Drug Research and Development for Adults Across the Older Age Span Proceedings of a Workshop (2021) / Chapter Skim
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7 Reflections and Key Takeaways
7 Reflections and Key Takeaways
Pages 79-90
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From page 79... ...
TRANSPARENCY AND ENGAGEMENT "Sunshine is the best disinfectant," said Bernard, quoting former Supreme Court Justice Louis Brandeis. The NIH strategy has been to leverage policy to allow more "sunshine" onto the issue of underrepresentation of older adults in clinical trials, she said.
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From page 80... ...
This requirement could potentially impact institutions because NIH could withhold funds for future clinical studies if the required reports are not made, Bernard said. One last "sunshine" policy is a requirement that a final Research Performance Progress Report2 be submitted "for any grant that is terminated and any award that will not be extended." This will provide the public with an opportunity to see the outcomes of NIH clinical studies "in a way that was not feasible previously." In addition to these policies, said Bernard, the NIH inclusion policy officer is cochairing a diversity collaborative with the Clinical Trials Transformation Initiative.3 This collaborative is working to develop resources to demonstrate the value of increasing diversity in clinical trials and adopting practices that include diverse populations in the development process for drugs and devices.
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From page 81... ...
Third, Califf said the complexity of comorbidity and polypharmacy is "daunting" and there is a need for a dedicated stream of research in this area. Research on individual issues will "not solve the problem"; rather, there is a need for a holistic approach that integrates research along the spectrum from basic pharmacology to aging organs to the phenomenology of frequent transfers between a hospital and an assisted living facility.
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From page 82... ...
the Orphan Drug Act,6 which gives sponsors increased flexibility for submission of orphan drug designation requests -- providing financial incentives for developing drugs for rare diseases; and (2) pediatric drug development policies, which require companies to assess safety and effectiveness of new drugs/biologics in pediatric patients and provide financial incentives for companies to voluntarily conduct pediatric studies.
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From page 83... ...
Particularly when working with older adults who may have experienced numerous complexities in life, stakeholders should "have compassion for all and recognize that this is hard and that we are going to have to all work in order to make it better." DISCUSSION Policy Considerations Appleby noted that NIH and FDA already had policies in place to ensure appropriate inclusion of various populations in clinical research.7,8 7 For more information on NIH policies, see https://www.niams.nih.gov/grants funding/conducting-clinical-research/trial-policies-guidelines-templates/nih-federalguidelines (accessed November 11, 2020)
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From page 84... ...
Abernethy added that one important contribution of any policy is seeing "what it looks like for these policies to be in action." Important steps are for clinical trialists to see what it looks like when eligibility criteria are widened, for companies to see that FDA is comfortable with these changes, and for statistical reviewers to consider how changes may affect the analysis plan. As has been learned from COVID-19, she said, "there is a lot to be learned just by doing it and then adjusting along the way." Califf noted that NIH has considerable power to enforce policies because it decides whether researchers get their next grant.
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From page 85... ...
In the future, said Abernethy, all three of these categories will come together: The changes that were already occurring will be amplified, stakeholders will learn from the practices that have been liberalized, and necessary additional features will be recognized. Pediatric Exclusivity Provision In 1997, Congress enacted a provision that provides companies with 6 months of marketing exclusivity in return for conducting pediatric studies.10 Appleby asked Califf if a similar model might be feasible to incentivize drug studies among the older adult population.
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From page 86... ...
Engaging Underrepresented Populations Although the focus of this workshop is on the inclusion of older adults in clinical trials, said Appleby, the disproportionate impact of COVID-19 on communities of color has highlighted the issue of underrepresentation of diverse populations in clinical trials. Appleby asked panelists to comment on what is being done to address this issue, both in general and in trials specific to COVID-19.
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From page 87... ...
What FDA found, she said, was that there seemed to be a mismatch between the trials and the medical needs of people: "We were not shooting our arrows in the right place." This type of use of ClinicalTrials.gov is one way to better understand deficits when it comes to clinical trials and can help stakeholders think through how to do it better, she said. REFLECTIONS Appleby asked the three panelists to give 1-minute summaries of their thinking on the issues discussed at the workshop, and the likelihood of seeing meaningful progress on inclusion of older adults in clinical trials in the next 5 years.
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From page 88... ...
• Innovative designs: There are clinical trial designs available that offer promise for increasing enrollment of older adult popula tions, including adaptive platform trial designs, home-based trials, mechanistic modeling, clinical trial simulation, real-world data, and pragmatic clinical trials. Clinical trials can be carried out in many environments, including, for example, at home, in barber shops, and in pharmacies.
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From page 89... ...
• Incremental change or sea change: Canin asked whether COVID-19 would lead to incremental change or a sea change in the con duct of clinical trials and health care in general. More broadly, asked Appleby, will there be a sea change in the systems that perpetuate ongoing health disparities?
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