Are Clinical Trials the Answer to COVID-19?

COVID-19 is a novel strain of the coronavirus, so it may be an uncomfortable amount of time until scientists find a cure. The fastest way to cure a disease is to test as many options as possible, so bringing an end to the pandemic will require cutting-edge science and research. For example, widespread testing, symptom tracking, and effective treatment options. Will COVID-19 be solved with the help of clinical trials?

Widespread testing will slow the spread of coronavirus and provide vital data for researchers. Symptom tracking will help people know when to get tested for coronavirus and when to seek treatment. As scientists explore effective treatment options along the way, such as creating a vaccine, fewer deaths, illnesses, and complications from coronavirus will occur.

How Long Does It Take To Develop a Vaccine?

In the United States, it usually takes a new drug 12 years to become available to the market. During these 12 years, the drug is tested through various clinical trials. Historically, viruses have been created in record-time, however. In 2003, it took 5-6 months to develop an H1N1 vaccine. But, knowledge and infrastructure for flu vaccines were already in place.

For more complex viruses, such as the novel COVID-19, scientists are essentially starting from scratch. With that being said, the fastest vaccine developed from scratch was the Mumps vaccine, taking just 4 years. Saying this, a COVID-19 vaccine can be developed much quicker than 12-years by using more advanced technology and trial mechanisms.

How Do Clinical Trials Work?

Scientists must first research and develop their drug, otherwise known as preclinical testing. A pharmaceutical company always conducts certain studies and evaluates the future drug’s safety before it is ever given to a Homosapien. This research can take up to 3.5 years.

Once scientists are confident their future drug is ready to test on humans, they must submit an Investigational New Drug (IND) Application to the FDA for approval. For additional safety, the IND must also be reviewed and approved by the Institutional Review Board, where the studies will be conducted. Approval is granted within 30 days, so the IND becomes effective if the FDA does not disapprove within that month.

In an IND, pharmaceutical companies are typically asked the results of their previous experiments, how, where, and whom the new studies will be conducted, how the drug is expected to work in the body, the chemical structure of the compound, any toxic effects found in the animal studies, and how the compound is manufactured.

After the IND is approved, the drug spends 1-3 years in phase trials. The first phase typically goes on for one year and allows 20-100 healthy volunteers to be tested – each receiving doses until side effects appear. The intentions of phase 1 trials are to determine how the drug is metabolized and its potential side effects. As of June 11, 2020, there were 6 COVID-19 vaccines in phase 1 trials. Additionally

The second phase typically lasts for 2 years, and 100-500 healthy volunteers are tested on – each receiving increasing doses until side effects appear. The intentions of phase 2 trials are to determine drug safety, efficacy, dosing, and patient outcomes. Currently, there are 3 COVID-19 vaccines in phase 2 trials.

The third phase typically lasts 3 years, and 1,000-5,000 are given the drug or a placebo. On top of that, patients and doctors don’t know who receives the new drugs. The third testing phase intends to compare the new drugs to the standard of care at multiple dosing levels. This phase’s data is used to develop labeling information and treatment regimes. Currently, there are 2 COVID-19 vaccines in phase 3 trials.

After 3 phase trials, the FDA determines if the drug can be approved for market use. At this point, pharmaceuticals would submit a New Drug Application to the FDA for their creation to enter the market. However, of all the drugs that enter clinical trials, just 10% are approved.

How Pharmaceutical Companies Can Improve Their Chances of FDA Approval

Again, the fastest way to cure a disease is to test as many options as possible. Pharmaceutical companies and scientists can work faster by building on knowledge gained from similar outbreaks like SARS-1. Furthermore, the FDA has promised to expedite development timelines for prevention and treatment options for COVID-19, including emergency authorizations for existing drugs used to treat other diseases.

In the United States, there are 144 active trials for coronavirus-related therapeutic agents. Developing a cure begins with the clinical trial process. For more information on clinical trials in the age of coronavirus, check out the visual below.

https://www.medidata.com/en/clinical-trials-covid19-infographic