Literature DB >> 23776778

The need to develop and sustain a symbiotic relationship between the industry and academia in the field of clinical pharmacology in India.

Sandeep Kumar Gupta1.   

Abstract

Entities:  

Year:  2011        PMID: 23776778      PMCID: PMC3657955          DOI: 10.4103/2229-516X.81986

Source DB:  PubMed          Journal:  Int J Appl Basic Med Res        ISSN: 2229-516X


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Sir, Clinical pharmacology is a research-orientated specialty, which has made significant contributions toward the improvement of healthcare, by promoting a safe and more effective use of drugs and developing and evaluating drug therapy. The scope of clinical pharmacology includes the teaching of undergraduates and postgraduates, involvement in research, and involvement in improving the health of the community. Clinical pharmacology has also developed as a major discipline in the pharmaceutical industry, with specific responsibilities for the evaluation of potential new medicines. The relationship between the academia and industry is more evident in clinical pharmacology than in any other discipline of medicine.[1-5] Apart from the financial contribution for research activities, the pharmaceutical industry can help in the establishment and smooth running of the Clinical Pharmacology Unit in the medical college. This unit will help the industry in conducting clinical pharmacological studies and the Pharmacology Department can also conduct their research project there.[2] Clinical pharmacologists working in the industry should be encouraged to take classes for postgraduate students of pharmacology. Also, the clinical pharmacologists from the industry can share their knowledge and experience about drug development and research methodology, which can help the academia in faculty development. Faculty development can have a great impact on the quality of education in the college.[2] Postgraduate students can also be benefited by working for a few months as trainees in the Clinical Pharmacology Department of a pharmaceutical company. Trainees attached jointly to the Pharmacology Departments of the medical college and pharmaceutical company would enhance collaborative research projects and common interests.[2] Pharmacovigilance is another area where the industry can help academia. The National Pharmacovigilance Program is encouraging ADR reporting, independently or in collaboration with an industry partner. In order to broaden the scope of drug safety monitoring, it has been proposed that the industry should synergize and support the initiative of the academia in undertaking pharmacovigilance projects. Also, training workshops and / or symposia by academia-industry collaboration will help in increasing the awareness about pharmacovigilance.[6] The pharmaceutical industry requires clinical pharmacologists to develop new drugs, conduct clinical trials on the efficacy and safety of the new products, and to monitor their safety after marketing. The scientific and medical challenges involved in taking a new chemical entity from the preclinical stage through to the marketing stage is an uphill task and postgraduates in pharmacology have a requisite training for this task.[234] The pharmaceutical industry needs the academia to train its scientific workforce. A sound and healthy academic environment is required by the pharmaceutical industry, because it fulfills their requirement of high quality trained manpower, with a sound training in research as well as medicine.[2-4] The Clinical Pharmacology Department in the industry often has difficulty in recruiting patients for their clinical studies. The attachment of the industry with the Pharmacology Department of the medical college can help in faster and timely recruitment of patients for clinical studies. Also a pool of good clinical practice trained investigators and an institutional review board would be of great help to the industry. Moreover, the lack of backup facilities such as access to resuscitation and an Intensive Care Unit can be overcome by opening a Clinical Pharmacology Unit in an academic and hospital setting.[1-4] The Clinical Pharmacology Department of the medical college can help the pharmaceutical industry in promoting ethical pharmaceutical marketing practices, by conducting training of prescribing physicians on topics such as clinical trial methodologies, critical evaluation of literature, concepts of patents and generics, statistics, and pharmacovigilance.[5] The initiatives taken at the Department of Clinical Pharmacology of the Seth GS Medical College and KEM Hospital, Mumbai, are few examples of the academia–industry collaboration in the field of clinical pharmacology in India. The Department has a Drugs Controller General of India's Center for ADRs Monitoring, World Health Organization's Special Center for ADRs Monitoring, and the Central Drug Research Institute's Clinical Pharmacology Unit. The Indian Council of Medical Research has set up an Advanced Research Center in Clinical Pharmacology at the department. The Clinical Pharmacology Department specializes in the conduct of all phases of clinical trials that come from both the pharmaceutical industry, as well as those initiated by the department. The department also conducts a Workshop on Clinical Pharmacology every year.[7] Another example of academia–industry collaboration is the Department of Pharmacology of the Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh. Many pharmaceutical company-sponsored clinical trials and bioequivalence studies have been conducted in the department. The department also conducts the National Workshop of Clinical Pharmacology every year.[5] It would be of great help to the people attached to clinical pharmacology if the cooperative relationship between the industry and academia is actively pursued. The collaboration between the academia and the industry would lead to a healthy growth of both parties and it would significantly contribute toward greater improvement in healthcare. Moreover, to broaden the scope of drug safety monitoring, the industry should synergize and support the initiative of the academia in undertaking pharmacovigilance projects such as post marketing surveillance in medical colleges.[2-6] Disclaimer: The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of his employer.
  5 in total

1.  The bridging function of clinical pharmacology.

Authors:  Ulrich Klotz
Journal:  Eur J Clin Pharmacol       Date:  2007-09       Impact factor: 2.953

2.  Clinical pharmacology in the pharmaceutical industry.

Authors:  J Vane; J O'Grady
Journal:  Br J Clin Pharmacol       Date:  1991-08       Impact factor: 4.335

3.  The scope of clinical pharmacology in the pharmaceutical industry.

Authors:  N S Baber
Journal:  Br J Clin Pharmacol       Date:  1991-05       Impact factor: 4.335

4.  Clinical pharmacology--mutual benefits from greater collaboration between academia and the pharmaceutical industry.

Authors:  J Posner
Journal:  Br J Clin Pharmacol       Date:  1991-11       Impact factor: 4.335

5.  What clinical pharmacology means to us.

Authors:  S Malhotra; N Shafiq
Journal:  Mens Sana Monogr       Date:  2006-01
  5 in total

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