Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Bhanu K Bhakhri

"The Journal of Clinical and Diagnostic Research (JCDR) has been in operation since almost a decade. It has contributed a huge number of peer reviewed articles, across a spectrum of medical disciplines, to the medical literature.
Its wide based indexing and open access publications attracts many authors as well as readers
For authors, the manuscripts can be uploaded online through an easily navigable portal, on other hand, reviewers appreciate the systematic handling of all manuscripts. The way JCDR has emerged as an effective medium for publishing wide array of observations in Indian context, I wish the editorial team success in their endeavour"



Dr Bhanu K Bhakhri
Faculty, Pediatric Medicine
Super Speciality Paediatric Hospital and Post Graduate Teaching Institute, Noida
On Sep 2018




Dr Mohan Z Mani

"Thank you very much for having published my article in record time.I would like to compliment you and your entire staff for your promptness, courtesy, and willingness to be customer friendly, which is quite unusual.I was given your reference by a colleague in pathology,and was able to directly phone your editorial office for clarifications.I would particularly like to thank the publication managers and the Assistant Editor who were following up my article. I would also like to thank you for adjusting the money I paid initially into payment for my modified article,and refunding the balance.
I wish all success to your journal and look forward to sending you any suitable similar article in future"



Dr Mohan Z Mani,
Professor & Head,
Department of Dematolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011

Important Notice

Original article / research
Year : 2010 | Month : October | Volume : 4 | Issue : 5 | Page : 3064 - 3074

Awareness Of Clinical Trials Among University Pharmacy Students – A Questionnaire Survey

MEENAKUMARI K*, AMBERKAR MB*, RAJAKANNAN T**, RAO E*, MOHAN L***, PRASHANTH****, MAHIMA****

*M D, Assistant Professor, ***M D, Associate Professor, ****Postgraduates, Dept of pharmacology, Kasturba Medical College, Manipal University, Manipal, India-576104 **M Pharm; Senior Research Fellow, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, India-576104

Correspondence Address :
Dr. Mohan Amberkar, MD,
Asst. Professor,
Dept. of Pharmacology,
Kasturba Medical College,
Manipal University,
Manipal
Ph No: 0820-2922365
e-mail: mini41178@yahoo.co.in

Abstract

Background
There is an increasing trend to undertake clinical trials in India from the past one decade, but its awareness has not reached to the maximum among the health care professionals and pharmacists in particular. The present study was aimed to evaluate the general awareness of the clinical trials among pharmacy undergraduates and postgraduates. To ascertain their interest to be involved in clinical trials and research studies in the present and future scenarios and to evaluate the various barriers in the way of conducting clinical trials from their perspective.

Materials and methods
This was a questionnaire based study which was conducted among the University Pharmacy students. The respondents were enrolled after explaining to them the aims and objectives of the study and their willingness was checked before their participation in the study. The basic demographic information and qualitative statements were noted.

Results
A total of 102 students participated in the study. A majority of the students had a very poor concept regarding the designing of the study, the sponsors, the role of DCGI, protocol writing/ IRB /ethics committee (60- 80%), etc. However, they scored on an average scale in knowing the basic concepts of clinical trials, preclinical testing, adverse events (30-40%), etc.

Conclusion
Increasing boom in clinical research opens a door for more job opportunities and advanced research; hence, it is mandatory to educate the students at the grass root level about this advanced branch in itself. From this study, we conclude that the awareness about clinical trials and research in pharmacy students stands at an average. These major pitfalls could be improved by conducting many workshops, CMEs, panel discussions and symposiums at the college level itself.

Keywords

Survey, clinical trials, awareness, pharmacy students,

Introduction
Clinical trials are research studies which are conducted with people who volunteer to take part in a study to find better ways to prevent, screen for, diagnose and treat a disease. There are certain steps and protocols which need to be followed while carrying out the actual clinical trials. The standard treatments used now are the base for developing future better treatments (1). It is estimated that 20-30% of the global clinical trials are conducted in developing countries (2). With escalating pressure on research and development across the global pharmaceutical industry, there is an increased focus on reducing the cost of clinical development. The additional problem of delayed development is also affecting new drug introductions, thus losing out on incremental revenues. 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 speciality contract manufacturing to innovative drug discovery and development in its own right, setting the stage for increased global competition (3). There is increasing difficulty for the testing of drugs in Western countries due to strict regulations, elaborate safety and compensation requirements and small populations. The scenario is different in India because of its rich technical resource pool, huge treatment-naive patient population, English speaking doctors, the relative ease and the attractive economics of recruiting a large number of patients and the sheer diversity in the country’s genetic mixture (4).
We did this study after thorough screening of the pharmacy course curriculum. Apart from teaching about research methodology and clinical trials, it is a routine job for all the senior faculties to conduct many workshops, CMEs, panel discussions and symposiums on these sensitive aspects, so that the students will be well aware about these subjects at least before they leave the college. In this respect, we did the study only on the final year B. pharmacy and all M. pharmacy students. Moreover, it was mandatory for all M. pharmacy students to know about clinical trials in the 1st year for the following branches, namely a) pharmacology b) pharmaceutics c) pharmacognosy d) pharmaceutical chemistry, etc. and also, they are expected to complete at least one research project in the 2nd year of their course.
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 (5). The majority of the clinical trials are conducted and held by pharmacists at different levels along with other healthcare professionals. There were no studies regarding the awareness of clinical trials in the recent past among both under and post graduate pharmacy students and hence, this study was undertaken to screen out their role at different levels in the pharmaceutical industry.

Aim
1) To know the awareness of the globalization of clinical trials in India, especially among the student population.
2) To evaluate the general awareness on clinical trials among the undergraduate and postgraduate students of pharmacy colleges.
3) To ascertain their interest in being involved in clinical trials and research studies in the present and future scenarios and to evaluate the various barriers coming in their way in conducting clinical trials.

Material and Methods

This was a questionnaire based study which was conducted in the Manipal College of Pharmaceutical Sciences after obtaining approval from the University ethics committee. It was conducted during the months of October and November 2009 when the students were in the second year of M. Pharmacy. The questions were reviewed and validated by experienced professionals who are currently involved in many clinical trials. The study protocol tool was examined and validated by conducting a well designed pilot study for readability and the ease of understanding.

The students were explained about the aims and objectives of the study and were invited to participate. Student feedback was obtained by using a questionnaire which was administered in English, which was the medium of instruction. The questionnaire was divided into three parts; part one contained demographic profiles, the second part was a general statement regarding the status of the participant as a student, research scholar or postgraduate and the third part contained 14 main statements with many sub statements. To understand the knowledge in depth and to avoid bias, certain statements were deliberately reframed as negative questions. The students who were enrolled in the study, were the ones who had a pharmacology background.

The answered questions were rewarded as follows:
A. Positive or Negative questions answered correctly - +02 points
B. Positive or Negative questions answered incorrectly - +00 point
C. If the question had multiple positive or negative answers; each option ticked correctly was rewarded +01 point

The percentage of questions which were answered correctly in each group was calculated and this was categorized to pre-fixed grades as follows; 80-100% as good, 50-80% as average and <50% as poor. The sample size was calculated by using the WHO epi info software.
Statistical analysis-Descriptive statistic analysis was done by using SPSS version 16.

Results

A total of 102 students responded to the survey. We enrolled only 40 B. pharmacy and 62 M. pharmacy students in our study. For the statement regarding the concept of clinical trials, around 21.6 % fell in the good category, 59.8% in the average category and 18.6% in the poor category. Regarding the statement for the need of clinical trials, 58.8% were poor responders, 27.5% were average and 13.7% were good. The information as to ‘from where people could find about the clinical trials’ was known by most of the students (73.5%), whereas 26.5% were ignorant about it. 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 preclinical and clinical testing was average in around 52.9% students, good in 22.5 % students and poor in 24.5% students. Around 73 students were not aware about the Institutional Review Board or the ethics committee in comparison to 29 students who showed average response. The role of the US-FDA in approving new drugs was not known to a majority of the student population (91 students) as compared to 10 students who had good knowledge about it. There was a similar response about the knowledge trend on the role of the “Drugs and cosmetics act 1940” and the “Drug controller general of India”, where 53.9% of the students showed poor response in comparison to 46.1% who showed good response.

Average response by 40 students was seen regarding the prerequisites for a participant before joining the clinical trial and also regarding the potential benefits and the risks involved, 45 students showed poor response and the rest were good. The statements pertaining to the knowledge regarding leaving a research study was responded by 41 students in comparison to 61% students who showed poor response. Ninety five percent of the students were not aware whether the participant should know the results of a clinical research study. A majority (85.3%) were not aware about what type of study design was to be incorporated. The knowledge about the sponsors was seen as average response in around 28.4% and as poor and good response in 66.7% and 6.9% students respectively. Around 15.7% showed good response regarding adverse event categorization and reporting and 35.3% showed average response.

Discussion

The present study was aimed to know the level of understanding and awareness about the most sensitive aspects of the clinical trials in pharmacy students. Also, we can plan to enrich their current knowledge by giving presentations at pharmacy colleges and by raising awareness on the growing career opportunities for pharmacists in clinical research. Pharmacists are often called clinical research officers or project managers, these scientists typically write protocols, choose investigators and study sites, monitor clinical trials and collect and analyze trial data, report adverse events and write and publish clinical-study reports. Within the clinical research enterprise, pharmacists often move into leadership positions in drug-development studies. But because the work is behind the scenes, only few pharmacists hear about these job opportunities. People who go through the Pharmacy course training have the knowledge of chemicals and the development process and how it interacts with the patient, which adds a tremendous dimension to the clinical trials. Individuals trained in pharmacy are in a perfect position to bridge the gap between the flood of genomic information becoming available and the goal of personalized medicine.

In the present scenario, why should an Indian pharmacist know about clinical trials at the student level?
It is mandatory to have a complete knowledge about clinical trials and research before joining and after completing the pharmacy course. Pharmacists play a variety of roles, some designing phase I, early-stage clinical trials and others occupying executive-level management positions. Still, other pharmacists work as clinical research associates in late-phase clinical trials, traveling to investigator sites to oversee compliance with clinical protocols and investigating adverse drug events and safety concerns. For most pharmacy students however, experience and training in clinical research comes from a postgraduate fellowship. These are typically 1- to 2-year training programs following the completion of a B. Pharmacy course. These can open the door to positions in the pharmaceutical industry or in academic research. Some programs allow the fellows to rotate through several departments, whereas others offer intensive training in one area such as regulatory affairs or drug labeling.
One main challenge which is related to patient compliance is education. As many patients in the trial scenario are from rural and semi-urban areas, care must be taken to ensure that they are well educated and that compliance issues are well understood. The last five years have also witnessed a tremendous interest and activity in the area of clinical research services in India; it is mainly due to a huge medical infrastructure, the availability of large banks of treatment-naive patients with a variety of diseases, increasing GCP awareness among the clinical investigators and the cost effectiveness of Indian operations. So, while India builds up on the potential of being an attractive clinical research destination, it is important that the emerging professional contract research organizations (CROs) maintain high standards of ethics and GCP compliance to support this endeavour. There is great boom in clinical research in India, since it is a home to a wide variety of diseases ranging from tropical infections to degenerative diseases; it offers the opportunity for pharma companies to develop drugs for a wide spectrum of diseases; to name a few multidrug resistant ones, pneumonia, hepatitis B, diabetes and cancers (6).

In this study, we had chosen sensitive, easily understandable and the most prolific areas of clinical trials and research which were at par with the student’s knowledge. From the derived results of the questionnaire study, we found that the students had excellent knowledge about, “Where can common people find information about clinical trials” and that they were well aware about the “general concepts of clinical trials and preclinical studies”; however, there was a poor response regarding “the participation in clinical research”, “designing the study”, “protocol writing /IRB/Ethics committee, the role of DCGI, US-FDA and the sponsors”, as shown in the (Table/Fig 1). Though quite a large number of students were totally ignorant regarding the important aspects of the clinical trials, their interest and zeal to know and be a part of the clinical trials could not be underestimated.

Based on history, what a Pharmacist can do in research is really limitless and what’s new is that we have an actual pathway to train the under and postgraduate students to go into research. Although pharmacists who pursue research careers are still a small minority, their ranks are expanding quickly within the pharmaceutical industry and in the myriad organizations which develop and test pharmaceutical compounds. However, pharmacists are perfectly poised to bridge the knowledge gap between laboratory data and opportunities for them in clinical practice are only going to expand.

(Table/Fig 1): Percentage of Response for each category of questions.
The profession of pharmacy has a lot to offer in the field of clinical trials and research. Such projects aim to meet a growing need for the pharmacists within the clinical research system. The recognition of international product patents is now expected to spur pharmaceutical research in India, to supplement the global efforts for searching for new molecules for unmet medical needs and to develop generic products to reduce healthcare costs.

Limitations of the study:
1) The study would have been more comprehensive if working industrial pharmacy researchers were also included and if their level of awareness was compared with that of the pharmacy students.
2) We received very good response from the students; however, one of the barriers for not responding correctly to our questionnaire study would have been the exhaustive teaching class hours.
3) This study was done randomly in students; we could have missed good scholar students.

Conclusion

We conclude from this questionnaire survey that the knowledge about clinical trials and research in pharmacy students stands average. These major pitfalls could be improved by conducting many workshops, CMEs, panel discussions and symposiums, so that the students would be well aware of these aspects right from the student level.
We can broaden the spectrum of the qualitative knowledge and the skills of pharmacists at the student level by conducting many questionnaire studies like this. Also, these kind of active programmes stir up the awareness levels regarding the clinical trials and research, which can help pharmacists and more ambitious Indian pharmaceutical companies to fulfill their aspirations of becoming players in the global pharmaceutical industry.
“There is always light at the end of the tunnel” 
.. So, in spite of all the present pitfalls, the country is certainly gearing up to attract more and more researchers from around the world to conduct their clinical trial studies in India. The regulatory system is being polished, laws are being amended to facilitate the entry of global clinical trials and massive concerted efforts are on to train research pharmacy professionals and to increase the base of investigators and supporting staff. These initiatives are certain to improve the current situation, especially for the pharmacists and doctors. In brief, Indian pharmacists are already off the starting blocks and are gearing up for an inundation of clinical research trials. India is poised to offer the global pharmaceutical industry high quality and cost-effective contract services to support drug discovery, clinical trial conduct, data management and manufacturing.

Key Message

There were no studies regarding the awareness of clinical trials and hence, this study was undertaken to know the awareness of the globalization of clinical trials in India among the student population.

References

1.
Maiti R & Raghavendra M. Clinical trials in India. Pharmacol. Res. 2007; 56:1-10.
2.
Bhatt A. Clinical trials in India Pangs of globalization. Indian J Pharmacol 2004; 36(4): 207-208.
3.
Agres T. Outsourcing spikes competition 2006;67-78. http://www.sciencedirect.com/science. Accessed on August 8, 2010.
4.
Bakhle D. Global clinical trials in India-challenges and opportunities www.touchbriefings.com. Accessed on August 1, 2010;90-97
5.
Sawant P & Roychowdhury V. What are the three main challenges faced by the Indian clinical market? www.pharmabioworld.com. Accessed on March 1, 2010
6.
India: pharmaceutical and biotechnology oppurtunities. www.researchandmarkets.com Accessed on February 3, 2010

Tables and Figures
[Table / Fig - 1]
JCDR is now Monthly and more widely Indexed .
  • Emerging Sources Citation Index (Web of Science, thomsonreuters)
  • Index Copernicus ICV 2017: 134.54
  • Academic Search Complete Database
  • Directory of Open Access Journals (DOAJ)
  • EBSCOhost
  • Google Scholar
  • HINARI Access to Research in Health Programme
  • Indian Science Abstracts (ISA)
  • Journal seek Database
  • Google
  • Popline (reproductive health literature)
  • www.omnimedicalsearch.com