By Liz Roberts, Jules Desmond, and Aaron Mann
Historical data from the control arms of clinical trials hold tremendous value for researchers. Clues can be extracted from the data that aid researchers in discovery, analysis, and the design and execution of future trials, influencing the success and speed of research. Yet, too often, that data is underutilized once a trial is closed—often trapped inside corporate walls with limited reuse, even internally.
While the biopharmaceutical industry has made significant strides in the sharing and use of external trial data to help bring medications to patients faster, many organizations can find it difficult to make sharing and using this data routine. Sharing data externally and using shared data within an organization often require new operating practices, resources, and behaviors.
The global COVID-19 pandemic helped to catalyze change. In parallel with a global collaborative effort to enable the rapid rollout of multiple COVID-19 vaccines and therapeutics from discovery to distribution, the industry also spearheaded new data sharing efforts with renewed vigor.
How do we build on this momentum to continue and accelerate the use of historical trial data to transform R&D in the future? We use the following three-pronged approach.
1. Reinforce The Value Of Data Sharing
One of the biggest pain points for clinical trials is getting enough people to enroll and stay enrolled. A lack of awareness, understanding, and access to clinical trials persists in the general public. The added uncertainty of being randomized to the control or the investigational arm is often perceived as a barrier to enrollment. Once enrolled, an individual’s participation in a trial can become burdensome or difficult to fit into their lifestyle. Finding ways to supplement new control arms with data from historical controls can help to reduce the number of participants needed in future trials, speed trial design and execution, better understand diseases, and improve overall patient experience. This helps advance research more efficiently.
TransCelerate Biopharma’s Historical Trial Data (HTD) Sharing Initiative was established to benefit patients and sponsors alike by maximizing the value of clinical data collected in the control arms of clinical trials by enabling the sharing of patient-level data from completed studies between biopharma companies– while also safeguarding patient privacy. Today, participating Member Companies share data through DataCelerate, a secure and fully validated platform developed to support a variety of data sharing initiatives.
Biostatisticians and researchers can gain access to high-quality historical data from the platform. Its voluntary adoption among TransCelerate Member Companies has steadily grown and the database becomes more valuable each time members upload new data.
As the pandemic took hold last year, the value of such data sharing specifically for COVID-19 became abundantly clear. A new COVID-19-specific module was created on DataCelerate allowing both members and, for the first time, eligible non-member biopharmaceutical companies and government research agencies to participate – provided they are engaging in COVID-19 research and meet defined participation criteria. Additionally, the scope of data sharing was expanded to include both investigational product and control arms from trials relevant to COVID-19. In all instances, the data are pseudonymized or anonymized prior to sharing to protect patient privacy.
These developments are exciting and demonstrate that companies are further embracing a collaborative spirit of sharing. In a matter of weeks, we were able to facilitate a shift from concept to executed data sharing agreements. This COVID-19 module has also started to see this data populate. And progress is continuing, as the HTD Initiative strengthens collaboration with regulators on using historical trial data in regulatory submissions. The team also continues to engage the research community to establish best practices to encourage more widespread use.
However, while the need for historical data sharing and utilization is gaining traction, internal roadblocks may still hinder progress. Understanding the value external trial data can bring to an organization is a key to both taking full advantage of an important data source and to reducing internal data sharing process and resource hurdles.
2. Improve Data Utility
Translating data sharing from a conceptual idea that a company supports to its practical execution can be challenging. There needs to be buy-in for additional resources, and there must be an awareness of the short-term versus long-term value of the control arm data that are collected during clinical research. It’s important to understand that the value of the database grows exponentially over time as more data is shared to the database.
Another key focal point is protecting participant privacy while still providing high-quality, functional data sets. Privacy protections and data quality standards exist to ensure both. Both the HTD and COVID-19 data sharing initiatives have physical, digital, and legal safeguards implemented to protect data sharing, including execution of key legal agreements relating to data sharing and data processing as well as sharing via a secure platform. Therefore, historical control data can be protected, while still enabling users to benefit from high levels of data utility.
The structure, governance, and requirements of quality data are all key to maximizing its utility and are ongoing priorities for TransCelerate’s HTD Initiative.
3. Take The Long View
Equally important is a mindset shift for sponsors to become comfortable sharing their data throughout the ecosystem. Of course, change doesn’t happen overnight, and companies must take a long-term view about the value of data sharing efforts and their role in the data sharing ecosystem. It will take time to ingrain new organizational behaviors and change mindsets to make sharing and utilizing historical trial data the norm. And as companies populate databases, such as DataCelerate, with more clinical trial data across different disease states, the value to users will continue to grow.
The COVID-19 pandemic may be the fuel that was needed to ignite stronger action around data sharing, as companies aren’t just talking about working together to solve global problems—they’re also making more tangible contributions. As data sharing picks up more steam, companies will be able to incorporate data sharing activities across other disease areas, bringing innovative medicines to patients faster.
But thinking about the exciting advancements that lie ahead, speed isn’t the only focus.
We also have a responsibility and obligation to respect patients’ time and contributions by maximizing the use of data collected during a clinical trial and, if possible, by reducing the number of patients needed to participate in the control arms of clinical trials. By maximizing the use of data collected from patients, we can move everyone closer to solutions that treat debilitating and life-threatening diseases, while reducing the future demands required of patients in research.
Ultimately, the hope is for it to become routine behavior that companies opt to share historical trial data and that data are then used to help design, execute, and analyze new clinical studies. The more we can ease and encourage the secure upload of clinical trial information, the more powerful the tool will become, and the greater the benefits to patients.
About The Authors:
Liz Roberts is data policy and privacy lead at UCB. She has almost 30 years' experience within pharmaceutical R&D. Her responsibilities include blending data enablement (maximizing the potential of available data sources) with data privacy (performing the role of fDPO), providing external thought-leadership to increase the value these activities can bring to people living with severe diseases, the legal framework supporting data sharing activities, and the co-creation of forward-looking, ethical policies and deliverables.
Jules Desmond is the strategic development organization head, Global Clinical Development at Amgen and the workstream lead for TransCelerate’s Historical Trial Data Sharing Initiative.
Aaron Mann is the global lead for product development industry collaborations data sharing initiatives for Roche and Genentech. He also serves as the member organization lead for TransCelerate’s data-sharing platform, DataCelerate. His work focuses on delivering innovative data solutions that make a transformative impact on drug development, with a particular interest in cross-industry information collaboration, data governance, and data privacy.