COTA, a real-world data (RWD) and analytics specialist focused on oncology, has released results and insights from a survey of practicing oncologists. A reported 83% of the doctors surveyed believe the use of RWD is critical to driving forward the development of new cancer therapies.
The survey weighed in with 200 oncologists across the US. According to the results, most believe it important to include RWD components in all trials. Further, 71% believe RWD, used as an external control arm, could lead to more efficient, representative trials.
Outsourcing-Pharma recently checked in with CK Wang, COTA’s chief medical officer, for a deeper look at the survey results, and what the findings might reveal about the future of cancer research and drug development.
OSP: Could you please share your perspective on how the use of RWD has increased and evolved in trials in recent years?
CKW: In recent years, there has been increasing use of real-world data (RWD) in the drug development space. The COVID-19 pandemic has increased interest in and brought attention to the potential of RWD to accelerate the speed at which we safely bring drugs to patients.
It typically takes more than 10 years for a cancer drug to go from bench to bedside. We conducted a recent survey and found that 66% of cancer patients and families think the speed of cancer clinical trials remains far too slow.
A rapidly growing use case for RWD that is impacting clinical trials today is the use of RWD-powered external control arms (ECA) to supplement a single-arm trial. The external control arm is composed of data curated from electronic health records (EHR) from the real world and creates a digital cohort of patients.
The potential benefits of an ECA include:
- Shortened drug development time, particularly in niche and rare populations, by reducing time-to-recruit
- Allows all clinical trial participants to receive promising new agents rather than placebos or existing standard of care treatments
- Creates digital cohorts of truly diverse populations without expending additional recruitment resources
OSP: What are some of the ways in which RWD holds even more potential to drive progress in oncology trials?
CKW: This is already happening to some extent today - but in the future RWD will be increasingly used to inform R&D strategy and streamline study design. RWD allows sponsors to generate and test hypotheses outside of a clinical trial and support “go/no-go” decisions - phase movement, trial completion, etc. This makes clinical trials more efficient by providing a better understanding of the likelihood of success and enabling sponsors to proceed with clinical trials for the most promising drugs.
Additionally, we will likely see increasing utilization of clinical RWD to drive commercial value and insight after a new product launch. RWD can help inform and validate commercial product launch strategies, support label expansion studies, and serve as evidence in drug pricing negotiations with payers.
OSP: Why did you decide to conduct this RWD survey with practicing oncologists?
CKW: We conducted this survey to better understand general oncologists’ perspectives on trending issues ranging from RWD to diversity in clinical trials. COTA works and collaborates with many industry thought leaders who have a deep understanding and appreciation of innovations that can help improve cancer patient outcomes. Surveys like this help us – and the cancer community at large – better understand where oncologists see the most potential for innovation, as well as where their perspectives actually differ from broader industry fact or point of view.
OSP: Could you please share some of the key takeaways from the survey?
CKW: While it’s well-documented that clinical trial participants are not representative of the general patient population, COTA’s survey found that 70% of oncologists believe patient populations enrolled in cancer clinical trials are representatively diverse.
Another takeaway is that while 64% of oncologists are satisfied with the pace of typical cancer clinical trials, surprisingly 71% also recognize increasing patient expectations for more expeditious drug development – especially in light of the recent speed of COVID-19 vaccine development, testing, and approval.
While this study found that a majority of oncologists characterized their patients as enthusiastic to participate in clinical trials (58%) and willing to share their health data (92%), a prior consumer study offered a contradictory view and showed that many oncologists may not be discussing clinical trial participation and data-sharing with their patients. According to this prior consumer study, while 86% of respondents believe oncologists should be actively discussing the value of data sharing during routine clinic visits, less than half reported that their oncologist has actually discussed the topic with them.
OSP: Also, were there any surprises in the study?
CKW: I was surprised by the level at which the survey respondents understand and support the use of RWD in drug development. According to the survey, approximately 95% indicated they’re familiar with the use of RWD to support clinical trial research for cancer treatments. Additionally, 83% believe that RWD can help accelerate treatment discovery, and only 9% reported being not convinced. Oncologists also overwhelmingly are urging pharmaceutical companies to include RWD in their trials, with 78% indicating RWD should be part of every clinical trial.
In my 10 years of working with COTA and previously at IBM Watson Health, I have found that providers can be skeptical about the idea of augmenting clinical trials with RWD and are concerned about the imperfections in data collected outside of a clinical trial. I personally spend a considerable amount of time addressing these concerns and educating providers about the benefits of RWD. I was pleased to see that so many oncologists in the survey are thinking about RWD and are generally supportive of its use.
OSP: Please expand upon some of the areas you mentioned in your announcement, starting with the need for more diversity.
CKW: It is critical that clinical trial participants reflect the real-world patient population because the experimental therapies, if approved, will be used in a non-selected patient population. We know that clinical trials tend to attract a relatively homogeneous patient population that is typically white, younger, and more fit than the overall patient population.
Secondly, clinical trials—through their strict inclusion and exclusion criteria—often select out an ideal patient population that has a better disease phenotype. The combination of these factors can result in approved therapies performing less well in the real world than in clinical trials.
OSP: What about the elevation of patient expectations?
CKW: Not surprisingly, the rapid development and approval of COVID-19 vaccines have changed patient expectations on the expediency of therapy development. While there are many learnings that we can apply to reduce the lengthy timeline for drug development, it is unrealistic to think that we can recreate the COVID-19 timeline for all drugs moving forward. The pandemic required certain accelerators that are not typically possible in routine clinical development:
- Global collaboration and investment
- Cross-industry collaboration across government, research, academic, and pharma organizations to share knowledge, data, and technology
- Large cohort of clinical trial participants
- Regulatory focus and priority to fast-track vaccine development
While there are many efficiencies to be gained in the clinical trial process, as highlighted by the COVID-19 pandemic, we can’t lose sight that the clinical trial mechanism was developed to ensure that approved therapies are ultimately safe and effective.
OSP: Please expand upon the engagement opportunities.
CKW: One of the more complex tasks that I performed in my medical oncology practice was enrolling patients in a clinical trial. The process was often lengthy and many times unsuccessful due to many different reasons including patient perception and bias.
Despite these difficulties, the medical community has a moral imperative to work tirelessly and expeditiously to break down barriers to clinical trial participation. This includes both educating and engaging with patients, their support groups, and their extended community.
OSP: How can COTA and other companies working in this sphere help meet the call for faster, better cancer trials?
CKW: We believe that faster, better clinical trials can only result through engagement and cross-industry collaboration. It is vital that companies engage with all stakeholders in the clinical trial continuum including patients, providers, sponsors, and regulatory agencies in conversations pertaining to the challenges surrounding clinical trials while encouraging innovative trial design. Additionally, cross-industry research collaborations play a critical role in advancing the understanding and acceptance of real-world data in the regulatory space.
OSP: Anything to add?
CKW: COTA is trying to close the gap between clinical trials and real-world data. We believe that there are tremendous insights hidden within each patient’s clinical documentation and that these insights can help us reduce treatment variation, improve outcomes, and reduce the cost of care. The company firmly believes that everyone touched by cancer deserves a clear path to the right care.