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Transforming clinical trials to accelerate drug development


There are great opportunities for the UK to take the learnings from the pandemic and build on our competitive advantages to strengthen and grow our clinical research environment. The aim of which should be to attract more funding, expertise and studies to the UK that has a significant positive impact on patient’s access to innovative medicines and the wider economy.

The value of the clinical research sector is significant and growing. The European Clinical Trials Market is worth approximately $4.6bn and is projected to reach $6.5bn by 2026. Pre-pandemic, in England, the National Institute for Health Research (NIHR) estimated that clinical research is worth £2.7bn a year – including £1.5bn from commercial sources – and supports more than 47,000 jobs.

The UK has traditionally led the way in Europe for the quantity of commercial trials initiated – especially in early phase studies. While the Association for British Pharmaceutical Industries (ABPI’s) latest report indicates that the UK retains its position as Europe’s leading location for early phase studies, the overall number of studies has declined in the last five years – partly impacted by the enormous disruption of the pandemic on non- covid related studies. What has also changed is a higher expectation from sponsors, shareholders and the third sector; they are increasingly questioning why the rapid development timelines for COVID-19 vaccines cannot also be achieved in other high- impact conditions such as cardiac disease, diabetes and neurodegenerative disorders.

This expectation, coupled with the fact that the average cost of initiating a clinical trial is more than £80,000, demonstrates why we all are right to expect that the pharmaceutical and biotech industries are constantly evaluating the clinical trial methodologies they commission and where there are efficiencies to be gained.

How early phase clinical research is adapting to deliver faster assessments
As director of operations at a CRO, it is my job to focus on the commercial management of the studies we perform and to constantly evaluate whether the processes we undertake deliver maximum value to trial sponsors while not compromising quality or patient safety.

Over the last decade there has been a transformation in the way clinical trials can be designed and delivered in the UK, aided by a flexible and forward-looking regulator in the MHRA, and welcome the shift they are initiating towards a more streamlined, combined review
of new clinical trial applications, speeding the process by which they are approved.

The development of adaptive trial protocols and the introduction of patient populations either instead of healthy volunteers or encompassed within the healthy volunteer trials – and how the MHRA has facilitated their use – has been a game changer in delivering more efficient trials.

The key advantage of adaptive trials is they provide the ability to operate flexibly, enabling the modification of a trial’s course in accordance with pre-specified rules set out in the protocol with the intention of providing earlier therapeutic benefit to patients. To use a sporting metaphor, adaptive trials enable activity to take place on a playing field which sets boundaries rather than a strict pathway, allowing investigators to safely use emerging data and the adaptive features to maximise trial output.

The MHRA has facilitated the use of adaptive protocol designs in the UK, and it is now possible to run an entire phase 1 programme as part of one protocol and following a single regulatory and ethical approval process. I’m pleased that the Government and the MHRA are working together to amend legislation to remove obstacles to innovation and streamline the regulation of clinical trials.


Why does this matter?
What adaptive trials mean in practice is that analysis of data is ongoing with the emerging data shaping the subsequent cohorts of healthy volunteers and patients studied in the trial – rather than having to reach a predefined end point later in the process.

This agile approach saves time and resource. For example, it enables important assessments to be made earlier, such as the need to change the patient sample size, the data collected, which groups of patients are responding and whether to end a study.

It also can enable trials to be more successful than they otherwise would be. For example, an adaptive design empowers trial leads to decide during the process to focus on a subpopulation – maybe a certain type of biomarker or a particular demographic. Adaptive protocols enable these modifications that can help to maximise the utility from a study, typically including patients from the commencement of the trial or at least in the latter parts of the trial – this is also known as trial enrichment.

Prior to the utilisation of adaptive trial protocols, follow-on studies would be required to wait for longer, for predetermined rigid milestones to be met before making similar assessments. What may surprise many is that the more agile adaptive patient-centric approach has not become standard practice among CROs operating trials on their behalf.

Recent health economic analysis evaluating the savings associated with adaptive trial design has suggested that in the US, wholescale adoption across all trial types could lower development costs for new drugs by $400m. On a global scale, this cost reduction would free up an additional $4.2bn for investment into pharmaceutical R&D. Beyond the MHRA, regulatory agencies across the world have also recognised the importance of innovations in trial design. For instance, former FDA commissioner Scott Gottlieb, highlighted that by “using more modern approaches to clinical trials, we can lower the cost of developing new drugs”.

More emphasis on trial design to speed results
As we look towards the future and how to ensure an equilibrium between the cost of healthcare and medicine development and bringing new therapies through to at-need patients, new clinical trial designs aligned with regulatory vision and innovations are a crucial way of increasing productivity in the pharmaceutical industry.

More organisations both privately and publicly funded need to re-evaluate how they plan and commission clinical research, and I expect an increase in analysis looking at the benefits of using new trial designs across systems and territories.

Keith Berelowitz is Director of Operations at Richmond Pharmacology

18th August 2022

Keith Berelowitz is Director of Operations at Richmond Pharmacology

18th August 2022

From: Marketing


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