Real-World Data and Real-World Evidence: Current status in the APAC region
In the third interview of our the Real-World Data series, our analyst Shilna Kunnath connected with Dr. Randeep Singh, Director Medical Oncologist, Narayana Hospitals and Oncomed Clinic, Delhi/NCR to discuss about the current status of Real-world Data usage in India.
... real-world data is helpful in clinical evaluation of rare diseases where conducting regular controlled trials is not feasible.
Considering the rapidly transforming healthcare space, what are your overall views on the usage of Real-World Data (RWD) in healthcare decision making?
Dr. Singh: The usage entirely depends upon the quality of the acquired data. But usually we don’t get good quality of data from the real world. In fact, real-world data is the exact reflection of what happens in the clinic. On the contrary, the data from the clinical trial is accurate data where a controlled situation with a well-defined patient selection criterion is considered. This sort of ideal patients we usually don’t see in the clinical practice.
Somethings cannot happen with the real-world data. For example, if you must compare new modality versus existing standard modality, it cannot happen with real-world data. On the other hand, real-world data is helpful in clinical evaluation of rare diseases where conducting regular controlled trials is not feasible.
We know that with the introduction of 21st Century Cures Act in 2016, USFDA has additional focus on using RWE in regulatory decision making. Coming to India, how is the regulatory landscape evolving in terms of usage of RWD?
Dr. Singh: In India, there is no regulatory landscape for the real-world data. There are no such laws or any other initiative by government or private authority to start accumulating real-world data. There might be some work in progress, but I don’t think so we have reached that stage yet.
In the U.S., a draft guidance on the appropriate use of RWD in regulatory decision-making is expected to be published by 2021. Are there any such measures in pipeline for India as well?
Dr. Singh: In India, there is no regulatory rule no draft guidance or guideline to include the real-world data in decision making or at least to start working on real-world data on a larger scale. On a smaller scale, some institutes may be working on this line.
Dr. Randeep Singh
MD, DM, ECMO, FCCP
Director, Narayana Hospitals and Oncomed clinic, Delhi/NCR
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How are the key stakeholders of the healthcare value chain responding to the use of real-world evidence in decision making?
Dr. Singh: Real-world data gives you the feel of real situations. It is the reflection of the actual practice and is simple to accumulate as compared to clinical trial data. For example, if there is a clinical trial that has already proven a drug to be of value in the western population, and you want to use it in Indian population, real-world data can be used to compare with the data from landmark trials.
Also being an oncologist, I see much value of real-world data. In molecular oncology, real-word data will be useful in gaining insights about patient sub-groups with a specific genetic aberration.
What are the common sources of RWD? Are there any specific indications or areas in which RWD is utilized more in India?
Dr. Singh: Insurance databases, hospital-based and population-based registries are good sources. Also, we have EMR data, where cloud-based software’s are used to merge data from multiple users.
What are the key barriers to increased use of RWD?
Dr. Singh: As already discussed, the first barrier is the quality of the data. The second barrier is the limited utility of the real-world data in specific situations, such as while comparing a new modality with existing standard modality.
Privacy is not an issue as we do not disclose a patient’s identity while analyzing it. At present, accessibility is an issue in India. There are issues related to data generation and willingness of the involved party in sharing the generated data. It remains to be seen, if in coming days, data generated across the multiple institutes will be made available.
Looking forward, what is the outlook for the usage of Real-World Data (RWD) in the future?
Dr. Singh: I feel that, at least in Oncology, real-world data will make sense and if you collect the data properly with all the parameters, it can at least cover 50 – 60% of the situations where you need clinical trials.
It was an insightful discussion. Thank you for your time!