This blog explores:
- Who are considered subjects in clinical studies.
- How the term subjects is defined and interpreted across various fields.
Table of Contents
Introduction
Many professionals remain uncertain about the concept of a subject and how to appropriately handle subjects during their work. In both clinical and marketing studies, the subject plays a critical role in the overall process.
This article aims to clear that uncertainty by providing a clear and detailed overview of what subjects are and their significance within studies.
Who are subjects referring to?
Clinical Trials:
Clinical trials that are grouped in plenty of phases so it defines as:
In context of clinical trials, a subject refers to the People (or sometimes animals, in preclinical research) who participate in a clinical study to evaluate the safety, efficacy, or pharmacokinetics of a drug, vaccine, or medical device.
Characteristics:
- Enrolled according to protocol inclusion/exclusion criteria.
- Can be healthy volunteers (Phase I) or patients with the condition (Phase II–IV).
- Data collected:
- Adverse events
- Lab values
- Efficacy outcomes
- Demographics
- Participation is controlled and monitored.
“Subjects are not just participants in a clinical study; they are the very foundation upon which medical progress is built.”
Pharmacovigilance:
In Human pharmacovigilance, “subjects” usually refers to patients or individuals who enrolled in the study, experienced adverse events related to medicinal products after approval in the real world.
Characteristics:
- Enrolled or not enrolled in a controlled study.
- Can be:
- Patients
- Consumers (From general public or even HCP)
- Data sources:
- Spontaneous reports (e.g., to regulatory authorities or MAH)
- Literature cases
- Post-marketing studies
- Information may be less structured than in clinical trials.
How Are Subjects Controlled in Studies?
In any clinical study, subjects must always be kept under strict anonymity to protect their privacy and confidentiality.
This is a core ethical requirement and is enforced by regulatory compliance guidelines such as ICH-GCP (Good Clinical Practice) and GDPR (General Data Protection Regulation).
Even if identifying information such as a subject’s name appears during processing, it must be anonymized or coded to prevent direct identification. Typically, unique subject IDs or codes are used instead of personal identifiers.
Reporter vs Consumer vs Subjects
In the context of pharmacovivilance, there are plenty of confusions and this is one among them. in more cases all the three refer the same as if the report generated by the patient itself.
Reporter: In case that may vary. The reporter referes too who reported or genrated from and in this case consumer ot investigator can be the reporter.
Consumer: A consumer is an individual who purchases, uses, or benefits from goods and services for personal use, rather than for resale or professional purposes.
Characteristics of Reporter and Consumer
Characteristics of a Reporter
- A reporter primarily acts as the source of information for a case.
- The reporter can also be the patient themself (e.g., in spontaneous reports).
- Individuals who can act as reporters include:
- Healthcare professionals such as clinicians, dentists, pharmacists, and nurses.
- Consumers and patients themselves who report adverse drug reactions.
- According to ICH-E2B, the primary source of an Individual Case Safety Report (ICSR) is the person who first provides the factual information about the case.
- The term specifically refers to the individual who initially reported the facts.
Characteristics of a Consumer
- A consumer is defined as a person who is not a healthcare professional.
- Examples of consumers include:
- Patients
- Lawyers
- Friends or relatives of patients
- Caregivers or carers
- This definition is in line with ICH-E2D.
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Conclusion
From the above comprehensive explanation, you may already have been familiar with some concepts, while others might have been new or previously unclear. Hopefully, this article has helped clarify your doubts and provided a clearer understanding of the differences between these three areas.
If you found this article insightful and gained new knowledge, please consider sharing it with your colleagues and friends who are eager to learn more about pharmacovigilance.
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