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Patient-centric disease registries: What, why, when and how?

Emma Bagshaw, Fatemeh Amini, Ellie Bowmar, Dr Mark Larkin

Patient-centric disease registries: What, why, when and how?

INTRODUCTION

Over the past 8 years, Vitaccess has built multiple disease registries to support medicines development and commercialization. In this white paper, members of the Vitaccess team share their experiences on why disease registries are so important to healthcare decision-makers and how and when to develop them, with an eye to the science, the operationalization, and the patient and clinical team burden.

Patient-centric disease registries: What, why, when and how?

What Defining the registry

Why The evidence case

When Timing in the lifecycle

How Five steps to build

Patient-centric disease registries: What, why, when and how?

WHAT

What is a disease registry? A disease registry is an organized system used to capture real-world data (RWD) from people with a particular disease or condition. It involves the prospective collection of structured data aligned with healthcare and research questions in a routine clinical environment over a period of time. 1-3 Unlike a clinical trial, a disease registry is non-interventional. That means that patients undergo their normal care, care decisions are made by clinicians and patients rather than by the study, and that (typically) no additional medical assessments, tests or protocolized procedures are expected beyond standard practice. However, registries should have a set of scientific objectives and can generate additional information that is not routinely captured as long as this can be done in an ethical, non-interventional way, which is aligned with the scientific objectives of the registry. For example, clinicians can provide further information about treatment decisions that they make (e.g., starting, stopping, or switching), they can share information on resources provided to patients to support their self-management (including enrollment in patient support programs), and can give context for non-clinical referrals. With the right approach, patients can answer questions related to their symptoms, perceptions of treatment, quality of life, and/or experience of side-effects .4

RWD accumulates in a registry over time as patients undergo their routine healthcare, and the data source long-term.

Patient-centric disease registries: What, why, when and how?

WHAT

What is a patient-centric disease registry? A disease registry is traditionally designed and governed by academic groups, hospitals, or industry. Typically, registries focus on clinical variables (data shared by clinicians) to examine treatment effectiveness or safety in a real-world setting, or quality improvement. The principles of patient-focused medicines development – where the patient becomes a key stakeholder in deciding how medicines are administered and how clinical trials are run – is not always extended to disease registries. A patient-centric disease registry is one that adheres to all or most of the following:

The scientific objectives of the registry are informed in part by patient priorities, preferences and needs Patients actively provide their own perspectives and experiences through patient-reported outcome measures (PROMs) during the conduct of the registry

Patients are involved in the registry design and development of materials

Data is collected, analysed and presented in a way that is meaningful to patients

Patients help govern/ control data access and use

Clinicians and patients are presented with aggregated data from the registry to increase knowledge and uanderstanding

In short, a patient‑centred disease registry differs from a traditional registry by actively involving patients in its design and data collection, and by focusing on PROMs and real‑world experiences—not just clinician‑reported clinical data.

Patient-centric disease registries: What, why, when and how?

WHY

Why should you build a patientcentric disease registry? Healthcare intervention manufacturers are increasingly looking to supplement their clinical trial data with RWD to support safety and effectiveness decisions with regulators and payers. Both the FDA and EMA recognize the value of disease registries as a source of RWD provided that they are “fit for purpose”: that is, adequately powered with a representative/generalizable sample, asking relevant scientific questions, providing reliable (accurate, complete, consistent) data, and using appropriate data standards and governance.1-2 Patient-centric disease registries span the regulatory focus on RWD as a data source and patient-focused drug development/patient experience data as a guiding principle. Intervention manufacturers have used RWD from patient-centric registries in multiple ways. For example, registry data has been used to support new indications for approved drugs5, fulfil post-approval study requirements6, assess long-term safety and effectiveness7, monitor real-world use of medicines8, and to serve as external control arms to clinical trials9; see Figure 1. Moreover, a well-maintained disease registry can serve as a central, reusable resource for multiple “nested studies” (or “registry-based studies” 1) and offers access to a substantial cohort of patients with whom it might be possible to establish productive collaborations and foster engagement in further research. In 2022, McKinsey estimated the potential return on investment (ROI) of a comprehensive and well-applied RWD strategy, including registries, to be $300 million per year for an established Pharmaceutical company. 10

Patient-centric disease registries: What, why, when and how?

WHEN

When should you build a patientcentric disease registry? As alluded to above, intervention manufacturers can use disease registries to inform both development goals (pre-approval) and commercialization goals (post-approval). The latter make up most use cases, owing to regulator and payer demands for post-approval monitoring. For example, in rare disease it is common for regulators and payers to request a commitment to collecting long-term efficacy data as a condition of approval. For products with significant safety concerns, a postauthorization safety study may be required for approval. However, there are also key questions that intervention manufacturers need to know earlier during medicines development, which may be answered through data collected in patient-centric disease registries. For example:

• • • • • •

What is the burden of disease? What is the natural history of disease? Are there patients for whom there is a significant unmet clinical and/or patient-perceived need? What is the socio-demographic make-up of people with the disease? How are decisions made about treatment for disease? What are the prognostic indicators of treatment response with existing treatments?

• • • •

Is there significant drug–drug interactions with existing treatments? Do outcomes of the disease differ by geography, sociodemographic status, or culture? What are the reasons for treatment discontinuation or switching? Are there differences in outcomes reported directly from patients versus via clinicians?

Answering these questions can provide valuable information which can be utilized to inform discovery and preclinical research, improve trial design and efficiency, and support investment and submission decisions. 11-13 Accordingly, intervention manufacturers should consider that a patient-centric disease registry should be designed, approved, and enrolling patients with some follow-up long before pivotal clinical trials are being considered in the disease. This way they will get the most value out of the registry. 7

Patient-centric disease registries: What, why, when and how?

Figure 1: Applications of real-world data (RWD) from a disease registry across the drug development pipeline

Medicines Development

R&D investment planning

Early phase trials

At this stage, registry RWD can:

enable and enrich disease models e.g. prog-nostic, biomarker and predictive factors of disease progression

assess the feasibility of conducting large-scale trials in specific populations

• • • • • • • 8

increase understanding of burden of disease and natural history be used to define unmet clinical need explore patient priorities, preferences and needs

• •

define distinct patient groups identify ideal recruitment sites (and potential patients) for future studies inform early pharmacology models, including drug-drug interactions increase understanding of burden of disease and natural history

• •

inform selection of patient-centric endpoints and patient-reported outcomes instruments for pivotal trials identify potential barriers to trial participation for patients inform dose selection for next-phase trials

• •

provide a detailed understanding of target populations to ensure representative/ generalizable recruitment serve as external control arms for single-arm trials inform an understanding of adherence barriers support regulatory review of medicine for marketing authorization

Patient-centric disease registries: What, why, when and how?

Medicines Commercialization

Launch of medicine

Post-launch of medicine

At this stage, registry RWD can:

• • • • •

help prepare the market for launch explain how treatment decisions are made in routine care provide insight into perceptions of medicine from clinicians and patients inform development of patient support programmes/ materials support payer/HTA review of medicine for reimbursement/ formulary placement

• • • • •

provide long-term safety and effectiveness data monitor adherence and persistence (and reasons for non-adherence/ discontinuation) examine how the medication is being used in routine care evaluate the prognostic indicators of medication response explore whether medication outcomes differ by geography, sociodemographic status, or culture

Patient-centric disease registries: What, why, when and how?

HOW

How should you build a patientcentric disease registry? There are multiple steps that should be followed when building a patient-centric disease registry. The five key steps followed by the Vitaccess team, grounded in experience and industry standards, are shown in Figure 2 and described below.

Figure 2: Key steps in building a patient-centric disease registry

Establish a registry design team and define scientific objectives

Design a relevant and systematic data collection framework

Plan registry reach and recruitment

Develop a study protocol describing the disease registry

Maintain advisory board(s) for the duration of the registry

STEP 1

Establish a registry design team and define scientific objectives A patient-centric registry design team should include a research lead, registry project manager(s), registry data manager(s), technology expert(s), and statistician(s) from the organization building the registry. They should also include one or more patient organization partners who understand the priorities, preferences and needs of the disease population and who can bring this perspective to the design and conduct of the registry. But first they must align on the high-level scientific objectives. The aim of setting scientific objectives is not to consider an exhaustive list of all and every question that someone may want to answer using the registry data, but rather to be the foundation for the design of the registry, including which variables are collected. Setting thoughtful and robust scientific objectives can be facilitated by collaborating with representatives of intervention manufacturers working in the disease area, 10

Patient-centric disease registries: What, why, when and how?

and by pulling together a scientific advisory board (SAB) and a governance and safety committee (GSC); see Figure 3. An SAB should, at a minimum, include clinical experts in managing the disease and patients and/or caregivers with lived experience of the disease. A GSC should, at a minimum, include clinical experts and registry data managers expert in pharmacovigilance and epidemiology. Ideally it would have overlapping membership with the registry design team. At this step the SAB and GSC can provide insights on research priorities, routine care activities and processes. These will directly inform the scientific objectives for the registry. The SAB and GSC will have ongoing responsibilities and should be maintained throughout the conduct of the registry (see Step 5). STEP 2

Design a relevant and systematic data collection framework Ideally, disease registries should be built to collect comprehensive demographic, disease-progression, and impact-of-treatment data consistent with the scientific objectives in a single reliable and coherent database 14. To yield the most comprehensive dataset, the registry should collect information from both clinicians and patients (and/or caregivers). Clinician-reported data can be collected in two ways; via electronic case report forms (eCRFs) which the clinician completes prospectively, and/or via existing electronic health records (EHR), claims data, and trial data, if relevant. In some settings, and with the right permissions, EHR, claims data and trial data can be extracted into an eCRF directly, facilitated by digital tokenization or medical record aggregation, without requiring clinician oversight. This manual or AI-driven process can both reduce clinician burden and open direct-to-patient channels of recruitment. Patient or caregiver reported data is collected via PROMs and/or Observer-reported outcome measures (ObsROMs) either at home or during routine clinical site visits, or both. A comprehensive, intuitive digital data capture platform – such as Vitaccess Real – with built in user support for patients with needs (e.g., eyesight problems) is key, as is a support team to assist patients as required. This data capture platform should be flexible, to enable local adaptations based on differences in ethical and 11

Patient-centric disease registries: What, why, when and how?

data protection requirements, cultural practices, and approaches to disease management (see Step 3). The registry design team and its collaborators (see Step 1) is key to deciding which data to collect. Specifically, involving patient organizations at this stage ensures that the data collected will be relevant for and informative to people directly living with or supporting the management of the disease. 15 Further, discussing data collection with the SAB, GSC and intervention manufacturers will offer important additional perspectives. SAB patient representative perspectives will help to improve the experience, and therefore engagement, of registry participants, by ensuring that the proposed data collection is feasible (i.e. not overly burdensome). The SAB clinical experts will be able to advise on what data is collected as part of routine care and how well documented that is in the EHR. The GSC members can advise on governance frameworks and data protection processes, and the representatives of intervention manufacturers will help to ensure that the data will meet their development and commercial needs and the expected needs of regulators and payers. It is also advisable to include statisticians and data analysts at this stage (if they are not a core part of the registry design team) to ensure that data is collected in a manner that will allow for straightforward and robust analysis and reporting, including consideration of bias handling and the estimands and testing methods 16 to be used in line with the scientific objectives. In particular, where clinician-reported data is collected via both a cliniciancompleted eCRF and EHR/claims data aggregation, an experienced analytics team may be required to clean and match the data EHR/claims data to the eCRF framework, with guidance from clinical experts.

Patient-centric disease registries: What, why, when and how?

STEP 3

Plan registry reach and recruitment Many disease registries collect data across different levels of care, healthcare systems, countries, and cultures to comprehensively answer their scientific objectives. Globally distributed disease registries can facilitate the inclusion of a large and heterogenous participant population and ensure representation from broad geographies, care settings, and genetic variants. In addition, as a global registry maximizes the number of patients that can take part, it enables a more comprehensive depiction of patients’ experiences. As it is not feasible to recruit to a global registry all at once, a staggered approach should be considered, prioritizing enrolment of sites in one or two key markets early in the registry-building process, with additional markets introduced at later stages. This helps both to manage costs and allows the researchers to apply learnings from onboarding the early enrollers to improve the process. When target countries have been decided by the registry design team, focus must turn to participant recruitment, engagement, and retention within each country. A disease registry will only be able to answer its scientific objectives if it recruits the right patients, retains them over time, and captures complete data from them and their clinicians. Recruitment can be facilitated via several avenues, including hospitals/practices, pharmacies, and “direct-to-patient” models. Recruitment through hospitals, practices and pharmacies (i.e. site-based recruitment) is often important – particularly outside the US – to ensure that sufficient clinical data is available to the registry design team; that is, a healthcare team is required to access medical records to verify eligibility and provide retrospective and prospective data from clinical consultations, tests, diagnoses and referrals. The registry design team should have a dedicated site team for onboarding and managing sites. In the US (and increasingly in Europe thanks to the advent of the European Health Data Space), patients can be recruited directly - through patient groups, patient databases, patient events/congresses, or marketing – and provide access to their 13

Patient-centric disease registries: What, why, when and how?

EHR to the registry design team. In such cases, engagement with at least one patient organization in each country is key to recruitment; ideally, they should be part of the registry design team and/or SAB (see Step 1). Patient organizations can support recruitment by engaging with local patient ambassadors, advertising the registry, offering visibility in patient conferences and webinars, supporting development of materials to be distributed at local patient events, such as sponsored walks, and drive a social media presence for the registry and any associated studies. However, not all patients of interest will be active members of patient organizations and so other avenues must be considered to ensure a broad and representative sample, including site-based recruitment and social media posts. Engaging with Patient Support Programmes, Specialty Pharmacies, and Compassionate Use/Early Access Programmes is also valuable, to connect with patients who are receiving treatments of interest. Establishing patient referral programmes can be valuable, encouraging increased visibility through “word-of-mouth”. Participant engagement and retention can be facilitated by ensuring regular touch points with participants, with patient dashboards, regular newsletters, webinars and data “nuggets”, which are particularly good at maintaining engagement 17-20. This also helps ensure data completeness, as does a user-friendly digital data capture platform (see Step 2), and automated reminders/behavioural nudges. It is valuable to have a compensation framework to encourage participation (and referrals, as relevant), such as gift vouchers for surveys completed, or donations to charities or patient groups on behalf of participants for completion of registry activities. It is vital that any compensation framework adheres to local regulations. Recruitment and retention strategies need to be developed by the registry design team (see Step 1) in collaboration with the SAB and GSC and localized to countries and cultures participating in the registry. In a global registry there may need to be multiple strategies for use in different places.

Patient-centric disease registries: What, why, when and how?

STEP 4

Develop a protocol describing the disease registry A protocol sets out the design of the registry and is a requirement when submitting the disease registry to ethics review boards for approval. The protocol should detail multiple aspects of the registry design, including:

• • • • • •

The scientific objectives (from Step 1) The list of variables (from Step 2) Sample size Recruitment approaches (from Step 3) Analytic overview (from Step 2) Patient-facing materials such as outreach text, informed consent document, etc.

The ENCePP Checklist for Study Protocols21 further details important points to be addressed when designing a registry and writing the study protocol. The protocol and associated materials (e.g., eCRF, PROMs, ObsROMs, informed consent form) should be translated and localized to countries participating in the registry. Engaging with linguists who have local and scientific expertise, as well as local clinical leads, is key here.

The protocol and associated materials (e.g., eCRF, PROMs, ObsROMs, informed consent form) should be translated and localized to countries participating in the registry. Engaging with linguists who have local and scientific expertise, as well as local clinical leads, is key here.

Patient-centric disease registries: What, why, when and how?

STEP 5

Maintain advisory boards for the duration of the registry When the registry goes live – that is, starts to recruit patients – it is important to maintain the SAB and GSC to support the quality, integrity, and utility of the registry. During the conduct of the registry the SAB typically has the following objectives:

• • • •

Ensure that the scientific integrity of the registry remains intact throughout, Generate a patient retention plan to ensure continued engagement of patients throughout the duration of the registry Develop dashboards for displaying real-time aggregated data to clinicians and patients Develop an analysis and dissemination plan

The GSC typically has the following objectives:

• • • •

Ensure that robust governance frameworks are in place, including ethics approvals and GDPR-compliant data protection processes, and that these remain intact throughout, including software, hardware, operating systems, and licensing updates Provide timely review of safety or side-effect data (if relevant to the scientific objectives of the registry) Review and discuss data missingness and strategies to handle it within the registry Discuss how to handle any changes in diagnostic criteria, clinical definitions, or other key evolutions in patient management over the time course of the registry

The registry advisory boards should meet frequently throughout the course of the registry.

Patient-centric disease registries: What, why, when and how?

Figure 3: Participants required to build and oversee a patient-centric disease registry

Scientific Advisory Board (SAB)

Linguistics & localization team

Clinical experts Patients/caregivers

Registry design team Technology expert Research lead Data manager Statistician Patient organization Project manager Site team Patient outreach team

Intervention manufacturers

Governance and safety committee (GSC) Clinical experts Data manager Pharmacovigilance specialist (if needed)

Patient-centric disease registries: What, why, when and how?

WHAT

What are the challenges in building a patient-centric disease registry? Operationalizing a valuable disease registry is not easy, and there are several potential challenges that must be overcome in order to maximize the value of registry data for decision-making. Some of these, along with mitigations, are presented in Table 1. Having a single organization that can manage all aspects of a registry, alongside an SAB and GSC, can reduce these challenges significantly. Table 1: Challenges and mitigations with disease registries Challenges Data of interest may not be routinely collected in clinical practice

Routinely collected RWD is at times incomplete, inaccurate, or not standardized for interoperability between systems

Mitigations

• • •

Registries require significant up-front investment

• •

It can be challenging to meet long-term ethical, legal, and data security requirements

• ••

Flexible registry design and development will include additional routes to accessing data of interest, beyond direct patient-reported and clinicianentered data. A detailed data collection plan will identify the best sources for data of interest, including claims, providers external to primary care physician (e.g., specialists, infusion centers, etc.), and biorepositories Implement standardized data models and common data elements, along with data validation rules and automated quality checks Use interoperable standards and regular quality audits to improve consistency, completeness, reliability

Phased registry implementation with prioritization of core datasets to enable early value demonstration Leverage existing infrastructure, partnerships, scalable digital data capture platforms to reduce up-front costs Establish robust governance frameworks, including ethics approvals, GDPRcompliant data protection processes, regular compliance reviews Engage with legal and compliance experts to ensure adherence Maintain a GSC throughout the registry

Patient-centric disease registries: What, why, when and how?

Maintaining long-term participant engagement and retention

Maintaining long-term participant engagement and retention Lengthy onboarding processes for hospitals/ tertiary institutions

Merging data from multiple countries

• •• •• • •• • • ••

Use patient-centric approaches such as ongoing communication, feedback of study insights, data dashboards, minimization of participation burden Collaborate with advocacy groups Maintain an SAB throughout the study Collaborate with trusted third-party tokenization services Early technical planning and testing to ensure accurate linkage while maintaining patient confidentiality Engaging with clinicians/sites with whom the registry team or stakeholders have existing relationships Early engagement and initiation of onboarding activities Working with experts in local regulatory requirements to avoid unnecessary delays Maintain an SAB throughout the study Adopt harmonized data standards and common data models to ensure consistency across jurisdictions Use standardized terminologies and mapping frameworks Establish centralized data governance, clear data dictionaries, regional compliance strategies

Patient-centric disease registries: What, why, when and how?

Discussion By capturing high-quality, patient-focused longitudinal RWD, patient-centric disease registries offer a powerful foundation for evidence generation across the drug development lifecycle. Moreover, a well-maintained disease registry can serve as a central, reusable resource for multiple “nested studies” If done right, the opportunities to use real-world registry data to facilitate the development and commercialisation of healthcare interventions is significant. At Vitaccess we believe strongly in a patient-centric science-driven approach to the generation and utilisation of RWD. We will continue to invest in our in house regulatory design and delivery expertise (considering scientific, digital tech, operational, localization, statistical, dashboarding, and site and patient management needs) to support intervention developers, regulators, payers and patient organizations in truly understanding patients’ experiences with disease and treatment, through high quality registry data, and ultimately, to help bring effective treatments to patients more efficiently.

Patient-centric disease registries: What, why, when and how?

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Patient-centric disease registries: What, why, when and how?

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Patient-centric disease registries: What, why, when and how?

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