Drug Research and Development for Adults Across the Older Age Span Proceedings of a Workshop (2021) / Chapter Skim
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6 Clinical Trials in the Era of COVID-19 and Beyond
6 Clinical Trials in the Era of COVID-19 and Beyond
Pages 65-78
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From page 65... ...
The goal of drug development is to assure quality, safety, and efficacy of products that are delivered to patients, said Sven Stegemann, professor for patient-centric drug development and manufacturing at the Graz University of Technology. This is achieved through a defined program that involves discovery, development, clinical trials, and presenting evidence for regulatory approval.1 In the past few decades, this process has 1 For more information, see https://www.fda.gov/drugs/drug-information-consumers/ fdas-drug-review-process-ensuring-drugs-are-safe-and-effective (accessed November 11, 2020)
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From page 66... ...
Acting thoughtfully and in sync with other stakeholders, he said, will bring innovative medicines to patients faster; these innovations "might be considered a quantum leap in health care a few years from now." In this session, speakers considered how clinical trials, research, and health care have changed in response to the COVID-19 pandemic, and explored how some of these changes might be beneficial for the future. A REGULATORY PERSPECTIVE FDA responded rapidly to the COVID-19 pandemic, said Harpreet Singh, acting division director of the FDA Division of Oncology 2.
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From page 67... ...
Former FDA Commissioner Gottlieb expressed support for such approaches before the pandemic, stating in 2019 that "pragmatic and hybrid clinical trials, including decentralized trials that are conducted at the point of care -- and that incorporate real-world evidence -- can help clinical trials become more agile and efficient by reducing administrative burdens on sponsors and those conducting trials, and can allow patients to receive treatments from community providers without compromising the quality of the trial or the integrity of the data being collected."4 In closing, Singh asked workshop participants to consider three issues: • Can researchers leverage clinical trials conducted during the COVID-19 pandemic to understand the implications of remote assessments and decentralized trial procedures for older adults? 4 For more information, see https://www.fda.gov/news-events/speeches-fda-officials/ breaking-down-barriers-between-clinical-trials-and-clinical-care-incorporating-real-worldevidence (accessed November 12, 2020)
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From page 68... ...
support coverage of devices for older adults with certain impairments? A CLINICIAN PERSPECTIVE Many common acute infections disproportionately affect older adults, said John Powers, professor of clinical medicine at The George Washington University School of Medicine.
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From page 69... ...
He said that value in health care "means improving patient outcomes, not just improving processes." There is a growing trend toward patient-focused drug development and the collection of real-world evidence about how interventions are used in practice, he said, but clinical trials often still do not focus on the outcomes or populations that are most relevant. There is also a need for clinical trials to measure outcomes that matter to patients, particularly for older adults, Powers said.
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From page 70... ...
TELEHEALTH APPLICATIONS Although telehealth has been reimbursable since 1997, said Erika Ramsdale, assistant professor at the University of Rochester Medical Center, limitations and restrictions on reimbursement have meant that implementation of telehealth has lagged behind the technology.5 Many of these restrictions were lifted due to the COVID-19 pandemic,6 and there has been rapid uptake of the use of telehealth. For example, the number of Medicare beneficiaries receiving telehealth services each week went from nearly zero to approximately 1.7 million over the course of 1 month (see Figure 6-2)
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From page 71... ...
FIGURE 6-3 Internet and home broadband access for adults age 65 and older. NOTES: Adults over age 80 are less likely than younger older adults to have broadband or Internet access, but age is not the only factor.
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. The study found that there was no difference in clinical outcomes compared with in-person visits, and not only were patients satisfied with virtual visits, but they preferred them (55 percent to 18 percent)
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Clinicians can leverage the "unfortunate opportunity" of the pandemic to rapidly iterate ideas, gather pilot data, and further the promise of telehealth for older adults. DIGITIZATION OF MEDICINE Eric Topol, founder and director of the Scripps Research Translational Institute, told workshop participants about a study that launched in March 2020 called DETECT (Digital Engagement & Tracking for Early Control & Treatment)
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From page 74... ...
There has been a major movement toward centering patients, including PCORI's engagement with patients,8 FDA and NIH routinely including patients in their decision making,9 and patients serving as members of peer review panels. Unfortunately, COVID-19 has spotlighted what has long been known: There are large disparities in health care outcomes among racial, ethnic, socioeconomic, and age groups.10 COVID-19 has exposed the systemic weaknesses in health care systems, and despite programs to overcome these disparities, we have made only incremental progress, she said (Zimmerman and Anderson, 2019)
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From page 75... ...
Remote Consent Stegemann noted that older adults sometimes have cognitive impairments such as dementia, and he asked panelists to address the issue of obtaining remote consent for older adults to participate in research. Singh started by saying that FDA has guidance that specifically addresses how to obtain remote or virtual consent from a legally authorized representative of an impaired patient.11 However, she noted that FDA guidance is not legally binding, and that many states, institutions, and health care systems do not permit remote consent.
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From page 76... ...
She said that the language is often complex medical language rather than "something that was easy for a layperson to understand." She noted that this is a barrier to trial participation that does "not need to be there." With the health inequities and disparities in this country, she said, researchers should be facilitating access to research participation rather than setting up barriers. Applications for Technology in Research and Clinical Care Stegemann asked panelists whether the pandemic will have an impact on how technology is used in research and clinical care.
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From page 77... ...
Canin noted that some people may prefer video visits when the alternative is in-person visits with both parties masked and distanced. COVID-19 as an Impetus for Change "We need to insist that a lot of these changes continue" past the COVID-19 pandemic, said Powers.
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