The Shift to Virtual Clinical trials

The pandemic propelled all things virtual and remote. On an individual level, we all experienced physical distancing and stay-at-home orders, and went from activities with friends to virtual happy hours, working in the office with our colleagues to videoconferencing in our homes, clinic visits to telehealth appointments.

On a research industry level, clinical trials were disrupted. In attempts to keep them ongoing, the U.S. Federal Drug Administration (FDA) encouraged virtual clinical trials. Also known as decentralized clinical trials or site-less trials, virtual clinical trial participants do not have to be physically present on site. Instead, technology and remote methods–such as telephone conversations, videoconferencing, mobile apps, wearable devices, email and social media–are used to provide investigators with real-time data and information about participants’ symptoms.

Due to the crisis, researchers had to adapt or rethink their studies as 80 percent of clinical trials were affected–either closed or postponed–in the United States, and on varying levels globally. In response, the FDA issued guidance in March (with an update in July) to pharmaceutical companies on how to run virtual clinical trials for any drug development, not just possible virus vaccines.

“The FDA is helping industry and investigators navigate the COVID-19 pandemic and help assess how to move forward with critical clinical trials,” said Anand Shah, M.D., FDA Deputy Commissioner for Medical and Scientific Affairs. “We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants.”

COVID-19 Impact on Clinical Trials for Alzheimer’s and Dementia

Clinical trials on Alzheimer’s and other dementias were not exempt from being upended. Prior to the crisis, there were more than 230 active trials supported by the National Institute on Aging, which have since been impacted.

In an interview with Medscape Medical News, Heather Snyder, PhD, vice president, Medical & Scientific Relations at the Alzheimer’s Association, said, “The pandemic is having a significant impact on Alzheimer’s research, and medical research in general. Many clinical trials worldwide are pausing, changing, or halting the testing of the drug or the intervention.”

And in this unpredictable environment, researchers are hesitant to say when things will kickstart again, some even citing up to a year or more before they resume. How the teams have adapted depends on the study,” said Dr. Snyder. “As you can imagine, things are changing on a daily basis.”

One can only conceive how trial participants, patients, their loved ones, and even researchers must feel. Currently, there is no cure for Alzheimer’s and other dementias, and clinical trials are the cornerstone of finding that treatment to fight against the sixth leading cause of death in the United States, and fifth in the world. And now, that search for a cure has paused or slowed down.

FDA Efforts to Modernize Clinical Trials

Before the crisis, the FDA already saw the benefits of innovation and looked to modernizing clinical trials. Back in 2014, when COVID-19 and physical distancing were non-existent in our vocabulary, the FDA had already begun exploring the use of technology and sought feedback on ways to improve clinical trials.

Two years later, the FDA signed the 21st Century Cures Act into law to “help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.”

And just last year, the FDA created the Technology Modernization Action Plan (TMAP) to bridge the gap between scientific advances and the technology needed to “translate those advances into new therapies for patients and new ways to protect the public health.”

Lessons Learned from COVID-19

Dare we say, if there are silver linings to the pandemic, they would be changes to FDA policies in drug development, and the increased awareness and push toward more virtual clinical trials.

In a quantitative survey, more than half of participants said their awareness of clinical trials increased as a result of news about COVID-19. And 68 percent of adults in the United States (diagnosed with at least one medical condition) said they are more likely to consider participating in a clinical trial now than they were before the pandemic.

In June, FDA Commissioner Stephen Hahn, M.D. cited lessons the FDA learned from COVID-19. He committed to making permanent some of the identified changes and improvements to increase the efficiency of the FDA in carrying out its regulatory responsibilities.

According to Dr. Hahn, the FDA also reviewed how clinical trials should be designed and conducted. Some of the permanent changes include the acceleration of decentralized clinical trials and in the area of real-world data, which has the potential to provide rapid and actionable information to better understand disease symptoms and evaluate therapies.

“To the extent that innovations and adaptations we implemented during the pandemic crisis worked and would be appropriate to implement outside of a pandemic situation, we will incorporate them into standard FDA procedures,” said Dr. Hahn. “And to the extent that we identified unnecessary barriers, we will remove them. This is one of my top priorities. Permanent change, where needed, will take place…Anything that makes quicker reviews and authorizations, we will see to make permanent.”

Why Shift to Virtual Clinical Trials?

While virtual clinical trials are nothing new and have been on the rise, COVID-19 has put them in the spotlight – accelerating them and making them a viable choice.

Some benefits of going virtual:

  • Better patient engagement
    – Studies show that with geographical barriers removed, the dropout rate in phase 3
    – Trials can be reduced up to 40 percent. Virtual trials are also safer as they allow participants to be remote in their homes and eliminate travel time (and reduce travel costs).
    – A larger more diverse population of participants is reached and granted greater access to treatment, especially those with mobility issues.
  • Improved data capture and collection
    With a larger number of participants recruited, data capture and collection also increase. Virtual clinical trials are a powerful means of collecting data and meet timelines at a faster rate.
  • Cost efficiencies
    Since clinical trial sites are not needed or reduced in number, operating costs are lowered.

How Savonix Can Help

If you’re doing research (virtual or traditional) on cognitive health, Savonix–a virtual neuropsychologist platform–can support your studies.

Savonix Mobile is the only digital evidence-based cognitive assessment based on the gold standard of neuropsychological measures. In 30 minutes, participants can independently and remotely test their cognitive health on any mobile device, and you’ll receive immediate results.

We have a growing database of 50 million data points to provide investigators with insights into test performance and cognition that can be leveraged for your research protocol.

Use Savonix to advance your studies:

  • Recruit the right participants remotely with our clinically valid platform.
  • Gather sensitive cognitive data and monitor lifestyle factors with our 3D Unity game mechanics and integration with Apple Health App.
  • Access our real-time data remotely to enable quick enrollment decisions and analysis of results.
  • Our digital cognitive assessments are device-agnostic, accurate, and reliable. As a researcher, you can choose from our battery of cognitive tests such as focus, memory, and attention, and tailor them to your research criteria.
  • Track compliance of your participant’s cognitive health remotely.

Other Features of Savonix Mobile:

1

  • Completion Rates – our experience demonstrates 98 percent completion rate and repeat testing capability.
  • Accuracy and Sensitivity – detects cognitive impairment 84 percent greater than traditional pen and paper tests.
  • Cost-Effectiveness – because participants can take the assessment on their own time from their own homes, you no longer require costly clinicians to administer the test.
  • Repeat Assessment Capability – uses parallel forms of configurable tasks to control for practice effects across repeated administrations.

2

Our HIPAA and Part 11 compliant dashboard is accessible on any mobile device, and ensures researchers receive valid, reliable, and secure data.

  • Clinical flagging ensures only the most meaningful data is being used for your trial.
  • Provides access to in-depth cognitive, demographic, and behavioral analyses.

3

Neuro Consulting – our neuropsychologists and clinical team consulting services range from help with study design to statistical analysis planning to data reporting and insights.


References

Benefits and Challenges of Virtual Clinical Trials. (n.d.) Clinical Research Society. Retrieved from https://www.clinicalresearchsociety.org/benefits-challenges-virtual-clinical-trials/#:~:text=They%20are%20safer%20and%20more,to%20increased%20number%20of%20patients.

Clinical Trials: Benefits, Risks, and Safety. (n.d.) National Institute on Aging. Retrieved from https://www.nia.nih.gov/health/clinical-trials-benefits-risks-and-safety

Grabski, J. (2019, November). Virtual Clinical Trials: Testing New Drugs from Afar. Harvard University The Graduate School of Arts and Sciences. Retrieved from http://sitn.hms.harvard.edu/flash/2019/virtual-clinical-trials-testing-new-drugs-afar/

Terry, M. (2019, July). What Are Virtual Clinical Trials? An Interview with Science 37’s Jonathan Cotliar. BioSpace. Retrieved from https://www.biospace.com/article/what-are-virtual-clinical-trials-an-interview-with-science-37-s-jonathan-cotliar/

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. (2020, July). Food and Drug Administration. Retrieved from https://www.fda.gov/media/136238/download

Coronavirus Takes its Toll on Alzheimer’s Clinical Trials. (2020, April 3). Global Alzheimer’s Platform. Retrieved from https://globalalzplatform.org/2020/04/03/coronavirus-takes-its-toll-on-alzheimers-clinical-trials/

FDA Affirms Interest in Promoting Decentralized Clinical Trials. (2019, August 12). The Association of Clinical Research Professionals. Retrieved from https://acrpnet.org/2019/08/12/fda-affirms-interest-in-promoting-decentralized-clinical-trials/

Gaffney, Alexander. (2014, October 28).  Regulatory Affairs Professionals Society. “FDA Wants Input on How to Improve Clinical Trials Process for Industry.” Available at: http://www.raps.org/Regulatory-Focus/News/2014/10/28/20636/FDA-Wants-Input-on-How-to-Improve-Clinical-Trials-Process-for-Industry/

The top 10 causes of death. (2018, May 24). World Health Organization. Retrieved from https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death

Facts and Figures. (n.d.). Alzheimer’s Association. Retrieved from https://www.alz.org/alzheimers-dementia/facts-figures

Taylor, P. N. (2020, June 2). Hahn: Permanently adopting R&D-accelerating COVID-19 measures is a top FDA priority. Retrieved from https://www.fiercebiotech.com/biotech/hahn-permanently-adopting-r-d-accelerating-covid-19-measures-a-top-fda-priority

National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Forum on Drug Discovery, Development, and Translation; Shore C, Khandekar E, Alper J, editors. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington (DC): National Academies Press (US); 2019 Jul 23. 2, Opportunities to Improve Clinical Trials. Available from: https://www.ncbi.nlm.nih.gov/books/NBK548971/

McNamara, D. (2020, April 29). Trials and Tribulations: Neurology Research During COVID-19. Medscape Medical News. Retrieved from https://www.medscape.com/viewarticle/929643#vp_1

Pretorius, S. (2020, April). Decentralized Clinical Trials (DCT) in the Time of COVID-19 and Beyond. Online PowerPoint presentation at Parexel Virtual Clinical Trials Conference Online.

Considerations For Improving Patient Recruitment Into Clinical Trials. (n.d.) Clinical Leader. Retrieved from https://www.clinicalleader.com/doc/considerations-for-improving-patient-0001#:~:text=The%20average%20dropout%20rate%20across,no%20patients%20in%20their%20studies

Drug Developers Actively Improving Efficiency of Clinical Trials, According to Tufts Center for the Study of Drug Development. (2011, April 26). The Tufts Center for the Study of Drug Development. [Press Release] Retrieved from https://static1.squarespace.com/static/5a9eb0c8e2ccd1158288d8dc/t/5aa92acd652dea0498443a51/1521035981653/apr2011-pr.pdf

Miseta, E. (2017, April 20). Survey: 50% of Americans Not Aware of Clinical Trials. Clinical Leader. Retrieved from https://www.clinicalleader.com/doc/survey-of-americans-not-aware-of-clinical-trials-0001