The pharmaceutical giant AstraZeneca is conducting a major review of diversity across its trials in an attempt to ensure its medicines work for all population groups, although it has admitted that including pregnant women is a particular challenge.
The head of oncology at Britain’s biggest drugmaker, David Fredrickson told the Guardian that the firm was among those leading efforts to improve participation of people of colour and other under-represented groups in clinical trials.
Speaking on the sidelines of the World Economic Forum’s annual meeting in Davos, he called it applying an “equity lens” to every phase of the medicine’s lifecycle.
Concerns have been raised that a lack of diversity among volunteers participating in clinical trials may result in drugs and medical equipment being developed that are less effective in certain groups.
Pregnant women are one such cohort of concern. “Pregnancy is a common and almost universal exclusion for clinical trials,” Fredrickson said, admitting that the issue is a “more challenging one to tackle” for the industry.
The situation meant that that group was excluded from trials for coronavirus vaccines, and public confusion over whether the shots were safe for pregnant women ultimately led to a low uptake. A major review eventually found that the jabs are safe and also reduce the risk of stillbirth by 15%.
However, last autumn pregnant women were still being turned away from Covid vaccine clinics despite advice to the contrary, and a disproportionate number of those in hospital with Covid were unvaccinated pregnant women. One study found they made up one in six of 118 Covid patients requiring the most intensive ventilation treatment.
While vaccine uptake among pregnant women rose from 23% in August to 54% at the end of last year, doctors believe thousands still have not had the jab.
The UK health secretary, Sajid Javid, has launched a review into systemic racism and bias in medical devices to examine why people of colour and women have worse health outcomes.
Early studies of Covid vaccine, including an Oxford trial conducted by AstraZeneca, were criticised for mainly involving white participants, despite the virus having a disproportionately larger effect on people of colour. The firm and others later ran larger trials involving thousands of volunteers around the world.
AstraZeneca has now embarked on what Fredrickson described as an “effort to catalogue what is the ‘state of the union’ of AstraZeneca’s trials” past and present in terms of how they reflect patient diversity. The early signs are that it has “pretty good representation” of different groups, “but there’s more we can do”.
Fredrickson said the pharma industry as a whole was working towards better representation of women, people of colour and Latinx people. Asked if the company was also looking at the inclusion of transgender people in clinical trials, he said he was “not aware of a specific effort” but added: “We’ are going to need to move to lots of different groups.”
He said the industry was “taking a hard look” at the eligibility criteria for clinical trials of new medicines. Many cancer trials exclude people with type 2 diabetes, which excludes people with obesity.
More than two-thirds of black adults were overweight or obese in England in the year to November 2020, the highest percentage of all ethnic groups, according to official figures.
Other ways of improving diversity include “bringing trials to patients” by letting them join trials from the comfort of their homes through greater use of technology, also for certain routine medical treatments and monitoring, said Fredrickson.
Fredrickson was speaking the day after he addressed a session at Davos about the future of health in the global south, and is due to speak about global action on lung cancer at the meeting in the Swiss resort on Wednesday.
