According to the dictionary definition, the word vulnerable means someone who is “exposed to the possibility of being attacked or harmed, either physically or emotionally”. So who constitutes the vulnerable population in Clinical Research and why do we need to protect them? To answer this question first, let’s take a brief look at the history […]
Informed Consent in clinical trial is often the most important part of clinical trial and sometimes neglected too, resulting in serious consequences, for the patient, the doctor involved in the trial and the pharmaceutical company sponsoring the trial. Which brings us to the question of what exactly is an Informed Consent Procedure? It is process […]
Clinical Pharmacology is defined as the study of the effects of drugs in human beings and Pharmacoepidemiology falls under the category of Clinical Pharmacology.
Malaria continues to be widespread disease in killing more than 2 million people annually in Africa. The sub Saharan desert registers the most number of cases of malaria with a whopping 90%. The World Health Organization, estimates that in the year 2010, malaria killed an estimated 660000 people, mostly children. It is estimated by the […]
Every professional in Clinical Trials will agree to the fact that clinical trials are an expensive, long and very complex activity. Sometimes it takes 10 to 15 years and billions of dollars for pharmaceutical companies to get their product marketed. Statistics have confirmed reports that the number of molecules which enter the market to become […]
Antibiotic resistance is defined as the infection which does not respond to a particular drug as a result of bacteria changes that make the infection immune to the drug. The drug resistance phenomenon is a huge source of concern with the doctors, physicians and scientists all over the world. If this continues, and if sources […]
Narrative writing is an important part of Pharmacovigilance and in patient safety as well. Usually patient narratives are written in case of Adverse Events and Serious Adverse Events including deaths. Patient narratives form a very important part of clinical study reports and all other post marketing activities. In case of a Serious Adverse Event it […]
The Supreme Court of India has acted upon the DCGI and has made it mandatory for all Multi National Companies and whoever wishes to conduct clinical trials in India to compulsorily video record the informed consent procedure in clinical trials.
So far in the year 2013, at least 573 people have died from Dengue fever in Brazil. This is alarmingly high and twice the figure of deaths than the previous year. A state of alert was declared in several cities in Brazil as the total number of serious reports escalated to 6,566.
The process of vaccine development lasts for a minimum of 10- 15 years and needless to say, it is a very complex process. Of all the candidates selected for development, only a tiny percentage makes it to the final licensing state, which makes the process of vaccine development extremely expensive. Vaccine development involves a combination […]