Amid COVID-19, Clinical Trials Must Go On

By Ed Miseta, Chief Editor, Clinical Leader

The COVID-19 pandemic continues to impact economies around the world, and many businesses and activities have been curtailed or shut down. Others, however, must continue to move forward. Clinical trials fall into the latter category.

Patients fighting disease will require new medicines to manage their conditions or, in some cases, to save their lives. According to ClinicalTrials.gov, there are over 112,000 registered studies in the U.S., and another 165,000 outside the U.S. Adding in studies taking place both inside and outside the U.S. as well as ones with no location designated, there are a total of 334,000 registered trials taking place around the world. Although a few sponsor companies have announced a moratorium on recruitment, the number of recruiting studies make up just 50,000 (15 percent) of the 334,000 registered studies. With billions of dollars and numerous lives invested in those other 284,000 trials, the life science industry simply cannot abandon these studies and the patients taking part in them.

In new guidance on the conduct of trials during the COVID-19 epidemic, the FDA acknowledges changes to protocols and patient visits may be necessary to protect the health and well-being of study participants. Those changes are hoped to be sufficient to allow the studies to continue. Still, acquiring the needed data from patients being told to stay home and avoid hospitals and clinics will require sponsor companies to acquire new solutions.

“Protocol, patient monitoring, and even some endpoints will have to change,” says Craig Lipset, advisor and founder for Clinical Innovation Partners. “One result of the pandemic is that organizations will begin to embrace more resilient, and often digitally enabled, endpoints that support options for remote participation. Unfortunately, most sponsors are scrambling right now because their study endpoints are so fragile they cannot be captured outside the clinic.”

Change Takes Time

Sponsors might suddenly want to embrace remote monitoring and digital devices, but solutions cannot be implemented overnight. Lipset notes change will take time as well as investment. A validated endpoint for a study cannot be urgently implemented when a pandemic suddenly arises.

Still, companies suddenly find themselves in need of help. Vendors that spent years calling on sponsors are likely having trouble answering the calls now flooding their phones.

There are many smaller companies in the drug discovery industry, and Joshua Gant, MD/MPH and senior manager of applied innovation and process improvement at Otsuka Pharmaceutical Development & Commercialization, Inc. believes their size may help them take a more leading role in identifying solutions that industry can quickly roll out to help address some of the effects on clinical trials. “Smaller companies likely have less momentum to overcome and a lower barrier to adopt new practices and may not have older legacy systems in place,” he says. “That means they are agile and can more easily incorporate a new technology into their infrastructure and clinical trial practice.”

For some companies, ePRO, eConsent, and wearable devices may have previously been thought of as technologies that were nice to have. In the post-COVID-19 world, Gant believes their role as fundamental technologies for conducting trials will be accelerated.

Help Is Available

Craig Lipset, advisor and founder for Clinical Innovation Partners

For those sponsors scrambling for help, there are numerous resources available to assist with technology needs. The problem for many companies will be to know what vendors provide the various solutions, and how to reach out to them.

To assist those companies, Lipset has put together a list of companies that specialize in the different technology solutions. He has shared the list on LinkedIn and continues to update it almost daily with new information that he discovers or is submitted by others in the industry.

“I created the list for two reasons,” states Lipset. “First, I was getting a lot of calls from connections in different pharma and biotech companies that were suddenly struggling with trial continuity. They knew I was connected and trusted at the intersection of sponsors and technology solutions. I also have a history with the REMOTE (web-based) trial and advocating for decentralized approaches.”

The second reason had to do with Lipset’s desire to help the industry in this time of crisis. He notes his background is not just in trial innovation (he is the former head of clinical innovation at Pfizer) but also epidemiology. Additionally, Lipset is a patient with an immune-mediated pulmonary disease. “That gives me three good reasons to do what I can to help organize solutions and tools during this pandemic,” he says.

A Clinical Trial Resource

Lipset’s list was created in Google Docs and can be seen here. It can also be found at online here. He notes the list is dynamic and growing by the day. He also points out the list is for informational purposes only and is not his endorsement for any company or technology included.

Every section on the list is a resource for companies hoping to deploy solutions that will help them continue their trials while protecting the safety of patients. Sections include home healthcare providers, video-based visits, virtual trial sites, decentralized trial service providers, remote medication adherence monitoring, sensor and measurement devices, direct-to-patient investigational product, and more. There is even a section on guidance related to the pandemic.  

Thus far, Lipset notes feedback on the list has been humbling and overwhelming. “I want to make this a resource for the clinical community, and make sure solutions which can help sponsors are known and visible,” he says. “I am also hearing stories of leaders in the research community that are driving these innovative solutions and approaches, and I am committed to helping those stories be shared and heard.”

Don’t Delay Implementation

Joshua Gant, senior manager of applied innovation and process improvement at Otsuka Pharmaceutical Development & Commercialization, Inc.

If you’re considering reaching out to any of these vendors for help, it would be best to do it soon. Gant believes sites are struggling to keep up with scheduled visits during this pandemic, and without help they may try to take things into their own hands.

“I have heard of some sites trying to implement their own solutions,” says Gant. “The proactive work should be appreciated but what they put in place may not be in the best interest of the sponsor or the trial. For example, to promote remote visits, sites may opt to communicate with patients via email or text messages. While that may seem like a good short-term solution, those actions are apt to bring up privacy and data security issues.”

If you do reach out to any of these solution vendors, Gant recommends you be patient when awaiting a response. Some of these vendors have been pitching their products to sponsors for years, and suddenly have hundreds of companies reaching out to them at once. “Our main goal should be to make sure our patients are safe, that they still feel comfortable participating in the trial, and that we are doing everything we can to reduce the burden on them,” adds Gant. “If our actions have the best interest of patients in mind, our trials will survive the pandemic.”