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Real World Evidence (RWE) 101 – Study Conduct

RWE 101 – Study Conduct

Once the study has been set up, the study conduct phase begins. This phase includes several key activities that ensure the smooth running of the study and the collection of high-quality data. Here are some of the key study conduct activities in the context of Real-World Evidence (RWE) studies:
 
[1] Patient Enrolment and Follow-up: After obtaining informed consent, patients are enrolled in the study according to the criteria outlined in the study protocol. The enrolled patients and/or their healthcare data are then followed up at regular intervals. Observational study designs seek to mirror routine clinical practice as closely as possible.
 
[2] Data Collection: This involves gathering data according to the study protocol. The data can come from a variety of sources, such as electronic health records (EHRs), insurance claims databases, patient registries, or directly from patients via surveys or interviews. Data collection must be systematic and standardized to ensure data quality and reliability.
 
[3] Monitoring and Quality Control: Monitoring is done (recommended by the FDA and AEMPs) to ensure that the study is being conducted according to the protocol and that data is being collected accurately and consistently (especially safety data). This could involve site visits by clinical research associates, remote monitoring, or data audits.
 
[4] Safety Monitoring: Any adverse events or side effects reported by patients to/by clinicians are recorded and reported to the appropriate authorities. Reporting requirements differ by region.
 
[5] Interim Analysis: Depending on the study design, interim analyses may be conducted at certain points during the study. This can allow early detection of safety issues or indications of effectiveness.
 
[6] Vendor Management: If vendors are being used for services such as data analysis or lab testing, regular communication is required to ensure that the work is being done according to the agreed timelines and standards.
 
[7] Regulatory Compliance: Throughout the study, all(regional) regulatory requirements must be followed. This includes maintaining proper documentation, protecting patient privacy, and reporting to regulatory bodies as required.
 
[8] Communication and Reporting: Regular updates about the study progress are typically provided by the study sponsor, to the investigators, the ethics committee or IRB, and any other relevant stakeholders.
 
These activities continue until all patients have been enrolled and all data has been collected. The study conduct phase is critical for ensuring that the data collected is reliable and that the results of the study will be scientifically valid and useful for informing healthcare decisions.

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Real World Evidence (RWE) 101 – Study Conduct2023-08-07T18:13:03+00:00

Real World Evidence (RWE) 101 – Monitoring

RWE 101 – Monitoring

Monitoring requirements for Real-World Evidence (RWE) studies may differ from those of traditional randomized controlled trials due to the nature of data collection and the sources of data involved.
 
According to recent (2021) draft FDA Guidance: Study monitoring may be focused on maintaining the reliability of the RWD and data integrity, beginning with extraction of the data from its origin through data curation and transformation and reporting of results.
 
Here are the key monitoring considerations for RWE studies:
 
[1] Data Quality and Integrity: This is the core of any monitoring activity. In RWE studies, data is often sourced from electronic health records, claims databases, registries, or directly from patients. The accuracy and consistency of this data should be monitored to ensure its validity. This can involve cross-checking data from different sources, checking for missing or inconsistent data, and using statistical methods to identify potential data errors.
 
[2] Regulatory Compliance: Even though RWE studies often use pre-existing data, they still need to comply with relevant regulations. For example, patient data must be handled in accordance with data protection laws such as the General Data Protection Regulation (GDPR) in the EU or the Health Insurance Portability and Accountability Act (HIPAA) in the US.
 
[3] Protocol Adherence: While protocol deviations may be less of a concern with RWE studies than with traditional trials (since there is no intervention being delivered), it’s still essential to monitor whether the study is being conducted as planned. For example, are the correct data elements being collected, and is the data being analysed according to the pre-specified plan?
 
[4] Safety Monitoring: Even though RWE studies are typically observational and don’t involve interventions, they still need to monitor for any potential safety signals that emerge. For instance, if the study involves a drug or device, any adverse events or side effects reported in the data nust be investigated.
 
[5] Ethical Compliance: Even though the patients involved in RWE studies may not be directly participating in the way they would in a clinical trial, ethical considerations still apply. If the study involves direct contact with patients (e.g., via surveys), the consent process and protection of patient rights should be monitored.
 
[6] Analysis and Reporting: As data is collected and analysed, it should be checked for completeness and accuracy. Any interim analyses or final reports should be reviewed to ensure they accurately represent the data collected and follow the pre-specified analysis plan.
 
In summary, while the specifics of monitoring may vary somewhat, the goal remains the same: to ensure the study is conducted with high standards of quality, integrity, and ethics, and that the data collected is reliable and valid.

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Real World Evidence (RWE) 101 – Monitoring2023-08-07T17:56:59+00:00

Real World Evidence (RWE) 101 – eConsent

RWE 101 – eConsent

Electronic consent or eConsent refers to the process of using electronic systems and processes to convey information related to the study and to obtain and document participant consent. While eConsent brings numerous benefits to the table, such as improved participant comprehension, streamlined workflows, and easier tracking and managing of consent versions, it is not universally accepted in Real-World Evidence (RWE) studies due to several reasons:

[1] Regulatory Variations: Regulatory guidelines and requirements vary across different jurisdictions and countries. Some regions may not yet have clear guidance or regulations that specifically endorse eConsent, causing uncertainty about its legal validity.

[2] Digital Divide: While digital technologies are pervasive (increasingly accepted), access to and familiarity with these technologies is not universal. Some potential study participants may lack the technology needed for eConsent or may not be comfortable using it, which could potentially exclude certain populations from participation (introducing bias).

[3] Data Security and Privacy Concerns: As with any digital system, there are concerns related to data security and privacy. Participants may worry about their personal information being mishandled or leaked, especially given the sensitivity of health data.

[4] Implementation Costs: Setting up a secure, user-friendly eConsent system that can also meet all regulatory requirements is a significant investment. Small research entities or those in low-resource settings might find it challenging to bear these costs.

[5] Technical Hurdles: eConsent systems require a level of technical infrastructure and support to function effectively. This can include the need for reliable internet connectivity, ongoing technical support, regular software updates, and more.

Despite these challenges, the adoption of eConsent is increasing due to the evolution of technology, better regulatory support, and the COVID-19 pandemic necessitating remote study processes. As these challenges are addressed over time, it’s expected that eConsent will become a more universally accepted practice in RWE studies.

 

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Real World Evidence (RWE) 101 – eConsent2023-08-07T17:48:32+00:00

Real World Evidence (RWE) 101 – Consent to Participate in Research vs Consent to Access and Process Sensitive Healthcare Data (GDPR)

RWE 101 – Consent to Participate in Research vs Consent to Access and Process Sensitive Healthcare Data (GDPR)

Consent to participate in research and consent to access and process sensitive healthcare data are two different but overlapping types of consent, each governed by distinct legal and ethical principles. In the context of Real-World Evidence (RWE) studies:

[1] Consent to Participate in Research: This is the informed consent given by individuals to participate in a research study. Informed consent is a process by which researchers provide potential and enrolled participants with information about the study (purpose, procedures, risks, benefits, alternatives), and the participants voluntarily agree to participate. This consent can be withdrawn at any time, at which point the individual’s participation in the study would end.

[2] Consent to Access and Process Sensitive Healthcare Data: This relates to the consent given by individuals to have their personal and sensitive health data accessed and used for specific purposes, such as research. This type of consent is governed in Europe by the General Data Protection Regulation (GDPR). Under the GDPR, the use of health data is considered a processing of special category data and requires explicit consent, which must be freely given, specific, informed, and unambiguous.

In a RWE study, both types of consent may be (are) needed. The first ensures that participants agree to be part of the study and understand what will happen during the study. The second ensures that participants agree to their data being used in the manner specified, and it provides protections around how their data can be stored, transferred, and otherwise processed.

One key difference between these two types of consent is that withdrawal of consent to participate in the research study generally means the individual will not be part of the study going forward, but it does not necessarily mean that the data collected up to that point cannot be used. In contrast, under the GDPR, if an individual withdraws their consent to data processing, not only does the data processing have to stop, but in many cases, the data collected up to that point cannot be used further and may need to be deleted.

Another difference is that, while there are legal and ethical requirements to obtain informed consent for research participation in most cases, there are certain circumstances under which health data can be processed for research purposes under the GDPR without obtaining explicit consent, such as if the processing is necessary for reasons of public interest in the area of public health, or if the data has been anonymized.

In both cases, the principles of transparency, respect for persons, and their autonomy are paramount. Proper management of both types of consent is crucial for ethical research and for maintaining trust with study participants.

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Real World Evidence (RWE) 101 – Consent to Participate in Research vs Consent to Access and Process Sensitive Healthcare Data (GDPR)2023-08-07T17:41:42+00:00

Real World Evidence (RWE) 101 – Patient Retention

RWE 101 – Patient Retention

 

Long-term Real-World Evidence (RWE) studies face significant challenges when it comes to patient retention, for several reasons:

[1] Time Commitment: Participants in RWE studies are often required to participate over extended periods, sometimes even years. This long-term commitment may lead to decreased interest and attrition over time, especially if the participants do not see immediate benefits from their participation.

[2] Life Changes: Given the long-term nature of RWE studies, life events such as changes in health status, relocation, changes in personal or financial circumstances, or simply a change in priorities can influence a participant’s ability or desire to continue in the study.

[3] Perceived Burden: Depending on the design of the study, the level of participant engagement required can vary widely. Some RWE studies may require frequent hospital visits, self-reporting of data, regular lab tests, or other potentially time-consuming activities. The perceived burden of these requirements can negatively impact retention.

[4] Lack of Engagement: If participants feel that they are just data points and do not feel personally engaged or valued, they may be more likely to drop out of the study. Personal engagement strategies, regular communication, and feedback are therefore crucial to keep participants motivated.

[5] Privacy and Data Security Concerns: In the era of digital health data, participants might worry about the potential misuse of their personal health information, which may lead to dropouts.

[6] Inadequate Understanding: If the participants do not fully understand the importance of their role, the relevance of the research, or the potential benefits to them or to society, they may be less likely to continue in the study. Education and clear communication are key to ensuring participants understand these aspects.

To address these challenges, researchers are increasingly looking to use technologies and strategies that can improve the participant experience and maintain engagement over time, such as remote monitoring technologies, digital health platforms, personalized engagement strategies, and clear, ongoing communication about the value and impact of the study.

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Real World Evidence (RWE) 101 – Patient Retention2023-08-07T17:33:26+00:00

Real World Evidence (RWE) 101 – Patient Recruitment

RWE 101 – Patient Recruitment

Real-world evidence (RWE) is health care information derived from real-world data (RWD). It can be generated through various study designs or analyses, including pragmatic clinical trials, observational studies, and health surveys. In the context of RWE, patient recruitment plays a significant role, as the data collected from these individuals helps in understanding the effectiveness, safety, and usage of medical products in the real world.

Traditional Patient Recruitment: In traditional methods, patient recruitment generally happens through methods like physician referrals, media advertising, patient registries, and patient advocacy groups. This method can be time-consuming, costly, and sometimes inefficient, as it often relies on manual efforts. It can also be challenging to find patients who fit specific inclusion and exclusion criteria for a particular study.

AI-Enabled Recruitment: Artificial intelligence (AI) has started transforming patient recruitment in many ways. AI can analyze vast amounts of real-world data from electronic health records (EHRs), medical claims, health surveys, and other digital health platforms to identify eligible patients rapidly. This approach reduces the recruitment timeline and the costs associated with patient enrollment.

AI algorithms can predict the likelihood of patients participating in the study, improving the precision of recruitment. They can also monitor and analyze patient behavior, enabling the refinement of recruitment strategies in real-time. AI can further enhance the diversity of recruited patients by considering a wide range of demographic and geographic factors, leading to a more inclusive and representative study.

AI-enabled recruitment can also help in mitigating potential biases in patient selection by utilizing a data-driven approach. By analyzing historical clinical trial data, AI models can identify patterns and biases in previous studies and correct them in future ones. Furthermore, AI can help in patient retention by predicting the potential drop-out risks and enabling timely intervention.

In conclusion, while traditional methods are essential and remain relevant in certain contexts, AI-enabled recruitment offers the possibility of increased speed, reduced costs, and improved diversity and representativeness of patients in studies generating real-world evidence.

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Real World Evidence (RWE) 101 – Patient Recruitment2023-08-07T17:26:18+00:00

Real World Evidence (RWE) 101 – HARPER

RWE 101 – HARPER

Regulatory agencies, health technology assessors, and payers are increasingly interested in studies that make use of real-world data to inform regulatory and other policy or clinical decision-making. However, concerns over the credibility of real-world evidence studies have led to calls for more transparency on the design and conduct of RWE studies.
 
A joint task force between ISPE and ISPOR created a harmonized protocol template for RWE studies that evaluate a treatment effect and are intended to inform decision-making. The HARPER template provides clarity, structure, and a common denominator regarding the level of operational detail, context, and rationale necessary in a protocol.
 
HARPER = HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects
 
Link: https://lnkd.in/erkyU2iT
 
Four protocol templates were identified for RWE studies:
 
1. The European Medicines Agency’s (EMA) Guideline on Good Pharmacovigilance Practices (GVP) Module VIII – post-authorizations safety studies (PASS) template,
2. ISPE’s guidelines for good pharmacoepidemiology practice (ISPE GPP) section on protocol development,
3. The National Evaluation System for health Technology (NEST) protocol guidance, and
4. The Structured Template and Reporting Tool for Real World Evidence (STaRT-RWE).
 
The HARPER protocol contains nine sections, including a title page, abstract, and a table for amendments and updates. Each section includes structured free text, a structured table, or a figure, and a free-text section to lay out context and rationale for scientific choices.
 
The study design diagram shows the context and rationale for the study setting, time 0 (index date), inclusion criteria, exclusion criteria, variables, exposure, outcome, follow up, covariates, sensitivity analyses, data sources, metadata, and software used in the study.
 
The data sources section includes a free text component followed by a structured table for specifying data sources. The data sources section can also include a detailed evaluation of the fitness-for-purpose of data source options.
 
Overall, the HARPER framework is a valuable resource for researchers and clinicians who are planning or conducting RWE studies. The framework can help to ensure that protocols are well-designed and will produce high-quality evidence.

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Real World Evidence (RWE) 101 – HARPER2023-08-07T17:19:12+00:00

Real World Evidence (RWE) 101 – STaRT-RWE

RWE 101 – STaRT-RWE

START-RWE (Structured Template for Planning and Reporting on the Implementation of Real World Evidence Studies) was developed to address the need for improved transparency and reproducibility in real-world evidence (RWE) studies.
 
Link: https://lnkd.in/dGp3auQ
 
The template includes sections on study design, data collection, data analysis, and reporting. The study design section includes questions about the study’s objectives, population, intervention, comparator, outcomes, and study period. The data collection section includes questions about the data sources, data collection methods, and data quality assurance procedures. The data analysis section includes questions about the statistical methods that will be used to analyze the data. The reporting section includes questions about the study’s findings, limitations, and implications.
 
The template is intended to be used by researchers and clinicians to develop and implement RWE studies in a rigorous and transparent manner. The template can also be used by funders, regulators, and other stakeholders to assess the quality of RWE studies. The publication includes a number of case studies that illustrate how the STaRT-RWE template has been used to develop and implement RWE studies.
 
In the context of RWE transparency and reproducibility, START-RWE is important for the following reasons:
 
1. Transparency: The comprehensive reporting facilitated by START-RWE allows for complete transparency in the methods and findings of RWE studies. It ensures that all important details regarding the study design, data sources, analysis methods, results, and interpretations are fully disclosed and clearly communicated. This openness supports better interpretation and use of study findings.
2. Reproducibility: Transparency leads to reproducibility. By providing a comprehensive and detailed account of the study methods, START-RWE enables other researchers to replicate the study, which is a cornerstone of scientific validation. Reproducibility also allows for the results of RWE studies to be confirmed and refined in different populations and settings, enhancing their generalizability and impact.
 
The STaRT-RWE template is a valuable resource for researchers and clinicians who are planning or conducting RWE studies. The template can help to ensure that RWE studies are conducted in a rigorous and transparent manner, which can improve the quality of the evidence and ultimately lead to better healthcare decision-making.

 

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Real World Evidence (RWE) 101 – STaRT-RWE2023-08-07T17:12:23+00:00

Real World Evidence (RWE) 101 – Protocol Design and ISPE GPP

RWE 101 – Protocol Design and ISPE GPP

The International Society for Pharmacoepidemiology (ISPE) Guidelines for Good Pharmacoepidemiology Practices (GPP) are a set of best practices for the conduct of pharmacoepidemiologic research, which includes the creation and analysis of real-world evidence (RWE).
 
Link: https://lnkd.in/eHSZVunX
 
ISPE GPP provides a benchmark for quality in pharmacoepidemiology studies, covering all aspects of the research process from study design and conduct to communication of study results. They provide guidance on maintaining ethical standards, ensuring data quality and integrity, managing study data and documents, managing and reporting adverse events, and many other facets of study conduct. Regulatory bodies in the USA, Canada, EU and Germany recommend that ISPE should be considered by marketing authorisation holders and investigators for the development of study protocols, the conduct of studies and the writing of study reports.
 
In the context of RWE and RWE study protocols, ISPE GPP is particularly important for the following reasons:
 
1. Enhanced Credibility and Quality of Studies: Adhering to ISPE GPP can help to ensure that RWE studies are designed and conducted to a high standard, which enhances their credibility and the reliability of their results.
 
2. Consistency and Comparability: ISPE GPP provide a consistent framework for RWE studies, which can facilitate comparison between studies and encourage uniformity in research practices. For example:
– Section II of ISPE GPP provides detailed guidance on protocol design and context
– Section IV covers study conduct and study reporting
 
3. Ethical Conduct: The guidelines provide recommendations for maintaining ethical standards throughout the research process, including the protection of study participants and the use of their data.
 
4. Regulatory Compliance: RWE is being increasingly used by regulatory agencies to inform decisions about the safety and effectiveness of treatments. Adhering to ISPE GPP can help to ensure that studies meet the standards expected by these agencies.
 
5. Transparency: The guidelines promote transparency in the reporting of study methods and results, which is crucial for the interpretation and validation of RWE.
 
6. Archiving: In the absence of national requirements or guidance, ISPE GPP recommends that study-related materials be maintained for at least five years after final report or first publication of study results.
 
In essence, following ISPE GPP can ensure that RWE studies are conducted to a high scientific and ethical standard, increasing their value to healthcare providers, regulators, and patients.

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Real World Evidence (RWE) 101 – Protocol Design and ISPE GPP2023-08-07T17:03:05+00:00

Real World Evidence (RWE) 101 – Protocol Design and Scientific Best Practices

RWE 101 – Protocol Design and Scientific Best Practices

 

Designing a robust Real-World Evidence (RWE) study is crucial for generating reliable and valid insights that are acceptable to regulators. Here are some scientific best practices to consider according to regional drug regulatory authorities:
 
EUROPEAN UNION – According to the European Medicines Agency (EMA), relevant scientific guidance should be considered by marketing authorisation holders and investigators for the development of study protocols, the conduct of studies and the writing of study reports…These scientific guidelines include the:
1. ENCePP Guide on Methodological Standards in Pharmacoepidemiology
2. ENCePP Checklist for Study Protocols, and
3. Guidelines for Good Pharmacoepidemiology Practices of the International Society of Pharmacoepidemiology (ISPE GPP)
Ref: Section VIII.B.1. of GVP Module VIII
 
GERMANY – The observation plan is to be drawn up according to recognized recommendations of scientific or regulatory guidelines…for example:
1.  Guidelines for Good Pharmacoepidemiology Practices of the International Society for Pharmacoepidemiology (ISPE GPP),
2. Recommendations of the ” ENCePP Guide on Methodological Standards in Pharmacoepidemiology”, and
3. Guidelines for Good Epidemiological Practice (GEP) of the German Society for
Epidemiology (DGEpi)
Ref:  Section 2.7.1 of the BfArM/PEI Recommendations – December 2022
 
CANADA – All research protocols should be well-designed and include a comprehensive assessment of good research principles. There are fifteen key elements that should be considered for each protocol, and are reflective of the:
1. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Protocol Checklist, and
2. The Guidelines for Good Pharmacoepidemiology Practices (GPP).
Both prospective and retrospective designs should attempt to address each element, or provide justification why it may not be applicable to the specific study.
Ref: Health Canada – Elements of Real World Data/Evidence Quality throughout the Prescription Drug Product Life Cycle, March 2019
 
USA – According to the FDA’s “Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data” of May 2013, the following provide general guidance applicable to all pharmacoepidemiologic safety studies:
1. ISPE guidelines (ISPE GPP),
2. STROBE reporting framework, and
3. The ENCePP methods checklist
Ref: FDA Guidance – Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data
 
These scientific best practices will help ensure that the RWE study is robust, credible, and provides meaningful information to patients, healthcare providers, and policy makers.

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Real World Evidence (RWE) 101 – Protocol Design and Scientific Best Practices2023-08-07T16:51:55+00:00
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