Vaccine Clinical Trials- Developing New Generation Vaccines:

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Chinese were the first to use smallpox inoculation in 1000 CE but the major success came with the work of Edward Jenner, 1796, using cowpox pustules to provide protection against smallpox; which led to the development of the first successful vaccine. It took nearly 200 years to completely eradicate the disease. Next impact on human disease was brought with the development of rabies vaccine, Louis Pasture in 1885. Mid of 20th century witnessed the development of vaccine research. Recombinant DNA technology and new innovative delivery techniques has led scientists in new directions to develop vaccines for most of the childhood diseases like measles, mumps, rubella, polio etc. and even the most epidemic disease like AIDS, hepatitis etc. Vaccines are prophylactic and therapeutic in nature. Prophylactic vaccines are administered to normal, healthy participants while therapeutic or curative vaccines are given to patients. Many prophylactic vaccines are administered to the paediatric group. Continue reading

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Importance of Clinical Trials in Children

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In nearly half of the visits made by children to doctors, 70% of medicines prescribed to them have never been tested in pediatric population. There remains no choice but to treat them that way, as there are very few clinical trials that are conducted in children. It is inappropriate to think of children as small adults as they are developing humans with specific age related developmental and physiological differences. The extrapolation of adult data on medicinal products for the child population is inappropriate, which makes age- and development-related research particularly important. The need to develop medicines safe and effective for children (whether a novel agent or an existing agent in need of pharmacokinetic studies) necessitates new drug testing in children. Continue reading

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Medical Journalism: Separating Facts From Fiction

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Medical Journalism has been largely ignored in the past, especially in developing nations such as India, but its immense impact on general public at large cannot be denied. Medical journalism can be defined as the promulgation of health and medical related topics and information through mass media. Good medical journalism is about covering scientific issues based on facts and avoiding misleading and speculative coverage. Articles written in medical journals by scientists for publications are not considered a part of medical journalism. Common health related topics covered in medical journalism include new methods for diagnosis and treatment, health risks related to organisations and funding of health care. Medical Journalism targets the public at large rather than specific professional groups within the clinical profession or health administration.

Most journalists subscribe to professional ideas while readers expect the stories to be true and significant. This distinguishes journalism from the world of advertising, fiction and show business. The public is getting used to seeing entertainment and advertising masquerade as journalism while also witnessing the proliferation of infomercials (ads that purport to be informative). Although advertising, fiction and showbiz can be a thrilling experience for the audience, good medical journalists offer their readers much more than just thrill. While narrating good stories, they also manage to weigh the information they receive, separate fact from fiction and serve their audience with probing, critical journalism. Continue reading

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CDSCO “DRAFT” Regulation for Approval of Clinical Trials and New Drugs

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As a part of ongoing effort to raise the standards of the conduct of clinical trials in India, Central Drugs Standard Control Organization (CDSCO) has recently issued a new draft guidance document for the industry that outlines new requirements for obtaining Clinical Trial and New Drug Approvals.

This document is still a DRAFT and has been provided by CDSCO to the pharmaceutical industry for any comments or suggestions which can be provided to CDSCO latest by 24th August 2011. CDSCO will consider all suggestions and issue a final document over the next few months.

Please feel free to download the draft document here:

DOWNLOAD: CDSCO Draft – Approval of Clinical Trials and New Drugs

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Understanding Pharmaceutical Medicine As a Career Option:

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Pharmaceutical medicine over a period of time has evolved as a medical scientific discipline and is related to the discovery, development, evaluation, registration, monitoring and medical marketing strategies of medicines for the patients and community health. Knowledge and understanding the action of the drug in body, variability and limitation of therapy response, optimal use of therapy in clinical practice form the basis of the pharmaceutical medicines.

Study of pharmaceutical medicine revolves around the clinical testing of drugs, translation of potential new molecules into new drug entities (medicine), safety of research participants during the clinical trial phases, development of the safety profile of the medicine in trial, and establishing the benefit-risk balance. In addition to these aspects a thorough knowledge of pharamcoeconomics is required as well. Along with other medical specialities; pharmaceutical medicine has developed its own ethos and a distinct body primarily based on clinical science knowledge. Continue reading

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Risk Management in Healthcare Industry

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Healthcare risk management dates back to four thousand years, with the “Babylonian Code of Hammurabi” ordaining severe punishment for physicians who caused death or harm through their own malpractice. After the malpractice insurance crisis in 1970s, healthcare risk management became an important component of hospital administration in the US. Healthcare administrators recognized the value of developing a proactive approach leading to an increase in malpractice verdicts and settlements. With growing cost and complexity of care, healthcare faces intimidate challenges.
A wide variety of personal and environmental exposures posed by quantitative and qualitative assessment of risk to human health has become a necessary expedient for government decisions on managing those risks. In hospital operations, risk management refers to self protective activities which help in preventing real or potential threats of financial loss due to accident, injury and medical malpractice. Continue reading

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Medical Journalism Courses in Nigeria, South Africa and Egypt

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James Lind Institute offers a number of programs in medical writing and medical journalism to students from Africa. All programs are offered on an online platform with access to faculty and fellow students. James Lind Institute is the first institute in India to start programs in Medical Journalism to cater to the needs to this evergreen industry. James Lind Institutes globally accepted programs have already attracted students from more than 40 countries. To know more about the programs offered by JLI and how they can benefit you in your career, please feel free to visit the James Lind Institute Website.

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Importance of Accreditation of Hospitals in Healthcare

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In the recent times demand for quality in healthcare services has risen due to various market forces such as medical tourism, insurance, corporate growth and competition. As a result of these the expectations of the consumer for best in quality has also risen, which has indeed lead to the introduction of national and international accreditation bodies to act as a quality assurance mechanism, thus enhancing customers access to better healthcare services. National Accreditation Board for Hospitals and Healthcare Providers (NABH) defines Hospital Accreditation as a public recognition by a national or international healthcare accreditation body, of the achievement of accreditation standards by a healthcare organization, demonstrated through an independent external peer assessment of that organizations level of performance in relation to the standards.
To further define, it is a “self-assessment and external peer assessment process used by health care organizations to accurately assess their level of performance in relation to established standards and to implement ways to continuously improve”. The various standards of accreditation are based on the principles of quality assurance, evidence based practice, medical ethics and prevention of medical error. Continue reading

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