The COVID-19 pandemic caught many sponsor companies and sites unprepared. Hospitals and clinics struggled to deal with patients sickened by the virus. Clinical trial participants were told to stay home for their own safety and to relieve the burden on site personnel. For companies that had millions invested in trials that required data from those patients, panic set in and the rush was on for new technology solutions.
“The global pandemic has impacted trials in multiple ways,” says Alison Holland, head of decentralized trials at Medable. “Locked-down travel, self-isolation, and the redeployment of clinical staff for other healthcare priorities are reducing the ability of staff to perform monitoring visits. This has increased the number of calls we are getting for home/remote based support. The demand we are seeing for these solutions have increased significantly over the past month.”
The most immediate solution for sponsor companies is the ability for sites to conduct televisits in a secure and HIPAA-compliant manner. A remote patient e-consent solution is helpful to facilitate the transition to televisits. The ability to use digital devices to capture data on patients or measure endpoints is another hot technology. That can include measures of weight, temperature, blood pressure, and more. Holland notes Medable is also seeing increased requests for digital patient reported outcomes assessments, which allow patients to report their symptoms in real time.
VirTrial is another company that is now inundated with calls. The company is attempting to respond to all calls within 24-hours, and then prioritizing the requests based on specific client need. Amanda Rangel, SVP of business development, notes the technology requests are quite varied.
“Most requests are directly from pharma or CRO's for a telemedicine platform allowing the patient and site to interact virtually,” she says. “Another urgent need revolves around using telemedicine to allow Clinical Research Associates (CRAs) access to clinical sites while they are no longer able to visit in person. That issue is impacting startup timelines and ongoing data verification. We are also receiving calls from companies exploring future adoption of these technologies, and third-party requests from other technology vendors looking to use telemedicine to enhance their remote data collection services.”
The Search For A Virtual Approach
Science 37 is one of the companies that have been leading the charge for virtual (decentralized) trials. Steve Geffon, Science 37’s chief commercial officer, notes the pandemic has produced a steady stream of sponsor companies looking to change their protocols to rescue ongoing trials.
“These companies are hoping to incorporate telemedicine, minimize in-person interactions with patients, and have investigational medical products shipped directly to patients,” states Geffon. “As the pandemic extends into spring, companies are realizing that a virtual approach can help reduce exposure to the virus and provide some measure of business continuity.”
Unfortunately, many companies that have not looked into these technologies are unsure of how to virtualize their upcoming or ongoing studies. They will need help with study design and delivery, endpoint virtualization, and change management.
“Having a protocol synopsis ready when you call helps us understand the challenges faced and is critical to getting started,” says Geffon. “That should include a schedule of assessments, investigator information, target geographies, and desired timelines. It is helpful to have someone from clinical operations on the call who is empowered to make decisions quickly. A representative from the scientific team should also be included, as discussions may lead to changes in new or existing protocols.”
Be Wary Of “Too Good To Be True” Solutions
Clinical Ink has also been busy, experiencing a record month for business in both March and April including 30 active proposals specific to COVID-19. The company is seeing many requests for direct data capture (DDC), bring your own device (BYOD) ePro, and remote patient visits.
“DDC is a great model for both virtual and “site-to-patient” home visits,” says Ed Seguine, CEO of Clinical Ink. “A lot of people don’t realize this model was also used for Ebola, influenza, tuberculosis, malaria, and respiratory syncytial virus. That makes it the gold standard for COVID-19 studies because it permits data access and remote monitoring in real-time. We even received a proposal to outfit a field hospital with tablets at each bed.”
Seguine does have concerns over the sudden rush to acquire new technologies. He fears some emerging technology companies may make unsubstantiated claims about their platforms and its ability to solve current problems. Sponsor companies rushing to implement new technologies should take the time to thoroughly research solutions. He also cautions potential clients to recognize and understand the challenges of implementing solutions mid-stream.
“I think the pandemic is absolutely a call to action for the industry to consider these technology options for running new studies,” says Seguine. “Rushing to do things differently in existing studies is fraught with risks, and sponsors should think carefully before they rush to implement new solutions.”
Seguine also notes the time it takes to plan, contract, and implement solutions, and then integrate data, will be longer than advertised. Companies should be prepared for those delays and be wary of any vendor that makes promises that seem too good to be true. It will be difficult to get the results you expect with any “add-on” solution. For many companies, it may be better to weather the temporary disruption than create more disruption that might outlast the pandemic.
HHC Can Reduce Trial Risks
Home healthcare (HHC) is another service that has exploded in popularity. Firma Clinical Research is a company offering that service, and David McCrary, director of business development, notes making the pivot to HHC is pretty simple. He has found sponsors seeking these solutions generally fall into two categories.
“The first camp is sponsors desperately trying to keep a study going,” says McCrary. “The other camp is companies hoping to use the service whenever possible moving forward, regardless of COVID-19. Those companies realize that although these services are necessary now, they can still help sites and patients even during more normal times.”
For companies considering HHC, there are several factors to evaluate. Timelines are the most important. No one really knows how long the pandemic will limit patient travel to clinics. The timeline to implement HHC can be two to three months, which might rule out many companies that fall into the first camp.
“Some sponsors think COVID-19 could go away as we get into warmer weather, and startup timelines for HHC are just long enough that it can’t help in that case” notes McCrary. “If it remains an issue through the summer months, or returns in the fall, HHC will definitely be able to help if sponsors start preparing now. For any trial expected to continue for at least four months, it may make financial sense to have HHC running in the background as a safety net, ready for use if needed. And regardless of the rationale, many sponsors are running with the assumption that patients will want the choice to stay home moving forward.”
There are two additional concerns to keep in mind. Patients may refuse to allow a nurse or medical practitioner into their home because of fears of contracting COVID-19 from the provider. And there is also the risk of a HHC provider refusing to go to certain homes that might be in a high-risk area or have active COVID-19 cases. That risk can be alleviated by selecting providers who are geographically close to trial participants and properly prepared to see COVID-19 patients.
Finally, the capabilities of HHC can vary by country. Therefore, sponsors should have a list of countries they plan to conduct a trial in along with specific procedures needed prior to contacting vendors. HHC providers should be able to provide services related to vital signs, blood draws, ECG/EKG, and questionnaire administration in all countries where HHC is commonly deployed. IP administration is also commonly done in-home but will be limited in certain countries due to liability insurance restrictions. Other services such as scales, breath tests, and holter monitors can be provided to sponsors willing to provide devices and support training.
The Time Is Now
If you have been considering implementing patient facing technologies, COVID-19 has demonstrated that the time for you to act was last year. Still, new technologies can help you manage your current trials more effectively and better prepare your studies for the next crisis that arises.
“We have talked for a long time about personalized medicine and designing our studies to be more accessible to patients,” adds Holland. “If there is one positive thing we can take away from this pandemic, it’s that we can be resilient, creative, and adaptable with our trials. Today the technology exists to allow us to place clinical trial activities into the hands of patients and clinicians in their remote settings. This can be a great experience for all parties and be transformative to designing clinical trials in the future.”
Seguine agrees, but recommends doing your homework before jumping into any technology. “Right now there is definitely a desire to do something,” he says. “The key for every company is to do the right thing at the right time. Any time that you implement a new technology or business process, it can be an arduous task. I recommend that sponsors be cautious in making wholesale changes in existing studies, but be bold in proactively planning for new ways to implement technology in upcoming studies.”
Finally, sponsors should be thinking about their patients and sites when looking at any solution. “We are encouraging companies to think about the needs of their sites and to closely partner with them during this transition,” says Bree Burks, VP of site strategy for Veeva. “Sites must work with many different sponsor-provided systems. That’s a very difficult situation for them. Our advice is to talk to your sites. Understand their perspective and the short- and long-term implications of the solutions you’re looking to put in place. Companies need to take a critical look at the available options and select the solution that best supports both the short- and long-term needs of sites.”