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#7 Practical RWE – Clinical Study Classification: Interventional or Non-Interventional?

#7 Practical RWE – Clinical Study Classification: Interventional or Non-Interventional?

 

And so…we come to the most painful, controversial, and confusing of the definitions… ”intervention” and “interventional”.

Ideally, we would classify studies according to the level of intervention i.e., interventional, low intervention, and non-interventional. However, most regulators have been hesitant to define ‘intervention’ in their regulations. Only a few countries (e.g., USA, France, and South Africa) [refs 1 to 3] have defined “intervention” in the context of clinical trials.

If ‘intervention’ isn’t defined in the regulations of the region of interest it becomes difficult (impossible) to define what is, and is not, an intervention, and therefore what is, and is not, a clinical trial.

There is a simple solution.  Most countries define a ‘clinical trial’.

For example, in Europe:  ‘Clinical trial’ means a clinical study which fulfils any of the following conditions [ref 4]:

(a)  the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned;

(b)  the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or

(c)  diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects

So…when classifying a clinical study, the recommendation is to determine whether the proposed study is a clinical trial.

If the study isn’t a clinical trial, then what is it?

In Europe, a ‘non-interventional study’ is a clinical study other than a clinical trial [ref 4].

Therefore, in Europe both clinical trials and non-interventional studies (NIS) are investigations in humans that involves a medicinal product.  Whereas, clinical trials involve protocol-defined healthcare interventions, and NIS do not.

 

References:

[1] Section III.A of the FDA Guidance – Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products (August 2023): https://www.fda.gov/media/171667/download

[2] Article L1121-1 of the Public Health Code (CSP): https://www.legifrance.gouv.fr/codes/article_lc/LEGIARTI000032722870/

[3] Glossary of the Department of Health – Ethics in Health Research Guidelines: Principles, Processes and Structures (2015): https://www.health.gov.za/wp-content/uploads/2022/05/NHREC-DoH-2015-Ethics-in-Health-Research-Guidelines-1.pdf

[4] Article 2 of the EU Clinical Trials Regulation (Regulation EU/536/2014): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02014R0536-20221205

In essence, definitions lay the groundwork for accurate, consistent, and meaningful research, especially in areas where the data and its sources are as diverse and complex as in RWD and RWE.

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#7 Practical RWE – Clinical Study Classification: Interventional or Non-Interventional?2024-02-01T14:57:36+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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