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Related Experiment Videos

Informed versus randomised consent to clinical trials

C Gallo1, F Perrone, S De Placido

  • 1Cattedra di Statistica Medica e Biometria, Facoltà di Medicina e Chirurgia, Seconda Università di Napoli, Italy.

Lancet (London, England)
|October 21, 1995
PubMed
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Informed consent procedures significantly impact participation in clinical trials. Prerandomisation consent can reduce refusal rates for new treatments but may increase them for standard treatments, depending on disease severity.

Area of Science:

  • Clinical Trials
  • Informed Consent
  • Medical Ethics

Background:

  • Understanding patient consent is crucial for ethical and efficient clinical trial design.
  • Varying consent procedures can influence participant recruitment and retention.
  • The perceived severity of a medical condition can impact decision-making regarding trial participation.

Purpose of the Study:

  • To compare different informed consent procedures in a simulated randomized clinical trial.
  • To assess the effect of perceived disease severity on participant refusal rates.
  • To evaluate the efficiency of prerandomisation consent versus conventional informed consent.

Main Methods:

  • 2035 healthy subjects aged 20-80 years participated in a hypothetical trial.
  • Participants were randomly assigned to conventional informed consent or prerandomisation consent groups.
Keywords:
Biomedical and Behavioral Research

Related Experiment Videos

  • Four specific consent scenarios were tested, varying treatment allocation and refusal options.

    • Main Results:

    • Refusal rates varied significantly across the four consent groups (12.1% to 49.2%).
    • Lower refusal rates were observed for consent to new treatments when disease outlook was perceived as severe.
    • Higher refusal rates occurred for consent to standard treatment when disease outlook was perceived as severe.
    • Prerandomisation consent to new treatment was more efficient than conventional one-sided consent.

    Conclusions:

    • Prerandomisation consent can be effective in specific clinical trial scenarios, particularly for novel therapies.
    • The efficiency of prerandomisation consent is context-dependent, with potential inefficiencies in trials comparing similar treatments.
    • Disease severity perception is a key factor influencing patient decisions in clinical trial consent processes.