PIPELINE 74

Issue 74

The Journal of the Pharmaceutical Information & Pharmacovigilance Association

July 2024

µPIPELINE

PIPA Conference 2024 The Value of Medical Information Advancing Patient Safety Through Inclusive Clinical Trials: Harnessing Real World Data Directly from Source

£12.00

or Free for Members

CONTENTS 03 06 09

PIPA Conference 2024

The Value of Medical Information Anne Turnbull

Advancing Patient Safety Through Inclusive Clinical Trials: Harnessing Real World Data Directly from Source Claire Williams

Copyright for any article accepted for publication in PIPELINE is transferred to PIPA once the article is submitted. Copyright covers the exclusive rights to reproduce & distribute the article in any form (such as photocopies or electronic copies) and applies to the complete article and any part within. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form without written permission from PIPA. PIPA will, wherever possible, grant permission to authors to subsequently use their articles, or to others to take limited numbers of copies, provided permission is obtained from the editors in advance. PIPA members are permitted to print a copy of PIPELINE and / or save a single copy of the electronic file for their personal use.While all reasonable efforts are made to ensure the accuracy of the information presented in this journal, the editors do not accept any liability for loss arising from reliance on the information presented. The opinions expressed in the journal are not necessarily those of PIPA, its Committee or companies to which members belong - unless otherwise stated.

PIPELINE Editor: Dora Amene

PIPA CONFERENCE 2024 18th & 19th September

Radisson Edwardian Blu Hotel, Heathrow, 140 Bath Road, UB3 5AW

In a break from tradition, this year’s conference will be dedicated to pharmacovigilance and medical information on alternate days, providing focused agenda and networking opportunities to support PIPA members’ interests and development.

Drinks receptions will be held at the end of both days ensuring a chance to relax and catch-up with colleagues.

A discounted rate is available to delegates who wish to attend both days, and a limited number of rooms have been reserved at the hotel on the night of 18th September should anyone wish to stay overnight. To book, please call reservations direct on +44 (0) 20 7629 7474 to book your room. Please mention block code: PIPA180924.

Day delegate rate: £475 + VAT 2-day rate: £850 + VAT Booking PV day, 18th September: https://pipaonline.org/civicrm/event/info/?reset=1&id=60 MI day, 19th September: https://pipaonline.org/civicrm/event/info/?reset=1&id=61 Both days: https://pipaonline.org/civicrm/event/info/?reset=1&id=64

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PIPA Conference Programme 2024 The programmes for each day are currently being finalised and maybe subject to change:

Wednesday 18th September – Pharmacovigilance 08:45

Welcome address

09:00

Case study; product acquisition management – integration of a product into an existing PV system: planning, pitfalls and lessons learnt – Tom Nichols, Drive Phase PV & Sukhcharn Sambhi, Pharmanovia

10:00

Inspectorate expectations & recent findings for audits and inspections – Zoe Hamill, MHRA What does the MHRA’s inspection programme look like? How should you prepare for an inspection? What can you learn from recent inspections? Attend this session for recent insights and tips from the MHRA GPvP Compliance Team.

11:00

Exhibition & Tea / Coffee

11:15

Panel discussion: Outsourced PV: considerations from vendor and utiliser – Helen Lowe, QA Consulting Ltd Panellists: Georgina Butler, ARTHEx Biotech & Jamie Portnoff, Truliant Consulting This interactive panel discussion includes considerations and keys to success when managing the full life cycle of activities for a sponsor or MAH when working with pharmacovigilance third party vendors. With over 64 years of experience between the panel, they have worked with, audited, and performed due diligence on multiple vendors and suppliers, as well as working for PV vendors directly. They will offer their insights into good and bad practices seen and hope to bring an open discussion into how to address good vendor selection, onboarding, and management practices within industry.

12:15

Arrested development: Cardiac safety concerns in phase 2 and 3 clinical trials – Professor Dave Lewis & Amalia Alexe, Novartis

13:15

Lunch & Exhibition

14:00

Personalised Safety At Roche – A safe journey for each individual patient everywhere – Felix Arellano, Roche

15:00

Panel discussion: Collaboration, Communication and Compliance: Key Pillars of Success in the QPPV Office – Elspeth McIntosh, Castle Pharmacovigilance Panellists: Priya Bhatt, Cadence Pharma Solutions, Armelle Donohoe & Louise Woodward, Roche

16:00

Exhibition & Tea / Coffee

16:15

The use of electronic health records for real-time safety monitoring and reporting in clinical studies – Claire Williams, NWEH In this presentation, we will explore the benefits of using electronic health records (EHRs) for monitoring, detecting, and reporting adverse events (AEs) in clinical trials. We explore how this innovative approach enhances patient safety by enabling real-time monitoring and providing comprehensive patient data for early intervention. EHRs increase the accuracy and efficiency of AE reporting by automating processes, standardising data, and reducing the manual workload on investigators and study teams. This also offers the potential to broaden eligibility criteria, leading to more inclusive and diverse clinical trials. This presentation, will aim to highlight how EHRs can transform clinical trial practices, ultimately contributing to more effective and safer drug development.

17:15

Conference close & networking event

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PIPA Conference Programme 2024 The programmes for each day are currently being finalised and maybe subject to change:

Thursday 19th September – Medical Information 08:45

Welcome address

09:00

Scaling up an MI service in response to demand – Jess Burgess, AstraZeneca We will look at the Med info service before, during and after the COVID-19 pandemic; discuss the types of enquiries we received and how we handled them, being a COVID-19 vaccine manufacturer. We will discuss upscaling the call centre, globally, and how med info contributed to AstraZeneca’s pandemic effort.

10:15

2024 ABPI Code Update – Jayne Packham, Jayne Packham Consultancy Explore the latest trends in the ABPI Code of Practice. Including proposals for the 2024 ABPI Code, the current landscape, recent cases and hot topics.

11:15

Exhibition & Tea / Coffee

11:30

Real world data use and interpretation – Adrian Parrott, PharmaSchool Training

12:30

Artificial Intelligence in Medical Information – Paul Dames, ApprovalFlow This presentation explores the transformative potential of Generative AI, particularly Large Language Models (LLMs), in revolutionising how pharmaceutical companies handle medical enquiries and product complaints. It addresses the challenges posed by traditional methods and highlights the numerous benefits AI offers, including increased efficiency, standardised responses, improved accuracy, and timely communication. The presentation also acknowledges potential pitfalls such as over-reliance on AI and data privacy concerns, emphasising the importance of human oversight and regulatory compliance. It provides practical guidance on implementing Generative AI in a regulated pharmaceutical environment, covering technical and compliance considerations. Lastly, the presentation offers a concise checklist of dos and don’ts to ensure a successful AI integration, ultimately empowering pharmaceutical companies to leverage this cuttingedge technology to enhance communication, patient care, and overall industry advancement.

13:15

Lunch & Exhibition–

14:00

The future of MI and MILE initiatives – Michelle Bridenbaker, MILE President & Helen Surrey, Communications Lead, MILE Don’t miss out on an engaging and enlightening talk on “The Future of MI and MILE Initiatives” with Michelle and Helen.

Join us as we delve into the evolving information seeking behaviours of Healthcare Professionals (HCPs) and explore the advancements in technology that will undoubtedly shape and transform the way we support our customer’s needs.

Together, we’ll highlight how MILE is at the forefront of educating and supporting Medical Information during this transformative era.

15:00

QR Codes: how do the different types of QR Codes work in practice when sharing medicines information? HCP insights – what have we learnt about what HCPs want – Rob Chapman, Datapharm

16:00

Exhibition & Tea / Coffee

16:15

17:15

Outsourced MI: collaboration between the vendor and client – Sonia Salzano, Astellas & Dominique Van Hoesel, PPD, part of Thermo Fisher Scientific Exploring the strategic decisions in outsourcing frontline medical information, emphasising key vendor requirements and the evolution of vendor-client partnerships. Highlighting future innovations aimed at enhancing collaboration, digital transformation, and continuous improvement.

Conference close & networking event

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The Value of Medical Information The remit of the medical information function is to provide evaluated, balanced, unbiased, up-to-date and high-quality information on medicines in response to questions from doctors, nurses, pharmacists and other healthcare professionals.

Medical Information professionals have access to a plethora of resources to answer such enquiries, including clinical papers and reference texts as well confidential data that is not in the public domain.

Information provided by the medical information team often plays a vital role in assisting healthcare professionals to make informed decisions about the clinical treatment of their patients.

When an enquiry has come in via email – either directly from an HCP, or via a member of the field force – it is also acceptable to clarify by return email their enquiry should the question be unclear initially.

Furthermore, with the evolution of the internet and the informed patient, more and more members of the public also turn to medical information teams with questions about their medication. Although MI teams cannot advise patients, they play an important role in signposting them to trusted sources of information that are more reliable than Dr Google.

Agreeing timelines and managing expectations Not all customers’ expectations regarding the timeline in which they wish to receive a response will be achievable. However, good customer service ensures that the customers’ expectations are managed from the outset, and that they are kept up to date should there be any unexpected delays.

SO WHAT DOES GOOD CUSTOMER SERVICE LOOK LIKE? I firmly believe that a back-to-basics, customer-centric approach to responding to medical information enquiries can ensure HCPs and members of the public receive an exceptional service, leaving them with a positive impression of, and confidence in, the pharmaceutical company.

One of the most important questions to clarify at the start of handling an enquiry is whether a patient is at the root of the question. If this is the case, and there is a time dependency, all efforts should be made to ensure the timeline is met.

So what does back-to-basics look like?

In a busy team, handling multiple and varied enquiries from a range of sources, it is often helpful to employ agreed means of triaging enquiries to ensure patient-centred questions are expedited.

Fully understanding the question I appreciate that this sounds obvious, but on a busy day when the questions are flying in quicker than they can be responded to, it can be easy not to fully digest the question that is being asked.

However, whatever the enquiry, being clear on the length of time it is likely to take to provide a response is vital to ensuring a good customer experience. This can be done verbally on a call, or via an automated email response should the enquiry come in via the MI inbox. For the latter, customers can be encouraged to call in should they need to request a more urgent response.

Taking the time to challenge their understanding of a question before attempting to respond to it is a vital part of ensuring that the MI professional provides a quality, helpful response. This can save time in the long-term – and avoid causing unnecessary frustration to customers – by ensuring they get it right first-time.

If it becomes clear that the agreed timeline will not be met, the customer should be updated as soon as possible with an explanation of the reasons for the delay, and the new anticipated deadline.

This can be done easily in real-time when on the phone to a customer, and reflective listening techniques are an effective tool for this: the MI team member can confirm their understanding of the question being asked by repeating it back to the customer and clarifying any aspects that are unclear. At this stage it is always good to confirm with the enquirer what resources they’ve already consulted, to avoid any unnecessary duplication of work.

Finally, there will always be the occasional enquiry for which the medical information team are unable to provide any further information. For example, perhaps a literature search was required but yielded no results. It is good practice to explain concisely why a response could not be provided.

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Service with a smile Although in recent years there appears to be a trend towards a higher proportion of electronic requests for medical information, telephone enquiries remain a staple for life in an MI team.

MI staff should be skilled in telephone skills, ensuring that they are courteous, helpful and easy to understand at all times. There is a myriad of techniques that can be employed when speaking to customers on the telephone – too many to discuss here – but it is important to remember that the minute an MI team member answers the phone, they become the voice of the company.

Empathy when dealing with a distressed member of the public, patience when responding to a stressed HCP, speaking clearly and concisely, using plain language and keeping a smile in the voice are all part of ensuring a positive customer experience.

I would argue, however, that using plain, clear language is just as important when responding to healthcare professionals. Wading through a complex, wordy response with an excess of disclaimers when working in a busy clinical setting is less than helpful. Ensuring a concise summary is provided at the start of a response, along with graphical and tabular representation of data ensures clear, effective communication. If data is not available, this should be put into context with a clear explanation as to why the team is unable to assist on this occasion.

IN CONCLUSION As a customer-facing department, Medical Information plays a vital role in ensuring a high quality customer experience and a positive image for the pharmaceutical company they represent.

If a customer hangs up the phone feeling heard and understood, with a positive outcome to the conversation, this can only help to build a strong image of the company.

And finally….answering the question It goes without saying that the raison d’etre of medical information is to provide clear, balanced high-quality responses to enquiries that fully and succinctly answer the questions asked. Most companies will utilise a combination of predeveloped standard clauses to help shape their responses, along with up-to-date standard response documents, FAQs and data on file that can be readily accessed in response to common questions.

Companies have embraced the use of plain English and patientfriendly language when responding to members of the public, ensuring complex medical words are avoided and simpler explanations are used instead.

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By Anne Turnbull

www.mipharmaceuticals.com anne.turnbull@mipharmaceuticals.com

Medical Information Outsourcing that Exceeds Expectations Our mission is simple: to deliver a medical information outsourcing service that exceeds expectations by providing a team of highly trained professionals that go the extra mile.

We pride ourselves on quality, flexibility and high levels of service that are tailored to the individual at a competitive price.

What we do >>

Additional services >>

mi pharmaceuticals provide a fully tailorable medical information service with any combination of the following services:

Our team of experienced medical information and copy approval specialists can also provide a range of additional services including:

• 1st & 2nd line medical information enquiry handling

• Copy approval

• Out of hours service

• Auditing services

• Standard operating procedure (SOP) and working instruction (WI) development and review

• Standard response document and FAQ creation and maintenance • Flexible retained outsourced support e.g. training days, peak time cover or support when your team are unavailable (e.g. over lunchtime)

• Training services

Costing >> We pride ourselves on our flexibility and ability to tailor our services to clients’ needs.

We offer three different models for fees:

For small companies without an existing medical information system in place, we can work with our partner IT company to deliver a high-quality cloud-based medical information database that captures and manages all medical enquiries, product complaints and adverse events.

• Retained dedicated provider service • Outcomes based payment • Fixed fee retainer

Finally, should a client’s medical information needs require a rapid change in scale, we can quickly flex to ensure a seamless maintenance of enquiry handling capability.

Email: info@mipharmaceuticals.com

Get in touch >>

Tel: +44 (0)7904 164812

Get in touch with our team for an informal discussion about your needs and how mi pharmaceuticals can help you.

www.mipharmaceuticals.com 8

mi-pharmaceuticals

Advancing Patient Safety Through Inclusive Clinical Trials: Harnessing Real-World Data Directly from Source Author Claire Williams

May, 2024 www.nweh.com

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Introduction This white paper focuses on the critical issue of inclusivity and diversity in clinical trials. We propose innovative solutions to bridge the gap between research and realworld healthcare with particular emphasis on the importance of these factors in improving patient safety and healthcare outcomes. Regulatory bodies will also be featured as playing a pivotal role in promoting inclusivity and diversity through the development of new guidance and legislation. Our objective is to leverage technology and real-world data, to enhance the inclusion of underrepresented groups in clinical research studies.

Understanding the scope of the problem Inclusivity is a key factor in clinical trials, to ensure that research findings are representative of the population and applicable to all patients, who may eventually receive the treatment. Clinical trials involve testing new medications, therapies, or medical devices to determine their safety and effectiveness. However, a lack of inclusivity in clinical trials can have negative consequences and hinder the progress of medical research.

The INCLUDE project examined underrepresentation in clinical design and delivery, and identified a range of underserved groups, and highlighted common barriers to participation. The project identified key groups such as older people, ethnic minorities, and women who continue to be underrepresented in clinical trials today [1].

Trishna Bharadia

Patient Engagement Consultant, The Spark Global; Visiting Lecturer, Centre for Pharmaceutical Medicine Research, King’s College London

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Implications of underrepresentation The involvement of women, ethnic minorities, and older adults is essential to the scientific, economic, and ethical value of clinical trials. Failure to include such individuals can lead to under diagnosis, undertreatment, and a lack of understanding of how certain medical therapies may affect specific groups of people.

For example, clinical trials investigating treatments for ischemic heart disease (IHD) often exclude older individuals despite their higher susceptibility of developing the disease [2]. To assess whether a drug is safe and effective for use by the elderly, a sufficient number of elderly patients are needed to be included in drug trials.

Evaluation of the exclusion of elderly adults from 839 randomised controlled trials studying drug interventions for IHD concluded that, from these trials, 446 (53%) explicitly excluded elderly adults. The estimated proportion of participants aged 65 and older was 42.5%, and the estimated proportion aged 75 and older was 12.3% [2]. As such, these trials create challenges for treating clinicians in evaluating the risk benefit of medications in their older patients.

Physiological variations can translate into differences in pharmacokinetics and/or pharmacodynamics for specific drugs, meaning that medications can work or be processed differently in people of different sexes [3]. For example, the medication Dofetilide was approved by regulators in 1999, to help control irregular or fast heart rhythms (atrial fibrillation). Despite this, it was only in 2018, that a subsequent study found that the recommended twice daily dose was too high in over half of female participants, as they developed other abnormal heart rhythms and had an increased risk of cardiac arrest. This study highlighted the importance of having adequate representation of women in trials, as in the original phase III DIAMOND study, females constituted less than a quarter of all trial participants [4], clearly demonstrating the serious consequences of underrepresentation in clinical trials.

There have been several studies suggesting that pulse oximetry may not be as accurate in certain populations, particularly in individuals with darker skin pigmentation, including those of black ethnicity. This discrepancy in accuracy could result in an overestimation of oxygen saturation levels. The lack of diversity in the patient populations studied in clinical trials has been identified as a contributing factor to this issue. Consequently, there is a growing call for prospective studies to investigate the impact of ethnicity on the accuracy of pulse oximetry to ensure care is optimised for all [5].

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These examples highlight the major consequences of not adequately representing these diverse groups in clinical trials, resulting in a lack of understanding of the drug’s true impact, leading to potentially harmful consequences for those affected.

The Food and Drug Administration (FDA) recognises that some eligibility criteria have become commonly accepted by sponsors over time and used as a template across trials, sometimes excluding certain populations from trials without strong clinical or scientific justification (e.g., older adults, those at the extremes of the weight range, those with malignancies or certain infections such as HIV, and children) [6].

Exclusion of these populations from clinical trials not only propagates inequalities in healthcare but, also puts these groups at higher risk of experiencing adverse effects to medical interventions once they have reached the market.

Why is there underrepresentation in clinical trials?

Despite the collective understanding across the industry to the value of inclusivity and diversity in clinical trials, underrepresentation remains a key challenge today.

This issue is complex and due to multiple reasons, involving systemic barriers, such as unequal access to healthcare and financial constraints, that can hinder the inclusion of individuals from disadvantaged backgrounds. Those individuals on lower incomes often face the responsibility of the care burden, such as looking after children or elderly relatives whilst working, which makes study participation more difficult [7]. Additionally, caregiving commitments shouldered by many women, often mean they lack the time to participate in research.

Recruitment strategies and trial logistics can pose significant barriers to trial enrolment and retention. For example, recruiting through tertiary centres located in urban areas, far away from rural populations, can make enrolment in this group challenging given the structural barriers and transportation issues [1]. Additionally, studies have found that failing to provide transport for individuals with limited mobility, or even translating study information for those who cannot read a given language, can further hinder recruitment efforts [8].

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Other barriers include lack of willingness to participate or a lack of awareness among certain populations about research opportunities, as well as mistrust by some individuals in medical research. The legacy of historical and contemporary abuses in medical research is an important factor in the lack of engagement in both healthcare and research, and careful consideration needs to be made when developing recruitment strategies and patient materials [9].

Another key reason for underrepresentation in clinical trials is the limitations of the study design. Clinical trial design tends to be conservative, often excluding minority groups such as the elderly or those with complex medical histories due to safety concerns and the desire to ensure favourable outcomes. Additionally, physicians’ perceptions and biases can influence the types of patients they consider to be suitable for participation into trials, older individuals may be perceived as more vulnerable or less likely to be able to tolerate new therapies, and therefore these patients are excluded from participation in trials even when not explicitly excluded in the protocol [10]. Implementing safer trial methodologies, and advancements in technology could potentially address these limitations and allow the inclusion of a broader range of patient populations, thereby improving the generalisability and applicability of study findings.

Addressing challenges and regulatory oversight Despite recognition that this problem exists, attempts to address these complex issues have had minimal impact. Different areas of research have different barriers to engagement to overcome and therefore there are no easy solutions, and a tailored approach is required. Nevertheless, there will be some common generic actions that would help address some of these issues. To achieve accurate and meaningful research outcomes, it is critical to evaluate improvements in trial design, particularly inclusion and exclusion criteria, which often lead to the underrepresentation of minority groups. Encouragingly, steps aimed to address this issue are underway. For example, the UK Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA) are working on a new guidance document to help support researchers. This guidance will encourage researchers to consider who will benefit from the research and how to include them, particularly individuals from marginalised populations who are frequently underrepresented or excluded [11].

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The UK’s proposed approach will go beyond the requirements currently in place in the US. While the FDA focuses its diversity plans on enhancing underrepresentation of racial and ethical populations, the HRA, who are responsible for overseeing ethics committees in the UK, will have a broader scope, encouraging sponsors to take a holistic approach to inclusion.

Improving diversity was also high on the agenda of the review undertaken by former health minister Lord O’Shaughnessy to improve the state of commercial clinical trials in the UK. The report highlighted several points in which the country could improve commercial clinical trial operations, including leveraging technology to enable a more diverse cohort of patients to be invited to take part in clinical trials, and making research more convenient, thereby allowing people to take part from the comfort of their own homes [12].

While regulatory bodies play a significant role in setting legislation and creating guidelines, sponsors of clinical trials also have a crucial role to play in improving inclusivity and diversity. One of the most effective strategies is community engagement. By involving patients and the public in the research process from the outset, sponsors can gain valuable insights to help improve and inform study delivery, as well as gaining a better understanding of the patient’s needs and potential barriers to participation. This engagement helps build trust, increase awareness, and ultimately, encourage greater participation from underrepresented populations.

Addressing the logistical burdens of trial participation must become a key consideration for sponsors, designing trials based on lifestyle factors such as work commitments, childcare and caregiver needs are strategies which will help improve the recruitment of minority groups. Reducing the frequency of study visits, considering flexibility in visit windows, and the use of electronic and digital health technology can help to streamline trial procedures, making trials less onerous, and potentially appealing to a broader range of individuals.

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Solutions and future outlook Decentralised clinical trials (DCTs) using real world data sources are becoming an increasing part of the clinical trials landscape. In the recent government response to Lord O’Shaughnessy’s independent review into commercial clinical trials in the UK, it recommends using innovative methods to delivering studies closer to where people live, including virtual studies and decentralised approaches [13].

The adoption of decentralised models, and the use of routinely collected data from patients’ electronic health records (EHRs), can provide important evidence on the safety and effectiveness of new drug therapies. DCTs allow participant’s to engage remotely and access research opportunities closer to home, rather than a traditional tertiary centre. These alternate locations can include their local GP practice, or pharmacy, mobile research units, or even visiting the participants home for those who may be medically complex, and/or house bound. Making trials more accessible and removing the travel burden, will help facilitate participation of more diverse patient populations within the community setting where their day-to-day care is delivered.

Using real world data sources enables richer, more comprehensive datasets to be collected, leading to deeper insights and more robust data analysis. The use of data direct from source allows access to real-time data streams, meaning researchers can monitor patient outcomes and safety continuously throughout the study. This has a key advantage over more traditional methods of capturing safety data, as the integration of multiple healthcare data sources allows for more comprehensive and accurate data to be collected, and the ability to monitor patients’ safety long-term in post-trial follow-up.

Such active surveillance technology was used in the Salford Lung Studies, two industry-sponsored, late-phase randomised controlled trials (RCTs), that were the first in the world to evaluate the effectiveness of a pre-licence medicine in a realworld setting. In comparison to traditional Phase III COPD trials, the Salford Lung Study (SLS) had a higher rate of overall Serious Adverse Events (SAEs), (27-29% vs 13-24%) and a higher rate of pneumonia SAEs (7% vs 1-3.2%) [14]. The higher rate of SAEs detected during SLS, compared to traditional trials demonstrates the effectiveness of using real-world data sources and innovative technology to significantly enhance patient safety and produce much richer datasets for analysis.

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Conclusion In conclusion, addressing the issue of underrepresentation in clinical trials is critical to ensure that the research findings are representative of the entire population, to promote equity in healthcare, and improve patient outcomes.

Despite the collective recognition of the importance of inclusivity and diversity in research, significant challenges persist. However, proactive efforts are underway to overcome these barriers and promote greater inclusivity in clinical trials.

The adoption of innovative solutions, such as community engagement, DCTs, and the use of dynamic safety monitoring, with real-world data taken directly from the source, holds immense promise in enhancing diversity and improving the representativeness of research findings.

In the future, continued efforts are still needed to address systemic barriers, reduce underrepresentation, promote equity in access to research opportunities, reduce risk in underrepresented populations, and ensure voices of all patients are heard and represented in clinical research.

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References 1. Witham MD, Anderson E, Carroll C, Dark PM, Down K, Hall AS, Knee J, Maier RH, Mountain GA, Nestor G, Oliva L, Prowse SR, Tortice A, Wason J, Rochester L; INCLUDE writing group. Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process. Trials. 2020 Aug 1;21(1):694. doi: 10.1186/s13063-020-04613-7. PMID: 32738919; PMCID: PMC7395975.

2. Van Marum RJ. Underrepresentation of the elderly in clinical trials, time for action. Br J Clin Pharmacol. 2020; 86: 2014–2016. https://doi.org/10.1111/bcp.14539 3. Brabete AC, Greaves L, Maximos M, Huber E, Li A, Lê ML. A Sex- and Gender-Based Analysis of Adverse Drug Reactions: A Scoping Review of Pharmacovigilance Databases. Pharmaceuticals (Basel). 2022 Feb 28;15(3):298. doi: 10.3390/ph15030298. PMID: 35337096; PMCID: PMC8950058.

4. Pokorney SD, Yen DC, Campbell KB, Allen LaPointe NM, Sheng S, Thomas L, Bahnson TD, Daubert JP, Picini JP, Jackson KP, Thomas KL, Al-Khatib SM. Dofetilide dose reductions and discontinuations in women compared with men. Heart Rhythm. 2018 Apr;15(4):478-484. doi: 10.1016/j.hrthm.2018.01.027. PMID: 29605013.

5. Bangash MN, Hodson J, Evison F, Patel JM, Johnston AM, Gallier S, Sapey E, Parekh D. Impact of ethnicity on the accuracy of measurements of oxygen saturations: A retrospective observational cohort study.

EClinicalMedicine. 2022 May 6;48:101428. doi: 10.1016/j.eclinm.2022.101428. PMID: 35706489; PMCID: PMC9096912.

6. The Food and Drug Administration. Enhancing the Diversity of Clinical Trials Population- Eligibility Criteria, Enrolment Practices, and Trial Designs Guidance for Industry (2020).https://www.fda.gov/media/127712/download#:~:text=FDA%20also%20recognizes%20that%20some,w eight%20range%2C%20those%20with%20malignancies 7. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. Washington (DC): National Academies Press (US); 2022 May 17. 4, Barriers to Representation of Underrepresented and Excluded Populations in Clinical Research. Available from: https://www.ncbi.nlm.nih.gov/books/NBK584407/ 8. Quay TAW, Frimer L, Janssen PA, et al. Barriers and facilitators to recruitment of South Asians to health research: a scoping review. BMJ Open 2017;7:e014889. doi:10.1136/ bmjopen-2016-014889 9. Griffith DM, Bergner EM, Fair AS, Wilkins CH. Using mistrust, distrust, and low trust precisely in medical care and medical research advances health equity. American Journal of Preventive Medicine. 2021;60(3):442–445.

10. Patients with Pulmonary Arterial Hypertension in Clinical Trials, Who Are They? https://www.atsjournals.org/doi/epdf/10.1513/pats.200803-032SK?role=tab https://www.atsjournals.org/doi/epdf/10.1513/pats.200803-032SK?role=tab 11. HRA-https://www.hra.nhs.uk/planning-and-improving-research/best-practice/increasing-diversity-peopletaking-partresearch/#:~:text=The%20HRA%20and%20MHRA%20Inclusion%20and%20Diversity%20Plan&text=This%20wil l%20help%20ensure%20clinical,by%20research%20are%20not%20overlooked.

12. https://www.gov.uk/government/publications/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessyreview/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review-final-report 13. https://www.gov.uk/government/publications/government-response-to-the-review-into-commercial-clinicaltrials/full-government-response-to-the-lord-oshaughnessy-review-into-commercial-clinical-trials 14. Effectiveness versus efficacy trials in COPD: how study design influences outcomes and applicability Ashley Woodcock, Isabelle Boucot, David A. Leather, Jodie Crawford, Susan Collier, Nawar Diar Bakerly, Emma Hilton, Jørgen Vestbo European Respiratory Journal 2018 51: 1701531; DOI: 10.1183/13993003.01531-2017

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