ICH-GCP guidelines govern the clinical trial conduct and ensure the protection of patient’s safety and well-being and also ensure that the data collected during the course of clinical trial is accurate and of high quality. For every clinical trial taking place at the investigative site, a clinical research coordinator (CRC) is the main line of communication for most of the activities carried out. A CRC performs many activities such as maintaining source documentation, patient follow-up, CRF filling etc.
In case of an oncology study, the Research Nurse (RN), would best suit for the role of a clinical research coordinator role as he/she is experienced in most of the trial procedures being carried out in the wards. The research nurse plays a vital role in maximizing patient recruitment and in making sure that both the trial protocol and GCP guidelines are closely followed by everyone involved in the trial. Continue reading
Clinical Research is a wonderful career opportunity. If one has the required skills, enthusiasm and commitment, this career path can bring very good returns, both in terms of monetary gains as well as satisfaction in professional life. Dentists have a very good future in clinical research primarily because they have a very good understanding of the basic physiology of the human body, its anatomy, pharmacology and many other medical aspects. Dentists in clinical research are eligible to work in any department. Dentists can work in clinical operations departments as a Clinical Research Associate (CRA), Sr. CRA, and later in their career grow to the level of a Clinical Trial Manager, Associate Director, Director, MD and CEO. Continue reading
Many doctors (physicians) look for online courses that can enhance their profile, add to their knowledge and skill set and in the long run have the potential of monetary gains for themselves. If you are looking for such an online program, have you ever thought of specializing in ‘Clinical Trials’/’Clinical Research’? Well, if you have not then it is important for you to know that as a doctor / physician you can participate in multi-national clinical trials as an investigator. Clinical research is big business funded by pharmaceutical & biotechnology companies and if you have well established private practice or if you work at a hospital you can become a part of these projects. Continue reading
The history of clinical trials has amazed many. The journey of clinical trials originated from the first recorded clinical trial from biblical era where Daniel tested the effects of a diet of pulses rather than meat. History was again inked with an iconic event when a surgeon from Edinburgh Dr. James Lind (1716-94) investigated the best treatment for scurvy and was probably the first person to have conducted a controlled clinical trial of the modern era.
James Lind is considered the first physician and father of clinical research who conducted a controlled clinical trial of the modern era. Dr. Lind (1716-94), a surgeon, serving on a ship, was appalled with high mortality from scurvy amongst the sailors. As a preventive measure he planned a comparative trial which resulted in most promising cure for scurvy. His description of the trial stated below covers the most essential elements of a controlled trial. His vision resulted in revolutionizing the research arena. Continue reading