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.
Clinical trials are studies performed for research in people who have an objective at evaluating a surgical, medical, or behavioral intervention. Clinical Trials are the primary method of researchers to determine whether a new treatment or drug, or diet is safe and effective in human beings. Clinical research requires trials conducted to collect information regarding the efficiency and safety of a new drug, device, or treatment. These are tested on certain individuals, and this process is termed clinical trial recruitment. The main aim of associate recruitment is to raise awareness about clinical research courses and to encourage the enrolment of patients. Clinical trials form the major portion of clinical research.
Clinical Research Function
The main function of a clinical research associate is to monitor clinical trials. The CRA may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a contract research organization (CRO). A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews case report forms (CRFs), and communicates with clinical research coordinators. Clinical research associates also "assure the protection of the rights, safety and well being of human study subjects. Additionally, a CRA must "make certain that the scientific integrity of the data collected is protected and verified" and "assure that adverse events are correctly documented and reported.
Clinical trials are conducted according to a plan, called a protocol, which describes:
- the types of patients who may enter the study
- the schedules of tests and procedures
- the drugs involved
- the dosages, or amount of the drug
- the length of the study
- what the researchers hope to learn from the study.
The most commonly asked question by the volunteers of any clinical trial recruitment process is the protection given to them. There are a number of measures that are taken to ensure that the participants of the trial are well protected and safe during the trial. The concerned authorities constantly review the protocols of every trial to ensure that it is done ethically and the patients' rights are protected. Apart from this, the FDA provides oversight for clinical trial testing of medical devices or drugs. Prior to human clinical trials, the FDA reviews the applications for the new treatments and medications to ensure that the studies and researches have protections in place for the volunteers. The completely informed consent forms of the patients are one of the most important pieces of the puzzle of any clinical trial that protects the volunteers. Any changes in the mind of the volunteers enable them to withdraw from the trail immediately, ensuring their complete safety.
Every clinical trial chooses the best Clinical Research Courses of action to collect as much data as possible. Before any of these medications reach the patients, it has to undergo our clinical trial phases. The first phase is also known as the recruitment phase. This is a very crucial stage of the process. It involves the selection of participants for the testing of the new treatment or drug. These participants have to meet certain criteria based on the drug or disease being treated. It involves the enrolment of 20-100 volunteers whose condition has been studied well and monitored over a specified amount of time.
Volunteers may receive information regarding these trials through newspapers, blogs, online platforms, healthcare providers, etc. This first stage mainly measures the safety of the drug or treatment by testing for any adverse or ill effects of the treatment. The criteria to be met by these volunteers can be extremely specific or generic. This is completely based on the best clinical research course of action chosen by the specialists. The following phases of any clinical trial include the elimination of unsuitable candidates for drug perfection along with FDA approval and monitoring of the drug.
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 courses 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.
As the best clinical research training based on clinical trials strive to investigate if a potential treatment is both safe and effective, there is a certain level of risk associated with it. When the recruited volunteers are chosen, there is a possibility that the treatment shall not be effective, and the volunteer can also be subjected to certain side-effects.
Clinical research trainings are given to every professional involved in the trial. Clinical research courses are continuously updated based on the disease and development of technology to ensure the complete safety of the participants of the trial.