"Between too much information and evolving regulations, data deluge is an ongoing challenge. This is why we apply the five Vs of data: variety, volume, value, velocity, and veracity."
EPM held a Q&A session with Vincent Rolland, associate director, expert lead data management programmer, biometry, Idorsia Pharmaceuticals, and Richard Young, vice president, Vault CDMS Strategy, Veeva, to discuss how investing in digital data management can benefit biopharma, from clinical trials through to market.
Q. What are the major considerations for biopharma companies wanting to invest in digital data management?
Young: Because digital data management is a very broad term, we break it out into two key areas – digital and decentralised. Digital is centered on how trial data is collected and shared, while decentralised is where trials and procedures are conducted. Addressing both, customers can conduct digital trials faster, through a connected trial experience for sponsors, sites, and patients with seamless data flow. For biopharma companies, it is also important to integrate a digital data management strategy with ongoing trial design and execution ideas, such as adaptive and hybrid trials.
Q: Is there a risk of biopharma companies being inundated with too much information due to the rise of clinical data sources?
Young: Yes. Between too much information and evolving regulations, data deluge is an ongoing challenge. This is why we apply the five Vs of data: variety, volume, value, velocity, and veracity. By leveraging these constructs, we can quickly sort through, prioritise, and address data challenges facing researchers.
Q: Has COVID-19 increased the use of cloud technology by biopharma organisations?
Young: We saw an immediate, necessary pivot to decentralised trials during the pandemic. Sponsors and CROs lost direct physical contact with sites, and in most cases, lost in-person contact with patients. Study teams had to move quickly and make strategic decisions on how to keep trials going. Today, we see the shift to decentralised, digital processes, with the flexibility of cloud-based solutions continuing under more centralised governance requirements.
According to a recent survey only 28% of sponsors and CROs ran decentralised clinical trials (DCTs) before COVID. 87% of respondents currently use DCTs, or plan to within the next 12 months, while 95% plan to increase use of DCTs within the next 24 months.
Q4: How can digital data management assist biopharma organisations with their clinical trials?
Young: Data managers are more important today than ever as they are influencing trial design to optimise the setup and execution of each study.
Modern trial design is about connecting every contributor and consumer of data in real-time to facilitate oversight and confident decision making. In its purest sense, digital data management enables accelerated mechanisms for data flow. This speaks directly to patient safety, but also optimises study design. With the right digital data management solution, sponsors can succeed quickly or fail early, helping to keep trials on track.
Idorsia is an example of a company whose team was looking for ways to accelerate study builds and trial execution, even before the pandemic. Streamlining how they manage a complex set of clinical data sources is critical.
Q5: In your opinion, what is the impact of cloud-based technology for data management during trials?
Rolland: We are growing quickly and have a rich portfolio of novel drugs in our pipeline. To keep up with these opportunities, we are bringing in modern clinical data management systems to ensure a smooth shift from an outsourced to an in-house model. Having a flexible cloud technology that allows our team to build and maintain studies across a wide range of products will help to ease this transition.
In the future, we will have the capabilities to build studies independently, make mid-study amendments without data migration, and accelerate data cleaning and review. Operationally, we need a broad understanding of what is and is not possible, and how we will execute on data.
Input from the data management team drives how our study teams approach trials during the R&D phase. Their input helps optimise study design, determine protocols, and improve execution.
Q6: Once a trial drug/therapy is approved, how can digital data management then help biopharma bring that product to market?
Rolland: Digital trials allow us to bring a broader, more robust data set to our submissions. This data also significantly supports reimbursement discussions. In addition, as we enter long-term, late-phase and post-marketing commitments, I believe patients will embrace research in new and unique ways. Theoretically, patients can stay involved throughout and beyond the research cycle. These factors can influence the process of bringing a product to market.
Q7: What advice can you give biopharma companies for implementing the right digital data management solution?
Rolland: First, don't let the past inhibit your future. Technology is moving too quickly for that, and with the growing complexity of trial design and rise of clinical data sources, legacy systems from the past shouldn’t hold you back. A new approach with the speed, accuracy and efficiency of a modern clinical data management system is critical.
Engage your colleagues in discussions about the vision for a future state. Then reconcile that information with your own corporate scientific and operational goals. Transparent discussions can yield excellent results and help determine where you put your focus.
Once you have your draft strategy in mind, discuss with your key target platform partners. Determine how you can bring your vision to life, working together. When it comes to technology, a metadata repository and computing platform should also be an integral part of the data management solution.
Execute, making sure that you can capture patient data seamlessly and remotely from smart devices. Take special care to ensure that all content from initial intake documents, like sleeping patterns and quality of life insights, can be used via integrated data sources. The ultimate goal is to capture, mine, and reconcile all data.
Q8: How will having a modern clinical data foundation help shape the future strategy of clinical trials?
Rolland: Better study design leads to higher quality data, and that leads to improved results. Every delay, and missed opportunity has an impact on the scientific value of the trials and can hurt patients. We have to shape the future clinical trials. Connected teams that operate in real-time with accurate data hold the key.