The decrease in mortality and morbidity across the globe has been contributed to investment in basic clinical research by health organizations or institutes, health professionals and patients participating in clinical trials.
Clinical trials are research investigations volunteering participants to test new interventions for the purpose to prevent, diagnose, treat or manage various medical conditions or diseases. Clinical research studies are conducted on humans with the goal of providing new therapies, vaccines or diagnostic procedures or treatments. The proposed clinical study is ethically reviewed before beginning the trials for the purpose of ensuring the safety and efficacy of human volunteers. Trials are conducted on medical devices and pharmaceuticals to demonstrate accuracy and consistency in the level of effectiveness and safety. The majority of these trials are possible due to resources invested in clinical development of new therapies provided by pharmaceutical and device companies. Approximately 10 to 15 years of time period is required to complete all four testing and approval phases before licensing or marketing the drug, device or therapy.
Trials may be observational and interventional or randomised to evaluate drug, therapy or experimental treatment; diagnostic or preventive methods. Randomized controlled trials are considered the most reliable way to ascertain the effectiveness of a test or treatment. Screening trials evaluate detection methods for health conditions before occurrence of symptoms. Clinical trial team members of principle investigator, nurses and other health professionals assess data and publish key findings of the study. Acquiring skills, knowledge and techniques in basic science and clinical research or other disciplines is necessary to conduct successful, efficient and high-quality clinical trials. Understanding and improving performance or controlling difficulty of translational and clinical science applications helps develop proficiency in the study design. Knowledge on specifications of various regulatory authorities to approve marketing of healthcare products also plays a critical role in clinical trials.
Significance Of Clinical Research
Clinical trials are well-designed to benefit the participants or volunteers, investigators, sponsors and the entire medical community. These trials conducted in four phases by a team of doctors, nurses and medical or healthcare professionals play an important role in providing medical options to patients in the present and future. Active clinical trials continue to help understand diseases; improve detection of acute or chronic illnesses; ensure discovery or development of medical innovations, large number of experimental drugs and therapies. Clinical trials play a vital role in the development of intervention to treat or combat chronic degenerative diseases and improve the health of the world’s population.
The large quantity and quality of clinical research conducted has increased the volume of devices, drugs and therapies under development. Clinical trials determine the safety and effectiveness of new drugs, treatments or diagnostic methods. Medicine or medical devices are highly regulated and closely monitored during clinical trials to ensure efficacy and safety. Clinical trials also provide important information on the clinical value of diagnostic tests and cost-effectiveness of a treatment that improves quality of life. These trials provide invaluable and reliable information to doctors and patients on safety or benefits of existing therapies and help choose between alternative treatments. Patients are encouraged to participate in clinical trials to receive expert medical care. The patients become active participants in their own healthcare and contribute to medical research by volunteering in clinical trials. Patients also actively participate to gain access to new research treatments unavailable in the market that contribute to research and development.
Online Clinical Research Course at JLI
James Lind Institute (JLI) provides online programs in clinical research, medical writing, pharmacovigilance, clinical data management, clinical regulatory affairs, clinical quality assurance, medical affairs and public health.
For more information please visit: www.jli.edu.in