Clinical trials are the core of medical research. Investigations are performed to determine how new treatments will work in human patients and valuable data concerning the benefits and risks of new drugs, medical approaches, and procedures are collected. Clinical trials are conducted to find effective ways to understand, prevent, diagnose, and treat diseases. However, clinical studies are also conducted to improve the quality of life of patients with chronic illnesses.
Covid-19 and clinical trials
The pandemic COVID-19 has created havoc all over the world. It has caused us to rethink everything, including how clinical research is conducted. Clinical research institutes have completely changed their way of working and processing data and results. The best clinical research course of action has changed drastically and has resulted in new trends in the research world. Clinical trial recruitment has become a challenge due to the global pandemic as people are socially distanced from one another. However, they have stayed connected through social media platforms. The benefit of reaching patients online or digitally is that they can be reached from any part of the world. Digital platforms make it easier to reach out to people, and it also encourages active participation in clinical trials. The latest trends in clinical trial recruitments include increased use of digital advertising to find the most suited patients for a trial.
Clinical Research Training studies are always in need of volunteers. Without these volunteers, medications and treatments cannot be approved by the concerned authorities and thus cannot reach the patients. Apart from gaining access to a potential treatment for a particular disease, other perks include receiving care at the topmost facilities, helping science, and making a potential impact on all those living in that particular condition. These studies generally offer generous compensation for your participation.
Each clinical trial is designed very carefully to provide the greatest amount of information at the lowest possible risk, and to achieve this, a protocol, or an action plan, is prepared. This plan describes what is to be done in the study, how it will be done, which information would be gathered, and why the different parts of the investigation are necessary.
The eligibility criteria for participating in a clinical trial are also listed in the protocol. Some studies require participants with a particular illness. Whereas some studies seek healthy volunteers or people with specific characteristics regarding gender, age, weight, lifestyle/habits, or others.
Interventional and Observational Studies
Clinical trials are of two types: Interventional and Observational studies. In case of interventional studies, the participants are treated in accordance with a research plan created by study investigators and the results are usually compared with the data obtained for subjects who receive either no treatment or a treatment that is already available. The “intervention” may include new drugs or devices, novel medical procedures, or changes in the participants’ behavior (diet, sport activities, etc.)
In an observational study, the participants are monitored to assess health outcomes under particular conditions. However, in this case the investigator has no direct control over the experiment and makes no attempt to affect the outcome of the study. Observational studies are advantageous as they involve patient populations that are closer to clinical practice, they are cheaper than interventional studies, and are used to investigate rare outcomes, detecting unusual side effects. Another advantage is that some studies are performed quickly and easily.
Before a new drug or an innovative medical approach can be tested on humans, extensive laboratory research is required, sometimes spanning over several years. In most cases, this research involves conducting experiments on animals and/or human tissues. In case the studies prove to be successful, the investigators may send the data to an independent committee (usually comprises physicians and scientists) who would then approve and monitor any further tests involving human participants.
Clinical research trainings are given to every professional involved in the trial. Clinical research trainings are continuously updated based on the disease and development of technology to ensure the complete safety of the participants of the trial