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Validation Strategy for Biomarker-Guided Precision/Personalized Medicine
Published in Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow, Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
For settings where there is a candidate biomarker but not sufficient basis for using it to restrict eligibility, the biomarker stratified design is more appropriate. An example of the biomarker stratified design is known as MARVEL (Marker Validation of Erlotinib in Lung Cancer), of second-line therapy in patients with advanced non-small-cell lung cancer (NSCLC) randomly assigned to pemetrexed or erlotinib (Figure 3.5). The detailed information can be seen in Twilt (2016). Stratifying the randomization is useful in particular because it ensures that all the patients enrolled in this study have received the treatment. However, the challenging issues in a prospective analysis plan include how to measure the test result which would be used in the primary analysis, how to control Family-Wise Error Rate (FWER), and how to determine the primary objective.
Critical appraisal of randomized clinical trials
Published in O. Ajetunmobi, Making Sense of Critical Appraisal, 2021
The randomization procedure used in a trial should be clearly described in the trial report. Randomization, that is, the random allocation of study participants into the various groups of a trial can be done using any of several recognized methods including computer generated random numbers, randomization tables, etc. Randomization ensures that confounding factors within subjects that may affect the study outcome have an equal chance of being present in all the groups of a trial.
Fundamental Principles of Clinical Trials
Published in Demissie Alemayehu, Birol Emir, Michael Gaffney, Interface between Regulation and Statistics in Drug Development, 2020
Demissie Alemayehu, Birol Emir, Michael Gaffney
The procedure used for randomization, and the blinding techniques should be explicitly stated in the study protocol and in subsequent reports to help regulators and readers evaluate the adequacy of the measures taken to minimize bias. In addition, there should be a clear statement of the process for breaking blind, if applicable, and the accessibility of the treatment assignment information to various stakeholders associated with the trial.
A practitioner's guide to conducting and analysing embedded randomized single-case experimental designs
Published in Neuropsychological Rehabilitation, 2023
This set-up allowed the authors to assess two different interventions (massed versus distributed practice) within and between six participants and to assess whether effects fade when treatment is withdrawn (i.e., including baseline phases). Randomization was implemented in a restricted manner: The child rolled a die before the first weekly session to determine which condition would be presented first in that session; the following session would have the reverse order. Thus, the order of conditions was counterbalanced by week but randomized across weeks, and each condition was presented an equal number of times. (Maas et al., 2019, p. 3167)For data analysis, the authors performed visual analysis combined with d-statistic calculations (Busk & Serlin, 1992). It would also have been possible to conduct a randomization test following the restricted randomization used in the design. An alternative or additional way of incorporating randomization would have been the random determination of phase change moments or the random assignment of participants to predetermined phase lengths.
Low Dose Atropine in Preventing the Progression of Childhood Myopia: A Randomised Controlled Trial
Published in Current Eye Research, 2023
Isha Sharma, Gopal K. Das, Jolly Rohatgi, Pramod K. Sahu, Pragti Chhabra, Rahul Bhatia
During the baseline visit, history of the patient was elicited and at each visit, distant visual acuity (uncorrected and best corrected visual acuity) using Snellen’s chart, near visual acuity using Roman test types, photopic and mesopic pupil size measurement using a ruler under ambient light conditions, cycloplegic refraction (attained using homatropine 2% eye drop for three doses 10 min apart) using an autorefractor (UNICOS, URK-800F) by considering an average of 5 readings, anterior and posterior segment examination, axial length measurement by A-scan (Biomedix Echorule Pro) by considering an average of 5 readings30, keratometry (UNICOS, URK-800F) considering an average of 3 readings31, pachymetry (TOPCON SP3000P) were done. All subjects were prescribed spectacles based on their post mydriatic testing. All the investigations were done by a single investigator. One group was given commercially available 0.01% atropine eyedrop (Eyedrop Myotry 0.01% Atropine sulphate ophthalmic solution, NRI Vision Care India Ltd) and the other was given artificial tear eye drop (hydroxypropyl methylcellulose 0.3%) in an identical vial, one drop in each eye at night in the allocation ratio of 1:1. The participants of the study were randomised into two groups based on a computer-generated randomisation. All participants were examined at baseline and were followed up three monthly till one year. Compliance was assessed based on history and the number of empty vials brought back by the parents of the children being studied.
A Tenodesis-Induced-Grip exoskeleton robot (TIGER) for assisting upper extremity functions in stroke patients: a randomized control study
Published in Disability and Rehabilitation, 2022
Hsiu-Yun Hsu, Kang-Chin Yang, Chien-Hsien Yeh, Yu-Ching Lin, Keng-Ren Lin, Fong-Chin Su, Li-Chieh Kuo
There are some additional limitations to this study. First, although this was a randomized control trial with a clinically applicable dose, the training for those patients in the control group was not exclusively focused on rehabilitation of the hand and wrist but included repetitive skill building for tasks of daily living in general. This may have led to less improvement in the hand and wrist function of the participants in the control group. A second limitation was the differences in the baseline characteristics of the study conditions and this, in turn, decreased the statistical power of the study. Thus, the obtained results should be generalized with caution. It is also worth noting that the training paradigm of the TIGER is only composed of continuous passive and functional modes but lacks the training paradigm of an assist-as-needed to provide assistance only as much as it is needed to complete the motor or functional task is the major limitation of the device. In the future, stratified randomization could be employed in the study design to prevent an imbalance in the baseline conditions between treatment groups and thus minimize the variations in treatment responsiveness. In future research, the test for the control system of the TIGER such as motor driving force test for validating mechanical safety shall be carried out to ensure a safer training process. Finally, the design will integrate the Internet of Things with the TIGER system to allow for investigation of the effects of applying the TIGER system as a home-based treatment for chronic stroke patients who have limited rehabilitation resources.