Since TransCelerate launched in 2012, the nonprofit consortium has partnered with a star-studded cast of biopharma companies to collaborate and develop solutions that overcome R&D pain points and speed up drug development. So far, its efforts have delivered over 400 new tools — most of which are free and publicly available — targeting clinical trial efficiency on multiple fronts such as improving patient experience, harmonizing processes and enhancing drug safety.
The number of users for its solutions is now growing. In September, the CRO Cognizant announced that its Shared Investigator Program, which the company developed alongside TransCelerate to standardize trial-related documents so they can be more easily exchanged between researchers globally, surpassed the quarter-million-user mark.
And when TransCelerate announced last year that it was teaming up with Microsoft, Accenture and the Clinical Data Interchange Standards Consortium (CDISC) to develop a digital data flow solution, TransCelerate CEO Dalvir Gills said the initiative had the potential to “be more transformative for the R&D ecosystem than anything TransCelerate has embarked on before.”
Called the Digital Data Flow (DDF) initiative, the vendor-agnostic program will create a repository for standards-based study definitions, and facilitate better and faster end-to-end data sharing across clinical trials.
To find out how the initiative has progressed one year after its launch, PharmaVoice caught up with Rob DiCicco, vice president of portfolio management at TransCelerate, who discussed its milestones and potential impact on the industry.
This interview has been edited for style and brevity.
PHARMAVOICE: Why is interoperability such an issue in clinical trials?
ROB DICICCO: Conducting a clinical trial is a multi-stakeholder enterprise. Every trial involves various life science companies, clinical labs, academic institutions, health authorities and a variety of third-party service providers. All of them have their own platform systems to ingest, process, analyze and archive data. Even within a single sponsor company, multiple-platform systems used to design, plan, execute and report on every trial are populated with study-level data.
Data is required for decision-making, executing business-critical processes and maintaining regulatory compliance. However, all the platform systems are designed for different functions by different technology companies. They each have distinct sets of data standards and data models. Consequently, systems are rarely able to share data automatically without bespoke integrations being built.
The problem with constructing bespoke integrations is that it costs money and, worse, time. It might take three or four months to build one integration and validate that it works the way it's supposed to work. So, right now, very often, the same data or subsets of data are manually curated from a single source to multiple systems and applications. This manual activity is time-consuming and opens the door to delays and errors.
Additionally, we are experiencing unprecedented growth in technologies that collect clinical data directly from patients. Yet this data is rarely available in real time. Because of the lack of true standards and, ultimately, the lack of interoperability, we cannot plug and play with technologies. So, we're not harnessing the full power of innovation from the digitization of healthcare.
What makes the DDF initiative partnership with Microsoft, Accenture and CDISC unique?
First, TransCelerate and CDISC are primarily resourced via volunteers from their respective memberships. Neither is a tech company. Instead, our expertise resides in supporting industry collaboration to innovate across the lifecycle of drug development inclusive of preclinical, clinical and pharmacovigilance. From these programs TransCelerate’s ambition is to see the broader ecosystem recognize meaningful efficiencies and improve the way new medicines are developed and evaluated.
TransCelerate is trying to deliver something that has long been coveted but not yet achieved. The ask is to develop a solution that will help life sciences companies get better value and efficiency from the platforms and applications they have invested in — not to build a solution that replaces them. So, given these dynamics, we recognized that producing the core components of this solution would require the complementary know-how of both Microsoft and Accenture. For their part, Microsoft and Accenture have leaned into an area that has been very difficult to tackle.
The second unique aspect for TransCelerate and CDISC is collaborating with Accenture as the lead vendor on a project using agile methodology. That methodology is forcing the discipline required for successful software development, but it may also pay dividends in other parts of our business. It’s well-suited to an environment of scarce resources, tight timelines and a business imperative to be more efficient.
How will an open-source, vendor-agnostic solution address some of these issues?
Developing a vendor-agnostic solution has been a prerequisite from day one. Changing core platform systems is a heavy lift for a life sciences company. Even when the ROI is positive on such a decision, the change management processes are often difficult enough to derail implementation. Our goal is to help the industry spend more time getting insights out of data rather than expend effort moving data around.
Likewise, we hope that being vendor-agnostic creates a greater incentive for vendors to participate, contribute ideas and provide feedback that benefits life science companies. So far, that has proven to be the case. Major electronic data capture (EDC) solution providers like MediData, Merative (formerly IBM Watson Health), Oracle, Castor EDC and Red Cap Cloud are collaborating with us. All these companies are experts in the areas of EDC and clinical trial execution.
Another area of innovation involves the “e-clinical” arena of study builders and protocol design and authoring tools. We have been working with InteliNotion, Nurocor, and Trials AI to inform both the minimum viable product (MVP) released in May and the next major release planned for early 2023.
Standards and other solutions are only good if they work. So, by bringing vendors to the table around open-source, vendor-agnostic solutions, we hope to ensure that they deliver on the desired use cases and are favorable for adoption.
Can you describe where the DDF partnership is in the process, which milestones it’s achieved and how it’s being leveraged?
Delivering a model where people can innovate in a safe space is a huge deal. Just building a safe space for collaboration creates a world of opportunity. That said, we've only begun to scratch the surface in terms of delivering benefits and accomplishments.
TransCelerate made the Study Definition Repository Reference Implementation (SDR RI) MVP available on GitHub in May. The SDR RI incorporates an industry standard data model, which enables the format of information from a digitized protocol and other sources to be standardized and stored centrally. This allows the information to be passed to systems through APIs used for study execution and data collection and reused throughout the clinical development lifecycle.
"Despite the success of digital transformation in other industries, we haven’t yet arrived at the same level with clinical trials."
Rob DiCicco
Vice president of portfolio management, TransCelerate
Since then, some of our collaborating vendors have already demonstrated the ability to push information into the Study Definitions Repository from their study builder platforms. EDC companies have been able to ingest that data and automate study setup in their platforms — thereby proving the concept. Feedback from both the vendor community and our member companies will be used to design the next major release scheduled for early next year.
So, we stand today with an MVP, which is enough to explore and automate a limited setup of EDC at a study level. Where we aspire to reach with the next release is something that's production-ready for automated EDC build. Meaning you can use it for a live, forward-looking clinical trial. You can document your critical study information in one platform one time, and have it seamlessly automate the EDC setup at a trial level — or even multiple trials simultaneously — without having to curate that information.
Will this solution help to break down the bottlenecks and drive more interoperability (and perhaps even openness) across the industry in the clinical trial process, and if so, how?
Despite the success of digital transformation in other industries, we haven’t yet arrived at the same level with clinical trials. Documenting critical features of study design, protocol authoring, study planning and execution remains highly manual. So, yes, we are confident that automation supported by the interoperability we will create will reduce cycle time, especially in the setup and reporting phases.
Adopting data standards, developing a common data model and applying standard APIs will be foundational. These elements are essential not only for the current use cases under development but perhaps for applications we haven’t even thought about.
What are the longer-term objectives of the DDF partnership?
Longer-term, we hope to create opportunities for innovation driven by actionable insights.
We generate clinical and operational data daily in clinical trials, but its use is limited by a lack of interoperability and adherence to standards. As new means of data acquisition and sharing become a reality, we hope this solution will permit all key stakeholders — including sponsors, sites and health authorities — to plug and play new best-in-breed technologies as they emerge.
We hope to help industry stakeholders run the kind of analytics applications they want to run. If Waze can help people analyze the best route for their journey and even change course midway, why not the same for clinical trials? We can’t do that today without either building a bespoke system that only works for one company with certain types of trials or using manual interventions.
I think you'll see the ability to layer analytics over the design process in a way that may improve the quality of study designs, the ability to recruit trials, and the ability to complete them successfully. I think trials can be designed smarter and react in real time. Those are high-value wins.
We also aim to reduce the technology burden on sites and patients. As clinical trials and health care become more democratized and patients rightfully have more control over their data, we must be able to answer important research questions far more efficiently and with the urgency that patients need.
