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Protocol for Standardized Data Collection in Humans
Published in U. Snekhalatha, K. Palani Thanaraj, Kurt Ammer, Artificial Intelligence-Based Infrared Thermal Image Processing and Its Applications, 2023
U. Snekhalatha, K. Palani Thanaraj, Kurt Ammer
Studies on the employment of thermal imaging as an outcome measure require the definition of the accuracy of thermal images to identify clinical endpoints. A clinical trial endpoint was defined as a characteristic or variable that reflects how a patient feels, functions, or survives. Thus, clinical endpoints are distinct measurements or analyses of disease characteristics observed in a study or a clinical trial that reflect the effect of a therapeutic intervention (Biomarkers Definitions Working Group, 2001). Surrogate endpoint is another important term defined as a marker that is intended to substitute for a clinical endpoint. Exploration of thermal imaging as an outcome measure is the evaluation of whether thermal images can serve as a surrogate endpoint, which is expected to predict clinical benefit (or harm or lack of benefit or harm) based on epidemiologic therapeutic, pathophysiologic, or other scientific evidence. The use of thermal images as surrogate endpoints in a clinical trial requires the specification of the clinical endpoints that are being substituted, the class of therapeutic intervention being applied, characteristics of the population, and the disease state in which the substitution is being made (Biomarkers Definitions Working Group, 2001).
Rare Diseases Drug Development
Published in Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow, Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
Shein-Chung Chow, Shutian Zhang, Wei Zhang
Table 10.2 indicates that there are four different types of two-stage seamless adaptive designs depending upon whether study objectives and/or study endpoints at different stages are the same. For example, Category I designs (i.e., SS designs) include those designs with the same study objectives and same study endpoints, while Category II and Category III designs (i.e., SD and DS designs) are referred to those designs with the same study objectives but different study endpoints and different study objectives but same study endpoints, respectively. Category IV designs (i.e., DD designs) are the study designs with different study objectives and different study endpoints. In practice, different study objectives could be treatment selection for Stage 1 and efficacy confirmation for Stage 2. On the other hand, different study endpoints could be biomarker, surrogate endpoints, or a clinical endpoint with a shorter duration at the first stage versus a clinical endpoint at the second stage. Note that a group sequential design with one planned interim analysis is often considered an SS design.
Meta-Analytic Approach to Evaluation of Surrogate Endpoints
Published in Christopher H. Schmid, Theo Stijnen, Ian R. White, Handbook of Meta-Analysis, 2020
Tomasz Burzykowski, Marc Buyse, Geert Molenberghs, Ariel Alonso, Wim Van der Elst, Ziv Shkedy
The suggestion of Buyse and Molenberghs (1998) to evaluate surrogates by using data from multiple randomized trials coincided with the proposal of The Biomarker Definitions Working Group (2001; Ellenberg and Hamilton, 1989). The definitions formulated by the latter group have since been widely adopted. A clinical endpoint is considered the most credible indicator of drug response and defined as a characteristic or variable that reflects how a patient feels, functions, or survives. In clinical trials aimed at establishing the worth of new therapies, clinically relevant endpoints should be used, unless a biomarker or other endpoint is available that has risen to the status of surrogate endpoint. A biomarker is defined as a characteristic that can be objectively measured as an indicator of healthy or pathological biological processes, or pharmacological responses to therapeutic intervention. A surrogate endpoint is a biomarker that is intended for substituting a clinical endpoint. A surrogate endpoint is expected to predict clinical benefit, harm, or lack of these. Toward this aim, a prediction model is needed. Such a model can be built using data from multiple randomized trials.
The notion of Surrogacy in Health Technology Assessment: an insight in the processes of Germany, UK and France
Published in Journal of Medical Economics, 2022
Panagiotis Petrou, Olga Pitsillidou, M. J. Postma
In oncology, surrogate endpoints are tumor-centered clinical endpoints that infer clinical benefit to the patient and are employed as a proxy for a patient-centered clinical endpoint. These endpoints refer to biological markers, either laboratory or histology ones, such as tumor response, circulating tumor cells, disease-free survival (DFS) and progression-free survival (PFS), which can define therapeutic response to an intervention. The rationale of surrogate endpoints is nested in the prediction of survival well in advance, thus perpetuating to fewer patients and shorter and cheaper trials. In some cases, as in the cases of crossover to subsequent treatments, the use of surrogate endpoints is justified. A validation must precede, which constitutes an intricate but obligatory process. Many surrogate endpoints, which meet the criteria of being assessable earlier in a patient’s life, have been assessed. Nevertheless, a simple correlation does not suffice3 (Table 1).
The effect of socioeconomic status on age at diagnosis and overall survival in patients with intracranial meningioma
Published in International Journal of Neuroscience, 2022
Ryan Brewster, Sayantan Deb, Arjun Vivek Pendharkar, John Ratliff, Gordon Li, Atman Desai
There are limitations to the current study. To account for the most recent data and advances in clinical practice, the scope of this study was limited to a 5-year period, including survival probability. Due to the typically benign nature of most meningiomas, mortality in this 5-year period may not provide a comprehensive reflection of meningioma outcomes. Quality of life and other more qualitative metrics may offer a more meaningful clinical endpoint, and provide a fertile avenue for future studies. Another limitation was the absence of data on other treatment modalities, including chemotherapy. Although surgical resection and adjuvant radiotherapy remains the most common therapeutic paradigm, the last two decades have seen increasing application of chemotherapy, particularly for inoperable or recurrent lesions [56]. A future study of medical therapies could thus supplement the findings regarding surgery and radiation therapy. Finally, we propose further investigating the specific components that make up SES categorization such as insurance status, ethnicity, income, and region of residence, which have been shown to exert individual and cumulative effects [57].
Deliberate teaching tools for clinical teaching encounters: A critical scoping review and thematic analysis to establish definitional clarity
Published in Medical Teacher, 2019
Navdeep S. Sidhu, Morgan Edwards
Twelve of 16 feedback surveys evaluated the OMP framework, two for SNAPPS, and one each for the Education Planning and Worksheet for Ambulatory Medicine (WAM) frameworks. Six (37.5%) administered a single survey after introduction of a teaching tool on teachers, learners, or both. Eight (50.0%) surveyed teachers and/or learners pre- and post-intervention, one surveyed learners after watching videos of the DTT being used, and another surveyed learners after live demonstration of the DTT. One feedback survey included a clinical endpoint as an outcome measure in its study design but reported on learners’ perception on ease of making a diagnosis without assessing their ability to make said diagnosis (Kachewar 2015). Incomplete or unclear reporting was evident in some of the feedback surveys, including statements of positive outcomes without providing figures (Dandekar et al. 2013; Harkare et al. 2013), and another where the pre- and post-intervention survey items did not match (Kachewar 2015). One study design involved a baseline survey at the start of a clinical rotation, making it unclear how learners were able to make an informed judgment on their perception of teaching in that clinical rotation as it was prior to any teaching occurring (Iyer et al. 2017).