Clinical Trials - Q2 2022 by Mediaplanet UK&IE

Clinical Trials

How we’re working to achieve equality, diversity and inclusion in clinical trials. Dr Jennifer Harris Director of Research Policy, ABPI

Public involvement in research leads to a better experience for all. Martin O’Kane Deputy Director, Clinical Investigations and Trials, MHRA

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Jim Elliott Public Involvement Lead, Health Research Authority

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How do we improve clinical trials post-pandemic? Clinical trials during a pandemic have shown that a “quality by design” mindset can future-proof and better clinical research.

T Janis Bernat Director, Scientific & Regulatory Affairs, IFPMA

he COVID-19 pandemic has taught us a lot Role of digitalisation and yet we can still keep learning. While the Secondly, we must look more extensively into the pandemic has impacted everyone globally in benefits of digitalisation and the use of virtual tools ways that could never have been imagined, it and methodologies within the context of clinical trials. has provided a spark for further exploration into how Digitalisation can help clinical research to be more clinical trials should be improved, strengthened and efficient and coordinated, principally via telemedicine, better coordinated globally. use of innovative health technologies, virtual healthcare To ensure this happens, we must first acknowledge visits, e-documents, etc. the critical role of well-designed clinical trials. During Digitalisation can also support clinical researchers the pandemic, there were many examples of small, with the conduct of decentralised (or hybrid) clinical under-powered clinical trials that trials by increasing recruitment, lacked coordination and did not deliver reducing screening failures and allowing scientifically meaningful results. for remote monitoring of patients. Governments recognised this early Thus, offering the best guardianship With a spotlight on patient on and helped lead the development of patients’ time and resources. of the G7 Therapeutics and Vaccines centricity, best practices Clinical Trials Charter to avoid Benefitting those in greatest need for greater diversity and proliferation of such trials in the future. Finally, we need to ensure that the inclusivity of under-served clinical trials we design benefit those When you are looking for hope in the form of prevention, treatment or cure, populations must underpin who need it most. With a spotlight such outcomes can be tragic and/or on patient centricity, best practices the development of all disheartening at best. for greater diversity and inclusivity future clinical trials. of under-served populations must Implementation of regulatory guidance underpin the development of all future Broader implementation of ICH Good Clinical Practice clinical trials. The pandemic highlighted the ongoing (GCP), specifically E6 R3, is key here. This regulatory disparity within clinical research and in the end, we guidance is critical to future-proofing clinical trials and must strive to make sure that these good principles seeks to support their modernisation by installing a become routine. ‘quality by design’ mindset. Bettering clinical research, in a more innovative and For those of us involved in clinical research sustained fashion, has the potential to accomplish far (e.g., national regulatory authorities, academia, greater results for global health that will be felt well biopharmaceutical industry), ICH GCP may be the beyond the present pandemic. best way to promote greater capacity and capability building around the world.

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Delivering better clinical trial datasets with the cloud and scale when traffic increases. The eClinical platform supports data capture for clinical research and uMotif applications are used to track and submit e-consent, symptom and wearable device data. “A patient-centric approach has the potential to benefit those who need it most – the patients - particularly in cases of rare diseases, where trials can provide hope with the shared goal of finding treatments and therapies that may provide relief,” says Dommel.

The cloud holds the potential to help hospitals, researchers and doctors to deliver clinical trials that scale and improve patient experience.

Jens Dommel Head of Public Sector Healthcare, EMEA, Amazon Web Services WRITTEN BY Mark Nicholls

he cloud has the potential to help life sciences organisations scale, improve the clinical trial process and offer a more patient-centric experience. Modernised clinical trials allow providers to focus on their role in discovering new treatments and therapies and improve patient outcomes. Jens Dommel, Head of Public Sector Healthcare, AWS (EMEA) sees patients, doctors and healthcare providers benefiting by having access to more enriched data sets and the ability to see health information that may previously have been unstructured or siloed. Modernising clinical trials Quality, structured data is a critical component to the success of clinical trials. Hospitals and providers face challenges in running clinical trials in terms of timescale, cost, enrolment of patients and low patient engagement, as well as managing stakeholders and sharing and analysing the collected data. Existing data may be unstructured, siloed, kept in paper format or even outdated. This can lead to challenges with steps critical to clinical trial success, like checking patient

consent, identifying cohorts and determining the best trial sites for patients. According to a survey by the Biopharmaceutical Investment & Competitiveness (BCI), execution of clinical trials is historically the most expensive part of the process, accounting for around two-thirds of all R&D costs. Clinical trial protocol design in its current state, explains Dommel “requires a great deal of administrative work.” Patient engagement Once a trial is underway, sponsors need agile tools to incorporate the use of mobile technologies, such as wearables and mobile devices, which could generate a wealth of data while promoting better patient engagement and streamlining report generation. AWS IoT services connect devices to the cloud for secure data collection, management and analysis. Devices can stream data to cloud environments and enable remote communication, reducing the need for patients to visit study sites and decreasing both the cost of clinical trials and the burdens they place on participants. UK-based uMotif has taken this patient-centric approach to capturing clinical trial data, using AWS services to build an easy-to-use cloud-based platform that can be deployed anywhere,

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New dimension He explains that AWS adds a new dimension to how providers collect and store data, and how that data is used for clinical trial cohort selection. “The cloud can help to build data lakes and comprehensive data models that make cohort selection easier and more accurate,” he says. For example, German EDC software provider, Climedo uses AWS to create secure, cloudnative, scalable solutions to better capture and manage clinical data in a decentralized, patient-centric way. The software is used by pharmaceutical companies, medical device manufacturers, hospitals and public health offices. The data is used by pharmaceutical companies, medical device manufacturers, hospitals and public health offices to rapidly recruit thousands of patients. Dommel points to artificial intelligence/machine learning technologies and their role in modernising clinical trials. Services like Amazon SageMaker, a fully managed machine learning service, can optimise studies by predicting the most productive trial protocols and study locations. Amazon Comprehend Medical Service can help providers quickly find appropriate patients to enrol for clinical trials by extracting information from medical text, without needing previous experience in machine learning. “AI/ML technology can help optimise patient recruitment, predict feasibility of clinical trials and recruitment timelines,” adds Dommel. Scalable solutions Looking ahead, Dommel says: “The future of clinical trials will require scalable, secure, connected and compliant services. The ability to collect, analyse and secure clinical trial data will be critical in achieving positive clinical trial outcomes that may form the basis for new lifechanging drugs, therapies and vaccines.”

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How we’re working to achieve equality, diversity and inclusion in clinical trials The pandemic has brought into sharp focus the health inequalities that currently exist in the UK, with some communities affected significantly worse by COVID-19.

T Dr Jennifer Harris Director of Research Policy, ABPI

he pharmaceutical industry is well placed to play a key role in helping to tackle the issue of health inequalities. A key mechanism for doing this is ensuring that the evidence generated through clinical trials is more inclusive and informs healthcare decisionmaking. We’re working on a number of fronts to make this happen. Collaboration with partners to develop guidance The ABPI partnered on the National Institute for Health Research (NIHR)’s INCLUDE project, which has co-designed guidance to summarise what an underserved group is and guide funders, researchers and delivery teams in how to design research to be more inclusive. Building on this and focussing specifically on race equality in health research, the NIHR Race Equality Public Action Group has also recently published a framework to assess how to better serve diverse communities. Health research organisations from across the sector, including industry, took part in a three-month pilot, which helped inform the development of this framework. Our response to the MHRA’s consultation on clinical trial legislation stresses the importance of regulatory

support for improving diversity and inclusion. It also emphasises the value of patient and public involvement in clinical trials. We have offered our support in co-developing guidance for researchers and sponsors. The opportunity of integrated care systems The establishment of Integrated Care Systems (ICSs) in England is an opportunity for parts of the system to work together to prevent disease and improve the health of the populations they serve. Following Royal Assent of the Health and Care Bill, the ICSs will have new responsibilities to drive the research agenda across primary, secondary and tertiary care settings. This is a major opportunity to unlock greater community engagement in research across the NHS and help diversify clinical trial participation. The Health and Care Act introduces a new requirement for ICS’s to facilitate or otherwise promote research.We look forward to supporting this strengthened mandate as the ICSs prepare to go live. The establishment of the ICSs is a once-in-a decade opportunity, and one we need to grasp with both hands if we are to be successful in leveraging the nation’s research and innovation ability to tackle health inequalities.

Smarter trials can tackle the rising health burden

Investigator of the RECOVERY trial into treatments for COVID-19 and the ORION-4 trial into Inclisiran undertaken as part Oxford University’s Clinical Trials Service Unit. These trials demonstrated the huge potential to cuts costs and enable the development of better treatments by minimising complexity and only including the essential elements needed for a trial. We will:

In recent decades, while global life expectancy has improved, the burden of common and other life-threatening conditions on global populations continues to rise.

espite this trend, the development of new treatments for major health conditions such as heart and lung disease, arthritis, depression and dementia has dwindled, with focus instead on rare conditions where returns on investment are more predictable.

just too high for most companies to ever reach this stage. This problem can be solved by increasing the availability and affordability of high quality, largescale randomised clinical trials to properly assess possible treatments for these diseases. This is why we have established Protas.

Billion-dollar price tag The economics of developing new treatments for common disease are challenging. Large, pivotal latestage trials typically have a billiondollar price tag which prevents the development and evaluation of new and exciting treatments that have the potential to benefit populations. The commercial risk is

Smart global clinical trials Protas will design and deliver smart global clinical trials of treatments for common and other lifethreatening diseases at a fraction of today’s costs. We are bringing our experience of conducting landmark trials of new and established treatments, including as Co-Principal

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Sir Martin Landray Chief Executive, Protas and Joint Lead, RECOVERY trial of treatments for COVID-19

• Focus on smart and robust design that will provide a reliable answer to an important question. • Streamline delivery: working with patients and clinicians to ensure trials are designed to be practical, accessible and inclusive. • Use technology to support the safe, trustworthy and efficient use of data. • Operate as a non-profit organisation, making trials more affordable to benefit public health. We are confident that this approach can transform the opportunities for development of new treatments for those common diseases that place a major threat to public health around the world.

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A new regulation to unify the European research space

States will base their authorisation of the trial.

The new European Clinical Trials Regulation, which came into application on 31 January 2022, has rung in a new era for clinical trials in the EU.

ver the next three years, the new regulation is going to unify the EU into one research space where the same rules and processes for the submission, evaluation and supervision of clinical trials apply, no matter where in the Union the trial takes place. Creating better clinical trials It will significantly reduce administrative burden and allow both sponsors and regulators to channel their efforts towards bigger, better, more impactful clinical trials that generate robust evidence. This will support the translation of scientific innovation into public health gains for patients. In the past, trial sponsors had to submit clinical trial applications separately to the national regulator

and ethics committees in each EU Member State where they planned to run a trial. Under the new rules, sponsors will be able to use one single process to apply for the authorisation of a clinical trial, no matter where they are located and with which national competent authorities or ethics committees they are dealing. Advantages of multinational trials The benefits, particularly for multinational trials, are substantial: sponsors can now apply for authorisation of a trial in up to 30 countries (27 EU Member States plus Iceland, Liechtenstein and Norway) at the same time by submitting one application to the relevant authorising bodies. These bodies will carry out one single assessment of the application dossier on which all other Member

Clinical trial workspaces streamline processes The unprecedented regulatory alignment for clinical trials in a region as large as the EU, with its nearly 500 million citizens, is made possible by harmonised and streamlined workflows powered by the Clinical Trials Information System (CTIS). Maintained by the European Medicines Agency, it provides a dedicated secure workspace for trial sponsors where they can apply for and manage their clinical trials. A similar workspace allows the authorising bodies to assess applications and easily interact with the sponsor and supports fast collaboration and information exchange with other authorities. The new system not only enables more efficient and streamlined processes. It also includes a publicly searchable database that will radically increase transparency of clinical trials data. The information that will be made available throughout the life cycle of a trial in CTIS is expected to stimulate information sharing and peer learning among researchers, while patients and healthcare professionals will be able to search for trials.

Dr Peter Arlett Head of Data Analytics and Methods, European Medicines Agency

The five principles for good clinical trials An abundance of tools is widely available to researchers today that can empower clinical trials to be more adaptive, connected, efficient, flexible, resilient and transparent.

T Nick Medhurst Manager, Good Clinical Trials Collaborative

he use of new tools in clinical trials can help bridge the gap between research in higher- and lower-income countries. But their potential can be wasted when used without thinking about the fundamental scientific and ethical components of a good trial. The Good Clinical Trials Collaborative worked with a global consortium of experts, organisations and communities to develop five principles of a good randomised clinical trial.

Cooperation, fairness and transparency help make better use of resources but also build greater trust and confidence in clinical trials. 1. Answer the question Conclusive results – not just positive ones – protect lives and ensure there is an end result for the time and resources invested in a trial. It starts with trial design: making sure a trial is set up to succeed is half the battle. Randomisation is the most powerful tool we have to make reliable comparisons.

2. Deliver for participants and the public Beyond consent, a good trial will ensure patients are empowered with relevant, understandable information, and their rights and wellbeing are respected and protected. Ensure important information is made available to the public too. 3. Think collaboratively Cooperation, fairness and transparency help make better use of resources but also build greater trust and confidence in clinical trials. This is not just for the organisations and individuals involved but for everyone, including the general public, who may be affected by the results. 4. Make sure the trial can work If design is half the battle, making a trial happen is the other. A good trial should act in harmony with where it is taking place, understanding the context, setting and communities involved. Trials that do not are frequently wasteful, duplicative and likely to fail. 5. Keep an eye on what matters Understanding what might go wrong and being ready to avoid or remedy important errors are indicators of a well-planned trial. Fine tuning the systems and processes that will track, highlight and address key challenges makes for a well-run trial too.

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The Good Clinical Trials Collaborative’s Guidance for Good Randomised Clinical Trials is available now at GoodTrials.org

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Increasing trust in real world data through new framework Public involvement in research leads to a better experience for all Clinical research shouldn’t just be shaped by the researchers conducting it – the voices of patients, carers and other members of the public are vital.

variety of voices involved in clinical research makes the clinical trial experience a better one for all, with richer results, drawing on patients’ experience and knowledge of what is being investigated. Greater public and patient involvement Despite this, current clinical trials legislation is silent on patient and public involvement. So, this year, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA) have taken big steps to try to change this. In January, the MHRA launched a public consultation in which we proposed ways to promote public involvement in clinical trials. For example, by introducing a legal requirement for the involvement of people with relevant and appropriate lived experience in the design and conduct of trials. Reaching under-represented groups Greater public involvement will facilitate the inclusion of under-represented populations, for example pregnant and breastfeeding women and other under-served communities. Working with patients, the public and the scientific community, we have an ambition to make trials as safe and as accessible as possible. That’s why our consultation includes a range of proposals that will benefit patients, such as improving transparency by introducing a requirement to publish a summary of results within 12 months of the end of the trial and to share that with participants in a suitable format. Through the proposals outlined in this consultation, the results of which will be published later this year, we aim to make the UK

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one of the best places in the world to conduct robust, safe clinical research. Improving extent and quality of involvement In March, the HRA and MHRA – alongside a number of other organisations – signed up to a shared commitment to improve the extent and quality of public involvement in research. Working together, we pledged to support the research community to carry out excellent public involvement by sharing guidance, policies, systems and incentives. We agreed to listen and learn from the people and communities we involve, support improvements in equality, diversity and inclusion in public involvement as well as to embed this commitment into our own organisations’ decisionmaking processes. Having left the EU and learning from our positive response to COVID-19, partners from across the UK research system are continuing to work together to make the UK one of the most attractive places in the world to conduct efficient and cutting-edge clinical research by putting patients and their voices at the heart of decision-making.

Martin O’Kane Deputy Director, Clinical Investigations and Trials, MHRA

Jim Elliott Public Involvement Lead, HRA

When new treatments are brought to the market, they go through multiple assessments to ensure that they are safe, effective and good value for money. However, questions still remain. Páll Jónsson Programme Director - Data and RWE, National Institute for Health and Care Excellence

he questions that need answering during this journey are many and diverse. It is therefore no surprise that no one study design is ideal for answering all of them.

Questions around randomised control trials Randomised controlled trials are well established as the key study design used by the medicine regulators. However, health technology assessment agencies such as NICE are increasingly looking to other sources of evidence to answer some of the questions that can’t be as readily answered by randomised controlled trials. There are multiple drivers behind this development, in particular, better data infrastructure that enables safe and secure collection and analysis of outcomes in patients in the health and care system. We work at the interface of health and care and the life sciences to facilitate early access to innovation and real world data therefore is increasingly important in our work. In fact, it is the preferred source for informing many aspects of health technology assessment, such as for characterising health conditions, care pathways and patient outcomes, all of which are important in NICE’s assessment of new treatments. This is because data collected when a treatment is used in a real clinical setting has the potential to better reflect what we expect to see in day-to-day practice.

Data collected when a treatment is used in a real clinical setting has the potential to better reflect what we expect to see in dayto-day practice. Real world evidence framework However, without the robust approach that is built into randomised trials, real world data is prone to biases, confounding and can be of poor quality. To help address this, we recently developed a real world evidence framework, which will be formally launched in June 2022. This is intended to signal “what good looks like” and enable the use of broader types of data, which will support rapid and robust technology evaluations and more dynamic living guidelines. The NICE real world evidence framework identifies when real-world data can be used to reduce uncertainties and improve guidance. It also clearly describes best-practices for planning, conducting and reporting real-world evidence studies to improve the quality and transparency of evidence. Delivering trust in real world evidence We realise that a concerted effort is required to deliver trust in real world evidence so that it is fit for healthcare decision making. We welcome constructive challenge and a broad range of views and we will continue to work with regulators, healthcare professionals, patients, innovators and other stakeholders to further develop our approach to this to ensure we have a robust way of using the most appropriate evidence in our decision making.

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Keeping the new clinical trial landscape safe Ensuring high adherence to regulatory requirements is critical with the growing emergence of hybrid and decentralised clinical trials.

Dr Rashmi Narayana Chief Scientific Officer, Aparito

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ith the transition to hybrid and decentralised clinical trials, the need to ensure they continue to meet stringent regulatory requirements remains paramount. Yet the shift away from the traditional trial format offers a number of benefits, such as increasing diversity in participating patient groups. Economic benefits Dr Rashmi Narayana suggests the digital elements of decentralised trials enables hard-to-reach patients who may not have previously participated, because of physical location, for example, the opportunity to be included in studies. This has also increased the reach from developed western populations to those in more remote areas in low-and-middleincome countries via better internet access. “This diversity of the people who enter trials improves outcomes for all,” she adds. There are also economic benefits for patients and accompanying family members in participating digitally in terms of reduced travel or accommodation costs, as well as lifestyle factors. “So many things in life are moving to digital, whether it is paying bills or day-to-day transactions,” she continues, “so to have a digital experience in a clinical trial via a smartphone should become a lifestyle choice.” Regulatory compliance An important component of this change lies in ensuring regulatory compliance from accreditation

and data management to legal factors. Dr Narayana says if trial data does not meet guidelines and standards, such as ISO 27001 covering information security management systems, or ISO 13485 for medical device software, the product and data will not be considered by pharma and biotech sectors. Dr Narayana is Chief Scientific Officer with global health-tech company Aparito. Their flagship Atom 5 ™ platform is an end-to-end platform for conducting hybrid and decentralised clinical trials. She says: “We have regular audits to ensure we meet all quality, compliance and regulatory requirements while maintaining highest standards of data security is central to everything we do.” Telemedicine features The platform provides support for its clients in patient recruitment - often in a rare disease context - and with consent, enrolment, patient experience and visibility of where patients are in the clinical trial journey, data capture, and monitoring and compliance, to decommissioning a study. “We also have telemedicine features on our platform for remote consultation that can be done securely, adhering to necessary regulatory guidelines,” adds Dr Narayana. The company’s in-house data scientists have devised an algorithm for a video capture functionality that blurs facial features to comply with patient confidentiality and privacy. It also has options for enhanced consent where facial features are required for diagnosis.

Digital endpoints The digital endpoint is an extra dimension with hybrid and decentralised clinical trials within the platform. Dr Narayana explains: “Digital endpoints are a relatively nascent area in the clinical trials space but gaining traction. “The most traction we are seeing is in digital endpoints in Parkinson’s disease, cardiology and in rare diseases such as Duchenne muscular dystrophy, mainly looking at upper limb and lower limb movements especially from the transition from ambulatory to non-ambulatory stages of the disease. “With our technology, there is a digital endpoint that will help clinicians, carers and academics, as well as help parents prepare better if a child is likely to go from the ambulatory to non-ambulatory phase.” Rigorous processes As regulation develops in this sphere, Aparito monitors European Medicines Agency and US Food and Drug Administration regulations to maintain high adherence and patient safety. While it has its own rigorous processes, it also recognises that clients have similar stringent processes, such as electronic consent and e-signatures, that it needs to harmonise with. That embraces adherence to FDA 21 CFR Part 11 on how to handle data regarding electronic records and signatures and GxP in good clinical and laboratory practice. “With every data point collected on Atom 5 ™ our clients in biotech, pharma and academics can be confident that data provenance is assured,” she says.

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Ensuring clinical research is at the heart of care The recent Health and Care Act will help drive a more research active NHS to deliver better healthcare for our communities.

I Dr Catriona Manville Director of Research Policy, Association of Medical Research Charities

t is well established that clinical research activity in the NHS delivers clear benefits to all involved. This includes improved outcomes, lower mortality rates and increased confidence for patients in care being delivered. The benefits don’t stop there; studies report greater job satisfaction for health workers who engage with research, as well as economic benefits and cost savings to the healthcare system and beyond. Using integrated care systems to embed research Following the introduction of integrated care systems in 2018, last summer, the Health and Care Bill started its passage through Parliament. The legislation initially included a duty to promote research, repeating the wording used in the Health and Social Care Act 2012. The community felt that this had not sufficiently changed activity and mindset on clinical research in the NHS. To address this, Parliamentarians supported by organisations across the life sciences sector, including AMRC, called for a stronger mandate, to increase the responsibility of organisations to conduct and promote research in the NHS. From amendments proposed in the Lords, the mandate strengthened the duty to facilitate as well as

promote research, and integrated care boards and NHS England have the responsibility to report on research through joint forward plans and annual reports.

We need to shift the perception that research is an add-on to it being a core purpose of healthcare settings. Policies putting research at the heart of care Of course, there is still work to do to explore how this will be delivered in practice. However, the combination of the Health and Care Act 2022, alongside the Government’s ‘The Future of UK Clinical Research Delivery vision’ published last year and learnings from COVID-19 provides the opportunity to put research at the centre of care delivery. We need to shift the perception that research is an add-on to it being a core purpose of healthcare settings and stress that research is fundamental to organisations delivering the best for our communities.

Harnessing the full potential of decentralised clinical trials

to learn how to best leverage decentralisation to mitigate patient burdens. However, it is equally important to understand how adopting a decentralised approach might introduce new burdens – such as IT barriers and privacy concerns about strangers entering the home – so that these can be addressed and mitigated before the protocol is developed. DCTs offer a rich continuum of locational flexibilities to patients – including local labs, local (or mobile) imaging centres and local pharmacies.

Studies that are intentionally planned as decentralised clinical trials provide the best opportunity to optimise the patient-centred capabilities of decentralisation.

ou would not buy a sportscar and just use it for the two-mile drive to the shops. Instead, you would take it on the open road to take full advantage of its capabilities. The powerful flexibilities of a decentralised clinical trial (DCT) are only realised when a study is intentionally planned, from the start, as a decentralised trial. Agility of decentralised clinical trials The COVID-19 pandemic put a spotlight on the agility of DCTs. Core remote capabilities – such as direct-to-patient shipment of

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IMP and telemedicine visits – enabled researchers to keep many ongoing studies up and running. However, it is clinical studies which are intentionally planned and designed as DCTs – from the start – that fully optimise the value of decentralisation. A planned DCT enables the development of a robust protocol with two key ingredients: first, early engagement across all stakeholders and second a risk-based, qualityby-design framework. Understanding new trial burdens Early patient engagement is crucial

Karen Nooman Senior Vice President, Global Regulatory Policy, ACRO

Quality by design framework In addition to early stakeholder engagement, a planned DCT permits the adoption of a qualityby-design framework with robust risk considerations. The ACRO DCT Working Party has created a DCT Toolkit, with detailed manuals on how to implement a risk-based quality by design approach to DCTs. Untethering trial activities from hospitals and other medical sites was a powerful factor in continuing clinical trials during the COVID pandemic. Planning decentralisation from the beginning of a trial is an even stronger force in decreasing burden on patients and investigators as well as facilitating trial participation.

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