The Future Of TransCelerate: Clinical Trial Modernization
By Ed Miseta, Chief Editor, Clinical Leader
In January 2023, Janice Chang will take over as the head of industry consortia non-profit organization TransCelerate BioPharma. Chang has been involved with TransCelerate since it was just a concept, and, like others in the industry, she was initially a skeptic. She notes the time spent in the group since its launch has been an amazing journey.
“I am a purpose driven person,” says Chang. “I always wanted my professional life to align with my personal mission. I wanted my career to serve a broader purpose, and when I learned about TransCelerate, I felt it was a way to have a career where I could help improve the lives of patients.”
“We have implemented hundreds of solutions and have no plans to drastically change course,” states Chang. “This has been an incredible journey. When I think about the next horizon, we have some real opportunities ahead. We will continue to build upon our success with the foundational building blocks we have been working on.”
TransCelerate started with five original projects. One of them was risk-based monitoring (RBM). RBM was not a novel idea at the time but bringing 10 organizations together back then to perform tasks consistently and in a harmonious way certainly was.
“That was the first real test for us as an organization,” says Chang. “We had to convince these companies to put aside their individual priorities and focus on what is right for patients and the entire ecosystem. We have clearly proven that we can do that.”
One of the hot trends today is decentralized clinical trials (DCTs). Although DCTs are also not a new idea, the challenge is getting companies to align on them from a people and processes standpoint and thinking about them from a true patient and sites perspective. There is also an opportunity to engage with health authorities with one united voice via TransCelerate. “There are a lot of opportunities ahead of us,” notes Chang.
The Next 10 Years
TransCelerate’s board members recently convened in Philadelphia for the organization’s annual meeting. The primary focus of that meeting was on what the next 10 years should look like. Many questions were raised. Should the group continue to push the development envelope? Did COVID allow the industry to learn what does and does not work? How can TransCelerate best align the 20 current member companies? How can companies put patients at the forefront of drug development? TransCelerate is actively defining a new road map for the next 10 years.
“People have asked how we will continue to grow the organization,” states Chang. “I define growth in a few different dimensions. Membership is definitely one, and we have doubled that number since inception. But more importantly, I envision growth in terms of value creation and the impact we have on the drug development ecosystem. We have always said we wanted to be an organization that doesn't just talk the talk. We want to walk the walk. And, over the years, we have also redefined what it means to walk the walk.”
TransCelerate did not want to be an organization that brought together brilliant minds to simply talk about what the future could be. The goal from the beginning was to be an organization that created tools and templates that could break down operational barriers. That goal is still in effect today. Individuals from the member companies are accountable for the organization’s solutions, but they also commit to ensuring the solutions are being used broadly.
“That is very important,” says Chang. “One of our jobs is ensuring the stakeholder groups are embracing innovative solutions. That has always been a focus for us. These solutions are not just for TransCelerate’s member companies. They are for the smaller biotech firms as well. We have worked to get our messaging out there via webinars and conferences, so everyone has access to the solutions. We also engage with site organizations, patient advocacy groups, and health authorities, because much of what we create is intended to reduce site burden, create a better patient experience, and streamline sponsor efficiencies. We encourage every part of the ecosystem to embrace these solutions.”
A Focus On Modernization
Some of the original projects started by TransCelerate have already completed their mission. Today the organization has 32 active projects with additional projects in the pipeline waiting to be launched in coming years.
Moving forward, TransCelerate will continue to pursue those projects important to all companies involved in drug development. Although Chang notes she doesn’t like to pick favorites, a primary focus will certainly be on how to best modernize the conduct of clinical trials.
“We have an initiative called Modernizing Clinical Trial Conduct (MCTC), which focuses on foundational processes that member companies can agree on,” says Chang. “We need to think about how we can transform trial processes. That thinking must involve the design of trials, technology innovation, and patient and site engagement. Those are high-priority projects for us. One of our more exciting projects has been years in the making and builds upon foundational blocks that we have been working on since year one. Our Digital Data Flow initiative involves an end-to-end digital data flow and how to best digitalize the entire clinical protocol from design through execution.”
Chang notes that one of these foundational blocks was through the Clinical Content & Reuse initiative which involved defining clinical data standards through a collaboration with CDISC (Clinical Data Interchange Standards Consortium) and FDA to establish a common protocol template. The common protocol template, already being used by several member companies, helped with the development of clinical data standards.
Today’s Digital Data Flow initiative will also collaborate with CDISC to align with CDISC’s Unified Study Definition Model standard. The move to a digital data flow will transform how member companies use a reference model to work with upstream and downstream technology solutions in a vendor agnostic manner. The current team working on digital data flow has IT and business leaders from a dozen member companies.
“Those folks are not looking through a vendor specific lens,” says Chang. “They are thinking about how we can, in a vendor agnostic way, define a reference model that will enable an end-to-end digital protocol design and execution within companies. We have started discussing how we can build upon the foundational building blocks we have already put in place. We are starting to explore opportunities such as how we can all align on a future vision. I am excited about those conversations.”
Looking ahead to 2023 and beyond, Chang is enthusiastic about the changes coming to clinical trials. She notes TransCelerate is in a position to bring needed change. Those changes will not be for just the 20 member companies, but for the every part of the trial ecosystem.
“There is an incredible opportunity ahead,” she adds. “We have an opportunity to work with regulators to create even more value for patients. We have an obligation to do things differently and keep pushing the envelope. The members of TransCelerate will welcome and embrace that opportunity.”