There has been a recent surge in new-age diseases everywhere. The novel coronavirus disease (COVID-19) is rapidly spreading across nations. Unfortunately, there is no cure for it yet. While the death toll increases because of this pandemic, we are still waiting for a vaccine that could potentially save millions of lives. Research and clinical trials to find a solution are moving at breakneck speed because only a vaccine can prevent any further damage. Over 35 companies and institutions are racing to find the answer. So, this begs for us to look at how important the field of medical research is.
WHAT IS A CLINICAL TRIAL?
Clinical trials are a type of clinical research that studies new treatments and tests and evaluates their effects on human health outcomes. Studies are done on participants to figure out answers to behavioral or biomedical interventions. Hence, they are also referred to as interventional trials. These interventions include new vaccines, dietary supplements, and medical devices. Clinical trials have to be approved before they start and are carefully designed, reviewed and completed. It is an application of a scientific method designed to test hypotheses and monitor and assess outcomes. In 2018, there were over 60,000 trials registered worldwide. And, May 20th is celebrated as the ‘International Clinical Trials Day‘ every year to commemorate the day Scottish physician James Lend began the first clinical trial in 1747.
PHASES OF A CLINICAL TRIAL
There are four phases of biomedical clinical trials. Phase I involves testing a small group of people. These participants are evaluated to check side effects, safety of the dosage and treatment. The second phase is where the treatments in Phase I are studied for it to be safe for a larger group of people. After that, Phase III deals with studies conducted on a larger population in different regions. Finally, Phase IV is after the intervention is marketed to further test in a wider population. So, these trials serve a different purpose at each phase of the trials. Also, there are different types of clinical trials based on what the researcher is studying. This includes treatment and prevention research, diagnostic and screening research, and genetic and epidemiological studies.
ADVANTAGES OF CLINICAL TRIALS
Beneficial to Participants
One of the favorable aspects of clinical trials is that it can be quite beneficial to the participants that partake in these experiments. There can be various reasons as to why people would like to join a clinical trial. People suffering from illnesses that currently do not have a cure or a vaccine would like to play a role in the process of finding it out. They can find out about new treatments before it enters the public domain. Additionally, people who take part in clinical trials may personally benefit from the up-to-date care from experts with a novel treatment or the best available standard treatment. They can even get monetary relief for these tests. Some clinical trials are done on healthy participants to discover ways to prevent certain diseases. This can help people in protecting themselves from diseases that may run in their family.
Earlier, patients saw clinical trials as a last resort. But now it has become increasingly common to get treatment through clinical trials. Recently, the first human trial for the coronavirus vaccine began with a healthy participant. The open-label trial, wherein no information is withheld from its participants, will enroll 45 healthy volunteers over six weeks. If successful, this could prevent a lot of avoidable deaths.
Beneficial to the field of Science
Clinical trials are hugely beneficial to the field of science. They test how well new interventions and approaches work in the participants which leads to new scientific discoveries. Each trial is an attempt to answer scientific questions. As a result, it contributes to the discovery of new medicine and treatment guidelines. The drug, vaccine or any other intervention could be more effective than the standard approach. Therefore, clinical trials help further the cause of medical research. World Health Organisation (WHO) has launched a Solidarity clinical trial to find an effective treatment or vaccine for COVID-19. This trial aims to discover whether any of the drugs slow disease progression or improve survival as expeditiously as possible.
Increased knowledge about clinical trials promotes a positive attitude towards its participation. The field of clinical research helps in increasing knowledge in terms of how a disease needs to be approached and treated. In other words, the information gathered from clinical trials adds value to scientific knowledge. This is important to upgrade medical care and make it more accessible. Subsequently, increased knowledge about existing illnesses can influence health laws to regulate the same better.
Trained Healthcare Professionals
Trials help in improving the way healthcare professionals are trained and educated. Due to the fragile nature of clinical tests, exceptional care will be required for a better quality of healthcare practice. Participants need to receive careful medical attention from a qualified team of doctors, nurses and other healthcare workers.
DISADVANTAGES OF CLINICAL TRIALS
It is highly risky for businesses that undertake clinical trials as well as for people who participate in these trials. New vaccines, drugs, supplements that are under study may not be necessarily better than the standard procedure. In other words, the side effects of the drug administered to participants can become fatal. Randomized clinical trials are subject to risks as patients do not know what interventions they will receive. Healthcare insurance providers also do not cover costs for these trials. Therefore, participants have to make an informed choice before volunteering themselves for any such clinical trial.
Costs for clinical trials are expensive and usually range in billions per drug. While planning the research, factors like tool design, protocol design, site selection and execution of the trial have to be considered. The costs vary accordingly. Sponsors for these trials are usually private corporations like pharmaceutical or biomedical company. Sometimes governmental organizations also fund them to speed up the trial to find life-saving drugs.
Not always Effective
Even if the treatment is a success, it might not always be effective. Some participants might not react to it favorably. In a trial design, there are placebo groups that get treatment with nonspecific effects. Hence, the participants of the placebo group do not reap the benefits of a successful clinical trial.
In the United States, the U.S. Food and Drug Administration (FDA) approves only ten percent of total drugs in clinical trials. An approved vaccine or drug might have a few more roadblocks before it sees the light. One of the challenges is to get it to people who need it the most. For instance, the tested and approved coronavirus vaccine will need immediately mass production. This is a remote possibility. Also, there is an imbalance between need and the purchasing power of vaccines. Developing countries with poor healthcare facilities will need it the most but will not have the capacity to fund it.
Clinical trials are at the end of the day our best hope against deadly diseases and illnesses. We must strive to understand the problem areas. And above all, we must fight to find the right solutions.
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Pros and Cons of Clinical Trials
Beneficial to Participants
Beneficial to the field of Science
Not Always Effective
|Trained Healthcare Professionals||