Outlook for Cancer Clinical Trials While the Pandemic Still Rages

2021 has already been “a lot” in internet meme-speak, and we’ve only just seen the end of January. In all of the digital exhaust on COVID vaccination(s), insurgency at the Capitol, and “is Biden doing things right, or nah?” the issue of cancer research seems buried under the fog. That’s not to say that the issue of clinical research on cancer, and the clinical trials that can lead to new diagnostics and treatments isn’t on anyone’s radar. It’s on the dashboards of countless researchers and research institutes across the globe.

I did a headline survey on how cancer clinical trials might continue to evolve in 2021, after researchers started figuring out what they could do remotely during the 2020 pandemic months. Here’s what I found:

• From the NIH, a post from June, 2020 that’s still in play for 2021, “Responding to Coronavirus, Cancer Researchers Reimagine Clinical Trials.” In the piece, NIH outlines how some hospitals started using home visits by nursing staff for patients under treatment. “A greater use of telemedicine has emerged as one of the positive changes to cancer clinical trialsthat could be continued after the pandemic has passed, according to the results of two surveys of clinical trial investigators and a series of recent commentaries by leaders of clinical trials. Other changes to trials during the pandemic that could be incorporated into future studies include the use of electronic signatures for patient consent forms, remote monitoring of clinical trial results, and shipping oral medications directly to patients participating in clinical trials.”
• From the pharma industry side of the house, on the Pharma Tech Management website, “2021 Clinical Trial Trends” recommends, among other things, increased implementation of adaptive and remote study models. That’s been visible in COVID studies, and has been emerging in other clinical research channels like cancer. My membership in the Digital Medicine Society gives me some heads-up early signals on how those adaptive and remote models are showing up. This needs to be a research-institute/industry partnership effort. If you participate in pharma industry discussions, push this idea.
• From The Advisory Board – a good site to follow all things healthcare policy – a post, “Will clinical trial innovation outlast Covid-19? Only if these 7 conditions are met.” The number one slot on that conditions list is academic medical centers and providers become active proponents of virtual and decentralized clinical trials. They also mention that FDA and other regulatory agencies need to develop guidelines that encourage clinical trial innovation. “FDA must capture lessons learned from decentralized and virtual trial design during the pandemic and establish guidelines that encourage their widespread use in the future.”
• From FierceBiotech, “2021 forecast: Clinical trial diversity has long been a thorn in biopharma’s side, but 2020 could turn things around,” the bete noir of clinical research – that trial participants generally are white, highly educated, and otherwise privileged – can be tackled using digital tools to make sure everyone’s included in trial enrollment, not just the usual suspects. Regarding COVID research, “’COVID impacts everyone. The virus does not care whom it infects,’ Shoham said. And that, for many, has illustrated the importance of testing drugs and vaccines in different groups of people. ‘We come to COVID from a range of backgrounds. Some people can isolate within their own home, others cannot. Some can get the best available medical care as soon as they need it, others cannot. Some can shrug off the virus with a few days of feeling miserable, others develop devastating complications,’ Shoham added. ‘While the virus and the treatments that we study to address it are the same, the people who are impacted in real life are not.’” On the cancer research side of this, there’s plenty of data indicating that people of color are left out too often in clinical trials for cancer. This is an opportunity zone for better science to fight cancer.
• A news release from the Dana Farber Cancer Institute about a study the Dana Farber researchers did on the impact of COVID on cancer treatment and research (the news release is here; the journal article in Cancer Cell is here). The net-net here that cancer patients can be severely impacted by COVID due to the immune system suppression common in most chemotherapy treatment regimens for cancer, and that cancer screening and treatment in medical facilities has taken a hit with COVID risk being seen by patients as a risk they may not be willing to take, along with the medical facilities themselves having to reassign resources and personnel to COVID rather than screening and oncology.

Driving forward useable, effective digital tools for both the clinical side and the patient/participant side of cancer clinical research will require both sides, along with regulatory bodies for safety’s sake, to work in concert to make real digital innovation happen. Any opportunity you have to advocate to researchers, the research institutes where they work, the pharma industry players they partner with, and regulatory bodies like FDA to make digital tech useful and effective for cancer research – take it. Speak up, and get your patient community to speak up as well.

That’ll be how shift happens.