Clinical Trials in the Age of Coronavirus

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<a href="https://www.medidata.com/en/clinical-trials-covid19-infographic/"><img src="http://media-s3-us-east-1.ceros.com/medidata/images/2020/06/26/6efb7b6d0547f854913d3f12929ae88b/medidata-solutions-the-end-of-covid-19final.png " alt="Clinical Trials In The Age of Coronavirus" width="500" border="0" /></a><br />Source: <a href="https://www.medidata.com">MediData.com</a>

To end the COVID-19 pandemic will require cutting-edge clinical trial technology and testing 

In the U.S., it typically takes a new drug 12 years to reach the market

• • • Research & Development: 3.5 years
    • Investigational New Drug Application: 30 days
    • Clinical Trials: 6 years
      • Phase 1: 1 year
      • Phase 2: 2 years
      • Phase 3: 3 years
    • New Drug Application: 2.5 years

Of all the drugs that enter clinical trials, just 10% are approved — The fastest way to find a cure for COVID-19 is to test as many options as possible 

Challenges For Clinical Trials

• Low Enrollment: More than two million patients are needed for clinical trials every year
• • • Just 5% of the patients recruited to participate in a trial enroll
    • 46 million patients are recruited in order to the 2 million needed — That’s more than the population of Spain

• Lack Of Diversity: Both drugs and diseases (including COVID-19) may affect diverse populations differently
  • African Americans make up less than 5% of trial participants, but 20% of the U.S. population
    • Similar disparities exist among Asian and Native American populations
    • Socioeconomic barriers and a history victimization in medical experiments may contribute to minorities unwillingness to participate in clinical trials
      
• COVID-19: The global pandemic has also impacted trials of experimental drugs for other diseases
  • • 69% of ongoing clinical trials and 78% of new trials have been affected by the pandemic
    • Researchers’ top concern is their ability to continue recruiting and enrolling patients
• Adaptive Trials: A Faster Path?
  • Test multiple treatments at one time and adapt as new data emerges
  • Increases number of participants given the most promising treatments
  • Enabled by advance algorithms that maintain the integrity of the trial data
  • REMAP-CAP is an ongoing adaptive trial for community acquired pneumonia, designed to be ready to fight new and emerging diseases
    • Already assessing multiple COVID-19 treatments
• How Soon Could We See A Cure?
  • In 2003, developing an H1N1 vaccine took 5-6 months
    • Knowledge and infrastructure for flu vaccines was already in place
    • Clinical trial requirements were brief or waived entire based on extensive study of existing seasonal flu vaccines
  • The fastest vaccine developed from scratch was the mumps vaccine — Taking just 4 years
    • A COVID19 vaccine may be developed much faster by
      • Building on knowledge gained from similar outbreaks like SARS-1
      • Using more advanced technology and trial mechanisms

Interested in joining a trial? Go to clinicaltrials.gov or contact a patient advocacy group and start a conversation with your doctor