COVID-19 has made 2020 one of the most challenging years of our lives. In the face of unrelenting challenges, our healthcare ecosystem has stepped up in a major way, creating multiple vaccines in record time for a virus heretofore unknown.
What governments, researchers, clinical trial sponsors and managers have done is unprecedented. Vaccine development typically takes 10-12 years. Yet, we are seeing these vaccines come out in well under one year. While some of the factors that enabled this response were years in the making, we are are all benefitting from a herculean, cross-industry effort to mobilize resources and funding when it matters. Healthcare providers have risked their own health to test, treat, and now vaccinate us. A massive logistical infrastructure is adapting to produce and deliver millions of doses. The world is forever in all their debt.
We want to shine a light on a group of unsung heroes who have been integral and essential in developing these vaccines. Without their independent oversight, we would have no assurance of vaccine safety and efficacy. Without them, we would not have vaccines going into arms today.
We are grateful for their service and honored to support them.
What Data Monitoring Committees do & why you should care
We believe that Data Monitoring Committees are indeed unsung heroes of 2020 because they deliver the things no one else can: Trust and safety in new and innovative healthcare treatments.
DMCs are independent groups of clinical research experts, including physicians and biostatisticians, who oversee clinical trials. Their role is to monitor patient safety, data integrity, treatment efficacy and protocol adherence during a clinical trial. Importantly, they work autonomously of the people, organizations, and institutions conducting the clinical trial.
These DMCs are in place to keep patients in a drug trial safe. Responsibility for recommending that a study proceed, pause, be amended or end rests with these influential committees. If any safety issues rise up in the data along the way, the DMC members will recommend pausing or stopping. On the other hand, if superior effectiveness is clear early on, they may also end a trial early to accelerate drug availability.
DMCs also help move things along. Their work helps ensure that less time and resources are spent on trials with unpromising results, while expediting support for drugs that are are exceeding expectations to find approval and availability as quickly as ethically possible.
The work of the DMC is highly regulated and tightly prescribed. DMCs must provide documentary evidence of their activities. This documentation is a key part of regulatory approval submissions.
These little known specialty governance committees and boards are indispensable. If only people knew of them, confidence in drug safety and effectiveness, even when brought to market with incredible speed, would soar. So herewith, we shout out the DMC.
Our Passion for the work of the DMC
This year, we at the Concinnity Company have been in a unique position to watch as these little-known yet incredibly important groups of experts have shaped and protected global health.
As a cloud software company rooted in governance expertise, we saw early on how important smart software is for doing this kind of work efficiently, safely, and with total compliance and transparency.
As the world sped up and adapted in response to the coronavirus throughout the year, we adapted our specialty governance software to serve the unique needs of data monitoring committees.
We are proud to provide smart software for DMCs and support them in doing their critical work more efficiently, effectively and with reduced risk.
To learn more about how our software platform can serve your unique governance and oversight needs, click below.