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

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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New webinar: Tackling drug discovery challenges in cancer research

Hosted by Drug Discovery World and supported by Sartorius and BioIVT, this webinar will explore the opportunities and challenges that exist within cancer research drug discovery and development.
You will hear from Dr Sudha Rao, Chief Scientific Officer of Kazia Therapeutics, Karol Budzik, PhD, Business Development Associate at Vyriad Therapeutics and Lars van der Veen, Chief Scientific Officer at iOnctura.
Presentations will cover how cancer treatments have shifted towards reprogramming the biology driving tumour growth, immune escape and treatment resistance, the trajectory that in vivo CAR-T treatments are taking, and how challenging tumours burdened by stroma and immune-mediated resistance can be tackled.
Q&A with the speakers follows the presentations.
The post New webinar: Tackling drug discovery challenges in cancer research appeared first on Drug Discovery World (DDW).
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Psilocybin proves promising in neuropathic pain mouse study
Amid the rise of psychedelics in the mental health space, researchers have begun to explore psilocybin as a treatment for chemotherapy-induced peripheral neuropathy.
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New Spectrometry Technique Could Aid Formulation Development
New Spectrometry Technique Could Aid Formulation Development
A new technique combining two forms of spectrometry could help biopharmaceutical companies improve their choice of formulation buffer for antibody manufacturing by revealing how molecular forms and three-dimensional shapes of complex biologics respond to their environment. That’s the view of Christian Bleiholder, PhD, a professor at Florida State University who helped develop the technique.
According to Bleiholder, what happens structurally when a complex biological molecule, such as an antibody or viral spike protein, binds to its target is currently poorly understood.
“This is where [this approach] can help with the bioprocessing and formulation,” he says, as structural changes “can affect the lifespan [of the product] and lead to issues, such as aggregation.”
Because antibodies are complex, existing techniques tend to be powerful at different levels of complexity, he explains. Mass spectrometry is particularly powerful for distinguishing molecular composition, while structural approaches such as X-ray crystallography and cryo-electron microscopy can provide high-resolution structural information.
The challenge is understanding the link between these things within a heterogeneous sample, he says.
To overcome this, Bleiholder and his team worked with Bruker Daltonics to develop Tandem-Trapped Ion Mobility Spectrometry (Tandem-TIMS). This combines tandem ion mobility spectrometry with tandem mass spectrometry to disentangle three overlapping layers of molecular complexity: molecular form, three-dimensional shape, and binding or assembly state, he says.
He explains that, if the proteins have different structures, they can be characterized with tandem ion mobility spectrometry, and then mass spectrometry can be used to look at their molecular forms and binding states.
Going forward, Bleiholder hopes the technique can be used for formulation development but also earlier, during drug discovery of new products, such as multi-specific antibodies, to determine which molecular states are important and how those change when a biologic engages its target. He also plans to look at automating the technique.
Bleiholder spoke about using Tandem-TIMS at the Bioprocessing Summit in Boston earlier this year.
The post New Spectrometry Technique Could Aid Formulation Development appeared first on GEN – Genetic Engineering and Biotechnology News.
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