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GERMANY | AKEK Launches New Resources for Streamlined Approval of Non-Interventional Studies

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GERMANY | AKEK Launches New Resources for Streamlined Approval of Non-Interventional Studies2024-11-06T16:59:36+00:00

#12 Practical RWE – Training: Study Team Training

#12 Practical RWE – Training: Study Team Training

 

Study team training is crucial in both Real-World Evidence (RWE) studies and clinical trials, but the importance and focus of the training can vary significantly due to the different natures and objectives of these two types of studies.

  1. Nature of Data Collection:

– In clinical trials, data is collected under controlled conditions with predefined protocols. Training emphasizes adherence to these protocols, ensuring uniformity and minimizing bias.

– RWE studies, on the other hand, use data from sources like electronic health records, insurance claims, or patient registries. Training here focuses on understanding these data sources, identifying relevant data, and ensuring its quality and integrity.

  1. Regulatory Compliance and Guidelines:

– Clinical trials are highly regulated with strict guidelines for conduct. Training ensures compliance with these regulations, including patient safety and reporting requirements.

– RWE studies, while still subject to regulatory considerations, have different compliance requirements. Training helps in understanding these nuances and applying appropriate methodologies.

  1. Study Design and Methodology:

– Training for clinical trials includes detailed study design, placebo controls, blinding methods, and other experimental procedures.

– In RWE studies, training focuses more on observational study designs, statistical methods for handling real-world data, and techniques for reducing bias in non-randomized settings.

  1. Patient Interaction and Consent:

– Clinical trials usually require direct patient interaction, informed consent, and continuous monitoring. Training includes effective communication with participants and managing adverse events.

– RWE studies often use existing data where direct patient interaction is minimal. Training focuses more on data privacy, patient consent in the context of data use, and ethical considerations.

  1. Data Analysis and Interpretation:

– Clinical trial training includes specific methods for analyzing clinical data and interpreting results according to clinical endpoints.

– In RWE studies, training often covers a broader range of data analysis skills, including dealing with large datasets, diverse data types, handling missing data, and applying real-world evidence to clinical or policy decisions.

  1. Collaboration and Multidisciplinary Understanding:

– Both study types require understanding roles across disciplines. However, RWE studies often involve more diverse teams (e.g., data scientists, health economists, healthcare providers, policy makers) and thus require training in effective cross-disciplinary collaboration.

In summary, while study team training is fundamental in both clinical trials and RWE studies for ensuring quality, compliance, and reliability of results, the specific focus of the training differs to cater to the unique challenges and objectives of each study type.

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#12 Practical RWE – Training: Study Team Training2024-02-01T15:50:04+00:00

#9 Practical RWE – Connecting the Dots: How to Identify Country-Specific Requirements for Non-Interventional Studies (NIS)

#9 Practical RWE – Connecting the Dots: How to Identify Country-Specific Requirements for Non-Interventional Studies (NIS)

 

Psstt…this is a secret…so please don’t tell anybody! 😳 🤔 😂

How do we identify the country-specific requirements for non-interventional studies? Much of our work with non-interventional studies involves determining what is NOT applicable.

We start with clinical trials…and run through this series of questions:

  1. What are the Requirements for Clinical Trials?
  2. Are NIS Covered in the Clinical Trial Regulations?
  3. Are There Specific Regulations for NIS?
  4. Are There Specific Regulations for Biomedical Research?
  5. Is There Local Guidance for Biomedical Research?

The answers to these questions help us to build our country-specific regulatory compliance roadmaps. Part of the process includes contacting competent supervisory authorities (e.g., IEC/IRB) to confirm (verify) NIS requirements.

Simple!

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#9 Practical RWE – Connecting the Dots: How to Identify Country-Specific Requirements for Non-Interventional Studies (NIS)2024-02-01T15:14:59+00:00

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 – Non-Interventional Studies vs Market Health Research

RWE 101 – Non-Interventional Studies vs Market Health Research

Key differences between a non-interventional study (NIS) and market health research include:

1. Research Objective: NIS are conducted to examine real-world data and generate evidence on the effectiveness, safety, and outcomes of healthcare interventions in clinical settings. Market health research focuses on understanding market dynamics, consumer behavior, and market trends related to healthcare products or services.

3. Participants: NIS involve patients, healthcare providers, or healthcare institutions as participants, with the goal of studying healthcare interventions and their impact. Market health research focuses on consumers, stakeholders, and market entities, aiming to understand their preferences, attitudes, and behaviors related to healthcare products or services.

4. Methodology: NIS employ observational study designs, analyzing existing data or prospectively collecting data without actively intervening or manipulating variables. Market health research typically involves surveys, interviews, focus groups, or other market research techniques to gather specific information from targeted populations or market segments.

5. Data Collection: NIS gather clinical and patient-related data, such as treatment outcomes, adverse events, medical records, or registries, to assess the real-world impact of healthcare interventions. Market health research collects data on consumer perceptions, attitudes, preferences, purchasing behaviors, or market trends related to healthcare products or services.

6. Ethical Considerations: NIS are subject to research ethics guidelines and regulations, ensuring participant privacy, informed consent, and data confidentiality. Market health research also follows ethical guidelines, focusing on obtaining voluntary participation, ensuring data privacy, and protecting personal information.

7. Stakeholders: NIS primarily involve healthcare providers, researchers, and patients, aiming to inform clinical decision-making and healthcare policies. Market health research involves a broader range of stakeholders, including consumers, healthcare organizations, manufacturers, payers, and policymakers, with the goal of informing marketing strategies, product development, or policy decisions.

8. Reporting and Dissemination: NIS findings are typically reported in scientific journals, presented at medical conferences, or used to inform healthcare guidelines and policies. Market health research findings are often shared through market research reports, industry publications, or utilized internally for strategic decision-making within organizations.

While non-interventional studies and market health research have different objectives and methodologies, they can complement each other by providing a comprehensive understanding of healthcare interventions, their real-world impact, and the market dynamics surrounding healthcare products and services.

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Real World Evidence (RWE) 101 – Non-Interventional Studies vs Market Health Research2023-08-09T15:02:58+00:00

Real World Evidence (RWE) 101 – Observational Study vs Non-Interventional Study

RWE 101 – Observational Study vs Non-Interventional Study

In the context of real-world evidence (RWE), the terms “observational study” and “non-interventional study” are often used interchangeably to refer to studies that collect data outside the controlled environment of a clinical trial. However, it’s worth noting that some subtle differences can exist based on the specific context or regulatory guidelines. Here’s an overview:

[1] Observational Study: An observational study is a research design where researchers observe and collect data on participants without intervening or administering any specific treatment. Observational studies aim to analyze associations, correlations, or patterns in real-world settings. They can be prospective (following participants over time) or retrospective (analyzing existing data or medical records).

[2] Non-interventional Study: A non-interventional study is a study type (EU and US regulatory definition)  that does not involve any healthcare or treatment interventions imposed by researchers. It is often used as an umbrella term for studies that collect data in real-world settings, without manipulating variables. Non-interventional studies are primarily focused on describing, analyzing, or assessing outcomes, exposure, or associations.

It’s important to note that regulatory guidelines and definitions may vary across different regions and agencies. For instance, the US FDA’s guidance on RWE refers to “real-world studies”, “observational Studies”, and “non-interventional (observational) studies”, while the European Union Clinical Trials Regulation (Regulation EU/536/2014) uses the term “non-interventional studies.” However, in practice, the intent of these studies—collecting data without actively intervening—is often similar.

In the context of RWE, both observational studies and non-interventional studies typically leverage real-world data sources such as electronic health records, claims databases, registries, surveys, or patient-reported outcomes. They aim to generate evidence (real world evidence) on treatment outcomes, comparative effectiveness, safety profiles, and other healthcare-related factors.

Ultimately, the precise terminology used may vary, but the fundamental principle is that observational studies and non-interventional studies within the context of RWE both involve the collection and analysis of real-world data without actively imposing healthcare or treatment interventions on participants.

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Real World Evidence (RWE) 101 – Observational Study vs Non-Interventional Study2023-08-07T13:29:05+00:00

Real World Evidence (RWE) 101 – Are Non-Interventional Studies Regulated?

RWE 101 – Are Non-Interventional Studies Regulated?

Yes, non-interventional studies (NIS) are regulated. While the specific regulations and requirements may vary by country, there are generally guidelines and provisions in place to ensure the conduct and reporting of non-interventional studies meet certain standards.

Here are some key points related to the regulation of non-interventional studies:

Ethical Considerations: Non-interventional studies involving human participants must adhere to ethical principles and guidelines (i.e., Declaration of Helsinki) and be approved by an ethics committe (IRB/REC). These guidelines often cover aspects such as informed consent, confidentiality, privacy protection, and the rights and welfare of study participants.

Data Protection: Regulations related to data protection and privacy, such as the EU General Data Protection Regulation (GDPR), are applicable to non-interventional studies. Researchers must ensure that the collection, storage, and processing of personal data comply with these regulations.

Regulatory Oversight: Regulatory authorities may have oversight over non-interventional studies, particularly when the studies are the results of a regulatory commitment (e.g., PMRs and PASS). In the EU, for example, the EMA provides guidance on non-interventional post-authorisation safety studies (PASS) (GVP Module VIII).

Good Pharmacovigilance Practices (EU): Non-interventional studies focused on post-authorization safety assessments of medicinal products are subject to good pharmacovigilance practices. These practices include the collection, analysis, and reporting of adverse drug reactions and safety data.

Reporting Requirements: Non-interventional studies may have reporting requirements (e.g., EU PAS Register) to ensure transparency and accountability. This may include the submission of study protocols, study results, safety updates, or other relevant data to regulatory authorities or ethics committees.

It’s important to note that the specific regulations and requirements for non-interventional studies can vary between countries and regions. Researchers conducting non-interventional studies should be familiar with the applicable regulations in their jurisdiction and seek guidance from regulatory authorities, ethics committees, or relevant professional organizations to ensure compliance with the required standards.

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Real World Evidence (RWE) 101 – Are Non-Interventional Studies Regulated?2023-08-07T13:12:49+00:00

Real World Evidence (RWE) 101 – ‘Interventional’ Clinical Trial vs Non-Interventional Study

RWE 101 – ‘Interventional’ Clinical Trial vs Non-Interventional Study

Interventional Clinical Trial: In this type of study, researchers actively intervene by assigning participants to different groups, administering specific treatments, or manipulating variables. The primary objective is to assess the safety and efficacy of new interventions e.g., drug or medical device.
 
Key characteristics of interventional clinical trials include:
 
Randomization: Participants are randomly assigned to different groups, such as the experimental group receiving the intervention and the control group receiving a placebo or standard treatment.

Intervention: Researchers actively administer a specific treatment or intervention to the participants.

Control Group: There is often a control group that receives a placebo or standard treatment for comparison.

Primary Outcomes: Trials are designed to measure predefined primary outcomes, such as improvements in health outcomes, survival rates, or reduction in symptoms.

Regulatory Oversight: Interventional trials require regulatory approval and are usually subject to stricter (risk-proportionate) regulations than non-interventional studies.
 
Non-interventional Study: These studies focus on collecting data without any active healthcare or treatment intervention imposed by the researchers. Researchers observe and collect information from participants in their natural settings (real world settings) or through retrospective analysis of existing data (secondary use of existing data).
 
Key characteristics of non-interventional studies include:
 
Observation: Researchers observe participants and collect data without actively intervening in the healthcare management of the participant or administering any specific treatment (treatment intervention).

Natural Setting: Data is collected in the real-world clinical practice or from existing databases, medical records, surveys, or interviews.

Descriptive Analysis: Non-interventional studies often aim to describe and analyze associations, relationships, patterns, or risk factors in the population under study.

Retrospective or Prospective: Data can be collected retrospectively by analyzing past records or prospectively by following participants over time.

No Randomization: Participants are not randomly assigned to groups, and treatment decisions are made by healthcare providers according to routine clinical practice.

Regulatory Oversight: Every country regulates non-interventional studies differently. The regulatory burden can therefore be much higher than expected.
 
Both ‘interventional’ clinical trials and non-interventional studies play important roles in advancing medical knowledge. Interventional trials provide more rigorous evidence for evaluating new interventions, while non-interventional studies offer insights into real-world effectiveness, population health, and long-term outcomes.

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Real World Evidence (RWE) 101 – ‘Interventional’ Clinical Trial vs Non-Interventional Study2023-08-07T12:55:06+00:00
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