- Delayed cancer screening and adaptations in care will have an uncertain impact on patient care and outcome, as well as create a gap in the data on both.
- The pandemic has created a rapid testing environment for telemedicine and highlighted challenges with virtual care.
- An ongoing challenge with collecting RWD is infrastructure; the software that collects information is intended for in-house billing purposes, so data collection isn’t standardized or optimized for wider-reaching research.
The spread of COVID-19 has disrupted many facets of normal life — including the collection of real-world data.
With fewer people enrolling in clinical trials, trials postponed, inpatient office visits delayed or canceled and routine cancer screening effectively on hold, a significant disruption in data around oncology care is to be expected.
What do these disruptions mean for those diagnosed with cancer and for the field of oncology at large?
In the latest episode of the “Real World Talk” podcast, we spoke with Dr. CK Wang, COTA’s Chief Medical Officer, and Dr. Ming He, COTA’s Senior Medical Director, about the importance of real-world data (RWD) and the difficulties the COVID-19 pandemic poses for collecting that data.
COVID-19’s Effect on RWD
Competition for trial participants has always been stiff, and access to patients can be difficult. COVID-19 has exacerbated this challenge by throwing the entire system into what can only be described as chaos.
“The COVID pandemic has essentially disrupted the well established clinical trial mechanism,” says Dr. Wang. As the disease has spread around the world, “patient enrollment has declined tremendously as inpatient office visits have declined precipitously.”
As a result, says Dr. Wang, ongoing trials had to adapt to remote monitoring, and many trials on the verge of launching were delayed until as late as 2021.
Still, real-world data is as important now as ever, especially in efforts to understand COVID-19. This pandemic may even underscore its importance in drug research and development.
“We have seen federal groups such as the CDC and FDA turning to real-world data during this time period,” Dr. Wang says, “to better understand this disease, and its real-world treatment as well as real-world patient outcomes. From my perspective, this has really brought real-world data to the forefront of drug development.”
The Social Distancing Effect on Patient Treatment and Data
Clinics have experienced changes in protocol around communication with colleagues, fellows and patients.
At the fellows clinic where Dr. He teaches hematology/oncology fellows, she says communication has been difficult. Training programs often require a large gathering of people, which obviously hasn’t been possible over the last few months.
“It’s very difficult to teach from the next room over,” Dr. He says of remote learning.
It’s also been challenging for doctors and fellows to communicate with patients in this environment.
For some patients, technology can be a barrier to communication. Patients lacking resources may not have access to remote communication technology like video conferencing, or they don’t know how to use it.
“It has been very difficult to provide the same effectiveness level that we have been able to in person, simply because of the difficulty in communication,” she says.
Dr. Wang, who runs his own clinic for cancer survivors, has been reaching out to patients by phone, which has let him postpone in-person clinic visits while still providing patient care.
“I have the luxury of doing that,” he acknowledges. “I know that many providers don’t, and as a result, many patients’ care is being delayed.”
Dr. Wang points out that routine cancer screening almost entirely stopped in waves around the world beginning two to three months ago, as regions shut down to prevent the spread of COVID-19.
“Arising from this [screening] gap is the concern of the potential long-term or short- to long-term impact of this disruption in patient care and patient outcome,” he says.
Missing opportunities for early cancer detection could mean potentially worse outcomes for patients in the near future.
Treating Patients You Can’t See
Care might not be in accordance with the best standards for patients diagnosed with cancer just before the start of the pandemic. Some cancer-related procedures haven’t been considered urgent, so hospitals have delayed elective surgeries.
The situation has forced oncologists to come up with alternative forms of care, including unproven therapy strategies, to care for patients until surgery becomes an option.
“We really don’t know what the ramifications are and what the outcome is going to be for these patients as a result,” says Dr. Wang.
But, he says, this time is also interesting, because clinics are almost forced to pressure-test new therapies and protocols for care, such as virtual consultations in place of clinic visits.
Traditionally, specialists have always wanted to see patients in person. That might not seem unreasonable, but reducing in-person visits due to the pandemic has highlighted the absence of alternative protocols. In an effort to adapt, institutions are creating new protocols for telemedicine and virtual visits.
“Certainly, everyone is just doing the best they can,” says Dr. He.
General Challenges in Creating RWD
Postponed patient care will mean fragmentation not only in the quality of care but in clinical documentation, as well. That is likely to mean gaps in data.
But even without the added barriers, a pandemic raises, real-world data is challenging to create. Clinicians don’t typically consider the potential use case for data they’re creating when entering information into an electronic medical record system (EMR). EMRs were designed for billing purposes and that is still one of its primary functions. The clinical documentation part is changing and evolving with each new generation of EMRs, and there is no consistency across the brands.
“They see it as a necessity to getting paid,” says Dr. Wang.
EMRs don’t typically require physicians to enter datasets in a specific way, so data isn’t standardized. Therefore, it’s difficult to curate and derive insights.
Both Drs. Wang and He are optimistic, however, that the field is moving toward more standardized methods and formats of clinical documentation.
Dr. He notes that newer data curated in recent years has tended to be more organized and easier to work with. She credits this to physicians’ comfort with electronic systems and documentation.
“Hopefully,” she says, “this will make our jobs a little bit easier going forward.”