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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).
Ablation therapy
Published in Riadh Habash, BioElectroMagnetics, 2020
To investigate and develop new techniques, and also to improve those currently employed, theoretical models and computer simulations are a powerful tool, since they provide vital information on the electrical and thermal behavior of ablation rapidly and at low cost. In the future they could even help to plan individual treatments for each patient [115]. Temperature is a frequently used parameter to describe the predicted size of lesions computed by computational models. In many cases, however, temperature correlates poorly with lesion size [116]. Many computational studies have been reported in the literature to predict the growth of lesion size during ablation [117–119]. However, the majority of these models do not directly calculate lesion size. Surrogate endpoints such as temperature [94,98] are calculated and are interpreted as being equivalent to lesion size. In many cases, these surrogate endpoints do not correlate well with clinical outcome and vary considerably. Many computational studies justify these surrogate endpoints by showing a high correlation between temperature isotherms and lesion size. However, temperature isotherms and lesion size have never actually been shown to be equivalent. On the other hand, there have been many FEM studies of cardiac RFA [120–122]. Fewer FEM modeling studies were conducted on hepatic ablation [123], blood, myocardium, and torso tissues [124].
Drug Discovery, Development, and Distribution
Published in Richard J. Sundberg, The Chemical Century, 2017
Accelerated access and fast track approval. With the appearance of AIDS (see Chapter 19), considerable pressure arose for access to drugs prior to final approval of the NDA. Various procedures were developed whereby drugs in the approval process could be made available to patients not in formal clinical studies. Subsequently, similar provisions were applied to potential anticancer drugs. These procedures were formalized as the Fast Track Approval Process in 1997. To be eligible for fast-track consideration, a drug must treat a condition that is considered “serious,” that is life-threatening or the cause of significant disability. The drug must also have the potential to significantly improve on existing therapies in efficacy, tolerance, or patient compliance. The fast track approval process permits use of clinical indicators or endpoints that predict clinical benefit, as opposed to the final evidence of clinical outcome. An example of a “surrogate end-point” is the CD4+ cell count in AIDS.
An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and recommendations
Published in Expert Review of Medical Devices, 2023
Rosanna Tarricone, Helen Banks, Oriana Ciani, Werner Brouwer, Michael F Drummond, Reiner Leidl, Nicolas Martelli, Laura Sampietro-Colom, Rod S. Taylor
Measures to mitigate uncertainty in evidence generation along the lifecycle of the high-risk implantable MDs accessing the program should be taken. The Expert Panel(s) (Figure 2) should provide advice on appropriate and feasible study designs for pre-market clinical evidence generation, ideally using tools to determine whether RCTs are possible. Ongoing dialogue should address any proposed adaptations to study designs and post-market study requirements.Where patient-relevant clinical outcome measurement is not possible, accept only validated surrogate endpoints for pre-market studies or, where unvalidated surrogates are accepted for market approval, establish clear requirements for subsequent validation and monitoring. The Accelerated Access Pathway Coordination Group (which incorporates representatives from the MD and HTA Coordination Groups and sub-groups), with Expert Panels, should develop harmonized criteria at the EU level for the acceptability and evaluation of surrogate endpoints that could be part of the open discussions with regulatory Competent Authorities for national-level adoption.