What You Need to Know About Clinical Trials?
When medical research involves involving live human beings as the object of study, it is called clinical research. Clinical research is divided into clinical trials and observational research. During observational studies, people are observed in normal settings or their everyday routines. In interventional trials, studies are performed on people to evaluate the results of certain interventions – drugs and therapy. The interventions studied in clinical trials could be behavioral, medical or surgical.
What does a clinical trial study?
A clinical trial could be used to study a host of medical problems, test solutions, or make a comparative assessment. Often a clinical trial is carried out to evaluate the efficiency of a new treatment or drug against the standard treatment in practice. Methods of a clinical trial are further employed to advance the predictive ability of medical sciences. Tests are carried out to help discover a disease at its earliest stages or even before it has started to express symptoms. Clinical trials can also be conducted to explore the options and lifestyle alternatives for people living with chronic health issues. It also involves assessing and analyzing the role of support groups and caregivers in certain medical conditions.
What are the phases of a clinical trial?
Clinical trials have to go through four phases to get the correct assessment. The treatment is first tested, then the appropriate dosage is determined, and finally, the side effects are evaluated. If after these three stages, a drug or treatment is deemed to be safe and effective by the researcher, it is sent for FDA approval for market and clinical use. FDA usually requires the successful completion of the three phases of trials – Phase I, II, and III, before approving Phase IV.
· Phase I typically involves an experiment to be conducted on a relatively smaller group of healthy individuals (20-80 persons) to determine the safety of the treatment.
· The Phase II trial involves a larger group (100-300 persons) and may go on for years. In this stage, the focus is to determine the effectiveness of an intervention on people with certain pre-existing conditions. Just like in Phase I, Phase II also involves a safety assessment by studying short-term side-effects.
· In Phase III, the safety and effectiveness are analyzed by studying the effects in a broader group of people from different populations. It evaluates the efficiency and overall impact of different dosages administered separately or in combination with other drugs and treatment.
· During Phase IV, the FDA assesses the three preceding trials and based on that determines whether a treatment can be certified for clinical use. Often the effects of a drug or treatment or device are only apparent once it has been in use for a long time among a large number of people.
How can a clinical trial be conducted?
A clinical trial is conducted by availing the clinical laboratory services. Clinical labs also allow body specimens to be studied in a controlled environment. Under a Clinical Research Organization or CRO clinical services for research can also be availed on a contractual basis.