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Clinical Trials
Published in Michael Ljungberg, Handbook of Nuclear Medicine and Molecular Imaging for Physicists, 2022
If a relevant level of efficacy is found in phase II, and no special toxicity concerns have been identified, the drug is ready for phase III – that is, a randomized trial comparing the new drug to placebo or standard treatment for the indication pursued. The gold standard for phase III trials is a randomized, double-blind, placebo-controlled and multicentre trial. Randomization means that the subjects are randomly assigned either to the experimental arm or to the standard/placebo arm. Double-blind means that neither the investigator/doctor nor the subject knows whether he or she is receiving the investigational drug or placebo/standard treatment. Placebo is an inactive substance that has been prepared in the same format as the investigational drug, and in such a way that it is impossible to know whether it contains the active substance or not. To include several centres in a trial is a way to minimize bias in patient selection, patient management, and so forth, that may otherwise differ between different sites/hospitals/countries in a way that may affect outcomes. The number of subjects required to prove a difference between the control arm and the experimental arm depends on how large the difference is between the two – the larger the difference the smaller the sample size required to prove it. Phase III trials generally include hundreds or even thousands of subjects.
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.
Instrument evaluation
Published in C M Langton, C F Njeh, The Physical Measurement of Bone, 2016
Christopher F Njeh, Didier Hans
The major approaches to increasing accuracy include the first four of the strategies listed earlier for precision, and in addition: Blinding: This classic strategy does not prevent an overall bias in the measurements, but it can eliminate differential bias that affects one study group more than another. In a classic double-blind experiment, neither the observer nor the subject knows whether active medicine or identical-looking placebo has been assigned.Calibrating the instrument: The accuracy of many instruments, especially those that are mechanical or electrical, can be increased by periodic calibration using a gold standard.
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.
Clinical trial supply chain design based on the Pareto-optimal trade-off between time and cost
Published in IISE Transactions, 2018
Hui Zhao, Kan Wu, Edward Huang
Although increasing the number of clinical sites accelerates the process of clinical trials, the total cost also increases. A larger clinical trial supply chain can be more complicated and hard to coordinate (Shah, 2004). As a result, the total cost of the clinical trial supply chain, including the enrollment cost of clinical sites and the delivery and holding costs in the distribution of clinical drugs, usually increases. The enrollment cost is the cost of recruiting a clinical site into a clinical trial. Tens of thousands of U.S. dollars are usually required for a typical clinical site (Miseta, 2013). Since clinical drugs are in the development phase, they can only be obtained from the pharmaceutical company. In addition, clinical trials are conducted in a double-blind manner; i.e., when a treatment is given, both the patient and the doctor do not know if it is a placebo or a real drug. Hence, the inventories at both the distribution center and clinical sites are managed and controlled by the pharmaceutical company.