What are Clinical Trials?
Clinical trials are research studies performed on humans with the aim of evaluating new tests, treatment methods and behavioural interventions. The purpose of clinical trials is to understand if the new treatment methods are safe and effective for people to use. Generally, clinical trials are done to understand if the new treatment method is more effective compared to the available standard of care treatment and has less side effects. Some of the other factors would be in trying to improve the life conditions for people who are undergoing chronic health problems and are subject to life threatening diseases.
Prior to conducting clinical trials, it has to be carefully designed, reviewed and approved. It is only after that clinical trials are available to the public and there is a protocol to follow with clinical trial subjects selected through a list of inclusion and exclusion criteria. It can include individuals of all age groups and both adults and children can take part depending on the clinical trial. The US FDA gives approval for a clinical trial to begin after pre-clinical studies have given positive results, showing the safety and efficacy. Once FDA evaluates the safety of the investigational drug, then it is given approval to be tested in humans. Clinical Trials are conducted in phases.
What are the phases of clinical trials and how it works?
Following pre-clinical laboratory studies conducted in lab animals, the real studies in humans occur in four phases The FDA requires, Phase I, II and III trials to be conducted prior to marketing.
Phase 1: This is when the new treatment method is first tested in humans and usually involves a small group of healthy volunteers. Usually, it involves 20 to 80 individuals where tests are done to identify the safety profile of the drug and evaluated for the correct drug dosage necessary to treat the condition.
Phase II: This phase uses more individuals and involves around 100 to 300 people. This phase mainly involves in measuring the effectiveness of the study drug. The aim of the first phase is to check the safety profile of the drug. This is the phase where tests are performed to check if the treatment is working on the disease condition and preliminary data is collected. Short term side effects are evaluated.
Phase III: This includes a large genetic pool with studies conducted across borders and is generally multi-centre global clinical studies. A set of inclusion and exclusion criteria are listed and subjects who voluntarily join are tested for the study drug. In this case, drug – drug interactions too will be studied, and the study population includes several hundreds to thousands. If the results are positive, the FDA would provide approval to market the drug.
Phase IV trial: This is when the study drug is in the real world following the FDA approval. The drug is available through prescription and physicians can report on any adverse events if noted. Thus, the effectiveness of the drug would be monitored in large diverse populations in the real world.
Taking part in clinical trials is voluntary and subjects are given an informed consent form to read through, understand and ask any questions if there are. Participation in clinical trials help in improving medical research and helps to improve the availability of new medications and interventional methods for future generations.
What happens in Clinical Trials?
If you show interest to participate in a clinical trial then the study staff will explain more details about the clinical trial and gather information from you. Once your questions are answered and you provide voluntary consent to participate in the clinical trial, then an informed consent form is given to sign off. If one qualifies to participate in the clinical trial, then screening procedures are done and if the results are as per eligibility criteria, then the subject will be called for further visits. The subject is randomly assigned to the treatment arm or the control arm and during the subsequent visits and physical evaluations and blood tests are performed.
How to locate a clinical trial?
The website www.clinicaltrials.gov provides details of clinical trials conducted and you can connect with clinical trials in your area. Support groups and websites too can have clinical trials listed in your area. Google ads and newspaper ads too will advertise clinical trials in your area and one can reach out. There are many clinical trials conducted in various therapeutic areas including Alzheimer’s disease and other dementia clinical trials.
Importance of conducting clinical trials for future generations
Conducting clinical trials are essential for clinical innovations and patient care. This helps researchers to understand what works best in humans. This helps doctors to weigh the benefits and risks of the new medication. Clinical trials help novel medication to be available to society and helps the advancement of medical research.