With the advancement in technology, the use of clinical trials in medical science is skyrocketing. But, besides enormous benefits, there are some potential risks of clinical trials. Thanks to regulated clinical trials that facilitate the development process of new treatments and drugs for diseases and help scientists scale their efficacy on the human body.
Clinical trials are crucial for the invention of new interventions and agents, and it may take several years to complete a study following the initial success.
In this post, we will review the advantages and common risks of clinical trials.
Clinical Trial: Definition
Clinical trials are a form of research that can help medical researchers and drug companies better understand how a new treatment works and its effects on the human body.
Volunteered by human participants, these trials focus on assessing a surgical, behavioral, or medical intervention and enriching medical knowledge.
A controlled clinical study consists of four phases:
- Phase 1: The research is carried out on around 50-60 participants and aims to evaluate the best practices to give a new treatment, its after-effects, safety, etc.
- Phase 2: Scientists study on 100-300 volunteers and evaluate the short-term efficiency of the medicine, determine the most effective dose with minimum side-effect, run placebo comparison limitedly, etc.
- Phase 3: Conducted on a pool of participants (700-several thousands), in phase 3, the researchers measure the efficacy of the new medicine by comparing it with other established therapies or drugs.
- Phase 4: Based on the above three phases, the governing authority may approve or reject the invented drug or treatment. If approved, in phase 4, researchers monitor thousands of participants to validate the medicine is safe and highly effective.
Types of Clinical trials
There are three types of clinical trials:
- Observational Trial: In this type, researchers do not use any drug on the participants. They may take necessary samples, monitor the patients’ physical condition, and conduct an interview.
- Interventional Trial: It involves giving drugs to the volunteers and finding out the impacts. It can be placebo-controlled, randomised, or double-blind.
- Qualitative: A patient with a specific health issue is monitored constantly by conducting open-question interviews to understand the patterns of the problems the patient is undergoing.
How Does a Clinical Trial work?
It is totally up to you if you would volunteer for a clinical trial or not. If you participate, you may go through multiple treatments, examinations and visit the hospital.
It may seem a bit different from getting a check-up from a doctor, as you have to visit the hospital or take tests more frequently.
In a clinical trial, you must follow the trial standards strictly so that you can evade potential after-effects and the researchers can ensure the outcomes are reliable.
Advantages of Clinical Trials
After the emergence of clinical trials, doctors can better understand which medications or therapies will work more efficiently on patients with specific physical conditions.
As a participant, the advantages of clinical trials you can enjoy:
- You can be an active participant in the process of inventing a new medicine or therapy. It is an excellent opportunity to help advance medical science. For example, the development of drugs and therapeutics like Perjeta, Anastrozole, etc., to treat breast cancer was possible as many women volunteered for clinical trials.
- It offers participants access to many promising advanced medicines that are still not available to the masses. The new medication may be more effective than the standard options.
- Volunteers can get a close inspection, monitoring, and supervision of expert researchers and physicians and understand their health issues better.
- In some cases, the research sponsors may wholly or partially pay for your treatment, visits, etc., throughout the trial period.
- Volunteering for a clinical trial can significantly increase your options for treating a health issue.
Risks of Clinical Trials
As a participant, you may be prone to some risks while volunteering for a clinical trial:
- Treating your health issue by partaking in a clinical study may need more time than standard treatments.
- You may notice some severe impacts, especially in the initial stages (phases 1 and 2). In worse cases, the side effects can be life-threatening!
- The protocol may include a lot of traveling, hospital visits, and tests. Sometimes you may require to stay in the hospital for several days or visit the study site for on-site monitoring.
- While partaking in a blinded trial, you or even your physician may not know what treatments you are enrolled in; for a randomised trial, you do not get the chance to choose the treatment process.
- Your insurance policy may not include the expenses of the trial processes.
- The new medication may not be as effective as standard options for you, even if it works for others. Before signing the contract, consult with your insurance company and research coordinator to comprehend what expenses they will cover.
- Research regulation may need lifestyle modifications, for instance, a change in your diet.
- Some trials may need sensitive data collection that can cause informational or physiological impairment.
How is Your Safety Ensured?
Clinical studies are highly controlled and ensure impeccable patient safety.
Throughout the process, the statistical experts regularly analyse data on the impacts and efficiency rates. If in any phase the efficiency rates fall below the estimated rate or severe after-effects arise, the study is revised or called off immediately.
Moreover, as a participant, you have the right to withdraw at any time.