local language to English for analysis. Qualitative analysis was used to report the findings. Results : Most participants could associate CTs with medicine or development of new medicine; however they did not have a good understanding of the manner and safeguards with which CTs are conducted. Participants were not aware about different types of CTs and phases of the CTs. CTs were felt to be of benefit to the community and advancement of science. However, due to fear of adverse effects, 80% of the respondents were not ready to participate in the CTs. Conclusions : The Indian Pharmaceutical company is the world's 3 rd largest by volume as per Dr. Shivathanu Pillai's report 17th March 2010, in spite of that it has been noticed that the awareness about CTs is very low; therefore there is a need to create awareness about CTs which helps the participants to participate in CTs based on their own decision. These FGD findings require validation in a larger sample.
  5 3,351 998
CTRI - Clicking to greater transparency and accountability
Bobby George
October-December 2012, 3(4):122-124
DOI:10.4103/2229-3485.103592  PMID:23293758
A clinical trial registry (CTR) is an official platform for registering a clinical trial (CT) with an objective of providing increased transparency and access to CTs to the public at large. Clinical Trials Registry - India (CTRI) is a free online public record system for registration of CTs being conducted in India. The vision of the CTRI is to ensure that every CT conducted in the region is prospectively registered with full disclosure of the trial data set items. With more number of CTs being conducted in the country, with a large number being global multicentre trials, it is binding on the industry/investigators/sponsor to comply with the requirements laid down. While there are pros and cons, there is enough scope for improvement of CTRI.
  3 2,905 1,963
Evolution of clinical research: A history before and beyond James Lind
Jeremy Hugh Baron
October-December 2012, 3(4):149-149
DOI:10.4103/2229-3485.103599  PMID:23293765
  2 2,017 469
Electronic medical record: Time to migrate?
Neeti Rustagi, Ritesh Singh
October-December 2012, 3(4):143-145
DOI:10.4103/2229-3485.103596  PMID:23293762
Gone are the days when records of patients were kept in paper format. Majority of things going digital, it is inevitable that hospitals will adopt electronic medical record in near future. It is simple, reliable and cost effective in long term.
  2 3,482 434
A study to assess completeness of project application forms submitted to Institutional Ethics Committees (IEC) of a tertiary care hospital
Yashashri C Shetty, Padmaja A Marathe, Gauri V Billa, CP Neelima Nambiar
October-December 2012, 3(4):133-138
DOI:10.4103/2229-3485.103594  PMID:23293760
Objectives: To review Ethics Committee (EC) application forms and to find out similarities and differences in content of five ECs forms in India. Materials and Methods: The completeness of EC application forms was assessed on the following themes: title, study team, sponsor responsibility, scientific aspects, patient safety, regulatory permissions, Informed consent process from 2008-2009. Application forms (available online) of 5 ECs were studied and compared. Results: A total of 445 application forms were analyzed, 382 were academic, 63 were sponsored. The common deficiencies in academic studies were inappropriate titles (25.13%), lack of budget details (90%). More than 95% studies had not mentioned the method of recruitment. The issue of vulnerability was not marked in more than 50% of studies. Compensation for participation/injury was poorly stated in academic (99%) studies. Among industry sponsored studies, 98% were compliant with regulatory permissions and 41% were CTRI registered. The information pertaining to Informed Consent was mentioned in all forms. Comparative analysis of application forms of 5 ECs showed that the requirements for submission were similar except 1-2 ECs asked for additional information like percentage of time allotted by investigator for studies, GCP training of study team, certification by investigator regarding accuracy of local versions of Informed consent. Conclusion: Our study recommends that increased awareness and vigilance by investigators of academic studies regarding submission of applications to EC will increase efficiency and speed of review process. A common application form for all ECs across India would be an important step to achieve uniformity in functioning of ethics committees.
  2 2,664 377
Ethics committee composition
Arun Bhatt
October-December 2012, 3(4):146-147
DOI:10.4103/2229-3485.103597  PMID:23293763
  - 2,051 428
Drug discovery and clinical trials: A poem
Lakshmi Balachandran
October-December 2012, 3(4):148-148
DOI:10.4103/2229-3485.103598  PMID:23293764
  - 1,456 332
Pharmacologists' participation in teaching hospitals for shaping future clinical research in India
Mohammed Imran
October-December 2012, 3(4):149-150
DOI:10.4103/2229-3485.103600  PMID:23293766
  - 1,540 238