By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical
In the past two months, the world has been turned upside-down by the COVID-19 pandemic. Even in my region, with a population about 275,000 and five confirmed cases, life is anything but normal. I am working from home for the first time in my life. I cannot go out to a bar, eat in a restaurant, go to a movie theater, or attend a sporting event. My only forays out of the house are to Wal-Mart for food and necessities. The virus has even cancelled my Friday night bowling league, something the cold and snowy Erie, PA weather has never been able to do.
What has surprised me most is the impact the virus is having on my own healthcare. In the past two weeks I had a dentist appointment cancelled and a radiofrequency ablation on my back postponed. This morning, I had a scheduled follow-up appointment with my primary care physician (PCP). Yesterday the office called to say the visit would be conducted via a teleconferencing app. Although my doctor wants me to get a blood test and see a specialist, he noted that would likely not happen for several weeks.
The impact of the pandemic has been severe in the life sciences industry. Clinical trials rely on the generosity and altruism of patients, who give up their time and quite possibly their health to test new medicines that might someday help other patients. When those individuals are no longer able to attend scheduled visits to hospitals and clinics, trials will suffer, and new medicines will be delayed in getting to patients in need.
Jeff Kasher, president, Patients Can't Wait
Unfortunately, that is the situation that now exists in pharma. Hospitals and clinics are overwhelmed by the pandemic. Staff is not available to complete trial visits, and some staff members themselves have been diagnosed with the virus. Patients are afraid to attend scheduled visits. Many are being told to stay home and avoid interactions with others. Trials will be delayed, recruitment will become more difficult, and the quality of data could be impacted.
While difficult, this upheaval to the clinical trials system is necessary during this period. Jeff Kasher, president of Patients Can’t Wait, applauds the recent decision by several Big Pharma companies to suspend the start of new trials. “During this pandemic, we have to remember the physicians, nurses, and other healthcare workers who are caring for patients while putting their own health and well-being on the line,” he says. “I know patients can’t wait for new medicines, but first we need our frontline medical professionals to get us through this pandemic.”
Covid-19: Never Waste A Good Crisis
My own experiences with COVID-19 had me thinking about what a post-pandemic world would look like related to clinical trials. Several years ago, I attended a clinical conference and was introduced to the concept of telemedicine visits. The speaker discussed the timeline of a typical visit to a doctor: A patient wakes up with the flu. All they know is they don’t feel well. Their body aches and they have a cough or sore throat. Perhaps they have a fever. So, they make an appointment and visit the physician’s office.
On the way to the visit, they touch their face. They cough into their hand. Perhaps they blow their nose and allow the mucus to touch their hand. Once they get to the office, they touch a pen and a clipboard. Perhaps they use their fingers to navigate a touch screen. They flip through a couple of magazines. They also breathe (or sneeze or cough) in the presence of other patients and employees in the office.
Unfortunately, the sick patient’s trail of germs is not over. If they are given a prescription, a visit to the pharmacy means more opportunities to touch objects and further spread their illness to others.
The speaker then presented a logical solution to this problem: Telemedicine. At the height of flu season, nearly every patient with a cough and fever likely has the flu. Physicians with the ability to see a patient and ask them questions would be easily able to diagnose the condition. Therefore, if that patient had the capability to interact with a physician on their smart phone or laptop, they could have skipped the office visit altogether and had a prescription called in and delivered to their home. I left that session convinced telemedicine was the only way I wanted to conduct physician visits in the future. Despite my excitement over the possibility of communicating with my doctor electronically, I was never presented with the opportunity to do so. Until today.
“Forced” Changes Benefit Patients
COVID-19 has impacted how people visit their physicians, and it will also change how participants in clinical trials conduct their study visits. For years we have heard about the benefits of virtual or decentralized trials. Patients can skip a visit to the clinic. They can use telemedicine to speak to a physician or nurse. If vital statistics are required from a patient, digital and wearable devices could capture and transmit the information. If a blood draw is required, a healthcare professional could be sent to their home.
Unfortunately, for most patients participating in trials, those virtual elements never materialized. Will COVID-19 be the impetus that finally drives sponsor companies to look for ways to keep patients at home?
With patients concerned for their health and hesitant about leaving their homes or visiting clinics or hospitals, incorporating virtual aspects into trials may be the only way to ensure their continued participation. New guidance from the FDA on conducting trials during this pandemic is stressing that sponsors make patient safety the paramount concern. The guidance specifically mentions phone calls and virtual visits to keep patients safe.
Craig Lipset, founder and advisor, Clinical Innovation Partners
If companies start to implement these measures now, will they become a best practice for trials once the pandemic is over? Kasher and Craig Lipset, founder and advisor for Clinical Innovation Partners, both feel there may be a positive to the challenges currently plaguing clinical trials.
“We are certainly seeing dramatic changes happening in both research and healthcare right now,” says Lipset. “Those changes are necessary to keep the lights on during COVID-19. When the pandemic is behind us, we will see whether innovation can outlast the crisis.”
Telemedicine is one of the areas Lipset sees changing. He notes in healthcare, telemedicine is getting better reimbursement, privacy restrictions on video platforms have been reduced, and interstate licensing barriers for physicians to provide care have been lifted. He sees similar flexibility being brought into clinical trials.
“Our challenge will be to ensure the right changes persist and outlast COVID-19,” he says. “I tend to be an optimist, but I believe the approaches that were once considered ‘risky’ will now be viewed as ‘risk-mitigation.’ Those approaches will survive, but it will take all of us in the clinical research community to make sure that happens. Adoption of new ideas in the field is typically rate-limited by culture more than other barriers.”
FDA Is Front-And-Center
The FDA will certainly be front-and-center in leading sponsor companies into these new monitoring methods. Kasher notes most companies are already trying to determine how to apply the FDAs new guidance.
“Sponsor companies need to determine how to best keep their patients safe,” states Kasher. “Their options will include decreasing required visits, replacing site visits with televisits or lab visits, and more remote monitoring.”
When the pandemic has passed, Kasher agrees that changes being made now can improve the trial experience for patients participating in studies in the future.
“If one good thing emerges from this pandemic, it will be the use of remote/centralized monitoring in all clinical trials,” he says. “Regardless of the cause, in 2020 we cannot have monitoring of ongoing trials compromised for any reason.”
There are three areas of trials operations that Kasher would like to see impacted in the future. The first is more virtual components inserted into clinical trials. While site visits will not be eliminated, there needs to be more visits taking place at home, in a pharmacy or retail environment, or over a smart phone or computer. Second, there needs to be less burdensome protocols for patients. That should include a decrease in the number of procedures performed by clinics. Finally, the industry needs to advance the distribution of investigational drugs to homes and pharmacies.
“We can’t keep conducting trials the way we have in the past,” adds Kasher. “Going forward, we need to see a new normal emerge for clinical trials. The changes we see taking place now might finally help the industry get to more patient centric trials.”