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Related Concept Videos

Blinding01:11

Blinding

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Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
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The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
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Internet-based randomized controlled trials: a systematic review.

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Conducting online randomized controlled trials (RCTs) is possible but challenging. While many internet-based RCTs exist, most suffer from poor reporting and high participant dropout rates, limiting their methodological rigor.

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Area of Science:

  • Digital Health
  • Clinical Trials Methodology
  • Health Services Research

Background:

  • The internet is increasingly utilized for conducting randomized controlled trials (RCTs).
  • Understanding the scope and quality of internet-based RCTs is crucial for future trial design.
  • This knowledge informs decisions on using conventional, fully online, or hybrid trial methods.

Purpose of the Study:

  • To identify and categorize internet-based RCTs for human health interventions.
  • To evaluate the methodological quality of these online RCTs.
  • To assess the feasibility and limitations of internet-based clinical trials.

Main Methods:

  • A systematic review was performed.
  • Included RCTs were conducted fully or primarily via the internet.
  • Focus was on health interventions for human conditions.

Main Results:

  • 50 internet-based RCTs were identified (23 fully online, 27 primarily online).
  • Most trials involved health information delivery; some tested self-administered interventions.
  • Methodological quality was variable, with poor reporting and significant risk of bias in most trials.
  • High rates of loss to follow-up were a major issue (47% fully online, 36% primarily online).

Conclusions:

  • Rigorously testing health interventions online is theoretically possible but practically difficult.
  • Internet-based RCTs are better suited for pragmatic than explanatory research.
  • Improving methodological standards and reporting is essential for online RCTs, mirroring traditional trial requirements.
  • Addressing high participant attrition is critical for enhancing the validity of online trials.