No one needs to be reminded of how COVID-19 has changed our world, and what it has cost us all. Moments with friends and family. Job stability, especially for small businesses and restaurants. Anxiety, isolation, and mental health. A nearly impossible challenge for teachers, students, and parents. And far, far too many lives.
But some good has come out of even this. Our perspective has changed and we will no longer take anything for granted. Every opportunity we have to share a meal with a friend, to hug an elderly relative, or to bring our kids to play with others in the park – because these moments we never questioned were suddenly taken away, we realize how much we need and cherish them.
We will not rest until we get our moments back. Everyone is doing their part, directly or indirectly, to meet this global challenge the only way we can – by showing how strong, resilient, and adaptable we are. For most people, this means keeping things going the best way they can. They’re working remotely and building tighter bonds with colleagues virtually. They’re managing distance learning and their own responsibilities the best way they can. They’re supporting local businesses and restaurants (who are in turn inventing new models to stay afloat). And they’re finding safe ways to stay active, gather outside with loved ones, and create new memories despite the pandemic.
In the clinical research industry, the eyes of the world are on us. We’ve always said we’ve chosen to work here because we wanted to improve lives. Well, today we have the opportunity, and the responsibility, to come together and realize this mission in a more accelerated way. And it is already happening, with an urgency and a pace never seen before. Companies like Pfizer, Moderna, AstraZeneca, Gilead and so many more are actively rewriting what is possible every day – with more innovations on the horizon.
I know I speak for sponsors, CROs, sites, vendors, and especially our brave patients by saying how proud I am to see the collaboration and the drive that make such change possible. Our industry is consistently derided for its slow adoption of technology, but the pandemic changed our attitudes essentially overnight.
Using virtual and remote technology for everything from site selection, eligibility screening and consent through video visits, data capture, and interim analyses, pharmaceutical and biotechnology companies proved what we’ve known all along – we are all eager and eminently capable to do things a better, safer, and faster way.
And it’s not just for COVID-19 vaccine studies. Oncology trials for potential new cancer treatments can’t just stop because of the pandemic. So, sponsors, sites, medical staff, and patients have adapted to do what they can virtually, to minimize site visits, and to put new procedures and processes into place at the clinic to ensure things keep moving forward – safely.
Meanwhile, urgent new studies are doing amazing things. Just look at Pfizer and how quickly they were able to mobilize a study using electronic clinical outcomes assessments (eCOA) for up to 40,000 patients in 17 languages. Historically, this would have taken months to kick off. They did it in five weeks, while also building in new capabilities for frequent data transfers for interim analyses, real-time notifications of potential AE indicators, and many more things paper could never do.
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The result? Thanks to companies like Pfizer, we’re starting to get our moments back. Our healthcare worker heroes and our more vulnerable and elderly community members are getting the protection they need and deserve to fight this pandemic. As the distribution and supply continues to improve, as more candidates are approved, and as public trust in the vaccines continues to increase, we’ll continue to see a brightening light in what has been a darker world.
One day, COVID-19 will be behind us. But we will face new (and existing) challenges. The patients dealing with chronic pain or mental health issues or cancer deserve the same unrelenting spirit and approaches to treat and cure their afflictions that we have just proved we are capable of.
That’s why it is so important not to lose the progress we were forced to make due to COVID-19. As the catalyst from the pandemic eventually fades – and it will fade, in time – we can’t return to the old ways of doing things. We can’t risk backsliding into the old familiar habits and processes of a paper age. The slower, less transparent, lower quality, and esoteric ways of the past must stay exactly there. In the past.
Simply put, there is #NoGoingBack.
#NoGoingBack is an industry-wide social movement that invites anyone who touches clinical research in any way to hold themselves personally accountable by making the pledge at www.nogoingback.health. Nearly 1,200 people have already joined, and word is spreading across the industry.
What does it mean to pledge? Your pledge is a commitment to progress. You are putting your name to an important movement and acknowledging you will continue the momentum for improving clinical research. The pledge carries no financial request of any kind. It doesn’t even ask for an email address. It simply asks for your word that you will focus on advancing the tremendous gains we’ve made in such a short time.
The pledge will mean different things to different people. Whether it is implementing new technology, investing in internal process improvements, reducing site burden, or treating patients like customers, you are pledging to move forward in the best way you know how - and not to lose the inspiring progress we've made in such a short period of time.
COVID-19 forced us to move trial conduct forward quickly and, as an industry, we came together and adapted faster than anyone thought possible. It wasn't just the right thing to do, it was the only thing to do. Now that we have glimpsed the future on the other side, where clinical trials are efficient, fast, reliable, and trusted, we can't afford to let this future fade.
When the catalyst of the pandemic wanes, we risk losing the progress we have made unless we collectively refuse to go back to the way things were before - and instead dedicate ourselves to implementing even more advancements and innovations that we've only dreamed of so far. The Charter Founder of #NoGoingBack is Signant Health and is Chaired by Craig Lipset (Clinical Innovation Partners), Allyson Small (SCRS), Scott Connor (Signant Health), Maimah Karmo (Tigerlily Foundation) and Sung Poblete (Stand Up To Cancer). It is further supported by signatories across the industry including ACRO, ACRP, Advarra, AiCure, BlueCloud, Castor, Circuit Clinical, Clinical Ink, Curebase, Datcubed, DIA, eClinicalSolutions, ERT, Genetic Alliance, Greenphire, GRYT Health, Healthentia, Innovation Spring, Lightship, Lokavant, Lupus Therapeutics, Medable, Medidata, Medrio, Oracle, RareX, Science37, Thread, TrialScope, uMotif, VirTrial (a Signant Health company), and YPrime.
Collectively, we congratulate the inspiring work being done to combat the COVID-19 pandemic. We thank the researchers, healthcare workers, and of course the patients who are stepping up to benefit our families and communities worldwide.
To the technology providers, our message is to keep innovating. Virtual visits have already gone from a nice-to-have benefit to a standard practice. What can we do next? Wearable devices for sleep and activity tracking. Real-time safety monitoring. Virtual site monitoring. True patient engagement. And direct to patient IP delivery. We must strive to integrate technology and processes within the trial ecosystem in a way that helps our sites conduct research in any setting and gives patients real choices for participation. The burning platform of a tragic pandemic cannot go unrealized.
There is so much more we can do to help sponsors and sites get the evidence they need while ensuring patient safety and convenience. Improving data quality and reducing burden are not mutually exclusive goals. These new capabilities – and many still to be dreamed up – are here to drive us forward into a new age of clinical research.
So, let's leave the past where it belongs. And for the patients we pledge to serve, let's agree - there is #NoGoingBack.
Please visit www.nogoingback.health to join the #NoGoingBack movement and share your commitment to preserve the progress we've made in clinical research.
Author Biography
Scott Connor joined Signant Health in 2020 as Chief Marketing Officer, bringing over 30 years of marketing experience in the life sciences and technology sectors. He is responsible for positioning Signant as the leading provider of evidence generation and digital enablement of clinical trial conduct. He graduated summa cum laude from the S.I. Newhouse School of Public Communications at Syracuse University with a B.S. in Advertising and English.