It’s been a little over one year since the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine for emergency use – and yet still, uncertainty surrounding the process abounds.
Despite a staggering 400 million doses administered around the country, Vaccine Hesitancy is still a very clear and present reality, with many individuals distrusting both the speed and scale from which the science went from ideation to ultimate implementation.
Increasingly, it seems as if misinformation and confusion surrounding the COVID-19 vaccine has caused many to doubt. Whether it’s actually safe and effective. As scientists and healthcare leaders, it’s our responsibility to educate these individuals not only about the facts and figures of the vaccine’s development, but also about the entire vaccine clinical trial steps against the backdrop of the pandemic.
The truth is that the COVID-19 vaccine is the product of innovative clinical trials practices and monitor by independent oversight committees – which have completely re-imagine the way that research is conduct and have even led to an increase in trial participation. In fact, 68% of US adults diagnosed with at least one medical condition Say they are more likely to consider participating in a clinical trial than before the COVID-19 pandemic.
Below is an overview of the reasons why Vaccine clinical trial processes. Across the research continuum, are perhaps safer and more efficient than ever before, as well as outline a few of the key players responsible for making this possible and it can help to overcome the Vaccine Hesitancy.
Advancements in large-scale data Monitoring:
Recently, We’ve seen significant progress in our understanding of digital health as it relates to Vaccine Hesitancy and Vaccine clinical Trials, catalyzing the emergence of new tools for large-scale study monitoring. These tools, such as wearables and telehealth have proven to be incredibly useful for serving as a real-time system of checks and balances for independent regulatory agencies, which analyze study data to ensure safety and compliance.
Just consider the Data Monitoring Committee (DMC) also known as Data Safety Monitoring Boards (DMSB), which are independent groups of experts who conduct a period review of accumulated worldwide clinical data at a macro level – during a clinical trial. When thinking about the future of clinical trials for a variety of potentially game-changing advancements, such as vaccines, targeted gene therapies and more these new and emerging digital monitoring tools have allowed organizations like the DMC to evaluate new studies faster and safer than ever before.
Reimagined patient care with safety and efficacy at the forefront:
Not only have emerging technologies proven to be incredibly powerful tools for monitoring trials at a macro level, but they can help catch red flags, analyze side effects and mitigate symptoms at a patient level as well. In recent years, a patient’s smart phone has become their gateway for 24/7 Vaccine clinical trials support, allowing them to ask questions and report problems in real time.
As a result, digital advancements like these have made trials conducted during the pandemic safer and more accurate – generating patient data from the comfort of their own homes. Equipped with these game-changing new insights, independent oversight groups like the Endpoint Adjudication Committee (EAC) are now able to more effectively drill down into the patient perspective, consequently getting a much fuller understanding of trial efficacy, side effects and more.
Rigorous Oversight at every step of the way:
If this past year has shown us anything, it’s the fact that speed and precision don’t have to be mutually exclusive attributes in trials processes. In fact, in many respects trials is conduct against the backdrop of the pandemic has been placed under more scrutiny and oversight than ever before. At the outset of the Trial process, regulatory agencies / oversight bodies in the new normal have worked tirelessly to ensure that remote monitoring practices were thoroughly vetted for risk, or even perceived risk, before proceeding.
To that end, all trials have undergone rigorous oversight by an Institutional Biosafety Committee (IBC) and an Institutional Review Board (IRB) to protect the welfare of research subjects and mitigate exposure to engineered genetic material respectively. Both committees have focused solely on ensuring that clinical trials even underpinned by a global pandemic were safe for both trial participants and ultimately the general public.
Final Thoughts:
In the past year, the COVID-19 pandemic is catalyze and profound changes in the way that clinical trials are run, maintain and evaluate. Because of the unprecedented times we found ourselves in, it’s certainly understandable that some individuals may have questions about these processes, however, as healthcare leaders it’s critical that we take every opportunity we can to educate them about the truly incredible transformations occurring in the clinical trials space today due to vaccine hesitancy.
The reality is that the past year has helped usher in a new era defined by ingenuity and diligence – propelling the emergence of breakthrough technologies and even game-changing therapeutics. Admittedly, we don’t know what the future holds; however, one thing’s for certain: the clinical trials space has never been safer and more innovative as a result.
James Riddle is Vice President - Research Services & Strategic Consulting at Advarra
