For patients, healthcare providers, researchers, and pharmaceutical companies, 2020 will mark the advent of massive disruption and progress for telemedicine and remote clinical trials.
In October 2019—before anyone could predict how things would change in just a few months—J. D. Power released the results of a study into telehealth in the United States. Although respondents who accessed these services were overall very pleased, at that point less than 10% of consumers had used any telehealth options.
The report cited a variety of challenges to increased usage—availability of services, awareness, access to technology for consumers, the time it takes to enroll, and the number of providers offering telehealth.
COVID-19 Has Changed the Trajectory of Telemedicine
A large percentage of the population who expected to go into work every day are working from home, and this shift towards what’s acceptable has extended to healthcare from home—telemedicine.
Suddenly, telemedicine is not only viable, but necessary. People can’t get to their healthcare providers. Healthcare providers are facing increased risks from in-person visits, and many are in their own set of lockdown and quarantine challenges.
Beginning in March 2020, a rapid transformation of the telehealth landscape has begun. News sites are doing the job of bringing awareness to telemedicine, medical service providers are quickly expanding their telehealth offerings, medical bodies like the AMA and the AAFP (American Association of Family Physicians) have issued guidelines for telemedicine, and the CDC is recommending providers leverage telemedicine as one way to protect patients.
But perhaps the biggest force pushing telemedicine since the WHO declared coronavirus a pandemic is demand. Demand from patients and demand from healthcare providers. When both sides of an interaction are demanding the same thing, companies will direct resources into rapid adoption that is embraced by their users.
The Medical Futurist quotes Dedi Gilad, CEO of telemedicine technology company Tyto Care: “Telehealth is bridging the gap between people, physicians and health systems, enabling everyone, especially symptomatic patients, to stay at home and communicate with physicians through virtual channels”.
Existing telehealth providers are seeing increases of up to 158% since January 2020, with an average 50% increase in March. Bertha Coombs reported for CNBC on April 4, 2020 that “Analysts now expect [virtual] medical care visits to top 200 million this year, up sharply from their original expectation of 36 million visits for all of 2020.” It’s been suggested that this number may even reach 1 billion.
There are still challenges that must be addressed. High demand is resulting in longer wait times (similar to the past experience of in-office doctor visits), telehealth reimbursement rates will impact long-term adoption by medical service providers, the difficulty of conducting full assessments remotely, misdiagnosis is a greater risk, and doctors practicing outside their jurisdictions.
Perhaps the American Journal of Managed Care states it best in their April 2020 report: “Although certain legal, regulatory, and reimbursement challenges remain, the COVID-19 outbreak may be the right impetus for lawmakers and regulatory agencies to promulgate further measures that facilitate more widespread adoption of telemedicine.”
COVID 19 Impacts Current Clinical Trials
Companies involved in clinical trials are reporting substantial challenges presented by the coronavirus and subsequent public shutdowns. Across the globe, clinical trials are being disrupted by suspended enrollment, delayed initiation, or slower enrollment.
The FDA has issued guidance about clinical trials during the COVID 19 pandemic, and is recommending various telemedicine actions such as virtual visits and remote monitoring to reduce the impact of the pandemic on current trials. But the impact is still being felt across all types of clinical trials.
While clinical trials will contribute to delays in drug approvals, there’s also a very personal impact for patients. Those holding onto hope that participation in a trial will help when all else has failed are left with indefinite delays. Even when trials can theoretically continue because participants can self-administer medication and self-report results, delays throughout the healthcare system—like canceled biopsies—are having a negative impact.
While telemedicine provides a solution to general healthcare, in some ways it’s not adequate for remote clinical trials. Donald Deieso, CEO of WCG Clinical had this to say when interviewed by Ed Miseta for Clinical Leader:
“Sponsor companies and sites are [desperately] calling on technology and service providers to ask what can be done and done quickly to preserve trial activities. They want to know what Zoom can be used for. They want to know if it is HIPAA compliant. They want to know how they can use SharePoint, WebEx, and FaceTime to interact with patients.”
The clinical trial industry and Big Pharma have traditionally been very reluctant to adopt new or innovative technologies. Now—perhaps along with regret for failing to adapt sooner—companies are forced to change, and change quickly. Suddenly, researchers are going from almost no telehealth appointments to thousands. The old face-to-face requirements have become outdated in a matter of weeks.
Impending Changes for Clinical Trials
Often, the participants in clinical trials are immune-compromised. They cannot visit sites during a pandemic. Companies need to determine how to measure vitals, collect data, ship treatments to homes, and even provide infusions off-site in order to continue operating clinical trials. Plus, some treatments simply cannot be provided remotely at this time. Either technology will have to create an at-home solution, or providers will have to establish a safe on-site alternative to the way this has been done in the past.
Immediate Adaptations for Clinical Trials
There are immediate changes being implemented to preserve current trials whenever possible. As WGN’s Deieso shares, these include things like deputizing clinical services organizations that meet HIPAA requirements to speak to patients, amending protocols to allow for decreased patient site visits, getting IRB approval to remove patients from trials who have tested positive for COVID-19, and maintaining excellent communication with patients about the changes.
The Clinical Trials Transformation Initiative (CCTI) offers the following recommendations:
- Keep participants informed
- Perform ongoing risk-benefit assessment
- Communicate with IRB/IED and regulatory authorities
- Pause (most) new study starts and enrollment
- Pivot to remote study visits
- Switch to remote monitoring
- Document everything with COVID-19 tag
Of course, many companies have also had to switch to work from home models for all their employees, adding a solid layer of challenges to an already difficult time for clinical trials.
The Future of Remote Clinical Trials
Let’s start with the good news. Shifting more services to remote/telehealth options will give access to more participants (such as opening up rural residents far away from urban centers) and provide cost-saving measures. Remote clinical trials that do not require participants to travel to study sites will reduce the impact of participation and increase accessibility to those who previously couldn’t commit to lengthy trips and site visits.
One example of this is suggested by Deieso. Before COVID-19, CROs had to send clinical monitors from site to site, taking up time for travel and related costs, and contributing to a CRA shortage. He says, “When you substitute video and other tele-based solutions, the productivity of the CRA increases dramatically and the cost of the CRAs work goes down tremendously.”
The recommendations in the Clinical Trials Transformation Initiative (CCTI) are good indications of how the future of clinical trials will unfold. What may have been a footnote for ‘in case of pandemic’ must now be planned into every trial. How are patients—particularly vulnerable patients, as most study participants are—going to be kept safe throughout the trial? What contingencies are needed to continue trials in case of mass disruption? Do patients have access to sufficient internet resources from home so they can participate in virtual visits and provide monitoring data? How can drug delivery be accomplished off site?
Companies must also look at their own staffing and systems capabilities. How are privacy requirements met and electronic health records maintained when employees are working remotely? What contingencies are in place in case of the sudden loss of a key researcher?
“For the last 5 or 10 years, some solutions have been deemed too risky for pharma. Now the risk of not implementing them has become greater than doing so. Right now, it is hard to envision the extent of the chances that are going to occur.” Don Deieso
The expert forecasts about the future of clinical trials written pre-COVID-19 provide a fascinating window into how quickly things are changing in this field. One article by Adam Berman and Kelsey Jakee published in October 2019 for Clinical Leader is still relevant for the most part. The predictions for trials to become open and focusing on collaboration, human-centered rather than operations-centered, and more integrated in the medical system are certainly coming to fruition.
What the article couldn’t have predicted was the forced transition to an almost entirely remote method of delivery whenever possible, and the general public’s new understanding and appreciation of clinical trials.
Back in August 2019, the most poorly regarded industry in the United States was the pharmaceutical industry, sinking below airlines, lawyers, and the federal government. Now, the population is looking to this industry to provide testing, treatment, and a vaccine for the virus that has stopped life as we know it around the globe.
The public has learned that new treatments take time, trials, money, regulatory approval, and production and distribution before they become readily available. They are learning of the long and arduous process of vaccine development. And, they are increasingly viewing the pharmaceutical industry as a literal life-saver. In a few months, the coronavirus achieved something that PR hadn’t achieved in decades.
During the recent eyeforpharma conference (adapted to a virtual format), there was much discussion about communication with patients and the public, collaboration across countries and companies, and the acknowledgment that companies must change in order to survive.
Switching to a remote format in as many ways as possible will be less costly for companies in the long run, more convenient for participants, reach a larger population, and improve health and safety for participants and evaluators.
However, it’s likely that consent will still need to be done in person—even when most contact is done remotely—and there will always be treatments that must be provided in a clinical setting.
There’s no doubt the will from companies, participants, and regulatory boards is present right now to accomplish a transition to remote trials for many cases. What remains to be seen is how far that motivation will extend into the future and create lasting change.
“Working together, medical professionals, regulatory experts, data scientists, software engineers, and so many others can use robust technologies to help ensure the efforts to conquer diseases may continue.” Fareed Melhem, Medidata for Technology Networks
Using the Current Situation to Build on Telehealth and Remote Clinical Trials
The advancements in usage, public awareness, and new policies since the onset of the coronavirus pandemic have set up both telehealth and remote clinical trials far better than anyone could have expected just a few months ago.
Now is the time to build on this awareness and openness to treating health differently. Social media is an excellent venue for showing the public that telehealth services are effective, efficient, and safer than going to the doctor.
People want to avoid places where others might be sick—the doctor’s office and hospitals in particular. Let them know how they can safely access services. Since women tend to make most household healthcare decisions, this is a great time to target them with information about how and when telehealth is the best decision for them.
Educating the public about remote clinical trials may be more challenging than general telehealth campaigns, but again, now is the time to raise awareness and communicate the advantages both to patients directly and to the doctors who will refer them.
As doctors begin to see the advantages to their patients of remote clinical trials, they will become its biggest advocates. Many patients will receive home monitoring solutions that will provide better information for healthcare providers. Rural, housebound, and disadvantaged patients will no longer need to make visits to major centers to participate in clinical trials. And cost savings may make both telehealth and remote clinical trials as commonplace as going to the doctor’s office was in 2019.
