Patient Centered Care & Diagnostics — Bioscience Research and Development Study Notes

Bioscience R&D

The structured process of discovering, testing, validating, and implementing new knowledge, tests, and treatments that improve health.

Unmet clinical need

A gap in care identified when patients are misdiagnosed or current monitoring is burdensome.

Discovery research

Scientists explore biology to find targets, mechanisms, or measurable indicators known as biomarkers.

Prototype development

The design of a potential test, device, workflow, or intervention.

Verification and validation

Checking that the tool works as intended and meaningfully improves clinical outcomes.

Clinical evaluation

Testing the tool in people using study designs that minimize bias.

Regulatory steps

Steps taken to demonstrate evidence, safety, and manufacturing quality before implementation.

Post-market surveillance

Monitoring real-world performance of a test after it has been implemented.

Patient-centered care

An approach to care that considers patients' needs, preferences, and circumstances.

PICO

A framework for structuring clinical questions: Patient/Population, Intervention, Comparison, Outcome.

Randomized controlled trials (RCTs)

Experimental studies that randomly assign participants to groups to test an intervention.

Blinding

A method used to reduce bias where participants and/or researchers do not know group assignments.

Cohort study

An observational study that follows a group exposed to a particular risk to determine outcomes.

Case-control study

An observational study that starts with an outcome and looks backward for exposures.

Cross-sectional study

An observational study that provides a snapshot at one time, good for prevalence.

Sensitivity

The proportion of true cases correctly identified by a test, indicating the test's ability to detect disease.

Specificity

The proportion of true negatives correctly identified by a test, indicating its ability to identify healthy individuals.

Positive predictive value (PPV)

The proportion of positive test results that are true positives.

Negative predictive value (NPV)

The proportion of negative test results that are true negatives.

Likelihood ratios (LR)

Metrics that summarize how much a test result shifts the probability of disease.

Analytical validation

Checks the measurement properties of a test itself, independent of patient outcomes.

Clinical validation

Evaluates how well a test identifies a clinical condition compared to a reference standard.

Clinical utility

Determines if using a test leads to better decisions or outcomes for patients.

Informed consent

An ongoing process ensuring participants understand the study's purpose and risks.

Institutional Review Board (IRB)

An ethics committee that reviews human subjects research to ensure ethical standards are met.

Biosafety

Set of practices designed to reduce exposure to infectious or hazardous biological materials.

Quality management system (QMS)

The organized structure of policies and processes to ensure consistent and quality laboratory work.

Aseptic technique

A method of working to prevent contamination of samples and exposure of workers in a laboratory.

PCR (polymerase chain reaction)

A method for amplifying specific DNA sequences, making tiny amounts detectable.

Immunoassays

Tests that use antibodies to detect specific proteins in a sample.

Flow cytometry

A technique to measure the properties of cells, often used in immunology.

Translational research

The process of bridging basic science discoveries to clinical applications.

Implementation science

The study of methods to promote the integration of research findings into healthcare.

Patient-centered communication

Communication that is accurate, understandable, actionable, and sensitive to patient emotions.

Regulatory evidence

Evidence required by decision-makers to ensure that a diagnostic test is safe and effective.

Post-market safety monitoring

Ongoing assessment of a product’s performance in the real world, ensuring safety and effectiveness.

Data integrity

Ensuring that data is complete, accurate, and protected from inappropriate changes.

Reproducibility

The ability of research results to be replicated by others.

Bias

Systematic error in study design that affects results.

Health equity

Fairness in healthcare access and treatment, ensuring all groups receive appropriate care.

Algorithmic bias

Bias that can occur in predictive models, affecting fairness and accuracy.

Stakeholder engagement

Involving various groups (e.g., patients, providers) in the development of diagnostic tests.

Quality control (QC)

Processes that monitor and maintain the quality of laboratory products.

Quality assurance (QA)

Systematic activities to ensure consistent quality in research and manufacturing.

Ethics in research

Principles that guide the conduct of research to protect participants and ensure fairness.

Biomarker

A measurable indicator of a biological state or condition.

Prevalence

The total number of existing cases of a disease in a population at a given time.

Incidence

The number of new cases of a disease that occur in a specified population over a defined period.