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Can technology help diversify clinical trials?

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create
The post Can technology help diversify clinical trials?…



This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. You can read part one of this article here.

As the shift to home working proliferated during the pandemic, work became decentralised – and many businesses were able to be productive with a workforce at home. Teams and Zoom became the backbone of communication and firms embraced new ways of working. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.

Virtual and decentralised clinical trials – where trials are conducted outside of traditional sites (i.e., within homes or within community hubs) – could potentially help reach more participants in rural communities or those who are not able or willing to regularly visit a traditional study site such as a general hospital. While virtual trials come with their own inherent access barriers, i.e. the need for a computer and reliable broadband, the theoretical benefits are clear to see.

How we use technology has gone through a paradigm shift already with telemedicine and remote monitoring becoming necessary during the pandemic. There’s a huge opportunity to work collaboratively with technology companies and make use of digital advances that can improve access, alleviate patient burden, and increase the diversity of participants.

By bringing the trial to the patient, we can build upon established and trusted health practitioner-patient relationships. Patient-centric clinical trials also expand access to clinical trials beyond conventional trial sites which can be expensive and time consuming to travel to.

How technology can be used

Digital technologies can cover a broad range of applications, and include mobile health (mHealth) tools (e.g. wearable device carried by patients to measure certain health-related parameters, remote patient monitoring) and tele-healthcare in clinical trials (e.g. video consultations), health data analytics (e.g. data processing systems that support bioinformatics modelling) and digital record systems (e.g. digital applications, also referred to as “apps”, that function as patient diaries).

Once stakeholders are confident that technologies are adequately validated, selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. The possibilities are endless, and in the context of trial participation and access to medicine technologies could assist:

  • Reduced assessment times and hence increased patient compliance
  • Improving access to individuals with rare diseases in remote settings
  • Reasonable adjustments to allow equal access for individuals with disabilities
  • Patient engagement from marginalised groups with a preference for remote access

To address the implementation of computerised systems, (including instruments, software and services) used in clinical trials in the creation/capture of electronic clinical data, the EU EMA have recently published the ‘Guideline on computerised systems and electronic data in clinical trials’. Using digital technology is no panacea and work needs to be done to ensure it is done correctly. The development of guidance to support companies who require risk assessments when working with clinical trial data on selected computerised systems is welcomed.

It is important for all digital healthcare tools to comply with national and supranational data protection legislation governing the processing of patient health data, where legislation falls outside the scope of medicines regulations. However, if considered early in the drug development plan, compliance is by no means insurmountable and would be offset by the benefits of digital healthcare tools for patient engagement. The adoption of digital healthcare tools in clinical research accelerated dramatically during the COVID-19 pandemic and it is expected that such tools will continue to contribute to clinical research in the future.

What comes next?

There is a huge opportunity for pharma companies to capitalise on by focusing on increased DEI in clinical trials. Not only can conducting clinical research in representative patient groups help actively address unmet areas of medical need for underrepresented populations, but it has the secondary effect of helping companies gain a competitive advantage in an evolving market.

Companies that can demonstrate a diverse and inclusive clinical trial data set to support the safety and efficacy of their product will not only secure payer and regulatory approval, but also improved patient confidence and use of their medicine. Ultimately, building a more comprehensive data set for new and generic treatments will lead to better health outcomes for everyone.

As we saw during the incredible response to the global COVID-19 pandemic, the industry demonstrated resilience and was able to rise to the challenge of an existential threat facing humanity and overcome incredible difficulties to develop and deploy lifesaving vaccines.

But there must be more work done to help instil trust in marginalised groups and navigate barriers in order achieve proportional representation in clinical research.

Underrepresentation is multifactorial, so concerted efforts from life science companies are required to address inequitable healthcare. If not, the paradigm shift in diversity, equity, and inclusion in clinical research, including any lessons we should have learnt during the COVID-19 pandemic, may be forgotten.

About the interviewees

Tanya Chambers is an ex-MHRA (Medicine and Healthcare Regulatory Agency) Senior Assessor with over 15 years’ experience principally evaluating preclinical data packages (small molecules and biologics) accompanying clinical trial applications, EU & UK marketing authorization applications (MRP/DCP/Centralised submissions) and variations across all therapeutic areas. Most recently, Tanya led the preclinical rolling review for COVID anti-viral applications resulting in national roll-out, and was product lead for the review of a vast array of development programmes via UK innovative licensing pathways: iLAP and EAMs. In addition, Tanya has working knowledge of the collaborative review of promising oncology treatments alongside Australia (TGA), Canada (Health Canada), UK (MHRA), Singapore (HSA), Switzerland (Swissmedic) and Brazil (ANVISA): ‘Project ORBIS’.

Liam Johnstone has six years of toxicology experience working across regulators in the UK, developing expertise in medicine, consumer product and agrochemical safety whilst working at the MHRA, OPSS and HSE, respectively. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines. He has provided scientific advice to companies both nationally and as part of the Scientific Advice Working Party (SAWP) on the suitability of non-clinical data packages and study plans, as well as generating guidance for the European Medicines Agency (EMA)


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Highlights of My Weekly Reading and Viewing

Timothy Taylor, “Some Economics of Pharmacy Benefit Managers,” The Conversable Economist, September 28, 2023. This is the nicest treatment of the facts…



Timothy Taylor, “Some Economics of Pharmacy Benefit Managers,” The Conversable Economist, September 28, 2023. This is the nicest treatment of the facts that I’ve seen. I confess that I’ve seen PBMs as something of a black box rather than doing the standard middleman treatment that Tim does.

Tim highlights the work of Matthew Fiedler, Loren Adler, and Richard G. Frank in “A Brief Look at Key Debates About Pharmacy Benefit Manufacturers,” Brookings Institution, September 7, 2023.

Ending paragraph:

As in most economic discussions about the role of middlemen, it’s important to remember that they (usually) don’t just sit around with their hands out, collecting money. Some entity needs to negotiate on behalf of health insurance companies with drug manufacturers and pharmacies. Some entity needs to process insurance claims for drug prices. I do not mean to defend the relatively high drug prices paid by American consumers compared to international markets, nor to defend the costs and requirements for developing new drugs, nor to defend some of the mechanisms used by drug companies to keep prices high. But while it might be possible to squeeze some money out of PBMs for slightly lower drug prices, and it’s certainly possible to mess up PBMs in a way that leads to higher drug prices, it doesn’t seem plausible that reform of PBMs is going to be a powerful lever for reducing drug prices.

Thomas W. Hazlett, “Maybe Google Is Popular Because It’s Good,” Reason, September 27, 2023. I think Hazlett is the best writer in economics. This piece is a good sample.

An excerpt:

The innovation was simple in design, complex in execution, and radical in result. The business achieved a rare triple play: First, a robust new web crawler devised a superior method for finding and tagging the world’s digital content, deploying cheap PCs linked in formations to achieve momentous computing power (Brin’s genius). Second, this more prolific database of global digital content was better cataloged. A clever “Page Rank” score evaluated keyword matches, countering the influence of scammers by scrutinizing the quality of their web page links (Page’s inspiration). Third, “intention-based advertising” displayed commercial messages to searchers self-identified as ready to buy. For instance, the internet user wondering about “coho salmon, Ketchikan, kids” gave Hank’s Family Fishing B&B in Alaska a digital target for its 10 percent off coupon, while signaling to Olay not to bother advertising its skin care products. This solved the famous marketing dilemma: “I know I’m wasting half my ad budget, I just don’t know which half.” Businesses loved these tiny slices of digital real estate, and Google mined gold.

Fiona Harrigan, “America’s Immigrant Brain Drain,” Reason, October 2023.


In June, The Hechinger Report outlined how foreign governments are welcoming U.S.-trained international students. The United Kingdom offers a “high potential individual” visa, which authorizes a two-year stay and is available to “new graduates of 40 universities….21 of them in the United States.” Recruiters from Australia are “attending job fairs and visiting university campuses” in the United States. From 2017 to 2021, according to the Niskanen Center, a Washington-based think tank, Canada managed to attract almost 40,000 foreign-born graduates of American universities.

Most international students want to stay in the U.S. after graduating, but very few are able to do so. The U.S. does not have a dedicated postgraduate work visa. Canada and Australia, meanwhile, have streamlined the steps from graduation to employment to permanent residency. Graduates in the U.S. can complete Optional Practical Training, but it does not lead to permanent residency and lasts a maximum of three years.

Personal note: Actually the maximum of 3 years for Practical Training sounds good. When I took advantage of the F-1 Practical Training visa to be on the faculty of the University of Rochester, the max was only 18 months.

David Friedman, “Consequences of Climate Change,” September 24, 2023. David does his typical calm, clear, masterful job of laying out the facts. He takes the IPCC reports as given and then follows the implications, uncovering a lot of misleading claims in the process. While David takes as given that the earth will heat about another degree centigrade by about the end of the century, he lays out why we can’t be sure that the net effects are negative or positive. Watch about the first 35 minutes of his speech, before he gets to Q&A. I would point out highlights but there is zinger after zinger. And he references his blog and his substack where you can get details.

The pic above is of David Friedman giving his talk.


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Russia’s Military Budget Set To Rise By 70%

Russia’s Military Budget Set To Rise By 70%

Via Remix News,

Russian military spending is set to rise by almost 70 percent — to €106…



Russia's Military Budget Set To Rise By 70%

Via Remix News,

Russian military spending is set to rise by almost 70 percent — to €106 billion — by 2024, according to a Russian Finance Ministry document published Thursday, an increase that illustrates Moscow’s determination to continue its military intervention in Ukraine despite the human and economic costs.

According to the document, Russian defense spending will increase by 68 percent in 2024 compared to this year and will reach 10.8 trillion rubles (€106 billion).

As a result, the amount allocated to defense will represent about 30 percent of total federal spending in 2024 and 6 percent of GDP — a first in Russia’s modern history.

The budget for internal security is set to rise to 3.4 trillion rubles (€33 billion), almost 10 percent of annual federal spending.

The priorities for this budget are outlined as “strengthening the country’s defense capacity” and “integrating the new regions” of Ukraine whose annexation Moscow has demanded, as well as “social aid for the most vulnerable citizens,” just months ahead of the Russian presidential elections in spring 2024.

Conversely, total spending on education, healthcare and environmental protection accounts for barely a third of the defense budget, according to ministry figures. Overall, federal spending will total 36.7 trillion rubles (€359 billion), a dramatic 20 percent increase over 2023.

The government, however, has explained little about how it will finance this large increase, as Russian Prime Minister Mikhail Musustin said last Friday that revenues from the sale of hydrocarbons will be down sharply and will account for “a third of next year’s budget” in 2024, whereas before the invasion of Ukraine, they accounted for half the budget.

The sector used to drive Russia’s growth, hydrocarbon sales are declining due to international sanctions and the European Union’s determination to move away from energy dependence on Moscow.

One indication that the government expects a delicate month ahead for the Russian economy is that it has announced that it has based its budget forecast on the assumption of a dollar worth around 90 rubles, thus betting on a weakening of the national currency in the medium term. The draft budget law for 2024-2026 is due to be sent to the State Duma, Russia’s lower house of parliament, on Friday.

Tyler Durden Sun, 10/01/2023 - 08:10

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Atlantic Overfishing: Europe’s Worst Offenders

Atlantic Overfishing: Europe’s Worst Offenders

Each year, agriculture and fisheries ministers decide on total allowable catches (TACs) for…



Atlantic Overfishing: Europe's Worst Offenders

Each year, agriculture and fisheries ministers decide on total allowable catches (TACs) for commercial fishing.

Scientific bodies, such as the International Council for the Exploration of the Sea (ICES), provide information on the state of fish stocks around the world and recommend maximum catch levels per zone to ensure sustainable fishing.

However, this scientific advice is all too often ignored by the authorities, jeopardizing the sustainability of marine resources.

Statista's Martin Armstrong shows in the following infographic, based on the latest report from the New Economics Foundation, these European countries are the worst offenders for this, having on numerous occasions set their fishing quotas in the North-East Atlantic in excess of the sustainability recommendations in recent years.

You will find more infographics at Statista

Sweden exceeded its recommended TAC by almost 33 percent in 2020 (the latest year available), equivalent to 12,000 tonnes of fish, followed by Denmark (6 percent, 20,000 tonnes) and France (6 percent, 17,000 tonnes).

Ireland, Belgium, Spain and the UK all exceeded their targets by between 2 and 4 percent.

The year before, in 2019, the overshoot of the sustainable fishing threshold in the zone was even more pronounced: 7 percent of the recommended TAC for Spain, 9 percent for France, 10 percent for Belgium, 18 percent for Germany, 20 percent or more for Denmark, the United Kingdom and Ireland, and 52% for Sweden.

Tyler Durden Sun, 10/01/2023 - 07:35

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