Clinical trials are an essential step in drug development. According to statistica.com, there were approximately 318,901 thousand registered clinical drug trials as of October 2019. The number of trials has increased exponentially since 2000 when that number was a mere 2,119. Additionally, clinical trials have become more complicated over the years.
Clinical trials are crucial for assessing biologics, drugs, medical treatments, and devices. Placebo treatments are usually discarded when successful treatment is established. Effective medical treatment is present for multiple ailments and is an essential criterion to qualify for a new medication. Some new treatments can provide increased efficacy while others can offer increased convenience, security, and reduced cost. Today, the clinical trials to test the vaccine efficacy for COVID-19 are held worldwide. Clinical trials like these will help the medical industry come up with possible cures that can flatten the pandemic curve, which by now has taken millions of lives. Dennis Begos, a medical expert outlines the pros and cons of clinical trials to better our understanding of medicine and the medical industry.
Dennis Begos highlights the pros of clinical trials
According to the National Institutes of Health (NIH), clinical trials result in unexpected medical advancements because they search for revolutionary means to treat, detect, and/or avert ailments. Trials shed light on new drug combinations, devices, surgical procedures, and innovative ways to use an existing treatment. People who take part in clinical trials can witness a path-breaking recovery to long-standing ailments like cancer, HIV, and spinal injury. Healthy people who volunteer for the trials gain ample know-how about their health and other crucial medical details.
The Cons of clinical trial
One of the biggest cons of clinical trials is that the treatment might fail. The trial might not go the way researchers anticipated. Other cons that participants might experience are:
- The side effects – Side effects can lead to a great number of trial participants dropping out. Sometimes, this is just a minor hassle and researchers can resolve it effectively. But other times, there have been rare clinical trial errors and side-effects that took the lives of the participants. Borg reveals that most times, side effects occur in Phase 1 and Phase 2 trials. The Phase 3 trials are the last to take place, and by this time, most problems have been solved.
- Placebo – Participants might be administered a placebo treatment. And in such situations, they don’t receive the complete advantage of treatment.
- Spending time in the hospital – The participants might have to spend more time in clinics or hospitals to cater to essential clinical trial needs. It might last for several months and years. When this happens, participants have to say yes to extensive reporting and paperwork.
The Food and Drug Administration (FDA) aims to secure people who take part in clinical trials. For that, in 2010, the FDA added value to its regulations by administering medication and new drug trials termed as biologics. The researchers should report crucial findings that can suggest a risk for participants within approximately 15 days of being aware of an ailment. Just in case, there are adverse reactions at an increased rate, than expected, effective reporting is essential.
Today, the majority of clinical trials occur in the U.S and outside it as well. The clinical trials conducted outside the EU and the U.S are pocket-friendly and simpler to manage. Their success depends on the trial stage and medications developed.