Scientists often use placebo-controlled trials to evaluate medical interventions, so understanding how and why these effects arise is important. After all, if people experience relief from their symptoms or develop side effects when they have only taken a sugar pill, this makes interpreting the results of studies more difficult. For…
When most people hear the phrase “Informed Consent,” they think of the legal document that explains the study and contains the required dated signatures. However, informed consent is first and foremost a continuing process. This includes a person voluntarily agreeing to participate in a research study after being fully informed…
As appreciation grows for the contribution of real-world evidence (RWE) and real-world data (RWD) to clinical research, the application of RWE/RWD within this space is treated with circumspection. The Renewed Importance of Documentation Inadequate/inaccurate case histories form the second most commonly cited deficiency in US-FDA inspections of clinical investigator sites….
India has a significant burden of typhoid, especially in young children. And, this disease is becoming more and more widespread along the length and breadth of the country. To help the entire country stay prevented against this disease, and effectively treat those that are already infected with it, it is…
India is among the countries with the highest amount of bacterial diseases in the world, and is also the largest consumer of antibiotics in the world, wherein the consumption has increased by 103% from 2000 to 2015! This is the highest increase in low and middle income countries. As per…
The blog title may scare you for once, wondering how you can take a medication without having it tested and approved. But hold on, there is more to what you have just read. You can trust the Indian government to not risk anyone’s life. So then, what it is about,…
All of us who are concerned with or interested in the clinical research field of our country would be aware of the New Drugs and Clinical Trials Rules 2019 that have been in effect since 19 March 2019. But, the journey of clinical trials hasn’t been easy to reach the…
The only purpose of clinical research is to find new drugs and devices to help improve the health of every citizen of the country, and even the world. Now, you may think how thoughtful it is for those clinical researchers to put out all their efforts and time into bringing…
The Nipah virus outbreak that was observed in Kerala was a nightmare, and has thrown several challenges that need to be addressed. Recalling the adverse effect of the outbreak, Dr. Chandni Sajeevan, professor and Emergency Medical Relief Head at Government Medical College, Kozhikode, said that everything came to a standstill…