Even before the COVID-19 pandemic created the urgent need for hundreds of new clinical trials for treatments and vaccines, the number of clinical trials performed worldwide was growing more than 10 percent each year.
Yet a successful clinical trial doesn’t develop by chance or luck. Creating a cohesive clinical trial requires strategic, ongoing collaboration and information sharing between scientists, sponsors, CROs, trial sites, and participants.
Clinical Trials Have Gone Global
In the past, clinical trials were traditionally limited to North America and Western Europe, but many factors have caused clinical trials to expand globally. Reduced operational costs, speed, logistics, diversity, and regional growth opportunities are just a few of the reasons that sponsors and CROs are expanding their horizons.
However, the steadily expanding footprint of clinical trials requires additional communication and considerations to ensure these trials are performed properly.
The Importance of Communication
With so many people, groups, and organizations involved in the steps of a clinical trial, ongoing communication is of paramount importance. While failed communication inevitably leads to protocol deviations, quality issues, trial errors, delays, and unwanted costs, strong communication does the opposite.
Kevin Crawford, associate director and head of clinical operations for Tenax Therapeutics, explains, “Ongoing communication is something that I have found to be profoundly helpful in a global environment. How many times are you touching base with that key opinion leader, or that site or that study coordinator or that vendor to check in on how things are going?”
This is especially relevant given how many sponsors use contract research organizations (CROs) to manage clinical trials.
An Example in Action: Moderna’s COVD-19 Vaccine
Moderna Therapeutics, headquartered in Cambridge, Massachusetts, began developing a COVID-19 vaccine just two days after Chinese authorities shared the genetic sequence of the novel COVID-19. Moderna partnered with NIAID, a part of NIH, to finalize the sequence for a potential vaccine, which was then manufactured by the Coalition for Epidemic Preparedness Innovations (CEPI).
The NIH announced its intent to run a Phase 1 clinical study using mRNA-1273 in response to the growing threat posed by COVID-19. In just 25 days, the first clinical batch of mRNA-1273 was completed and sent for analytical testing.
After Moderna supplied the first batch of mRNA-1273 to the NIH for use in their Phase 1 clinical study, the FDA approved the NIAID’s request, which allowed the study to proceed to clinical trials with human participants. Volunteers in Washington, Georgia, and other states were enrolled to participate in the clinical trial.
Moderna requested FDA approval for a Phase 2 study of mRNA-1273 on April 27, shortly before Moderna and Lonza Bioscience announced a global strategic partnership to manufacture up to 1 billion doses of the vaccine per year. On March 18, Moderna announced positive interim Phase 1 clinical trial data for its mRNA-1273 vaccine.
Such a rapid progression of events was only made possible by continued collaboration between Moderna, the NIH, CEPI, Lonza Bioscience, research teams at multiple hospital sites across the country, and participants at each site.
Now that the FDA approved Moderna’s Fast Track designation for mRNA-1273 and BARDA awarded Moderna up to $483 million to accelerate large-scale production the vaccine candidate, the continued progression of the NIH and Moderna’s cohesive clinical trial will most likely result in a safe, successful vaccine for COVID-19.
Sources
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3373653/
- https://www.pharmasalmanac.com/articles/the-relevance-of-global-clinical-trials
- https://www.clinicalleader.com/doc/major-challenges-with-global-clinical-trials-and-how-to-overcome-them-0001
- https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19