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 Table of Contents  
MEDICAL EDUCATION
Year : 2014  |  Volume : 2  |  Issue : 2  |  Page : 234-237

Low awareness of clinical research in India amongst final year medical students and physicians: Need for increased emphasis on clinical research in medical curriculum


1 Department of Cardiology, UN Mehta Institute of Cardiology, Sir Byramjee Jeejeebhoy Medical College, Civil Hospital, Ahmedabad, Gujarat, India
2 Department of Dermatology, Sanjay Gandhi Memorial Hospital, New Delhi, India

Date of Web Publication11-Nov-2014

Correspondence Address:
Kamal H Sharma
A/406, Shivalik Yash, Opp. Shastrinagar Brts Bus Stand, 132 Feet Ring Road, Naranpura, Ahmedabad - 380 013, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2321-4848.144359

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  Abstract 

Background: There is an increasing trend to undertake clinical trials in India, but its awareness among the health care professional remain far from satisfactory. Aim: To assess the level of knowledge regarding clinical research training amongst a group of Indian medical students and postdoctoral physicians who had already completed training in subject of pharmacology. Materials and Methods: A cross-sectional descriptive questionnaire based study was conducted among university undergraduate medical students and postdoctoral physicians. Questionnaire was administered to 155 final year medical students and 33 postdoctoral physicians. Results: Out of 155 undergraduate students, for the statement regarding the concept of clinical trials, around 20.2% fell in the good category, 61.4% in the average category and 18.4% in the poor category. Regarding the statement about International Conference of Harmonization (ICH), 58.8% were poor responders, 28.7% were average, and 12.5% were good. The statements regarding the participation in the clinical research study showed that a majority was in the poor response category (89.2%) as compared to 9.8% in the good category. Conclusion: Boom in clinical research opens a door for job opportunities and advanced research. Teaching good clinical practice (GCP) guidelines at the most formative years shall go a long way in development of ethical and healthy learning environment for clinical research in the country.

Keywords: Awareness, clinical research, medical students


How to cite this article:
Sharma KH, Jindal A. Low awareness of clinical research in India amongst final year medical students and physicians: Need for increased emphasis on clinical research in medical curriculum . Arch Med Health Sci 2014;2:234-7

How to cite this URL:
Sharma KH, Jindal A. Low awareness of clinical research in India amongst final year medical students and physicians: Need for increased emphasis on clinical research in medical curriculum . Arch Med Health Sci [serial online] 2014 [cited 2019 Jul 19];2:234-7. Available from: http://www.amhsjournal.org/text.asp?2014/2/2/234/144359


  Introduction Top


Health research training forms an important part of medical education. The progress in modern medicine is to a substantial extent a consequence of Evidence Based Medicine. Modern medicine has become more rational and scientific over the years. Clinical trials have been the backbone of newer frontier that medicine envisages to grow in. However the irony is that a new Principal Investigator (PI) who is primarily responsible for conducting the study at the site often gets first understanding of the ethics, principles, and methodology of clinical trials during the process of first ever investigator meeting or related International Conference Of Harmonization-Good Clinical Practice (ICH-GCP) training being imparted during the same.

Aim

To evaluate general awareness regarding clinical trials in India, especially among undergraduate students of medical college and postdoctoral physicians.


  Materials and Methods Top


Study design and study site

This was a cross sectional descriptive questionnaire based study, conducted amongst medical students of Gujarat University, during month of April 2012. We approached 170 final year (Third year-part II) MBBS students of a reputed government medical college. Of these 155 students consented to participate in a blinded written survey. Similar interview was conducted amongst 33 postdoctoral physicians.

In India, medical school offers five and half years program leading to Bachelor of Medicine; bachelor of surgery (MBBS) degree. Basic health sciences which include pharmacology are the primary focus of instruction during first two-and-a-half years. Currently Clinical trial related practices are mostly covered in the subject of Pharmacology.

Study sampling

The undergraduate students (n = 155), who were enrolled in the study, were ones who had a pharmacology background (who have cleared pharmacology exam in the second year of MBBS). Post doctoral physicians (n = 33), were also enrolled in the study separately. The questions were reviewed and validated by four experienced professionals who are currently involved in many national and international clinical trials. The participants were explained about the aims and objective of the study. The questionnaire was distributed after seeking verbal consent.

Questionnaire

The questionnaire was framed in English language, which was the medium of instruction. Questions were reviewed and validated by four experienced professionals who are currently involved in many clinical trials. The questionnaire was divided into three parts. Part one contained demographic profile of the participant. Part two was the general statement regarding the status of participant as an undergraduate student or postgraduate student or physician. Third part contained four main descriptive set of 12 questions pertaining to awareness about clinical trials [Appendix 1]. [Additional file 1]

To understand the knowledge in depth and to avoid bias, questions were framed to analyze the basic knowledge of participants. Multiple choice based questions were avoided to prevent the element of probability playing a role. The 188 completely and properly filled questionnaires formed the basis of analysis.

Analysis

All answers were assessed by a two independent reviewers to avoid interpersonal variability in assessment and results. Study was not powered to assess the difference between the two groups as the aim of the study was to assess only the awareness amongst those who have studied pharmacology and not the difference between different groups.

The percentage of questions which were answered correctly in each group was calculated and this was categorized to pre-fixed grades as follows; 75-100% as good, 51-74% as average, and < 50% as poor. Statistical analysis was done using Epi-info version 7.0. P < 0.05 was considered as statistically significant with confidence interval (C.I) of 95%.


  Results Top


Out of 155 undergraduate students, For the statement regarding the concept of clinical trials, around 20.2 % fell in the good category, 61.4% in the average category, and 18.4% in the poor category. Regarding the statement about ICH, 58.8% were poor responders, 28.7% were average and 12.5% were good. The statements regarding the participation in the clinical research study showed that a majority was in the poor response category (89.2%) as compared to 9.8% in the good category.

The knowledge regarding drug testing was average in around 1.4% students, good in 9.8% students and poor in 88.8% students. There was a similar response about the knowledge trend on clinical research, where 44.1 % of the students showed poor response in comparison to 18.7% who showed good response [Table 1].
Table 1: Proportion of undergraduate students and postdoctoral physicians with correct answers

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The average number of questions (mean ± 2SD) answered correctly (out of 12) by undergraduate and postgraduate students were, 6.9 ± 2.2; 8.4 ± 3.4, respectively. As the statistical analysis shows, awareness about basics of clinical research was low in both the groups and statistically significant [Table 2].
Table 2: Number of questions answered correctly out of 12, based on stream of participants: Undergraduate vs. postgraduate students

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  Discussion Top


The present study was aimed to know the level of understanding and awareness about the most basic aspects of the clinical trials in medical students and postdoctoral physicians. The newer trends in medical education focus on acquisition of skills, knowledge and attitudes rather than factual learning. [1]

In the present scenario, why there is a need for increased emphasis on clinical trials in medical syllabus? Following are the main reasons:

Firstly, because clinical research is a science which is dynamic and evidence based. "Future Investigators" need to be trained in their basic education days about the methodology of the same. Secondly, increased awareness regarding clinical research can act as a career avenue in future. Thirdly, training on ethical aspects is necessary, especially to "catch them young". Lastly, it will help in refining our concepts regarding how to do ethical and scientific research.

Analyzing the medical education syllabus in India would show that only in second year in subject of pharmacology this topic is covered partly and that too with little emphasis on the subject from exam oriented teaching and study. Since clinical trials impact all the clinical subspecialty coverage for the subject seems bit inadequate. Performance amongst postdoctoral seems to slightly better on certain aspects and can probably be ascribed to increased exposure amongst them to clinical trials. It is estimated that 20-30% of the global clinical trials are conducted in developing countries. [2] As the multinational drug companies in the United States and Western Europe look eastwards to outsource research and clinical trial activities, countries such as India will gain proficiency and expertise, assisting its move from generic and specialty contract manufacturing to innovative drug discovery and development in its own right, setting the stage for increased global competition. [3] Training for research skills and experience of research early in career has been associated with continued professional academic work and may help inform residents' career decisions. Research experience is invaluable to the physician's evidence-based practice as it imparts skills such as literature search, collecting and analyzing data and critical appraisal of evidence΂. Efforts are needed to create a more widespread awareness of clinical research amongst the general public, patients and medical community, especially doctors and pharmacists to build confidence and move away from the "guinea pig" syndrome, if India is to take the fair share in the clinical outsourcing business. [4]

Based on our study results, we would like to state following recommendations:

  1. There should be increased emphasis on basics of clinical research in the current setup of pharmacology. Current textbooks and curriculum doesn't even have its fair amount of share for clinical research so, increased emphasis will help in cultivating the basis.
  2. Unfortunately the teaching methodology and the study patterns of a medical student are exam-centric. Including clinical research topics as the "exam centric" learning will lead to increase orientation and willingness in the students to focus on these topics.
  3. There should be more emphasis regarding clinical trials, their result and data analysis in clinical subjects like "Medicine" rather than just the clinical implication of the trial in form of therapy guidelines. Presently, physicians are trained to learn the guidelines in "what to use when" then "why to use when" fashion. Certain studies like African-American Heart Failure Trial (A-HeFT) have shown that certain drugs tend to have more efficacy in certain race/ethnic groups and hence extrapolating the Caucasian population data to Asian-Indian group or vice versa may just be a hypothesis that needs to be validated in Ethnic population. [5] Genetic variability as in clopidogrel efficacy is also another aspect that warns us that efficacy of medication may not be universally equal. [6],[7],[8] So, increasing reliance on studies on indigenous population is hence the need of the hour.
  4. Undergraduate students should be given some basic clinical research project, under the guidance of faculty. It can help students to garner experience.
  5. Rotation in clinical trial department during internship period can help students to know basics.



  Conclusion Top


We conclude from this questionnaire survey that the awareness for certain basics for clinical trials was low both amongst undergraduate medical students as well as postdoctoral physician though postdoctoral candidates fared statistically better than undergraduate students.



 
  References Top

1.Khan H, Khawaja RH, Waheed A, Rauf A, Fatmi Z. Knowledge and attitudes about health research amongst a group of Pakistani medical students. BMC Med Educ 2006;6:54.  Back to cited text no. 1
    
2.Bhatt A. Clinical trials in India: Pangs of globalization. Indian J Pharmacol 2004;36:207-8.  Back to cited text no. 2
  Medknow Journal  
3.Agres T. Outsourcing spikes competition. Available from: http://www.sciencedirect.com/science [Last accessed on 2010 Aug 8].  Back to cited text no. 3
    
4.Sawant P, Roychowdhury V. What are the three main challenges faced by the Indian clinical market? Available from: www.pharmabioworld.com [Last accessed on 2010 Mar 1].  Back to cited text no. 4
    
5.Taylor AL, Ziesche S, Yancy C, Carson P, D'Agostino R Jr, Ferdinand K, et al; African-American Heart Failure Trial Investigators. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med 2004;351:2049-57.  Back to cited text no. 5
    
6.Seip RL, Duconge J, Ruaño G. Implementing genotype-guided antithrombotic therapy. Future Cardiol 2010;6:409-24.  Back to cited text no. 6
    
7.Scaria V. Whisking research into medical curriculum: The need to integrate research in undergraduate medical education to meet the future challenges. Calicut Medical Journal 2004;2:e1  Back to cited text no. 7
    
8.Deo MG. Undergraduate medical students research in India. J Postgrad Med 2008;54:176-9.  Back to cited text no. 8
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Introduction
Materials and Me...
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