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LSM4221 Drug Discovery and Clinical Trials > Biomarkers in clinical studies > Flashcards

Biomarkers in clinical studies Flashcards

Definition of Biomarkers, Types of Biomarkers, Role in Disease Diagnosis and Management, Application in Personalized Medicine, Biomarker Discovery and Validation, Technological Advances, Regulatory Considerations, Challenges in Biomarker Development, Pharmacogenomics, Ethical and Practical Considerations

1
Q

What is a biomarker?

A

A measurable indicator of biological processes, pathogenic processes, or responses to interventions.

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2
Q

True or False: A biomarker assesses how an individual feels or survives.

A

FALSE

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3
Q

What was an early method to detect diabetes using ants?

A

Ants were attracted to urine with high sugar levels, indicating diabetes.

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4
Q

How do modern methods measure glucose levels compared to older methods?

A

Modern methods are quick and sensitive, allowing reliable blood glucose quantification.

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5
Q

What role do biomarkers serve in advancing medicine development?

A

They act as surrogate endpoints for measuring patient responses to treatments.

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6
Q

How can biomarkers tailor treatments to individuals?

A

By predicting disease risk, progression, and treatment response.

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7
Q

What characteristics make an ideal biomarker?

A

Significant expression in disease, quantifiable, correlates with outcomes, and is economical.

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8
Q

What is a diagnostic biomarker?

A

Identifies presence of a disease.

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9
Q

What is a predictive biomarker?

A

Predicts response to treatments.

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10
Q

How do susceptibility biomarkers work?

A

Indicate the probability of developing a disease.

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11
Q

What is the role of blood pressure in diagnosing hypertension?

A

It serves as both a diagnostic and monitoring biomarker.

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12
Q

How common is cancer today compared to AIDS, malaria, and tuberculosis?

A

More people die from cancer than from AIDS, malaria, and tuberculosis combined.

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13
Q

What is the significance of HER2 overexpression in breast cancer?

A

It is associated with aggressive tumor growth, and poorer prognosis

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14
Q

What does biomarker validation involve?

A

Assessing precision, accuracy, detection limit, and robustness of analytical assays.

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15
Q

How are extracellular vesicles (EVs) used in cancer diagnosis?

A

EVs from cancer cells can be purified from blood for non-invasive detection.

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16
Q

What is mass spectrometry used for in biomarker identification?

A

To identify and quantify proteins in a mixture, aiding new biomarker discovery.

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17
Q

How do flow cytometry and ELISA contribute to biomarker detection?

A

They are sensitive methods for detecting surface proteins on individual cells.

18
Q

What is the significance of integrin proteins in breast cancer metastasis?

A

They are more abundant in EVs from more metastatic breast cancer cells.

19
Q

What are the steps in the biomarker development process?

A

Discovery, analytical validation, clinical validation, and qualification.

20
Q

What is a prognostic biomarker?

A

Indicates the likelihood of a clinical event, disease recurrence, or progression.

21
Q

Give an example of a safety biomarker.

A

Hepatic aminotransferases for hepatotoxicity.

22
Q

What is a pharmacodynamic biomarker?

A

Shows a biological response has occurred after an intervention or exposure.

23
Q

What role does blood pressure play in hypertension management?

A

It’s a pharmacodynamic biomarker for treatment efficacy.

24
Q

How do mutations like BRCA1/2 influence cancer treatment?

A

They serve as risk biomarkers for breast cancer.

25
Q

Define a monitoring biomarker.

A

Monitors disease status or response to treatment over time.

26
Q

What is the purpose of molecular imaging in biomarker development?

A

To visualize the cellular function and the follow-up of molecular processes in living organisms.

27
Q

How do genetic markers aid in personalized medicine?

A

They help in predicting an individual’s response to certain medications.

28
Q

What is the challenge in biomarker discovery?

A

Identifying biomarkers that are both sensitive and specific to a particular disease.

29
Q

Why is biomarker validation critical?

A

It ensures that a biomarker accurately reflects the biological process it is intended to measure.

30
Q

How do proteomic technologies contribute to biomarker discovery?

A

They allow for the analysis of the entire protein content of a cell or tissue.

31
Q

Explain the term bioinformatics in biomarker research.

A

The use of computational tools to manage, analyze, and interpret biological data.

32
Q

How are circulating tumor cells (CTCs) used as biomarkers in cancer?

A

They can be detected in the blood of cancer patients and used for monitoring disease progression or response to treatment.

33
Q

What is microRNA (miRNA) and its relevance in biomarkers?

A

Small non-coding RNAs involved in gene regulation, serving as potential biomarkersto reflect disease states, prognosis, and treatment response .

34
Q

Describe the importance of liquid biopsy in cancer detection.

A

It allows for the detection and monitoring of cancer through non-invasive means, such as blood tests.

35
Q

What is next-generation sequencing (NGS) in biomarker development?

A

A method for rapidly sequencing large amounts of DNA, enabling the discovery of genetic markers.

36
Q

Explain the role of immunohistochemistry (IHC) in biomarker analysis.

A

A technique used to detect specific proteins in cells of a tissue section, aiding in disease diagnosis.

37
Q

What is the future potential of biomarkers in healthcare?

A

To enable earlier disease detection, improve patient stratification, and facilitate personalized medicine approaches.

38
Q

What regulatory guidelines influence biomarker validation in clinical studies?

A

Guidelines from the US FDA, EMA, and OECD influence biomarker validation by setting standards for analytical methods and clinical utility.

39
Q

How do preclinical pain biomarkers inform clinical trials?

A

They help in patient stratification, reducing variability in response to interventions, and guiding personalized pain management strategies.

40
Q

What challenges exist in biomarker discovery and validation?

A

Challenges include ensuring sensitivity, specificity, and clinical utility, as well as navigating complex regulatory requirements.

LSM4221 Drug Discovery and Clinical Trials (4 decks)

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