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Clinical trial diversity: the drug developer’s guide in 2024

How to have quality data and high chances of market success


Going after diversity in clinical trials may not sound like the highest ROI activity.

Executives rarely see it as a priority. They often perceive diversity as a way to improve the public image.


The last thing drug developers want is to worry about more regulatory restrictions. 


However, recent data proved clinical trial diversity is a cornerstone of market success.


So how do savvy drug developers navigate this complexity? The answer lies in understanding diversity in clinical trials.


We are Rubix LS, a patient-centric research catalyst (CRO+) specializing in cancers and diseases that lack access. In this article, we’ll guide you through everything you need to know about diversity in clinical trials. Fundamentals, actionable steps, real-life examples, and lessons from 12 million patients on Rubix LS’s sites.


(More about Rubix LS at the end.)


Keep reading, or choose a section to jump ahead


 

Why is diversity in clinical trials important?


Having a representative pool of participants goes beyond PR and public image. Lack of diversity can kill a drug’s chances at market success.


The cost of biased clinical data is as high as market failure, and the repercussions ripple through later stages.


People of different ages, races, and ethnicities react differently to medical products.


This can lead to unpleasant surprises when the drug hits the market – if ever.

But what is clinical trial diversity?



What does it mean to have clinical trial diversity?


Clinical trial diversity means including a representative and diverse range of participants in clinical trials.


It ensures that different demographic groups (races, ethnicities, genders, and age groups) are well-represented.


This is crucial for:


  • Having generalizable research findings

  • Ensuring that the benefits and risks of medical interventions are understood across diverse populations

  • Improving health access


We often associate clinical trial diversity with overlapping terms, like patient centricity, patient advocacy, and health equity.


Patient-centricity


Patient-centric drug development means incorporating patient viewpoints and preferences into clinical trial design. The primary goal of patient-centricity is informed decision-making.


Patient-centricity makes trials more engaging and collects data more efficiently.


Patient Advocacy


Patient advocacy is the active support and promotion of patient rights. It involves individuals or organizations supporting the patients’ needs. Patient advocacy is more of a characteristic of healthcare design.


Patient advocacy influences design, development, regulation, public perception, ability, and patient satisfaction in clinical trials.


Patient advocacy positively impacts business metrics for hospitals and healthcare systems.


Health Equity


Healthcare equity (or health equity) is a state where everyone has a fair opportunity to attain their highest level of health. It addresses social determinants of health and health disparities. Clinical trial diversity is a result of practicing health equity.


But what prompted such approaches to healthcare? And what does the regulatory scene look like today?


The science behind the disparities: why are diseases biased?


Social inequality is enough by itself to cause higher rates of health issues and mortality in minorities.


But increasing chances of market success starts with knowing the complex genetic-biological-social interplay.


The genetic influence, in turn, involves a web of anatomy, biochemistry, physiology, and immunology – all tied to environmental factors. Consider the following recent facts:


  • Biomarkers. Different ethnic groups display stark differences. A 2019 study demonstrated differences in biomarker concentrations between ethnic groups. The study involved healthy children and adults from different ethnic backgrounds (Black, Caucasian, East Asian, and South Asian). Of the biomarkers tested, 14 out of 18 showed statistically significant variations between at least two ethnicities

  • Heart health. Another 2019 study showed that biomarkers of lipids, adipokines, endothelial function, inflammation, myocyte injury, and neurohormonal stress varied from one race to another. These variations are at the root of heart disease disparities.

  • Markers of metabolism. More recent data showed ethnic differences in complement system biomarkers and their link to metabolic health in men of Black African and White European ethnicity.


The role of race as a biological and genetic determinant is still a topic of debate. Racial health disparities are easier explained by social determinants such as structural racism, rather than genetic differences.

When talking about health disparities, socioeconomic and environmental factors often come to mind. But ethnic-specific variations in biomarkers are obvious.

With such complex differences between ethnic groups, the question posts itself:



Why don’t minorities participate in clinical trials?


Successful recruitment starts with answering a key question:


"Why would minorities be reluctant to join a trial?"


Minority groups can (and do) participate in clinical trials. But they are often underrepresented.


Several factors have historically led to minorities being left out:


  • The lack of minority investigators on top of trials

  • Not being asked to participate

  • Lack of trust in the medical community

“The first thing we learned was even the brightest kids from the African-American and Hispanic communities—when they finish their pharmacy, nursing, or medical studies –don't stay at the universities and engage in clinical trials because they have to go back home and work and support their families. Therefore, they can't do clinical trials in a sustained manner.”

~ Dr. Patrice Matchaba, MD (Via AAMC)


A common myth is that inclusivity increases trial costs. Taking the time to and curate participants and recruit a representative population might seem trivial and time-consuming.


Yet, a 2022 study identified instances where the lack of diversity in clinical trials resulted in adverse patient outcomes.


Neglecting proper recruitment, then, can be detrimental to the outcome of clinical research.


But how do these intricacies translate in regulatory filings? Do clinical trial authorities today see the discord?


Regulatory challenges: the evolution of clinical trials


Another element of a successful drug development strategy is knowing the regulatory forces in control.


The regulatory landscape in clinical trials has evolved rapidly over the years.


The FDA


The first turning point was the FDA inheriting regulatory authority over new product areas in 1976.


Since then, the FDA put efforts to streamline healthcare development, but also modernize clinical trial design and make it more adaptive to change.


2020-present


The roller coaster of the 2020s impacted the landscape of clinical trials.


The COVID-19 pandemic prompted crisis management and critical thinking. We had to come up with pragmatic, integrated, and efficient approaches to clinical care and trial administration.


The pandemic led to changes in study sites, extended programs, and amendments to planned trial closure, monitoring, and screening activities.


The FDA issued new guidelines for conducting clinical trials during the pandemic. There was a need for risk-based decision-making and evidence-based recommendations to address on-site challenges.


Cancer care was another pressing need during the pandemic. Efforts to modernize cancer clinical trials have been emphasized to more quickly produce prevention, detection, and treatment measures to combat cancer.


The COVID-19 pandemic exacerbated the challenges in clinical trial accrual, leading to the need for flexible, faster, simpler, less expensive, and higher-impact clinical trials.


The latest turning point was the FDA’s draft guidance for decentralized clinical trials (DCTs). The guidance included updated recommendations for good clinical practices. The goal was to make clinical trials more agile and receptive to change, without compromising data integrity.


The 2020s taught us a lesson: remote interventions and the collection of outcomes data using electronic health records. They are being considered for implementation in the post-pandemic world to enhance the efficiency of the clinical research enterprise.


With changes in mind, what do clinical trials look like today?


Current struggle with diversity: mistakes to avoid


Recent data shows that clinical trials are drifting away from clinical best practices:


  • Lack of diversity in participant populations resulted in adverse patient outcomes

  • Of US-based trials, 40% didn’t report the race of participants

  • Of those that did report race, 78% of the participants were white, while only 11% Black, 6% were Asian, and <1% were Native American

  • Other statistics state that Black patients account for as low as 5% of clinical trial participants in the United States.

  • A 2022 analysis stated that 40% of US cancer clinical trials did not have a single black patient, despite Black Patients having the lowest cancer survival rates!

  • The total percentage of minority inclusion from all randomized controlled trials (RCTs) published in the United States during the last 25 years was 3.95%


Many strategies aim at refining the recruitment process. Such practices are not appealing to sponsors, because they can incur additional costs initially.

But the long-term benefits of producing quality results outweigh these initial costs. Otherwise, the consequences can be severe.


Consequences of limited diversity


Rubix LS’s experience with over 12 million clinical trial patients taught us that diversity is key. Here are the lessons that patient data teaches us every day:


Extended recruitment periods


What seems like a way to save time might do the opposite. Researchers may struggle later to comply with regulatory requirements. They end up taking more time than they would have initially if the recruitment process were lean


Market access and reimbursement failure


Regulatory agencies and payers may ask for evidence of a drug's efficacy and safety in diverse patient populations. If a drug has a biased clinical trial, it may face challenges in obtaining market access and reimbursement, hurting its commercial success.


Delayed Drug Development


If the trial results are not generalizable to the broader population, regulatory authorities may ask for additional studies. Meaning more cost, longer development timelines, and missed deadlines.


Health disparities


People of different ages, races, and ethnicities may react differently to certain medical products. Without enough representation, it is challenging to understand how medical products will affect different populations.


Questionable science


The scientific validity of a new drug development. This lack of representation may lead to inefficiency or irresponsibility in releasing drugs to the public.


Inequitable access to care


Minorities are more likely to face health disparities and issues related to access to care. The underrepresentation of minorities in clinical trials can also perpetuate these disparities by limiting their access to potentially beneficial treatments.


The different statistics all point to the same pattern. Healthcare is leaving minorities, and drug success is going down.


Real-life examples


In 2015, the FDA approved a new drug after trials showed that patients taking the medication could go an average of six months without multiple myeloma spreading.


The problem was that there were only 13 (out of 722) black participants. While 20% of Americans who suffer from the disease are black, less than 2% of the patients studied were black.


Black Americans have the highest death and lowest survival rates of any group in the US for most cancers. Yet ProPublica also found that in trials for 24 of the 31 cancer drugs approved between 2015 and 2018, less than 5% of the subjects were black.


Big pharma is guilty of misrepresentation as well. AstraZeneca’s “Tezspire” got FDA approval for severe asthma after its Phase III trial results in 2022. Only 5.8% of Tezspire’s Phase III trial participants were Black. 


"Releasing drugs without good science is at best inefficient and at worst irresponsible”

~Jonathan Jackson, PhD (via aafp.org)


However, there are positive examples of using diversity.


Here at Rubix LS, we address disparity with data. Here are three cases where diverse data helped supercharge drug development and improve health outcomes.


Case study 1


Creating a fast, high-engagement, low-dropout clinical trial by using real-time mapping.


Challenge


A research group wanted to improve patient recruitment, cycles, engagement, and trial outcomes.


Goal


Using smart data to reduce intervention time and track recruitment.


Solution


The team chose Rubix LS for their eight-month study.


We used Rubix LS 12-million-patient-deep data to create a real-time mapping system for patient recruitment, cycles, engagement, and trial outcomes.


The Rubix LS team collected data on patient characteristics, diseases, and even environmental factors to create precise medical outcomes.


Result


The results were impressive. Our system:

  • Reduced the time for interventions and patient care by 77%

  • Patient retention went up to 98%


Patients stuck to the trials, showing the impact of proactive engagement and diverse data.


Case Study 2


Up to 60% faster lead candidate selection with Rubix LS's advanced platform.


Challenge


Lead candidate selection extends for a full cycle of 31-40 months.


Goal


Compressing this lifecycle to under 21 months.


Solution


  1. Rubix LS started from similar models and real-world evidence. Then segmented the diverse data into microlibraries (scientific, genetic, environmental, etc.).

  2. Then designed around the current development process, using key compression factors to shorten the lifecycle of required testing.

  3. Rubix LS created a dual consulting and technology platform. It served as both a knowledge hub and a scientific AI analytic repository (i.e. digital libraries).


The platform’s libraries were at distinct levels of sophistication:


  • Level 1: Hit confirmation.

  • Level 2: Comprehensive biophysical drug criteria.

  • Level 3: Lead optimization (LO).

  • Preclinical level: Thorough physical performance assessment (toxicity, mutagenicity, etc.)


Result


  • An all-in-one Hit to Lead protocol

  • A compressed development cycle

  • A harmonious balance between speed and safety

  • Fast delivery of effective drugs to those in need

  • A profitable drug development process


Case study 3


Data-driven insights on COVID-19's disparate impact on minority communities.


Challenge


The COVID-19 virus spread rapidly worldwide. The US faced a significant challenge in responding to the increasing demand for testing and treatment.


The impact of the virus extended beyond health. It affected both public well-being and the economy.


The main challenge was the lack of transparent data about the specific impact on underrepresented minority communities and vulnerable populations.


Equitable access to testing and treatment was key.


Goal


A report explored data on underrepresented minorities with potential COVID-19 symptoms.


To understand the disparities and facilitate access to testing. Ultimately contributing to better outcomes for all affected individuals.


Solution


Rubix LS leveraged intelligent data networks and its data machination. Rubix LS also collaborated with 103 healthcare institutions in seven regions.


Through a basic algorithmic log application, Rubix LS was collected on patients consenting to participate.


Underrepresented groups (Black, Native Americans, Hispanic, and others) were a specific target for data sorting.


Result


Rubix LS:


  • Conducted 41-day data collection with 67,610 symptomatic patients.

  • Matched over 40% (27,344 patients) with their final diagnosis

  • Revealed disparities, particularly among African-Americans and Hispanics with a household income under $50,000 per year

  • Demonstrated an opportunity for comprehensive national data collection

  • Highlighting a need for collaborative efforts to address health disparities and ensure accurate reporting of COVID-19 cases


Rubix LS also started designing data collection programs. Rubix LS can supplement reporting systems and provide accurate information on COVID-19 cases at local, state, and national levels.


In all three examples, Rubix LS data diversity was the factor behind drug development success.


Benefits of clinical trial diversity


The case studies above show a sample of the pros of inclusivity. Participation in clinical trials by people of all backgrounds can have a long list of benefits:


Higher volume of actionable patient insight


A diverse trial produces a higher volume of actionable patient insight at every development stage. The higher volume of data leads to well-informed decisions in the future. This leads to more successful clinical trial design and lower patient recruitment costs – more profitable processes.


Improved public perception and increased profits


A patient-centric, diverse culture improves the public perception of stakeholders. This presents an opportunity for hospitals, companies, and healthcare systems to show a good image and values.


Diverse workforce and advisors


Inclusion does not just include patients. Pharmaceutical companies can have a diverse workforce, advisors, investigators, and vendors. Being inclusive on both ends of a trial – the patients and the personnel – leads to a better understanding of real patient needs and preferences. This clarity removes a lot of the blind spots and gives more successful products.


Enhanced engagement, retention, and recruitment


Patients enroll more, engage more, stay longer, and drop out less in an in inclusive, patient-centric atmosphere. Patient comfort minimizes cost bleeding that results from dropouts or delayed recruitment. This means better quality data, more continuous data, and a more sustainable trial.


Regulatory mandates and patient-centered drug development


Regulators often demand adding the patient perspective into the product development and approval process. This extra piece of data can inform clinical, regulatory, and patient decisions, potentially leading to faster regulatory approvals and market access, positively impacting profitability.



How can patient diversity help pharma executives?


In short, it de-risks and speeds up the journey to the market.


There is no shortage of ways a drug can fail at any point along the development funnel. Hedging against the population’s non-uniform response to drugs removes a huge statistical risk.


Executives who practice diversity rest assured that they did their diligence on the trial's statistical credibility.


They know that later trials will be easier. They're also more confident in regulatory submissions.


Practicing diversity also makes later rounds of funding easier. Meticulous pharma companies gain respect among investors. Investors feel (and look) good giving money to companies that advocate health equity.


Small pharma companies try to strike a balance between risk and innovation. This is an opportunity for young leaders to position themselves as drivers of positive change in the industry.


Now that you know the challenge, it’s time to take a step towards staying ahead of the curve.


Getting help is a wise decision. And CROs who have deep patient data experience can supercharge your drug development’s R&D.


Rubix LS: AI-enabled therapeutics for inclusive health


Imagine a world where developing medications doesn’t take as long. Where therapies are efficient regardless of demographics. Where the drug hits the real needs of the population.


This is what we’re achieving at Rubix LS—a research catalyst (CRO+) rewriting the playbook of clinical research.


Here’s how we do it:


We don’t just license


Rubix LS allies with research institutions, pharmaceutical organizations, and other life science companies, acquiring their FDA-approved intellectual property (IP). We leverage data, AI, and technology to reveal broader efficacy. We ensure these medications work for the largest population of patients.


We don’t do cold transactions


We work hand-in-hand with the manufacturer to secure FDA approval. We guarantee inclusivity in the very fabric of these groundbreaking treatments.


We don’t inherit success.


We evolved it. Our secret weapon? The power of AI and a dataset record of our over 12 million patients!


We lead the R&D


While the original manufacturer takes charge of the final production and distribution. This dynamic ensures success for all stakeholders.


Rubix LS not only guarantees smoother sailing. But also an efficient product.


Rubix LS is crafting a new era. We’re redefining healthcare with diversity-centric innovation.

Looking to supercharge your drug’s R&D? The Rubix LS team is a message away. Reach out to us today.


Conclusion


Drug development is a risky and data-sensitive journey. And your data is technically inaccurate if it comes from a narrow population.


Diversity is now more than a mere buzzword. It's a pillar of efficient and safe treatments. This is why deep expertise in inclusivity, data, and R&D can help boost your chances of market success.


More data and better treatments are on their way. Rubix LS is leading the charge.


Looking to catalyze, supercharge, and inform your drug’s R&D with data? Reach out to Rubix LS today! (We're a message away).



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