STP Research, Development & Innovation 2 — Questions and Answers
Question 1: Which statistical concept describes the probability of detecting a true effect in a study, given that the effect actually exists?
- Specificity
- Statistical power (Correct answer)
- P-value threshold
- Confidence interval width
Correct answer: Statistical power
Statistical power (1 − β) is the probability that a study will correctly reject the null hypothesis when a true effect exists.
Question 2: In clinical research, what is the primary purpose of a Data Safety Monitoring Board (DSMB)?
- To recruit participants into the trial
- To independently review accumulating data and recommend stopping the trial if necessary (Correct answer)
- To audit the sponsor's financial accounts
- To design the randomisation schedule
Correct answer: To independently review accumulating data and recommend stopping the trial if necessary
A DSMB independently monitors participant safety and trial data, recommending early termination if harm or clear benefit is detected.
Question 3: Which type of validity refers to how well study findings can be applied to populations or settings beyond the original study?
- Internal validity
- Construct validity
- External validity (Correct answer)
- Content validity
Correct answer: External validity
External validity (generalisability) concerns whether results can be applied to other populations, settings, and time points.
Question 4: A researcher wishes to reduce the risk of allocation bias in a randomised controlled trial. Which technique is most effective?
- Using convenience sampling
- Concealed allocation with a centralised randomisation service (Correct answer)
- Stratifying participants by age only
- Assigning alternate participants to each arm
Correct answer: Concealed allocation with a centralised randomisation service
Concealed allocation prevents recruiters from predicting the next assignment, eliminating selection bias at enrolment.
Question 5: Which Good Clinical Practice (GCP) principle states that the rights, safety, and wellbeing of trial subjects must prevail over the interests of science and society?
- Principle of beneficence
- The overriding primacy of participant welfare (Correct answer)
- The principle of justice
- Non-maleficence alone
Correct answer: The overriding primacy of participant welfare
ICH GCP Principle 2.3 explicitly states that the rights, safety, and wellbeing of trial subjects are the most important considerations and should prevail over the interests of science and society.
Question 6: In qualitative research, what does 'transferability' most closely correspond to in quantitative terms?
- Reliability
- Internal validity
- Statistical significance
- External validity / generalisability (Correct answer)
Correct answer: External validity / generalisability
Transferability in qualitative research parallels external validity in quantitative research, asking whether findings apply in other contexts.
Question 7: When a laboratory introduces a novel diagnostic assay, which regulatory framework in the UK governs its validation before clinical use?
- CLIA '88 regulations
- UKCA/CE marking and UKAS accreditation under ISO 15189 (Correct answer)
- FDA 510(k) clearance process
- EMA scientific opinion procedure
Correct answer: UKCA/CE marking and UKAS accreditation under ISO 15189
In the UK, in-vitro diagnostic devices require UKCA/CE marking, and clinical laboratories must meet ISO 15189 standards audited by UKAS.
STP Research, Development & Innovation 2
Which statistical concept describes the probability of detecting a true effect in a study, given that the effect actually exists?