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Precision medicine may mean smaller clinical trials. Collecting real-world data can help supply some of the same information as a control group.
Real-world clinical data is becoming increasingly important in clinical research trials, particularly in oncology. To that end, Kite Pharma, a Gilead Sciences company, is the latest pharmaceutical manufacturer to partner with COTA, an oncology real-world data and analytics company.
The Miami Cancer Institute, Novartis, BristolMyersSquibb, Hackensack Meridian Health, Regional Cancer Care Associates, and other manufacturers and cancer centers have also teamed up with COTA to obtain and supply RWD and other oncology clinical research trends.
FormularyWatch® recently caught up with Viraj Narayanan, vice president of Life Sciences at COTA, to discuss the importance of real-world data.
Here is edited transcript of our conversation:
How did COVID-19 increase the importance of utilizing RWD for clinical research trials?
We are in the speed game of trying to accelerate drug development. With COVID-19, the collaboration between regulators, scientists, manufacturers, and the government in funding research forced society to look at drug development in a whole different way. And it is really difficult to argue that we didn’t have tremendous outcomes. COVID-19 vaccines were approved in record time. I genuinely feel like we are on a journey with regulators in terms of looking at new ways of doing things; we are going to look back at COVID-19 as a key accelerator.
Why is real-world data so important to pharmaceutical manufacturers at this time?
The crux of relevant clinical information is found outside of clinical trials: 3% of all cancer patient data is seen in clinical trials, while 97% of cancer patient data is seen in the real world, in their electronic medical records.
Within the last decade, with advances in precision medicine, many patients are getting treated in a more advanced way with biomarkers and CAR-T cell therapies. Cancer is no longer one disease; it is thousands of diseases. The downside is that the sample size gets really small.
Now, instead of enrolling a control group in your trial, which takes time and money, you could use data from the real world. To do that, you need high quality data and you need data with outcomes, so you can match a real-world synthetic arm.
How does COTA help oncology pharmaceutical manufacturers with real-world data?
COTA was founded by cancer scientists with a lot of experience in the hematology cancer space and we have access to 1.2 million oncology patient records. The data is comprehensive and diverse because of our partnerships with some of the leading cancer centers.
We use nurses and doctors who are trained for abstracting data from clinical records. We train our abstractors on specific cancers — such as breast cancer and multiple myeloma — and each of those teams goes through a really rigorous process. Once they are onboarded, they are entering data into our technology platform, which has ways of catching errors built into it.
We maintain a live dynamic feed, so we are able to continually update the medical record with the latest information. It shows you what the ultimate clinical outcome for patients are and that allows us to keep up with the latest therapies approved and monitor how they are being used in the real world.
How will COTA’s real-world data help Kite specifically?
Kite is one of the pioneers in CAR-T therapies. They are looking to COTA to make sure they are accelerating their drug development pipeline. In addition, now that they have a product market, they need to know the clinical benefit of that product in patients in the real world.