The Culture Wars Strike Clinical Trials

FDA purges material on clinical trial diversity from its site, showing stakes of Trump DEI ban

In recent years, the importance of diversity in clinical trials has gained significant attention in the medical research community. This focus is not just a matter of inclusivity; it’s a crucial scientific and ethical imperative that directly impacts the quality and applicability of medical research.

Why Diversity in Clinical Trials is Essential

Scientific Validity and Generalizability

Different populations may respond differently to the same treatment due to variations in genetics, lifestyle, and environmental factors. By including diverse participants, researchers can better understand how a treatment works across various groups, leading to more accurate and widely applicable results.

Addressing Health Disparities

Minority groups often experience poorer health outcomes in various diseases. Including these groups in clinical trials is a crucial step towards understanding and addressing these disparities, potentially leading to more targeted and effective treatments for underserved populations.

Innovation and Discovery

Diversity in clinical trials can lead to unexpected discoveries. For instance, the identification of PCSK9, which revolutionized our understanding of cholesterol homeostasis, was a result of studying variations in cardiovascular risk factors among different racial groups.

Alignment with ICH Guidelines

The International Council for Harmonisation (ICH) has recognized the importance of diversity in its updated guidelines, particularly in ICH E6(R3) and ICH E8(R1).

ICH E6(R3)

This guideline emphasizes the importance of including diverse patient populations in clinical trials. It encourages the use of innovative trial designs and technologies to enable wider participation and inclusion of diverse populations. The guideline also stresses the need for quality by design (QbD) and a focus on critical-to-quality factors, which inherently includes considerations of diversity to ensure the reliability of trial results.

ICH E8(R1)

ICH E8(R1) focuses on the general considerations for clinical studies and emphasizes the importance of engaging with a broader range of stakeholders, including patients and patient advocacy groups. This approach naturally leads to more diverse perspectives in trial design and conduct, potentially increasing participation from underrepresented groups.

The Impact of Recent Policy Changes

The recent purge of FDA pages on clinical trial diversity, as reported by STAT News, raises significant concerns about the future of inclusive clinical. This action, part of a wider executive order banning diversity, equity, and inclusion (DEI) initiatives, could have far-reaching consequences:

Reduced Guidance: The removal of these resources may leave researchers and pharmaceutical companies with less clear direction on how to ensure diverse representation in their trials.
Potential Setbacks: Years of progress in improving trial diversity could be undermined, potentially leading to less representative studies and, consequently, less generalizable results.
Health Equity Concerns: This move could exacerbate existing health disparities by reducing the focus on including underrepresented groups in clinical research.
Scientific Integrity: The quality and applicability of clinical trial data may be compromised if diversity is not actively pursued, potentially affecting the safety and efficacy of new treatments for certain populations.

Moving Forward

Despite this setback, the scientific and pharma community must continue to prioritize diversity in clinical trials. The principles outlined in ICH E6(R3) and E8(R1) provide a strong foundation for this effort. Researchers, pharmaceutical companies, and regulatory bodies should:

Continue to develop innovative recruitment strategies to reach diverse populations.
Engage with community leaders and organizations to build trust and awareness about clinical trials.
Design trials with flexibility to improve access for all populations, including the use of decentralized trial elements.
Maintain a focus on quality by design, ensuring that diversity considerations are built into trial planning from the outset.

It is important to remember that E6(r3) is the regulation in Europe, while it is a guidance in the US. So companies need to follow it for their EMA approval possibilities.

In conclusion, diversity in clinical trials is not just a matter of equity; it’s a scientific necessity that ensures the development of safe and effective treatments for all populations. While recent policy changes may present challenges, the medical research community must remain committed to this crucial aspect of clinical research, guided by international standards and ethical imperatives.

Robert Morris and Koko are Violators of International Standards

The Declaration of Helsinki is the bedrock of international principles in human research, and the foundation of governmental practices, including the ICH E6 Good Clinical Practice. The core principle is respect for the individual (Article 8), their right to self-determination and the right to make informed decisions (Articles 20, 21 and 22) regarding participation in research, both initially and during the course of the research. Principles that Dr Robert Morris violated when his firm, Koko, used artifical intelligence to engage in medical research on uninformed participants. The man, and his company, deserves the full force of international censure, including disbarment by the NHS and all other international bodies with even a shred of oversight on healh practices.

I’m infuriated by this. AI is already an ethically ambigious area full of concerns, and for this callous individual and his company to waltz in and break a fundamental principle of human research is unconsciouable.

Another reason why we need serious regulatory oversight of AI. We won’t see this from the US, so hopefully the EU gets their act together and pushes forward. GPDR may not be perfect but we are in a better place with something rather than nothing, and as the actions of callous companies like Koko show we are in desperate need for protection when it comes to the ‘promises’ of AI.

Also, shame on Stonybrook’s Institutional Review Board. While not a case of IRB shopping, they sure did their best to avoid grappling with the issues behind the study.

I am pretty sure this AI counts as software as a device, in which case a whole lot of regulations were broken.

“Move fast and Break Things” is a horrible mantra, especially when health and well being is involved. Robert Morris, like Elizabeth Holmes, are examples of why we need a strong oversight regime when it comes to scientific research and why technology on its own is never the solution.

The Supreme Court’s Decision in Dobbs v. Jackson Women’s Health is a Bleak One for the Life Sciences Industry

I think it is no secret that I inherently view Quality as a progressive endeavor, and do not see eye-to-eye with colleagues who are conservative. How anyone can take our anti-Taylorist endeavor and not get to stands like the importance of human rights and the need to center those whose rights are challenged – like women – is beyond me. How can we stand for autonomy and not fight for the autonomy of all.

The silence of quality organizations is deafening.

What I want to write about now is how the roll-back of Roe in Dobbs should be a real clarion call to the life science industry, which needs to stop funding conservative politicians because those politicians do not have our best interests at heart.

The fight over Mifepristone and Misoprostol has already begun. The religious conservatives will go after it, and this reactionary court will need to gut the FD&C and the rest of the regulatory regime behind drugs in this country to let that happen. This will be really bad. It will cause life science companies to pull research, clinical trials, and manufacturing from this country as we will no longer be the gold standard in the life sciences. We will be a joke.

Take action:

Give to abortion funds
Check your company’s PAC and see exactly who it is giving to and make noise that funding anti-abortion, anti-science politicians is not acceptable
Support your colleagues. If you are male-identifying realize that most of your colleagues just got gut-punched today. Support them.

Sackler family sweetens deal to $6billion

I will not be happy with this story until every member of the Sackler family who was involved in the decision-making at Perdue is in jail and the family has lost every dollar they made. But I am heartened to see the failure of their failed bankruptcy ploy leading to the addition of another 1.5 billion in settlement.

Sackler family members to contribute up to $6 billion in latest agreement to resolve opioid claims

For the regulatory state to function there needs to be teeth, and quite frankly we do not see the teeth nearly enough.

Toyota is a horrible exemplar

Just like the immense sins of Jack Welch and GE will always tarnish six Sigma it is past time to realize that the conservative, looking backwards to Toyota of much of Lean thinking is a mistake that limits adoption and more importantly innovation.

As a company there is much at Toyota that is just wrong. The 2020 recalls were significant, but frankly not the first year the company has been having major quality contorl issues.

But more important is the fact the company is a liar and a supporter of authoritarianism. As a promponent of the pillars of Lean thats just damn hypocritical. After the failed coup of Janaury 6th, Toyota pledged to no longer fund anyone who supported the attack against US democracy. As of June they are the top fundraiser to those Republicans, giving to nearly a quarter of the 147 GOP politicians who objected to certifying the election results.

Toyota is showing us who they are. A company that stands apart from the principles so important to the Quality profession.