It would be hard to argue that the COVID-19 pandemic has not thrown the clinical trial industry for a loop. Despite the challenges, sites, sponsors and other professionals have managed to come up with numerous new ideas to adapt to the new world they are operating in, so that their vital work can continue.
In order to keep this progress and innovation moving forward, a number of industry professionals have banded together to create #NoGoingBack, an initiative that seeks to unite research experts—even people that might ordinarily be considered competitors—to continue the forward momentum.
Outsourcing-Pharma (OSP) spoke with Scott Connor (SC), chief marketing officer of Signant Health, about the mission of the #NoGoingBack initiative, leaders that have already signed on, what it’s accomplished, and what lies ahead.
OSP: What is the main aim of the #NoGoingBack movement?
SC: COVID-19 created a widespread and urgent need for contingency planning in clinical trial operations, with study teams working hard to define study-specific strategies to maintain trial continuity and patient engagement. Through this, we have seen rapid transformation that has led to efficient, fast, reliable, and trusted ways to conduct clinical trials.
However, we know that tipping points can swing back the other way, particularly in more conservative industries like life sciences. The idea behind #NoGoingBack is to celebrate our achievement at moving forward, while also challenging and inspiring all clinical trial stakeholders to not retreat to the past. We cannot let progress and momentum fade, even when the pandemic wanes.
The #NoGoingBack movement will mean different things to different people, from implementing technology to investing in internal process improvements to reducing site burden and treating patients like customers. Those who pledge are promising to continue the progress we’ve made without losing the inspiring synergy that has taken place over such a short period of time to move trial conduct forward quickly and efficiently.
OSP: Could you please share some of the ways trial professionals have been able to keep their important work going—changes they’ve made, technology tools they’ve relied upon, etc.?
SC: When the pandemic hit, trial sites and sponsors needed to adhere to guidelines around social distancing to keep patients safe. Trial professionals needed to evaluate core risk mitigation strategies and implement them to replace face-to-face clinic visits with remote visits, where telemedicine and other technologies enabled a participant to complete study activities from their home.
By leveraging technology platforms, deep therapeutic and scientific knowledge, and operational expertise we’ve been able to implement thoughtful and scalable solutions that have kept clinical trial research going.
In our case specifically at Signant Health, we are doubling down on technology and services to help sites and sponsors with direct evidence generation and data stewardship regardless of whether the trial is traditional, virtual, or hybrid. We believe that modern technology platforms infused in the research enterprise are critical to ensure trial continuity and high-quality data regardless of a pandemic or other context that catches the industry flatfooted.
Even tech enabled services are important to continuous trial conduct and quality. For example, in depression studies, our scientific experts consult with instrument owners to determine appropriate and optimal ways to deliver ratings remotely to ensure the integrity and validity of clinical assessments. These combinations of technology and expert humans are incredibly important in the new world of clinical research.
OSP: Who are the current leaders/participants in the movement? How did these folks come together?
SC:The charter founder of this movement is Signant Health. We developed the core awareness materials and recruited leading signatories including SCRS, Oracle, VirTrial, Lupus Therapeutics, ACRP, Stand Up to Cancer, Advarra, and many more; a comprehensive list to-date can be found at www.nogoingback.health. It’s what we call an “above brand” movement where our goal is to unite under the same cause to inspire all clinical trial stakeholders to keep moving forward even if the natural instinct is to roll back to previous methodologies.
OSP: Why is it important for professionals (including potential competitors) to collaborate on the continued success of the trial industry?
SC: The impact of COVID-19 on clinical trial research has been a profound accelerator of new approaches and solutions. It’s critical to put the health of people above everything else now more than ever, and the reality is, collaborative competition and productive tension is good for our industry. It keeps everyone sharp and improving.
Also, the pledge we ask people to make on the NGB website is an explicit and very public promise to keep moving trials forward. This collaboration shines a light on everything and everyone, in a very tactful and inspiring way.
OSP: What activities and programs have been put forth already?
SC: The movement just recently launched but has already made an impact, with pledges from many clinical research and pharmaceutical companies in just the past month. Our hope is that the campaign continues to generate momentum and engagement from professionals across the clinical research landscape, and that it continuously evolves to meet the most pressing issues facing our industry. It is unclear if it will ultimately manifest itself in other ways, but there are no hard and fast plans other than to keep the inspirational torch lit.
OSP: How do folks take part in the initiative?
SC: Industry professionals can participate in the #NoGoingBack initiative by making the pledge at www.nogoingback.health. Then we ask all pledgers to share the initiative with friends and colleagues, and we provide tools to do so on the website.
OSP: Is there anything you’d like to add?
SC: Just my personal thanks to all of our current pledgers, our growing list of signatories, and my fellow chairpersons for their unwavering support and tireless energy in getting NGB launched: Craig Lipset [Clinical Innovation Partners], Allyson Small [SCRS], Maimah Karmo [Tigerlily Foundation], and Sung Poblete [Stand Up to Cancer].