From The Editor | December 21, 2020

Tread Carefully Into Virtual Clinical Trials

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

Decisions Ahead

With the COVID-19 pandemic’s impact on clinical trials in the U.S. and around the world, everyone is suddenly focused on virtual (decentralized) clinical trials. But if you plan to move your trials to a virtual model, at least one industry executive is recommending that you use caution when doing so.

“Everyone wants to migrate to virtual trials, but when doing so I think we need to be careful,” says Jeff Kasher, president of Patients Can’t Wait. “It’s important, from a clinical development standpoint, that we have contingencies in all of our trials to help us avoid the massive shutdowns that we saw in the second quarter of 2020. We saw a lot of trials flip over to the virtual model, but I think we need to take a closer look at that and ask ourselves if it is sustainable.”

From a pharma company’s perspective, virtual trials were a way to keep trials going and keep patients engaged. That meant a continued flow of vital data that is necessary for regulatory approval. However, Kasher notes not all patients were ready for the switch or prepared to take part in them.  For example, not all areas of the country have the broadband service required to participate in a virtual trial. Additionally, not everyone has a smart phone or home computer that might be required.

“We did not ask patients their opinion of these trials before making the switch,” says Kasher. “We assume everyone will welcome the change, but every patient will not want to do a trial in their kitchen. Everyone will not want healthcare workers coming into their homes, especially during a pandemic. These are things the industry will have to consider when moving forward.”

Focus On The Data

For pharma companies, the data generated from a trial is what will ultimately lead to a regulatory approval. For those companies, virtual trials are a way to continue gathering needed data from patients. Although there will likely be some forgiveness by regulators for data gaps that occurred during the COVID crisis, Kasher believes drug developers need to take a hard look at the data currently being generated.

Jeff Kasher
Jeff Kasher
“Going forward, how are we going to ensure that we get a rich, robust data set?” asks Kasher. “We are definitely going to see an increase in the number of hybrid trials. I have even heard people discussing an ala carte approach, where patients could opt to do all of their site visits at home, in the clinic, or select a mixture of both. The question we need to be asking ourselves is whether the data we receive from those different visits is unbiased.”

Kasher notes he is not against virtual trials. In fact, he strongly supports the use of them across all disease states. He believes they meet an industry need, and COVID has allowed pharma to make 10 years of technological progress in just a few months. That is welcome news for many patients, and Kasher believes clinical trials will not regress back to the pre-COVID days. Still, he believes it is time to pause and reassess where we are and where we need to go from here. 

“We need to perform robust validation of the data being collected,” he says. “We need to know what exactly a hybrid model will do to the integrity of the data. What is the impact of physicians not interacting with patients in person? How ala carte can we make these trials? This is a huge step forward for healthcare, clinical trials, and patient convenience. But clinical trials are still about putting unproven molecules into human beings. Now is a good time to pause, look at the methodology, and ask ourselves if we are still ensuring their safety and wellbeing.” 

Changes In Remote Data Monitoring And RBM

When pausing to assess where we stand, Kasher also recommends examining remote data monitoring and the use of risk-based monitoring (RBM).

“When we migrated from sites faxing in case report forms to putting them in an EDC, that shifted work/responsibility from sponsors to sites,” he says. “We cannot allow the changes we are making with virtual trials to have a negative impact (add additional burden) on the work sites are required to perform. In terms of remote data monitoring, the industry has made great steps forward. Our goal should be to build on that success.”

Remote monitoring can benefit patients and greatly reduce or eliminate the need for monitors at sites. It is certainly timelier and more cost effective for both sponsors and sites. It also improves the lives of CRAs. Kasher has heard the horror stories about the lives of CRAs. It’s a tough job and the travel is crazy. With remote monitoring, the job of CRAs can be performed from almost anywhere, creating a better situation for CRAs, sites, and sponsors. 

Risk-based monitoring (RBM) is another advancement to keep an eye on. Kasher believes many large sponsor companies continue to struggle to implement it in an optimal way. There are certainly companies that continue to send people to the site to review source data, apparently feeling more secure about the results. This is in spite of the fact that the FDA has said it is not necessary.

“CROs are certainly not going to dissuade those actions,” adds Kasher. “There is still a lot of data verification going on, which is a big revenue driver for CROs. This likely comes from the fact that Big Pharma companies remain risk averse. COVID has forced them to take on a little more risk, but they will continue to monitor in ways that are old school. Companies may add RBM to the mix, but they will not eliminate sending people to sites. The same is true of smaller companies. They have one molecule and don’t want to mess it up. Most of them also have sufficient funding that they can afford to continue to send people to the sites. Therefore, they are not in need of new approaches to perform the monitoring.”