Got Sleep? How to Sleep Better at Night

This week in the Guardrail, simple adjustments to your grocery list can lead to immediate improvements in nighttime rest. New research highlights that prioritizing nutrient-dense whole foods can be an accessible strategy for boosting an individual's health. And maybe the vitality of your whole organization.

By Michael Bronfman
March 2, 2026

How to Sleep Better at Night

From counting sheep to white noise machines and weighted blankets, people have tried almost everything to get a good night's sleep. For many adults, restful sleep feels frustratingly out of reach. Trouble falling asleep or staying asleep is common, and it is not just an annoyance. Poor sleep can affect heart health, blood sugar control, memory, learning, mood, productivity, and relationships. Over time, chronic sleep problems raise the risk of serious health conditions and increase health care costs.

New research suggests that one of the simplest tools for better sleep may already be part of your daily routine, or at least it could be. According to a study led by researchers at the University of Chicago Medicine and Columbia University, eating more fruits and vegetables during the day is linked to better sleep that very same night. This finding points to diet as a practical and affordable way to support healthier sleep.

Diet is something people choose every day. Unlike medications or devices, food is accessible, familiar, and often easier to change in small steps. This study provides strong evidence that what we eat during the day may directly affect how well we sleep at night.

Why sleep quality matters

Sleep is not just about how many hours you spend in bed. Quality matters just as much as quantity. Deep and continuous sleep allows the brain and body to recover. During sleep, the body repairs tissues, regulates hormones, supports immune function, and consolidates memory. When sleep is broken or shallow, these processes are interrupted.

Over time, poor sleep quality has been linked to high blood pressure, heart disease, obesity, type two diabetes, depression, and anxiety. It can also make it harder to focus, learn new information, and manage emotions. From a public health standpoint, sleep problems contribute to workplace accidents, lower productivity, and higher medical spending.

Because sleep affects so many systems in the body, researchers are eager to understand all the factors that influence it. While stress, screen use, and sleep schedules are well-known contributors, diet has been harder to pin down.

What we already knew about diet and sleep

Past studies have shown that sleep and diet influence each other. People who do not get enough sleep tend to eat more high-calorie, high-fat, high-sugar foods. Lack of sleep can disrupt the release of hunger hormones, making people feel hungrier and crave less nutritious foods.

However, the reverse relationship has been less clear. Scientists have suspected that diet affects sleep, but many earlier studies relied on self-reported sleep quality. Participants were often asked how well they thought they slept, a subjective measure. These studies also struggled to determine whether diet changes preceded sleep changes or vice versa.

The new study from the University of Chicago and Columbia University addressed these gaps by examining timing and using objective sleep measurements.

Inside the new study

The study focused on healthy young adults. Participants were asked to record everything they ate each day using a smartphone app. This allowed researchers to track fruit and vegetable intake, as well as other aspects of the diet, in real time.

At the same time, participants wore a wrist monitor that measured their sleep patterns. This device provided objective data on sleep duration and sleep fragmentation. Sleep fragmentation refers to how often a person wakes up or shifts between deep and light sleep during the night. Higher fragmentation means more disrupted sleep.

By matching daytime diet data with sleep data from the following night, researchers found that food choices during the day were associated with sleep quality just hours later. This approach helped establish a temporal connection between diet and sleep.

Clear and meaningful results

The findings were striking. On days when participants ate more fruits and vegetables, they tended to sleep more soundly that night. Their sleep was deeper and less interrupted. Similar benefits were seen in participants who ate more healthy carbohydrates such as whole grains.

Using statistical modeling, the researchers estimated that people who meet the Centers for Disease Control and Prevention recommendation of five cups of fruits and vegetables per day could experience a sixteen percent improvement in sleep quality compared to people who eat no fruits or vegetables.

According to Esra Tasali, MD, director of the UChicago Sleep Center and co-senior author of the study, this level of improvement is meaningful. She noted that it is remarkable to see such a significant change in sleep quality in less than twenty-four hours.

This suggests that even short-term dietary changes may have immediate benefits for sleep.

Why fruits and vegetables may help with sleep

The study did not focus on exact biological mechanisms, but existing science offers some clues. Fruits and vegetables are rich in fiber, vitamins, minerals, and antioxidants. Fiber plays a key role in digestion and blood sugar regulation. Stable blood sugar levels may support more consistent sleep patterns.

Many fruits and vegetables also contain micronutrients involved in sleep regulation. These include magnesium, potassium, and vitamin C. Some plant foods are sources of compounds that support the production of serotonin and melatonin, hormones that help regulate sleep and circadian rhythms.

Healthy carbohydrates, such as whole grains, may also help by increasing tryptophan availability, an amino acid involved in serotonin production. Together, these nutrients may create conditions in the body that favor deeper and more continuous sleep.

A natural and cost-effective approach

One of the most appealing aspects of this research is its simplicity. Dietary changes do not require prescriptions or specialized equipment. Fruits and vegetables are widely available and can be incorporated into many types of meals.

Tasali emphasized that dietary modification could be a natural and cost-effective way to improve sleep. From a public health perspective, this matters. Sleep medications can be helpful for some people, but they may come with side effects and are not always intended for long-term use. Lifestyle-based strategies can complement medical care and support overall health.

Marie Pierre St Onge, PhD, director of the Center of Excellence for Sleep and Circadian Research at Columbia University and co-senior author of the study, highlighted the empowering nature of these findings. She noted that small changes can impact sleep and that better rest may be within reach through everyday choices.

What this means for health care and pharma

For the pharmaceutical and health care industries, this research adds to a growing body of evidence that lifestyle factors play a crucial role in managing chronic conditions. Sleep is closely tied to metabolic and cardiovascular health, areas where many pharmaceutical therapies are used.

Improving sleep through diet may enhance the effectiveness of existing treatments and, in some cases, reduce reliance on medications. It may also open the door to new approaches that combine nutritional guidance with medical care.

From a research standpoint, these findings highlight the importance of studying non-drug interventions alongside traditional therapies. Understanding how diet interacts with sleep and metabolism can inform prevention strategies and support more holistic patient care.

Next steps for research

While the results are promising, the authors are clear that more research is needed. The study focused on healthy young adults, so future studies will need to examine whether the findings apply to older adults, children, and people with chronic health conditions.

Researchers also want to better understand the biological pathways that link fruit and vegetable intake to sleep quality. This includes studying digestion, brain signaling, and metabolic processes in more detail.

Longer studies could help determine whether sustained dietary changes lead to lasting improvements in sleep and whether better sleep, in turn, leads to improvements in other health outcomes over time.

Practical takeaways for everyday life

For people looking to improve their sleep, this study offers an encouraging message. Adding more fruits and vegetables to daily meals may help support better sleep the same night.

This does not require a complete diet overhaul. Simple steps such as adding fruit to breakfast, including a salad or vegetables at lunch, and filling half the dinner plate with vegetables can make a difference. Choosing whole grains over refined carbohydrates may also help.

While diet is not the only factor affecting sleep, it is one that people can often control. Combined with good sleep habits such as consistent bedtimes, reduced screen use before bed, and regular physical activity, dietary changes can be part of a comprehensive approach to better sleep.

About the study

The study titled “Higher daytime intake of fruits and vegetables predicts less disrupted nighttime sleep in younger adults” was published in June 2025 in Sleep Health, The Journal of the National Sleep Foundation. The research was led by scientists from the University of Chicago and Columbia University and supported by grants from the National Institutes of Health and the Diabetes Research and Training Center at the University of Chicago.

More information and a summary from the University of Chicago Medicine.

Reach out to Metis Consulting Services today to learn more. And to take your organization to a competitive advantage with Risk-mitigation and Quality Strategies and Systems.

How to REMS – A Practical Regulatory Guide

This week in the Guardrail, we look at mastering the FDA’s toughest safety oversight protocols -REMS.  As scrutiny intensifies, your team must move beyond simple checkboxes to build a truly resilient system.

Written by Michael Bronfman

Risk Evaluation and Mitigation Strategies, or REMS, are required by the FDA for certain drugs with serious safety concerns. The goal of a REMS program is to ensure that the benefits of a drug outweigh its risks. REMS programs can be complex and highly visible to regulators. Companies must be prepared not only to design and implement a REMS but also to demonstrate that it works.

REMS inspections are increasing in depth and frequency. Being prepared requires a clear understanding of regulatory expectations, strong operational controls, and a culture of compliance.

When a REMS Is Required

The FDA may require a REMS at the time of approval or after a drug is on the market. This decision is based on known or potential risks associated with the product.

REMS may be required when labeling alone is not enough to manage risk. Examples include drugs with serious side effects, high misuse potential, or risks related to pregnancy or long-term use Understanding when and why a REMS is required helps sponsors plan early and avoid delays.

FDA information on REMS

Key Components of a REMS Program

Not all REMS programs are the same. Some are simple, while others are complex and involve multiple stakeholders.

Common REMS components include:

• Medication guide – information provided to patients about risks
  

• Communication plan – educational outreach to healthcare providers
  

• Elements to assure safe use – such as prescriber certification, pharmacy certification, patient enrollment, or monitoring requirements
  
  

Each component must be clearly defined and supported by procedures and training.

The FDA provides REMS guidance .

Regulatory Expectations for REMS Inspections

During a REMS inspection, FDA investigators focus on whether the program is implemented as approved and whether it effectively manages risk.

Inspectors will review policies, procedures, training records, and systems used to support the REMS. They may also interview staff responsible for REMS operations.

Key expectations include clear role definitions, documented processes, and evidence of oversight. Sponsors must show that they monitor compliance and address issues promptly.

Failure to meet REMS requirements can lead to warning letters, fines, or other regulatory actions.

Documentation Is Critical

Documentation is one of the most important aspects of REMS readiness. Every part of the program must be supported by written procedures.

This includes how prescribers are certified, how patients are enrolled, how data is collected, and how compliance is monitored.

Inspectors often ask to see examples of records. Missing or inconsistent documentation is a common inspection finding.

Companies should ensure that records are complete, accurate, and easy to retrieve.

Training and Accountability

Training is a core regulatory expectation for REMS programs. Staff involved in REMS activities must understand their responsibilities.

Training records should show who was trained, when training occurred, and what content was covered. Refresher training should be provided when procedures change.

Accountability is equally important. Roles should be clearly assigned, and oversight should be documented.

Strong training programs reduce the risk of errors and inspection findings.

Monitoring and Auditing REMS Performance

Sponsors are expected to monitor REMS performance on an ongoing basis. This includes tracking compliance with program requirements and identifying trends.

Regular audits help identify gaps before they become regulatory issues. Audit findings should be documented, and corrective actions should be implemented and tracked.

FDA guidance emphasizes the importance of continuous evaluation of REMS effectiveness

Inspection Readiness Best Practices

REMS inspection readiness should be built into daily operations. Waiting for an inspection notice is too late.

Best practices include:

• Maintaining up-to-date procedures
  

• Conducting mock inspections
  

• Ensuring staff can confidently explain the program
  

Centralized documentation systems help ensure consistency and access. Leadership involvement reinforces the importance of REMS compliance.

Evolving REMS Inspection Trends

REMS inspections are becoming more detailed. Inspectors increasingly focus on how data is used to evaluate effectiveness.

They may ask how the sponsor determines whether the REMS is meeting its goals. They may also review how changes to the program are assessed and implemented.

Technology systems used to support REMS are also under greater scrutiny. Data accuracy, security, and access controls are key areas of focus.

Sponsors should be prepared to explain system validation and oversight.

Managing Third-Party Vendors

Many REMS programs rely on third-party vendors. These vendors may manage call centers, data systems, or training.

While vendors perform the work, the sponsor remains responsible. Inspectors will review vendor oversight and contracts.

Clear agreements, regular performance reviews, and documented oversight are essential. Vendor issues are a common source of REMS inspection findings.

REMS Modifications and Updates

REMS programs may need to be modified over time. Changes may be driven by new safety information or operational challenges.

Regulatory expectations for REMS modifications are strict. Changes must be reviewed and approved by the FDA before implementation unless otherwise permitted.

Sponsors should maintain clear change control processes and documentation.

Preparing for the Inspection Day

On the day of a REMS inspection, preparation makes a difference. Staff should know who will interact with inspectors and where documents are stored.

Responses should be clear and factual. If information is not immediately available, it is better to follow up than to speculate.

A calm and organized approach supports a positive inspection outcome.

Looking Ahead

REMS programs are a critical tool for managing drug safety. Regulatory scrutiny in this area will continue to increase.

Companies that invest in strong REMS design, clear documentation, and continuous monitoring are better positioned to meet expectations.

REMS compliance is not just a regulatory requirement. It is a commitment to patient safety and public trust.

Is your safety strategy ready for the spotlight? Don’t wait for a knock at the door—Contact  Metis Consulting Services to sharpen your oversight and secure your path to market

Regulatory Pathways FDA and EMA – Are You Prepared for Ongoing AI Supervision?

As regulators deploy advanced digital tools to scan for inconsistencies in real-time, pharmaceutical companies must redefine their approach to data integrity and organizational transparency to stay ahead of the curve. This week, the Guardrail analyses how the FDA and EMA are transitioning from milestone-based reviews to the new model of continuous AI-driven oversight.

By Michael Bronfman, for Metis Consulting Services

February 16, 2026

Regulatory pathways in the United States and Europe are becoming more complex. The FDA and the EMA continue to raise expectations for data quality, transparency, and oversight. At the same time, regulators are expanding their use of advanced digital tools, including artificial intelligence, to review submissions, monitor compliance, and identify risk.

For pharmaceutical companies, this shift changes how regulatory readiness should be defined. It is no longer enough to meet written requirements alone. Companies must be prepared for continuous supervision supported by AI-driven systems that can detect patterns, inconsistencies, and signals faster than traditional reviews.

Understanding how FDA and EMA pathways work today and how AI supervision fits into them is essential for long-term success.

Core FDA and EMA Regulatory Pathways

The FDA and EMA share the same goal of protecting public health, but their regulatory pathways differ in structure and process.

In the United States, drugs are typically approved through the New Drug Application or Biologics License Application process. These submissions include clinical, nonclinical, and manufacturing data. The FDA evaluates whether the product is safe, effective, and manufactured under appropriate quality standards.

FDA drug approval information is available at https://www.fda.gov/drugs

In Europe, the EMA oversees centralized marketing authorization for many products. A single approval allows access to all European Union member states. The review is conducted by scientific committees that assess quality, safety, and efficacy.

EMA regulatory guidance can be found at https://www.ema.europa.eu

While the pathways differ, both agencies expect robust data, strong quality systems, and ongoing compliance after approval.

The Shift Toward Continuous Oversight

Historically, regulatory oversight followed clear milestones. Sponsors submitted data. Regulators reviewed it. Inspections occurred at defined points. Today, oversight is becoming more continuous.

Post approval commitments, real-world evidence, and ongoing safety reporting mean that regulators receive data throughout a product life cycle. AI systems allow agencies to process large volumes of information efficiently.

This means issues may be identified earlier and more frequently. Trends that once took years to surface can now be detected in near real-time.

How AI Is Used by Regulators

Regulators use artificial intelligence in several ways. These tools help prioritize reviews, flag anomalies, and focus inspections on higher risk areas.

For example, AI can analyze adverse event reports to identify safety signals. It can review clinical datasets for unusual patterns. It can also examine manufacturing data to detect deviations or data integrity concerns.

The FDA has published information on its digital transformation efforts.

The EMA is also investing in advanced analytics to support regulatory science and supervision. More information. While AI does not replace human judgment, it guides attention and speeds decision-making.

What This Means for Regulatory Submissions

AI supervision changes how submissions are evaluated. Inconsistent data, unexplained outliers, and poor documentation are easier to detect.

Sponsors must ensure that datasets are clean, traceable, and well explained. Narrative justifications should align with underlying data. Discrepancies between modules or sections can trigger questions.

Regulators may compare current submissions with historical data from the same sponsor. Patterns of issues across programs may influence review focus.

This makes consistency and standardization across submissions more important than ever.

Data Integrity Under AI Review

Data integrity has long been a regulatory focus. AI-driven oversight raises the bar further.

Systems that automatically scan data can detect missing values, duplicate entries, or unusual trends. Manual workarounds and undocumented processes are more likely to be noticed.

Sponsors should ensure that data governance is strong across clinical, manufacturing, and pharmacovigilance systems. Access controls, audit trails, and validation remain essential.

Preparing for AI supervision means assuming that data will be examined at scale and in detail. FDA data integrity guidance is available for reference.

Clinical Trial Data and AI Scrutiny

Clinical trial data is a major focus of regulatory review. AI tools can evaluate consistency across sites, subjects, and time points.

For example, unusually similar data across different sites may raise questions. Unexpected enrollment patterns or protocol deviations may be flagged.

Sponsors should strengthen monitoring and quality control during trials. Early detection of issues allows corrective action before submission.

Clear documentation of deviations and decisions is critical. AI may identify the issue, but human reviewers will expect clear explanations.

Manufacturing and Quality Oversight

Manufacturing data is another area where AI supervision plays a growing role. Process data, deviation reports, and change records can be analyzed to identify trends.

Repeated deviations, delayed investigations, or weak corrective actions may draw attention. AI can also compare performance across sites or products.

Companies should ensure that quality systems are proactive rather than reactive. Trending and root cause analysis should be meaningful and timely. The FDA quality system expectations are clearly outlined on their site.  Strong quality culture supports both compliance and operational performance.

Pharmacovigilance and Safety Monitoring

Post-market safety surveillance generates large volumes of data. AI helps regulators process adverse event reports more efficiently.

Signals may be detected earlier, leading to faster regulatory action. Sponsors must ensure timely and accurate reporting.

Safety databases should be validated and monitored. Follow-up procedures must be consistent and documented. Preparedness means having clear roles, trained staff, and reliable systems.

Here is a good description of FDA pharmacovigilance requirements 

Transparency and Traceability Expectations

AI supervision increases expectations for transparency. Regulators may ask how conclusions were reached and how data was managed.

Traceability from raw data to final conclusions is essential. This applies to clinical analyses, manufacturing decisions, and safety assessments.

Documentation should be clear and accessible. Teams should be able to explain decisions without relying on informal knowledge.

This level of readiness supports inspections and builds regulator confidence.

Organizational Readiness for Ongoing Supervision

Preparing for AI-supported oversight is not just a technical challenge. It is an organizational one.

Leadership must support investment in systems, training, and governance. Teams must understand that oversight is continuous, not episodic.

Cross-functional collaboration becomes more important. Issues in one area may affect regulatory perception across the organization.

Training programs should emphasize data quality, documentation, and accountability.

Engaging With Regulators Proactively

Open communication with regulators remains important. Early discussions can help clarify expectations and reduce risk.

Sponsors should be prepared to explain how data is generated, managed, and reviewed. Transparency builds trust.

Regulatory science is evolving. Staying informed about guidance updates and regulatory initiatives helps organizations adapt. 1 2

Looking Ahead

AI supervision is becoming a permanent part of the regulatory landscape. It allows regulators to oversee more products, more data, and more activities with greater efficiency.

For pharmaceutical companies, this means readiness must be continuous. Quality, consistency, and transparency are no longer just best practices. They are essential expectations.

Organizations that embrace this shift and strengthen their regulatory foundations will be better positioned to navigate FDA and EMA pathways with confidence

Don’t wait to discover the gaps in your data integrity or submission strategy.  Metis Consulting Services provides the expert governance frameworks and guidance you need to ensure your organization is not just compliant, but competitive.

Contact: hello@metisconsultingservices.com to fortify your regulatory foundation and navigate the complexities of FDA and EMA pathways with total confidence.

Clinical Trial Optimization

This week in the Guardrail, we dig deeper into clinical trial optimization. This article breaks down the essential strategies—from patient-centric design to proactive compliance—required to navigate the high-stakes journey from protocol to regulatory approval.

By Michael Bronfman for Metis Consulting Services

February 9, 2026

Clinical trials are the backbone of drug development. They provide the evidence needed to show that a product is safe and effective. They also represent one of the largest investments a pharmaceutical company will make. As development costs rise and competition intensifies, optimizing clinical trials is no longer just a nice-to-have or a good idea; it is essential.

Clinical trial optimization means designing and running studies in a way that protects patients, meets regulatory criteria, controls cost, and delivers clear answers. It is about working smarter, not cutting corners.

Why Optimization Matters More Than Ever

Clinical trials take time. Phase 2 and 3 trials may last several years from the first patient enrolled to the final data analysis. Delays are common and expensive. Missed enrollment targets, protocol amendments, and site performance issues can add months or even years to a program.

Each delay raises cost and reduces the effective patent life of a product. In competitive markets, delays can also mean losing the first-mover advantage. Optimization helps reduce these threats by improving planning, execution, and oversight.

Regulators expect sponsors to design trials that are scientifically sound and ethical. Poorly designed trials waste time and expose patients to unnecessary risk. Optimized trials support both business targets and regulatory compliance.

Strong Protocol Design Is the Foundation

Every optimized trial begins with a strong protocol. The protocol defines the study objectives, endpoints, population, and procedures. Weak protocols are one of the most common causes of trial failure.

Common protocol issues include excessively complex procedures, unclear endpoints, and overly restrictive eligibility criteria. These problems slow enrollment and increase protocol deviations.

Sponsors who involve cross-functional teams early have a higher success rate. Ideally, clinical, pharmacovigilance, regulatory, biostatistics, operations, and quality would all review protocol drafts. Early feedback identifies risks before the trial begins.

The FDA provides guidance on clinical trial design and conduct.

Patient Centric Design Improves Performance

Patients are at the center of clinical research, yet many trials are designed with little consideration for patient burden. Long visit schedules, frequent procedures, and complex instructions can discourage participation.

Optimized trials consider the patient experience. Simplifying visit schedules, decreasing unnecessary procedures, and using explicit communication improve enrollment and retention.

Patient-focused drug development initiatives encourage sponsors to incorporate patient perspectives.

FDA resources on this topic are available here 

When patients stay engaged, data quality improves, and timelines are more predictable.

Site Selection and Support Are Critical

Clinical sites play a major role in trial success. Selecting sites based only on past performance or relationships may lead to poor results. Sponsors who use objective criteria such as patient population, access, staffing levels, and infrastructure are more likely to succeed.

Once sites are selected, how is ongoing support managed? Clear training, attentive communication, and realistic expectations help sites perform well.

High-performing sites reduce protocol deviations and data queries. This lowers the monitoring burden and improves inspection readiness.

Enrollment Planning Requires Realism

Enrollment challenges are one of the leading causes of trial delays. Overly optimistic enrollment projections often fail to account for competing trials, complex eligibility criteria, and patient availability.

Optimized enrollment planning uses real-world data where possible. This includes understanding disease prevalence, standard of care, and referral patterns.

Sponsors should also plan for contingencies. Backup sites, flexible enrollment strategies, and regular performance reviews help keep trials on track.

Data Quality Must Not Be an Afterthought

High-quality data is necessary for regulatory approval. Data errors, missing data, and inconsistencies can delay submissions and trigger regulatory questions.

Optimization includes building data quality into trial processes. Clear case report forms, standardized procedures, and timely data review help prevent issues.

Risk-based monitoring approaches focus attention on the most critical data and processes. The FDA provides guidance on monitoring clinical investigations. 

These approaches support efficiency while continuing compliance.

Compliance Coordination From the Start

Optimized trials are designed with regulatory expectations in mind. This includes alignment on endpoints, comparators, and statistical analysis plans.

Early interaction with regulators can help clarify expectations and reduce surprises later. Meetings such as pre-IND and end-of-Phase 2 discussions grant valuable feedback.

FDA meeting guidance is also available.

Coordination with European regulators is also important for global programs. EMA guidance on clinical trials is found here.

Designing trials that meet multiple agency expectations lowers the need for additional studies.

Managing Protocol Amendments

Protocol amendments are common but costly. Each amendment adds time, cost, and operational complexity. Frequent amendments may also raise questions during inspections.

Optimized programs focus on reducing avoidable amendments. This starts with a thorough protocol review and feasibility assessment before trial launch.

When amendments are necessary, clear documentation and training are critical. Regulators expect sponsors to understand why changes were made and how they were implemented.

Vendor Supervision and Responsibility

Most clinical trials rely on vendors such as contract research organizations, laboratories, and data management providers.

While vendors perform key tasks, sponsors remain accountable.

Optimization includes strong vendor selection and oversight.

Clear contracts, defined roles, and success indicators help manage expectations.

FDA gives guidance on sponsor responsibilities. Regular oversight meetings and issue tracking help resolve problems early. Inspectors often review vendor oversight during inspections, making this a vital area of focus.

Inspection Readiness Starts During the Trial

Clinical trial optimization supports inspection readiness. Regulators may inspect sites, sponsors, or vendors during or after a trial.

Optimized trials maintain complete and accurate documentation. Training records, monitoring reports, and issue resolution logs should be readily available.

A culture of quality helps teams respond confidently to inspections. Waiting until a submission is filed to prepare for inspection is too late.

Using Lessons Learned Across Programs

Each trial generates valuable lessons. Optimized organizations capture and apply these understandings across programs.

Post-trial reviews can identify what worked and what did not; these insights may advance future protocol design, site selection, and operational planning.

Continuous improvement helps organizations remain competitive in a challenging environment.

Gazing Forward

Clinical trial optimization is an ongoing effort. As expectations evolve and pressures increase, sponsors must persist in refining their plans.

Well-optimized trials protect patients, support regulatory success, and control cost. They also help organizations deliver therapies to patients faster and with greater confidence.

In a market where delays are costly and scrutiny is high, optimization is far more than a best practice. It is a necessity.

Don’t let trial complexities stall your breakthrough. In an industry where every day counts, Metis Consulting Services can help you get to a streamlined, successful clinical program. Contact Metis Consulting Services today to optimize your path to approval and bring life-changing therapies to market faster.

Why the US Leaving the World Health Organization is Short-Sighted

This week in the Guardrail, what it looks like when a major player walks away from a seat at the global health table and what that power vacuum actually means for the pharmaceutical industry's bottom line. Especially for businesses trying to stay competitive in a connected world. 

By Michelleanne Bradley and Michael Bronfman, Metis Consulting Services

February, 2, 2026

On 22 January 2026, the United States announced that it was formally withdrawing from the World Health Organization. Public health experts, analysts, scientists, and those of us who work in the field find this a dangerous decision that will jeopardize national and global security and is scientifically reckless.

Leaving the World Health Organization is more than a political decision. The consequences are practical, measurable, and deeply connected to health, safety, and a stable economy. This decision weakens disease surveillance, slows drug development, raises health risks, and reduces US influence at a time when worldwide cooperation is imperative.

What the World Health Organization Does

The World Health Organization coordinates global public health efforts. It tracks infectious diseases, sets international health standards, supports vaccination programs, and helps countries respond to emergencies, including pandemics, natural disasters, and outbreaks of emerging diseases.

The WHO's role in medicine, quality, and safety is significant. It runs global systems that monitor drug shortages, counterfeit medication, and adverse drug reactions. These systems support regulators like the US Food and Drug Administration and help pharmaceutical companies operate safely across borders.

The mission of the WHO is to promote health, keep the world safe, and serve the vulnerable.

The US needs the WHO as much as the WHO needs the US. 

How WHO Membership Protects the US

Many in the US assume that global health work benefits only other countries. In reality, WHO programs are a first line of defense for the United States.

Disease outbreaks do not respect borders. Viruses travel by plane faster than governments can react. The WHO operates a global disease surveillance network that alerts countries to new threats early, giving US health agencies and pharmaceutical companies time to prepare diagnostics and treatments. Without direct access and influence, the United States risks slower warnings and less reliable information.

During outbreaks such as Ebola, Zika, and COVID-19, WHO data-informed US public health decisions and supported early research efforts.

Currently, US companies are world leaders in medical research and diagnostics, and the WHO is a massive buyer of those goods. In 2023 alone, the WHO purchased over $600 million in US products. When the US is an active member of WHO, contributing to the stability of the global health market, we help prevent mass economic shutdowns. Interruptions to the supply chain, like those that cost the US trillions of dollars during the COVID-19 pandemic, are a concern. Withdrawal from the WHO creates a leadership vacuum that our rivals will fill. With the US  involved, we can be sure that global health standards, norms, and research agendas will be consistent with our national interests.

Historically, the US has provided expertise in eliminating diseases worldwide, including smallpox, and has brought polio to the brink of eradication. U.S.-funded programs targeting HIV/AIDS (PEPFAR), tuberculosis, and malaria rely on the WHO’s coordination to be effective. By disengaging from these efforts, we risk collapsing the infrastructure we have built. This can lead to a resurgence of diseases we have spent decades and billions of dollars fighting to suppress.

Impact on Pharmaceutical Research and Drug Development

The pharmaceutical industry depends on worldwide coordination of clinical trials. Regulatory standards rely on shared frameworks. Safety signals are detected through international data sharing.

• The WHO supports the development of harmonized guidelines for clinical research, manufacturing quality, and pharmacovigilance. These guidelines reduce duplication, lower costs, and speed patient access to new therapies.

When the US withdrew, companies lost a seat at the table where these standards are shaped. Other countries will still move forward, led by Europe or China, and US firms will then face rules they did not help design. Agencies, including the CDC and NIH, have been instructed to halt official collaboration with the WHO, including co-authoring technical papers and participating in coordinated clinical trials, which previously helped US scientists quickly test treatments in diverse populations. This will create friction in drug development, increase compliance costs, and delay product launches. 

Effects on Drug Safety and Quality

The WHO estimates that one in ten medical products in low and middle-income countries is falsified or substandard. These products do not stay overseas. Global supply chains mean unsafe medicines can enter the US market through imports, online pharmacies, or contaminated raw materials.

The WHO helps countries detect and stop these products before they spread. The WHO shares alerts with national regulators, including the FDA. Leaving the WHO weakens the safety net, putting US patients at greater risk of receiving ineffective or dangerous medicines.

Pandemic Preparedness and National Security

The US government has repeatedly recognized pandemics as serious threats to the economy and defense.

The WHO coordinates pandemic preparedness plans, emergency stockpiles, and rapid response teams. It helps countries share virus samples and critical research data for vaccine development. During COVID-19, early sharing of genetic sequences allowed US companies to begin vaccine development within days. That speed saved innumerable lives. Walking away from the WHO does not make the United States more independent. It makes it more isolated at precisely when cooperation matters most.

On 23 January 2026, California became the first US state to join a WHO-coordinated international network independently. California has joined the Global Outbreak Alert and Response Network (GOARN). California accessed international expertise and data for disease monitoring, allowing the state to stay connected to global health security and utilize early warning systems.  

Loss of Leadership

For decades, the United States has helped shape global health policy through the WHO. This influence helped to align global health goals with values such as integrity, transparency, and accountability. The US's leaving does not eliminate the WHO; it creates a leadership vacuum. Other nations step in and shape priorities in their stead.

Without US participation, our perspectives on data sharing, regulatory science, and ethical research lose impact. This shift affects everything from outbreak reporting to drug approval standards.

Economic Consequences for the United States

Global health stability supports global economic balance. Outbreaks play havoc with supply chains, reduce workforce productivity, and slow trade. The World Bank estimates that pandemics can cost the global economy trillions of dollars. When the US invests in global disease prevention through organizations like the WHO, it reduces the risk of expensive disruptions that negatively impact businesses and workers.

Future of Global Health

Globally, health challenges are becoming more complex. Climate change is expanding the range of infectious diseases. Antibiotic resistance is rising. New viruses continue to emerge.

No single country can manage these risks alone. The WHO remains the only organization with the reach and mandate to coordinate a global response.

Renewing trust and reforming international institutions are difficult, and abandoning them is not a solution. Active participation allowed the United States to push for transparency and efficiency from within.

Leaving the World Health Organization is a mistake with real consequences. It weakens disease surveillance, slows pharmaceutical innovation, increases safety risks, and reduces US leadership worldwide.

For patients, it means greater exposure to health threats and fewer protections. For the pharmaceutical industry, it means higher uncertainty and reduced influence. For the world, it means a less coordinated response to crises that affect everyone.

Global health cooperation is not a favor to other countries. It is an investment in safety, prosperity, and leadership. Walking away from the WHO does not make the United States stronger. It makes the world, including the US, more vulnerable.

While the current administration maintains that leaving the WHO restores accountability for US taxpayers and allows more autonomous health policy, this is actually a penny-wise, billion-dollar-foolish move, leaving the US more vulnerable to the inevitable return of transnational health threats. 

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