Medidata Solutions is America’s principal health-tech company, responsible for most of the country’s clinical trials. Fervidly committed to elevating life sciences, Medidata has joined health and biology gurus in their race to develop a coronavirus vaccine. Their role? Providing spearheading data to those on the frontlines of decision making – i.e., pharmaceutical, biotech, and medical device and diagnostic affiliates.
Since the outbreak, Americans have been left in the dark as to when, or even if, a medicinal cure to coronavirus will ever rollout. By acting on their data collections, Medidata has the potential to help society return to calmality – allowing millions of patients to regrasp hope for the future of their health.
How Does Medidata Work?
Medidata’s platforms are judiciously assembled, uniquely capable of answering the trickiest questions in the industry such as:
- What happens in clinical trials?
- How do drugs get FDA approved?
- Are there faster paths to adaptive trials?
- How quickly could we cure coronavirus?
Using Saas, PaaS, and cloud computing, Medidata can digitally capture, manage, and report clinical research data. Their Acorn AI platform is the industry’s largest structured, standardized clinical data repository – comprising over 20,000 clinical trials including more than 5 million patients.
What Is A Clinical Trial?
Cited by the World Health Organization, clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.
As a rule of thumb, 12-years is needed for a new drug to reach the American market.
Why? Years of research and development is needed before medicinal scientists can apply for their drug to be investigated. If approved, the drug can enter clinical trials, which are broken down into 3-4 phases.
The 1st phase will last one year, and every phase after that requires an additional year of testing. After phase 3 trials, the drug can then ask the FDA to determine its market readiness. Yet, just 10% of the numerous drugs that enter clinical trials actually gain FDA approval. In response to this debacle, Medidata has found the fastest way to cure a disease is to begin testing as many options as possible.
However, we may see progression much sooner than 12 years. The fastest vaccine developed from scratch was the Mumps vaccine, which only took 4 years. To assist, the FDA has promised to expedite development timelines for prevention and treatment options for COVID-19 given its historically rapid diversion – including emergency authorizations for existing drugs used to treat other disorders.
What Can Prevent New Drugs From Marketation?
Lack of patient diversity and low clinical trial enrollment.
It’s believed both drugs and diseases – including COVID-19 – can affect diverse populations differently. Perhaps socioeconomic barriers, as well as the history of victimization in medical experiments, could be the reason minorities are more prone to deny clinical trial participation. Nonetheless, the only way to truly answer these theories is to begin including more minorities in experimental drug trials.
Take this into perspective: African Americans make up 20% of the United States’ population. Now, when analyzing the demographics of those in clinical trials, less than 5% turn out to be black. Relatable disparities can also be seen in Asian and Native American demographics. For the sake of evolution, scientists need to widen the spectrum of demographics included in all clinical trials.
However, clinical trials are extremely under supported as it is. 2 million patients are needed for clinical trials every year, yet just 5% of patients recruited actually enroll. Statistically speaking, an additional 46 million patients need to be recruited in order to find the remaining 2 million participants needed. That’s more than the population of Spain.
Moving along, systemic backups are another reason as to why new drugs can have trouble entering the market. Since the pandemic went global, essentially every field has had to accommodate – even those working to find a cure. Data shows the global pandemic has 69% of ongoing trials have been affected by the pandemic, as well as 78% of new trials.
When Can We Expect a Cure For COVID-19?
As aforementioned, the quickest vaccine developed from scratch was for the Mumps, which took 4 years. The H1N1 vaccine is noteworthy when discussing effective vaccines that were not made from scratch. In 2003, it took 5-6 months for treatments to become available for the Swine Flu. Why? H1N1 was not as complex as COVID-19. At the time of its outbreak, knowledge and infrastructure for flu vaccines were already in place. As a result, clinical trial requirements were extremely brief, or even waived entirely, based on extensive study of existing seasonal flu vaccines.
By building on knowledge gained from similar outbreaks like SARS-1 and using more advanced technology and trial mechanisms, a COVID-19 vaccine may be developed much faster than both the Mumps and H1N1 vaccines.
Remember, scientists are 2 million participants short for clinical trials. If you’re interested in volunteering, start a conversation with your doctor, contact a patient advocacy group, or simply visit www.clinicaltrials.gov.