Creating the Evidence

Rebecca G. Baker, Ph.D.

Rebecca G. Baker, Ph.D., is the director of the NIH HEAL Initiative®. Read more about Dr. Baker.

Dear HEAL Community,

Scientific findings are not an end but rather a beginning. Data from the more than 1,000 HEAL research projects underway need to be converted, applied, used, and shared. This month, I’ll focus on data by another name: evidence. This topic was top of mind last month when we gathered for the Fourth Annual NIH HEAL Initiative Investigator Meeting. You may want to listen to what we heard from our federal agency leaders about the essential link between research and policy.

Experts in the Field

Science-driven federal agencies like NIH, the U.S. Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), and others rely on the advice of “experts in the field” to make science useful to people through drug approvals and insurance coverage. To make those decisions, regulatory agencies and policymakers at various levels of government (including counties and states) need to know what works and for whom – as well as what the real-world barriers are. Members of the HEAL research community are the experts in the field, guided by partners with the voice of lived experience.

HEAL-generated evidence is arriving, such as recent findings that show both health and public safety benefits of treating addiction in jails. Implementation science projects like this aim to boost uptake of evidence-based practices into regular use, and currently, HEAL funds hundreds of them. HEAL research is also building evidence about how best to deliver life-saving naloxone, drug-testing strips, and sterile syringes (such as through mobile vans or emergency departments).

Many real-world questions about pain management can be addressed through research.

HEAL-generated evidence is emerging from clinical trials conducted in varied healthcare settings to answer questions like these that could transform healthcare access and provide safe choices for people with pain.

Designing Research to Create Useful Evidence

Government-funded insurance coverage decisions often provide a benchmark that private insurers match, which affects millions of people’s access to care. The way HEAL research studies are designed and conducted is an important detail for informing these impactful decisions. For example, HEAL-funded research was deliberately designed to match coverage needs for the use of acupuncture for chronic low back pain in older adults with Medicare coverage. Multimodal care, sometimes called bundled care, is known to be effective but hard to deliver given real-world limitations in provider availability and access to services. To meet this need, HEAL research is testing a bundled treatment for addiction and mental illness that involves a case manager and specialists, nurses, social workers, counselors, and peer recovery coaches. The study was co-designed by Medicaid, with future coverage requirements in mind.

Development of new therapeutics is a key goal for addressing challenges in pain management and all aspects of the addiction lifecycle. There is always a trade-off between safety and risk (nearly all treatments carry some side effects), and FDA looks at this balance carefully. To date, HEAL researchers have submitted to FDA 41 applications for investigational new drugs (INDs) and investigational device exemptions (IDEs). Any or all of these could become new treatments – but each has to be tested in a stepwise fashion to ensure it is safe, works as expected, and improves a person’s health.

As research teaches us more about complex conditions like pain and addiction, FDA is looking for ways to define success beyond traditional measures. HEAL research is paving this path. All HEAL clinical pain research studies are measuring success according to patient-reported outcomes that include pain relief but that also address a person's ability to work, enjoy relationships, and get enough sleep. To encourage clinical use, this information is posted on a website used by CMS as a resource for referring providers.

One of HEAL’s key strategies is to use a whole-person focus for research, which aligns with an increasing federal emphasis on value-based (patient-centric) health services. A large portion of HEAL studies include patients with co-occurring conditions like chronic pain and opioid use disorder, or anxiety and back pain, infections, or any of a range of common health conditions. The initiative’s research is also evaluating the use of different types of providers (pharmacists, peer recovery coaches) and nontraditional care settings (religious organizations, barber shops, neighborhood clinics pdf  2.11 MB) to best meet community needs while adhering to federally defined safety standards.

Looking Ahead

Recently enacted laws that expand buprenorphine prescribing and update medical training requirements about how best to treat substance use disorders are expected to strengthen the context for HEAL research. We hope these policy changes will speed the process of putting results into practice in communities across the country, but challenges arise, such as state-by-state variation in coverage access. More high-quality evidence will be needed to understand the impact of new laws on individual and community health.

Science holds great promise for solving difficult problems. But although research is necessary, it is not sufficient. Our research community must be tethered to reality on the ground: contextualizing data to form solid evidence required to change rules and make laws. The research-policy cycle is dynamic, increasingly so with 24/7 sharing of opinions and news about health. As the world changes, so does science and the data we generate. We need to be very sure that data becomes the evidence needed to help as many people as possible, and fast.

Connect with us by email at [email protected], and subscribe to the NIH HEAL Initiative email list to get the monthly HEAL Digest sent directly to your inbox.