Have you ever wondered: why is your doctor so confidently prescribing certain medications to you? How does your doctor even know if the medication is safe and effective for your medical condition?
Not really magic, but it’s something better— we have one of the greatest inventions in modern medicine called clinical trials. As we will discuss below, clinical trials are the cornerstone to safe and effective medical treatments.
Take COVID-19 vaccines as an example.
Image credit: https://www.clinicaltrialsarena.com/analysis/covid-19-vaccine-mixing-the-good-the-bad-and-the-uncertain/
The clinical trials of COVID-19 vaccines show that they are safe and effective to prevent the disease before they are approved into the market. Soon after that, many people all around the world received a jab in the arm.
What’s the purpose of clinical trials?
Clinical trials are essentially a series of rigorous tests for new ways to prevent, detect or treat diseases before they are approved to be used by the general public. Treatments might be new medications or combinations of medications, new surgical procedures or devices, new vaccines, or new ways to use existing treatments. Clinical trials can also test other aspects of medical care, such as ways to improve the quality of life for people with chronic illnesses.
In a clinical trial, there will be a team of people who run the trial (who are often scientists, doctors, pharmacists and other professionals); and volunteers who receive the new treatment that is being tested. These volunteers are known as the subjects (or to put it more straightforwardly, the ‘lab rats’). There will be strict protocols and rules in place to protect the volunteer’s rights and safety, while ensuring the clinical trials are being conducted in an objective manner.
Clinical trials are important because they allow us to make new scientific and medical discoveries in a safe and efficient manner.
Designs of clinical trials
Depending on the stage of clinical trials, they are often an expensive and laborious undertaking for pharmaceutical companies and institutions. A good clinical trial design starts from the very beginning. For instance, the team recruits a group of volunteers that is similar to the target population for the new treatment. If the new treatment is intended to be used in young people, the group of volunteers of the clinical trials should consist of young people too.
Then, these volunteers will be divided randomly into placebo groups and treatment groups. Such randomness is an important aspect of a clinical trial. This is because the applications of treatment in the real world setting is going to be random and a good clinical trial design should reflect that to eliminate biases that can affect the results.
The placebo group receives the “fake” treatment that is harmless but unknown to the volunteers, while the treatment group receives the new treatment. In the end, the clinical trial team will study the difference of results yielded from these two groups, and conclude whether the new treatment is effective or not.
Clinical trials are conducted in several stages, each stage with different numbers of volunteers and purposes:
Image credit: https://www.nih.gov/sites/default/files/about-nih/public-trust/clinical-trials-infographic.pdf
However, clinical trials are not always feasible for every intended scenario. For instance, if we want to know if a new treatment can help people quit smoking, we cannot randomly assign people to start smoking and test the new treatment on them, because that would be unethical.
Who conducts clinical trials?
Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, pharmacists, nurses, social workers, and other health care professionals, depending on the requirements of the trials.
In some clinical trials, research teams from a contract research organization (CRO) are hired by the sponsors to perform the clinical trial. Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to government agencies. Doctors, other health care providers, and other individuals can also sponsor clinical research.
Clinical trials are usually held in hospitals, universities, medical centres or doctor’s clinics.
How believable are the results of clinical trials?
The Internet is never short of conspiracy theories about modern medicine— some may even question the believability of clinical trials, claiming that they can be fabricated.
Even before a clinical trial can be conducted, the trial team would need to go through a rigorous application process scrutinized by the National Pharmaceutical Regulatory Agency (NPRA). In addition to that, the NPRA may even inspect and investigate clinical trials while it is still ongoing or completed, known as the Good Clinical Practice (GCP) inspection. Such inspection is to ensure the trial is conducted ethically in accordance to the regulatory requirements and assure the integrity of the study conduct. If the clinical trial was found to be ‘fishy’, e.g. manipulation, fraud or fabrication of the data, actions will be taken against the research team.
After the results of the clinical trials are published, they will also be peer reviewed by other scientists, doctors and healthcare professionals who were not involved in the trials. It’s like asking your classmate to check your homework for you to make sure they are accurate and relevant.
Of course, nothing under the sun is perfect, even for a well-designed clinical trial. Not all possible side effects or risks about the product/treatment will be captured or studied during the clinical trial. This is why even after a clinical trial ends, the product/treatment will undergo post-marketing surveillance, i.e. monitoring of the safety and effectiveness of the product in the market after it is approved. This process is overseen by the NPRA.
Volunteer for a clinical trial
Interested to become a volunteer subject for a clinical trial? This section is for you!
Generally, each clinical trial will have different requirements for participants such as age, sex, medical condition, etc. (known as the inclusion-exclusion criteria). The research team will decide if you are eligible to participate in the trial.
The team also has to undertake an “Informed Consent” process to educate you on the potential risks-benefits of participating in the clinical trial. You have the right to ask any questions you may have about the clinical trial. If you agree to participate after the informed consent process, you may sign the Informed Consent form. Very important: even after you have signed the form, you will always have the right to change your mind and withdraw from the clinical trial at any time. Even before you’re being recruited into the trial, the clinical trial application is reviewed by an independent ethics committee such as the Medical Research and Ethics Committee (MREC), who ensures the trial design is ethical and the volunteers' rights well-protected.
During the trial period, the research team will review your medical history, give you instructions on what to do and when-and-how to do it and monitor your health carefully. Some clinical trials may need regular tests and doctor visits. In most cases, this high standard of medical care is paid for by the trial sponsor. Your participation will directly help advance scientific knowledge and will benefit future generations. Depending on the project, volunteers may be compensated accordingly.
Talk to your doctor to see if you would benefit from participating in a clinical trial. Your doctor can find out what clinical trials relevant to your medical condition that are going on or will soon be initiated by contacting Clinical Research Malaysia (CRM) or the Clinical Research Centre (CRC) Units in major public hospitals.
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