Viraj Narayanan, vice president of life sciences with COTA Inc. discussed with Outsourcing-Pharma how the company’s use of real-world data and other complex, advanced analytical tools help its team of researchers in their patient-centric approach to drug discovery.
OSP: Could you please share the ‘elevator presentation’ description of COTA—who you are, what you do, key capabilities/services and what sets you apart.
VN: Founded by oncologists, COTA is committed to creating a precise, patient-first approach to cancer care through the use of real-world data (RWD). We leverage technology-supported human data abstraction methods to make sense of complex, fragmented patient data from the real world.
Offering the highest quality oncology real-world data from leading academic and community-based cancer centers and an advanced analytics platform, we partner with leading life sciences companies, providers, and payers to ensure that everyone touched by cancer has a clear path to the right care.
OSP: Please share about the evolution of RWD’s use and adoption in drug discovery and research.
VN: When it comes to cultural appetite, there’s certainly an adoption curve and some organizations are more innovative than others. We see a lot of disparity in organizations that are ready to adopt real-world evidence (RWE) in the clinical development setting.
The main challenge they face is around positioning RWE as a different way of meeting a goal to help augment and accelerate insights, rather than as a threat or risk to the status quo. On top of that, there’s the associated challenge of developing the set of capabilities needed for RWE—a data science capability, an epidemiology capability, and a medical capability, for example.
Most recently, because of COVID-19, we’ve experienced increased interest in RWD from sponsors. As in-person visits for clinical trials have slowed, we could speed things up with RWD—it’s digital and doesn’t require someone going to an office or a trial site.
How do you use that digital patient experience to ensure that you've got the right patient population, study design, and external comparator? It could be a pivotal moment for sponsors to leverage RWE to speed up development timelines when the system returns to normal
OSP: What are some key aspects of RWD that you feel pharma firms and their research partners might not understand?
VN: The key issues sponsors should keep in mind when introducing RWD to their work include addressing challenges with the data itself and the process of establishing an overarching strategy for using RWD and RWE.
Within the data component, we see challenges with sample size (“we don’t have enough data to match the control arm”), data harmonization (“how do we know that we’re measuring endpoints in the same way across data sets?”), and assessing data fitness for purpose (“is this the right fit-for-purpose data we need to answer our question?”).
In clinical development, companies like COTA are uniquely equipped to provide fit-for-purpose data because of their deep clinical data—claims data is less useful in such instances where a specialized clinical outcome is required for the purpose.
From a strategy perspective, there are important questions to answer: When do you use RWE, and at what phase of development? Do you have advocacy at the right levels of the organization? There has to be an overarching strategy and someone responsible for it.
Our most successful partnerships with life sciences companies are open and collaborative. We typically have senior sponsorship at a very high level in the organization, and we learn together and transparently. These challenges are difficult to solve, and neither of us will be able to solve them alone, so we must share back and forth. That's the model we try to build towards in our biopharma partnerships.
OSP: In your introduction, you mention that many industry professionals tend to consider using RWD only when things go wrong. Can you please share some thoughts on the “911” conversations with pharma companies and researchers who’ve hit a tight spot and then call with RWD questions?
VN: In some instances, an oncology trial might be designed with a traditional randomized control arm, which is based on the standard of care. During the course of enrollment of that control arm, the standard of care may have changed due to new approvals for patients.
In such a situation, if the sponsor already has a RWD strategy in place, then it can easily leverage such data to explore the new standard of care. However, many sponsors are not there yet – and, in such instances, we are brought into a conversation with a significant amount of urgency to get contracting, scoping, and delivery all done in an exceptionally short period of time.
We are grateful to have the opportunity to positively impact patients in such circumstances, but we also know there is a more proactive way to anticipate RWD needs.
OSP: What are some of the mistakes and misconceptions sites and sponsors have regarding RWD?
VN: Clinical trials will not be replaced by RWE. In the next 3-5 years, augmentation or supplementing clinical trials will be the primary use of RWE in a regulatory setting. Over time, I believe the use of RWE will become the norm for all trial submissions because having some element of the real world experience for patients when considering a new investigational therapy helps the FDA make the best regulatory decision for patients.
OSP: How can life-sciences companies accurately calculate the ROI on their RWD investments?
VN: One of the reasons we are bullish on the impact we can have on patients with RWD in clinical development is the clear ROI it provides. Within clinical development, our value proposition is simple - it is speed. We are in the business of helping sponsors speed up clinical development and get patients access to life saving cancer therapies earlier.
OSP: If companies seem tentative about adopting an RWD strategy, what are some things you might say to them to help quell their fears?
VN: We have the privilege of working across sponsors in the use case of RWE to support clinical trials. Organizations that are leading in the adoption RWE seem to have strong visionary leadership, good buy-in across cross functional stakeholders, and an integrated team that can interface between the clinical trial stakeholders and COTA, translating medical requirements into data requirements.
A major hurdle that exists today is education or lack thereof. Key questions that need to be addressed by sponsors include:
- What is the best way to determine if a clinical trial is a good candidate for an external comparator?
- How would we engage with the FDA if we were to consider this path?
- What is the timeline we should anticipate when working with an RWD company to curate the data?
Anecdotally, we find that many sponsors understand, conceptually, the importance of anticipating their RWD needs but struggle to execute on translating this into a RWD strategy. As an example, for a breast franchise or breast cancer pipeline drug they fail to plan for a breast cancer data acquisition based on use case, pre- vs. post-market, etc.
For the use case we are focused on, the type of curation required to match a clinical trial team is intensive and you cannot just “turn on” the data. Companies with strong visionary leadership are able to build an anticipation mindset and avoid thinking about regulatory RWD in a purely reactionary way.
OSP: Could you please share an overview on COTA’s three-year oncology partnership with the FDA?
VN: COTA’s real-world data is being utilized by leading regulatory bodies and organizations on the forefront of cancer care and innovation. COTA has a strategic partnership with the FDA, for example. The focus is on the impact of COVID-19 on cancer patients in clinical trials and other oncology research.
The pandemic inspired an all-hands-on-deck mentality, sparking cross-sector collaboration and real-world data sharing in the interest of speeding our understanding of the virus. The seminal example of this is the COVID-19 Evidence Accelerator, an initiative launched in June 2020 by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research, which created a forum for data holders and researchers to pool data and share insights to speed understanding of COVID-19 treatment and response.
OSP: Is there anything else you’d like to tell us about we didn’t touch upon above?
VN: Another critical issue that real-world data is beginning to help solve is the lack of diversity in clinical trials. I recently wrote about this very topic with global HEOR leader from AbbVie, Chris Boone - Achieving Diversity And Building Trust In Clinical Trials.
At COTA, we use real-world data to explore differences in tumor biology, treatment patterns, and outcomes to further characterize disparities in underrepresented and underserved populations. Leveraging RWD to gain insight into cancer health disparities affecting underserved populations is key to ensuring equitable access, care, and outcomes for all patients.
