Skills for Medical Scientists in Research

Skills for Medical Scientists in Research

• Medical research involves systematic investigation into materials and sources to establish facts and reach conclusions.
• Biomedical research, also called bench science, aims to advance knowledge in medicine.

Clinical Research

• Clinical research determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products, and treatments for human use.
• These may be used for prevention, treatment, diagnosis, or symptom relief of diseases.

Research Questions

• Research questions require meticulous design to ensure that they aim to test a specific theory.
• Question must pertain to health/scientific concerns and demonstrate relevance. The question must have a meaningful/important purpose.

Research Studies: Types

• Observational Studies: Researchers observe participants for biomedical or health outcomes without assigning them to intervention groups. Participants may receive standard care.
• Interventional Trials: Participants are assigned to specific groups by researchers to receive one or more interventions and be evaluated for health outcomes.

Research Studies: Phases

• Preclinical: Primarily conducted in vitro (in a lab) to understand how drugs operate in the body, toxicity effects.
• Phase 0: Involves fewer than 10 participants and assesses pharmacokinetic processes (how the body processes the drug). Sub therapeutic doses are used in some cases.
• Phase I: Involves less than 100 healthy volunteers to observe side effects, drug efficacy, and appropriate dosage ranges.
• Phase II: Involves 100-300 patients using a therapeutic dose of the drug to gather further data on side effects and efficacy.
• Phase III: Involves 1000-2000 patients to fully evaluate the potential efficacy and effectiveness of the drug. This phase compares it to commonly used alternatives.
• Phase IV: The licensed drug's long-term effects and wider use are analyzed. Post-marketing studies are used.

Key Terms in Clinical Studies

• Treatment: The active drug or device being studied in the clinical trial.
• Placebo: A substance that does not contain the active drug or treatment but is used as a control in the trial.
• Randomization: Randomly assigning patients to specific treatment groups.
• Blinding: Concealing the treatment allocation from either the participant or the researcher (or both) in a clinical study. This method prevents bias during data collection.
• Power Calculation: Calculating the number of participants needed for the study to detect a statistically meaningful treatment effect. This is usually done using a pilot study.

Types of Clinical Trials

• Open Label Trials: Both researchers and participants know the treatment being administered.. The treatment is not hidden.
• Single Blind Trials: The participant doesn't know if they are in treatment group or placebo, but the researcher does.
• Double Blind Trials: Neither the participant nor the researcher knows which participants receive the treatment or a placebo. A third party manages the randomization.

Randomised Control Trials (RCTs)

• Participants are randomly allocated to receive one of various interventions (treatment or placebo etc).
• One intervention/treatment is often used as a control group.
• A control group may utilize a standard procedure, placebo, or no intervention.

Ethical Considerations in Research

• Participants 'right to informed consent': Must receive, and understand, information about the study in a clear, readable format. Participants have the ability and time to hold onto that information. Information must be provided in a understandable style and format for everyone involved.
• Participants right to refuse/withdraw: Participants are allowed to decline the study/withdraw from it at any point for personal or any other reason.
• Participants right to potential risks and benefits: Participants must be told about the potential risks and benefits of the research study.

Historical Research Misconduct

• The Tuskegee Syphilis Study (1932-1972): Denied treatment to African American men with syphilis for the purposes of a research project. This highlighted unethical behavior in research.
• CIA MKUltra Project (1950s-1970s): The CIA conducted research on the use of mind-control drugs.
• Nazi Medical Experiments (1930s-1940s): Nazi researchers conducted unethical medical experiments on prisoners and other individuals. The Nuremberg Code resulted from these discoveries.

Nuremberg Code

• The Nuremberg Code (1947) establishes ethical guidelines for human experimentation. It emphasizes voluntary consent and the avoidance of unnecessary harm.
• The code consists of 10 principles to ensure that human research follows ethical guidelines, and does not endanger potential subjects.

Glossary of Terms

• Ethics: Moral values that guide conduct or behaviour in any field.
• Research Question: A specific inquiry or a set of inquiries aimed to investigate a topic and answer the enquiry.

Explore the essential skills needed for medical scientists in conducting research. This quiz covers topics ranging from clinical research methodologies to the formulation of relevant research questions. Test your knowledge on observational studies and the overall landscape of biomedical research.