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Real World Evidence (RWE) 201 – A Tale of Two Regulatory Paths: Non-Interventional Studies in the USA

RWE 201 – A Tale of Two Regulatory Paths: Non-Interventional Studies in the USA

 

Non-interventional studies are different from randomized controlled trials (RCTs). Instead of actively intervening in a patient’s healthcare, researchers just observe and record what happens naturally during the patients normal (routine) healthcare journey. The data from these studies is useful because it helps generate ideas for further research, flag potential safety concerns, or even provide additional evidence for regulatory decisions, like updating product labels or expanding the use of approved medical products.

Now, if you’re thinking of submitting this data to the FDA, there are certain regulations (rules) you must follow. In the U.S., there are two main pathways:

[1] For studies that will be submitted to the FDA: There’s a ‘checklist’ to follow, such as complying with certain sections of the Code of Federal Regulations (21 CFR 11, 21 CFR 50, 21 CFR 56, etc.) and listing your study on public databases like clinicaltrials.gov.

[2] For studies that won’t be submitted to the FDA: The requirements are a bit different, focusing more on the Common Rule (45 CFR 46), but still following similar safety rules, such as 21 CFR 314 (drugs) and 21 CFR 600 (biologics).

Despite the differences, there are common themes between the two. Both need ethical green lights in the form of Institutional Review Board (IRB) approvals, and participant informed consent is a must. With health data involved, ensuring privacy is non-negotiable, meaning regulations like HIPAA come into play. And regardless of the regulatory pathway, the study should be well-designed and use rigorous methodology to ensure data quality, integrity, and reliability. This includes clear definitions of exposures, outcomes, confounders, and other variables.

Because it’s hard to predict if non-interventional study’s results (RWE) might be submitted to the FDA, it’s a good idea to play it safe and align with FDA regulatory requirements and guidelines from the start.

In both cases, it’s essential to follow good epidemiological and statistical practices to ensure that the findings are robust, valid, and interpretable. Non-interventional studies, by their nature, are more susceptible to confounding and bias than RCTs, so it’s crucial to apply methods that address or mitigate these potential pitfalls.

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Real World Evidence (RWE) 201 – A Tale of Two Regulatory Paths: Non-Interventional Studies in the USA2023-08-20T15:40:46+00:00

Real World Evidence (RWE) 101 – Compliance Maps

RWE 101 – Compliance Maps

In the context of multi-country Real-World Evidence (RWE) studies, “Regulatory Compliance Maps” are essentially a detailed representation of the diverse regulatory requirements specific to each participating country.
 
RWE studies involve the analysis of data derived from a number of different sources outside of typical clinical trials, such as electronic health records (EHRs), medical claims and billing data, patient registries, and patient-generated data. Different countries have varied regulations regarding the use and sharing of such data, including the handling of patient privacy, data security, and informed consent among others.
 
To navigate through this complex landscape, regulatory compliance maps are created for several purposes:
 
[1] Understanding the Regulation: These maps help in identifying the specific regulatory requirements in each country. They define how to handle, process, store, and share patient data.
 
[2] Comparison: They also provide a comparative view of the regulatory landscape across different countries. This comparison allows companies to understand the relative complexity of conducting RWE studies in different regions.
 
[3] Planning: Based on these compliance maps, companies can strategise and design their RWE studies to ensure they meet all regulatory requirements. This might involve altering the study design or selecting specific data collection tools in different regions.
 
[4] Risk Mitigation: By understanding the specific regulations in each region, companies can take proactive steps to minimize risks associated with non-compliance, which might lead to legal repercussions or reputational damage.
 
[5] Collaboration: These maps also facilitate better communication and cooperation with local authorities, including IRBs/RECs, as they demonstrate the company’s understanding and respect for local regulations.
 
Creating and maintaining regulatory compliance maps can be a complex task due to the evolving nature of regulations, the diversity of data sources, and the need for expertise in different jurisdictional laws. However, it is an essential part of conducting efficient and ethical multi-country RWE studies.

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Real World Evidence (RWE) 101 – Compliance Maps2023-08-07T20:50:45+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 – Regulatory Compliance

RWE 101 – Regulatory Compliance

Regulatory compliance in the context of real-world evidence (RWE) refers to ensuring that the generation and use of RWE for regulatory purposes are in accordance with applicable laws, regulations, and guidelines. RWE is increasingly being used to support regulatory decision-making in healthcare, particularly in the evaluation of the safety and effectiveness of medical products.

To ensure regulatory compliance when using RWE, organizations must follow the regulatory requirements and guidelines set forth by regulatory agencies such as the FDA in the United States, the EMA in the European Union, and other national regulatory bodies. These requirements and guidelines include criteria for the selection and use of RWE sources, study design, data quality, data privacy, and transparency.

For example, the FDA has published guidance on the use of RWE in regulatory decision-making, which outlines the criteria for using RWE to support the approval of new indications for existing drugs and to satisfy post-marketing study requirements. The guidance stresses the importance of ensuring that RWE studies are designed to address the regulatory question at hand, have appropriate data quality, and include appropriate statistical analyses.

In addition, regulatory compliance in the context of RWE also requires organizations to adhere to ethical standards for the protection of human subjects and patient privacy. Organizations must ensure that RWE studies are conducted in accordance with ethical principles, and that the data collected and analyzed are anonymized, pseudoanonymised, or de-identified to protect patient privacy.

Overall, regulatory compliance in the context of RWE requires organizations to carefully follow regulatory requirements and guidelines to ensure that the RWE generated and used for regulatory purposes is of high quality, meets ethical standards, and meets the regulatory agency’s criteria for acceptability.

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Real World Evidence (RWE) 101 – Regulatory Compliance2023-08-07T12:34:31+00:00
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