I've never been known as a "glass half full" kind of gal, especially if said glass once contained a Grey Goose martini (up; dirty) - 5 minutes after the server had set it before me, the only "half" that is left is the skewered olives.
Friends, family, colleagues, strangers on Reddit, and the manager at Dunks on Mass Ave, might say I'm a pessimist. And they are correct. But I have a confession - as traumatic as the pandemic was, I believe we reaped many benefits for going through it.
Don't get it twisted; I "intellectually" know that the early days of lockdown were confusing, chaotic, and occasionally downright terrifying (I'm looking at you, "wiping down boxes of cereal"). But like childhood memories of camping through relentless rain, now I look back on those rough days with an odd nostalgia, like a cozy blanket made of quarantine-induced trauma. Frequent hits include such classics as "Homeschooling is quality time!", "I calibrated my oven AND my freezer," "Did you know that you can buy Brazillian soap nuts on Amazon, and if you prepare them just right, they still are nothing like actual soap - isn't that fun?".
But it isn't just warped nostalgia that has my Gray Goose closer to the brim than usual; many positive changes arose from the ashes of the pandemic.
I'll have a Massachusetts Martini, To Go!
Remember when "can't, won't" ruled the day? But out of necessity, we because to see people actually driving change! Suddenly, what was once thought impossible became the new norm. Take, for example, alcohol delivery in MASSACHUSETTS. Amid lockdowns and social distancing, bars and restaurants struggled to stay afloat. But lo and behold, they found a way to serve their customers safely from a distance. And it didn't take long - good ole' Charlie Baker had taxpayers happily sipping Sam Summahs before mid-July; he approved the legislation on July 10, 2020.
When restaurants did begin to open up again, they did so with newfound outdoor seating. Not only did these "parklets" and "streateries" allow for more customers while following social distancing guidelines,n and but let's be honest, who wouldn't want to dine al fresco instead of cramped indoors? Give me those jersey barriers and rush hour views any day.
With the advent of remote work policies, people gained the much-needed flexibility to balance work and personal life, which paradoxically convinced them to add to the responsibility of a pet. And this, in turn, has positively impacted the life of Sarah McLachlan, who no longer has to shoulder the burden of adopting every stray animal at the ASPCA.
Going from "ugh, do I have to?" to "heyy, let's go!" - The rise of decentralized clinical trials
Saving the best (of this piece) for last, the pandemic brought the Decentralized Clinical Trial the attention it has long deserved. With its patient-centric model, this technology will surely disrupt the traditional clinical trial method.
What I witnessed firsthand as a trial sponsor is well characterized by Jonathan Cotliar (Chief Medical Officer at Science 37) in his article, "How A Pandememdic Acceleralerated the Adoption of Virtual Trials," According to Coltair,
"A number of people have spent years trying to convince pharmaceutical executives, clinical development teams, physicians, regulatory authorities, and other stakeholders in our industry that virtual trials can provide a more efficient path to drug development—often only to be met with great skepticism. The COVID-19 pandemic is now rapidly impacting the clinical trial landscape; those who were once skeptical of the virtual model are now compelled to embrace it out of necessity."
Necessity became the name of the game for Sponsors. The pandemic shut the world down, and all unnecessary medical procedures were on hold. Still, the patients who would eventually benefit from our product couldn't wait (and, honestly, neither could the board). So, we took the leap of faith and decided to expedite our shift to a virtual trial. Initially, we attempted to manage our first DCT internally. Though we tried to learn our way through it, a tsunami of enrollments was looming, making it apparent that we needed an experienced CRO. We partnered with Curebase, whose expertise gave us the tools to reach our enrollment targets while expanding operations to accommodate the demand.
Patient Centricity Never Goes Out of Style
Virtual/decentralized clinical trials are patient-centric, and that means they need to be here to stay. They leverage mobile devices and a network of remote healthcare professionals (doctors, nurses, and data managers) to help patients organize study-related procedures and assessments from home, eliminating the need to travel long distances to research sites.
Increased Access to Rare Patient Populations
Geographical constraints are particularly problematic for trials involving rare diseases, as the patient population is already limited and often widely dispersed. By removing geographical barriers, DCTs enable more patients to participate, thus increasing the diversity and representation in the trial. This broader inclusion can lead to more comprehensive and robust data, improving the understanding of the disease and the generalizability of the trial results.
Power to the Patient
When used at their best, DCTs can be patient empowerment tools by shifting some control from investigators to patients, making patients more active participants in the research process. For instance, digital platforms used in DCTs often provide patients with direct access to their health data collected during the trial, promoting better understanding and management of their condition. Moreover, DCTs can give patients greater flexibility in scheduling trial-related activities around their daily routines, thus allowing them more control over their participation. This greater involvement can foster a sense of empowerment among patients, which could improve their engagement and adherence in the trial.
Better for Patients, Better for HCPs.
The clinical trial industry has undergone a significant transformation due to the pandemic. The accelerated adoption of virtual trials has provided a safer and more convenient option for participants while reducing the risks associated with the pandemic. This shift towards DCTs has the potential to alleviate the burdens faced by healthcare systems and personnel during the crisis. Decentralized trials go beyond merely offering convenience and accessibility; it enhances real-world data collection while guaranteeing better safety and efficiency in clinical research.
In Conclusion, this is not the end...
Decentralized clinical trials are an essential part of ensuring safety, data accuracy, and convenience for participants in clinical trials. Although the pandemic may have sparked greater awareness of virtual/decentralized trials for some, many organizations had long been exploring the potential of this revolutionary technology. By leveraging mobile devices and a network of telehealth professionals to facilitate study-related activities and assessments, this patient-centric method can make participation easily accessible to many patients who would previously have difficulties traveling or living far from research sites. Overall, decentralized clinical trials can provide greater control to those participating in research while reducing hospital visits overall. In short, decentralized clinical trials are here to stay and promise a better future in terms of safety, convenience, and data accuracy for those undertaking clinical studies.
Mirvie's Miracle of Life Trial
My involvement with Mirvie's Miracle of Life Trial sparked my passion for decentralized clinical trials. This experience showed me the wide-ranging potential of DCTs. Recently, the Mirvie team presented a scientific poster at ACOG 2023 titled "Decentralized clinical trials: A flexible and efficient adjunct to accelerate pregnancy complication research." While I am no longer with Mirvie, Inc., I am honored to have contributed to this poster. (The poster is linked below).
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