R&D,Clinical Development,Clinical Operations,Race and Ethics,Precision and Personalised Medicine,News

Avoiding Bias in Precision Medicine

6 months ago By admin
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Precision medicine, or the tailoring of healthcare towards either a select group or individual based on their needs and physiology instead of their illness, is a well-known and highly-anticipated aspect of healthcare pharmaceuticals, with thousands of articles written on it. 

But for its many touted advantages (greater survival rate and quality-of-care for patients; vastly improved drug efficacy; a greater understanding of disease mechanisms), some elements of precision medicine have faced criticism. Perhaps one of the most well-known and troubling concerns of the model is its inherent biases involving ethnicity. While such a fundamental flaw in the underlying data remains, the field cannot advance. We looked at what is being done to change the model, and how effective such initiatives currently are.

The Current Problem

The bias problem has been a known issue for quite a while. In 2018 the Data & Society Research Institute reported that precision medicine could cause harm through discrimination against minority groups. They determined that almost exclusively rich, white men would benefit from the model due to their good insurance and lifestyles. Women, minorities and immigrants would be far less supported.

The major problem of bias lies in historical studies and current datasets: most overwhelmingly consist of white communities. One example is the guidelines for U.S. lung cancer screenings. These are based on a study of 53,000 people, with African Americans making up only 4%. As recently as October 2019 it was found that all minorities are under-represented in U.S. cancer studies, with only 2% of clinical trials focusing on minorities. Earlier in 2019, a study found that 10% of the African genome is missing from the human genome project. 

The issue is not purely in early research and R&D: it is also largely in the clinical trial space. Such trials have long had issues with diversity, caused by several factors. These include a lack of knowledge or awareness of the need for such diversity, a bias against the traditional healthcare system or a lack of insurance and cost problems. Around 20% of drugs are thought to act differently based on race and ethnicity. Pharmacokinetics particularly behave wildly differently between Europeans and East Asians. Other drugs can be more effective in men than women

Solutions to the Bias

Aware of the problem, many researchers are taking correcting measures. In 2015 the U.S. National Institutes of Health, undertaking an enormous Precision Medicine Initiative study, made significant efforts to address the issue. In the study, minority groups were over-represented relative to the general population, allowing for greater statistical significance when studying them.

Similarly, the Population Architecture using Genomics and Epidemiology study, published in June 2019, conducted a genome-wide association study of 26 phenotypes in almost 50,000 non-European individuals. It found that a mutation rare in Europeans occurs in 1% of Latinos and 6% of African Americans, proving the utility of such research. A CDC study found African American individuals twice as likely as Europeans to die from uncontrolled hypertension. Another found that Native Americans are ethnically most inclined to type 2 diabetes.

These programs, and others such as the All of Us Research Program, are addressing the issue in an extremely slow and long-term way, however. They do not in themselves take steps to correct the issue today, nor do they address fundamental underlying concerns around patient engagement and current pharmacological incompatibility. 

National genomic initiatives and their kind can greatly help target the demographics of each country. However these still avoid the issue that so many pharma companies create drugs with a particular, largely white, population in mind. A lack of efficacy and arguable safety here is often still unaddressed. 

This touches on the issue of clinical trials: with limited trial diversity, the effect of a drug on a given population just cannot be accurately ascertained. Having said that, last year the FDA issued draft guidance on enhancing trial diversity and improve enrolment practices to better represent a population along racial and ethnic lines. 

There are also many wider ways to address the lack of diversity in clinical trials. CROs and universities, which often have a wider reach and better connectedness than many pharmaceutical companies, can use their influence to encourage awareness and understanding. 

Pharma companies seeking to increase diversity can increase their cultural and linguistic competency. This means understanding cultural differences and requirements as well as simply speaking the common language. New technologies which increase comfort and access to medicine, such as wearables or virtual trials, can also have a big impact in trial uptake. 

On a broader front, scientists can ensure that from the outset studies take into account variable cost management policies. This ensures greater individualisation of treatment, dependent on ethnicity and heritage. 

One alternative is the customisation of current medicines for different minority populations. The H3D company is a great example of this, created to tailor medicines for African-American communities. It also fosters the running of clinical trials in Africa, a continent on which only 2% of global studies take place. This is for a number of reasons: lack of predictability, long timelines and the centring of quality trials on only a few centres across the landmass stand among others. The centre attempts to treat malaria, tuberculosis and anti-microbial resistance, particularly optimising those drugs for the treatment of individuals of African descent. 

Several other organisations are doing excellent work in the area, including the Wellcome Trust DELTAS program and the GSK Africa OpenLab.

What Difficulties Remain?

Even with programs like H3D, a number of challenges remain. Alongside the lack of big pharma clinical trials held in the continent, the attracting and retaining of talent in such organisations is difficult. 

Another concern is regulatory pressure. While the African Medicines Agency has moved the regulatory field forward in recent years, much still needs to be done. Collaboration between drug regulators and the pharma industry must increase. Regulators must widen their capacity to review drugs, allowing for simultaneous introduction of products. Drugs take on average five to ten years to reach Africa after U.S. launch, and as such increased speed and efficiency of getting to market are imperative. 

Conclusion

From a cursory glance at the hundreds of statistics on the subject, it is clear there is still a considerable lack of diversity in precision medicine research. Until it is confronted and overcome, precision medicine will be at best biased and at worst unreliable and potentially unsafe. Both immediate and more far-reaching initiatives are certainly in the pipeline. It is clear however that more must be done to rebalance the issue as soon as possible.

Precision medicine is the future. As it stands, it is one of the most promising pathways to greater healthcare and better, safer treatment for all. But until the mentioned methods see greater take-up, the future is a hope more than an inevitability. 

Joshua Neil, Editor
Proventa International


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