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Classical Statistics and Modern Machine Learning
Published in Mark Chang, Artificial Intelligence for Drug Development, Precision Medicine, and Healthcare, 2020
Blinding can be imposed on the investigator, the experimental subjects, the sponsor who finances the experiment, or any combination of these actors. In a single-blind experiment, the individual subjects do not know whether they have been assigned to the experimental group or the control group. Single-blind experimental design is used where the experimenters either must know the full facts (for example, when comparing sham to real surgery). However, there is a risk that subjects are influenced by interaction with the experimenter—known as the experimenter’s bias. In double-blind experiments, both the investigator and experimental subjects have no knowledge of the group to which they are assigned. A double-blind study is usually better than a single-blind study in terms of bias reduction. In a triple-blind experiment, the patient, investigator, and sponsor are all blinded from the treatment group.
European regulatory guidance
Published in Sarfaraz K. Niazi, Biosimilars and Interchangeable Biologics, 2016
Clinical comparability efficacy between the similar biological medicinal product and the reference medicinal product should be demonstrated in at least one adequately powered, randomized, parallel group clinical trial. Clinical studies should be double-blind to avoid bias. If this is not possible, at a minimum the person performing height measurements should be effectively masked to treatment allocation.
Specific collagen peptides increase adaptions of patellar tendon morphology following 14-weeks of high-load resistance training: A randomized-controlled trial
Published in European Journal of Sport Science, 2023
Simon Jerger, Christoph Centner, Benedikt Lauber, Olivier Seynnes, Till Friedrich, David Lolli, Albert Gollhofer, Daniel König
Therefore, the main purpose of the present investigation was to evaluate the effects of the daily supplementation of 5 g SCP for 14 weeks in combination with high load resistance training on morphological adaptions of the patellar tendon across the entire tendon length using magnetic resonance imaging (MRI). The results were compared to a control group with the same training regimen and daily supplementation of a placebo, in a double-blinded manner. In addition, effects of the SCP supplementation on mechanical properties of the patellar tendon (stiffness) as well as maximal dynamic knee extensor strength and morphology of the rectus femoris muscle were assessed. We hypothesized that the group receiving SCP would show higher adaptions of patellar tendon CSA than the placebo group. Additionally, we hypothesize based on the results of previous investigations, that training-related supplementation with specific collagen peptides has a reinforcing effect on mechanical patellar tendon adaptions as well as muscle CSA and maximal voluntary knee extension strength.
Medical textiles
Published in Textile Progress, 2020
Trials may be blinded to improve the accuracy of the results and evidence. Blinding reduces conscious and unconscious bias in the design and execution of a clinical trial [299]. In a blind trial, participants are not told whether they are receiving the new treatment or the alternative. In a double-blind trial, the clinicians treating or data collects and the patients are unaware of the treatment the participant receives. In a triple blind trial, participant, clinicians/data collectors and the outcome adjudicators/data analysists are all unaware of the treatment the participant receives. Randomisation allocates participants randomly to a trial. This may be undertaken by a computer programme. It may be done such that each group within the trial contains a similar mix of individuals of different ages, sex and state of health to allow for meaningful data analysis. As one can see, trials are regulated to ensure that they are safe to participants and comply with ethics yet still produce meaningful results that can be used to optimise human health.
Approaches to Mobile Health Evaluation: A Comparative Study
Published in Information Systems Management, 2020
Samantha Dick, Yvonne O’Connor, Ciara Heavin
All of the methodologies outlined in Table 1 include a randomization process. Randomization is used to eliminate certain biases and confounding factors and therefore allows a high level of confidence to be placed on the results. The randomizations in SMART allow unbiased comparisons between treatment components at each decision stage in their development (Almirall, Nahum-Shani, Sherwood, & Murphy, 2014). As outlined, there is a difficulty in blinding recipients of a mHealth intervention due to the physical presence of the device but the SMART trial suggests the use of an independent evaluator who is blind to treatment assignment to eliminate any information bias which may result (Almirall et al., 2014). This is important because a lack of blinding in a study design could lead to an over-estimation of the effects of an intervention, as was illustrated by Colditz, Miller, and Mosteller (1989) who found that medical interventions evaluated within randomized trials that did not use a double-blind design reported a significantly greater likelihood of success on average than the studies that used double blinding.