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NHS health data should be used for clinical trial recruitment, says ABPI

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The UK has an opportunity to enhance its global competitiveness in the delivery of industry clinical trials by harnessing NHS health data to more efficiently recruit patients, according to a new report from the ABPI. 

Following a period of decline, the number of industry clinical trials in the UK is rising again. Despite this good news, participation in these trials is falling, and is now at its lowest level since 2017/18, representing only 3.4% of individuals taking part in all UK trials. 

The ABPI’s new report, ‘Globally competitive UK-wide data-enabled clinical trials: the time is now,’ argues that the solution to rapidly recruiting more patients who are suitable for industry clinical trials is better use of NHS health data.  

A key driver of declining recruitment into industry trials is inefficient methods of identifying eligible patients. Current processes are costly and resource-intensive for an overstretched NHS, and they waste patients’ time when they are turned away because they don’t meet the trial criteria to take part. 

NHS records contain comprehensive medical information on the UK’s 69 million population. This globally unique asset could dramatically improve how patients are recruited into industry clinical trials in the UK, resulting in faster, more efficient and more inclusive processes. 

Anonymised NHS records are already being successfully used in pockets of the UK to support trial recruitment. The recent government announcement to establish a Health Data Research Service (HDRS) provides a mechanism to coordinate and streamline locating the most suitable patients for an industry clinical trial across the UK. 

A new model for health data use 

The ABPI proposal involves conducting centralised searches of anonymised NHS records within the HDRS and providing this information to NHS trial sites, which have the authority to identify patients and review their eligibility for a specific trial. This evidence-based approach matches trial eligibility criteria to information within a patient’s medical record. 

In addition to inviting more eligible patients to participate in a trial, invitations would be targeted only to those who meet the eligibility criteria based on their medical history, meaning fewer patients would be turned away at the recruitment screening stage. 

The new ABPI report sets out industry’s view of how adopting data-enabled methods would improve the predictability and accuracy of carrying out trials in the UK, by accelerating recruitment timelines and ensuring that the right patients are matched to the right studies. 

Dr Janet Valentine, ABPI Executive Director of Innovation and Research Policy, said: “Because of the benefits industry trials bring to patients and the economy, global competition to attract commercial trials is fierce. It is therefore vital that the UK acts now to secure industry investment and builds on the public’s growing enthusiasm to take part in research. 

“NHS health data offers the UK a potential leading edge on our competitors by transforming how we find and recruit patients into trials, reducing delays, costs and avoiding wasted effort. Importantly, the approach we are recommending improves efficiencies in the NHS whilst maintaining patient confidentiality. 

“Our model, which has been developed in consultation with industry, NHS leaders and service providers, aligns with the government’s priorities for research and use of health data. If we get this right, we will restore the UK’s reputation for predictable and rapid recruitment into trials, making the UK a far more attractive place for global industry research investment.” 

The post NHS health data should be used for clinical trial recruitment, says ABPI appeared first on Drug Discovery World (DDW).

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Gilead Swallows Another Partner, Paying up to $5B for ADC Specialist Tubulis

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The acquisition of Tubulis GmbH—Gilead Sciences’ latest of the year after buying Arcells and Ouro Medicines—brings into the fold a novel ovarian cancer candidate that has demonstrated promising mid-stage data.

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STAT+: Pharmalittle: We’re reading about FDA backing domestic production, another Gilead deal, and more

Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where clear blue skies and comfortable breezes are greeting us. Who could ask for anything more? Actually, we could — it is time to reheat the kettle for another cuppa stimulation. Our choice today is ginger peach. And here is a helpful tip — a teaspoon of honey enhances the flavors splendidly. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few tidbits to help you along. As always, do keep in touch. We appreciate feedback, criticism, and tips. …

The U.S. Food and Drug Administration used the president’s budget to propose policies aimed at encouraging domestic development and manufacturing of drugs, STAT notes. FDA Commissioner Marty Makary has said the agency needs “giant, big ideas” to counter China’s dominance in early-stage clinical development of drugs. Among the FDA’s ideas are proposals to make it easier to run early-stage trials in the U.S. and to hand an advantage to U.S.-based generics manufacturers. The Trump administration has been using a variety of policy levers to try and bring drug manufacturing to the U.S. One of the legislative proposals in the FDA’s budget justification would let domestic manufacturers of generic drugs challenge brand drug patents a month before foreign companies, a major advantage in an intensely competitive process. 

Two more drugmakers, AbbVie and Genentech, will officially start selling their medicines on the TrumpRx website, CBS News tells us. Abbvie, which struck a deal with the Trump administration in January to cut the cost of certain medicines, will sell Humira, a popular medication used to treat rheumatoid arthritis, Crohn’s disease, and ulcerative colitis, on the site at an 86% discount. The prescription prices on the site, however, are only available to patients who are uninsured, or whose insurance does not cover it, and who must pay the full list price out of pocket. Those with insurance coverage generally pay lower prices already. TrumpRx now sells over 61 drugs at a lower price, up from about 40 when the website went live in February. 

Continue to STAT+ to read the full story…

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Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where clear blue skies and comfortable breezes are greeting us. Who could ask for anything more? Actually, we could — it is time to reheat the kettle for another cuppa stimulation. Our choice today is ginger peach. And here is a helpful tip — a teaspoon of honey enhances the flavors splendidly. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few tidbits to help you along. As always, do keep in touch. We appreciate feedback, criticism, and tips. …

The U.S. Food and Drug Administration used the president’s budget to propose policies aimed at encouraging domestic development and manufacturing of drugs, STAT notes. FDA Commissioner Marty Makary has said the agency needs “giant, big ideas” to counter China’s dominance in early-stage clinical development of drugs. Among the FDA’s ideas are proposals to make it easier to run early-stage trials in the U.S. and to hand an advantage to U.S.-based generics manufacturers. The Trump administration has been using a variety of policy levers to try and bring drug manufacturing to the U.S. One of the legislative proposals in the FDA’s budget justification would let domestic manufacturers of generic drugs challenge brand drug patents a month before foreign companies, a major advantage in an intensely competitive process. 

Two more drugmakers, AbbVie and Genentech, will officially start selling their medicines on the TrumpRx website, CBS News tells us. Abbvie, which struck a deal with the Trump administration in January to cut the cost of certain medicines, will sell Humira, a popular medication used to treat rheumatoid arthritis, Crohn’s disease, and ulcerative colitis, on the site at an 86% discount. The prescription prices on the site, however, are only available to patients who are uninsured, or whose insurance does not cover it, and who must pay the full list price out of pocket. Those with insurance coverage generally pay lower prices already. TrumpRx now sells over 61 drugs at a lower price, up from about 40 when the website went live in February. 

Continue to STAT+ to read the full story…

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FDA Seeks Expanded Authority To Regulate Postapproval Manufacturing Changes

FDA Seeks Expanded Authority To Regulate Postapproval Manufacturing Changes

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Aiming to protect patients, the FDA sent lawmakers a wish list of legislative proposals intended to clarify and expand its oversight of updates to approved drug production processes.​ ​Read More

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