Liposomes as nanomedical devices

1011: A Review of the Activities of the ITC in Support of RTOG Advanced Technology Clinical Trials

Materials for Drug Delivery: Innovative Solutions to Address Complex Biological Hurdles

We as medical physicists have a crucial role to play in ensuring that all patients on radiotherapy protocols are treated comparably. Without this comparability, the validity of outcome results from the pooled patient data may be jeopardized. Advances in radiation therapy technology and delivery techniques have naturally led to the desire to incorporate such new tools into clinical trials, yet standardized quality assurance (QA) procedures are not fully developed and widely practiced. Although several task groups within the AAPM have been formed to set standards for QA for these new technologies, a major challenge is to conduct clinical trials that involve both the old and new technologies without overwhelming individual physicists with additional testing. National and international multi‐institutional clinical trials uniquely challenge the medical physics community to maintain comparability while at the same time requiring or permitting patient treatments that incorporate advanced technologies such as IMRT, image guided radiotherapy,imagefusion, and other techniques. The AAPM Working Group on Clinical Trials presents this continuing education symposium in order to discuss the efforts underway to design QA methods for advanced radiotherapy technologies especially in the context of clinical trials with the intent to address the issue of comparability and standardization of protocol data. We will present the work of Task Group 113, an important player in these efforts, on providing guidance as to physics practice standards for QA for radiotherapy clinical trials. The task group's recommendations on QA procedures and reporting methods are intended to facilitate highly consistent protocol treatments and data submission. The Working Group on clinical trials has identified several topics that pose significant challenges with respect to consistency of physics practices: dose calculations with heterogeneity corrections, localization verification, imagefusion techniques, and the treatment of moving targets. In this course, the history and the current state of the art will be described for each topic. The discussion about these areas should be of interest whether or not one is involved in clinical trials. Learning objectives for the entire CE course: 1. Understand the quality assurance issues facing Medical Physicists using advanced technologies and how these relate to clinical trial data validity. 2. Learn what Task Group 113 is doing to address the accuracy and consistency of data we send to quality assurance review centers. 3. Understand the problems and potential solutions to controversies in quality assurance measures for imagefusion, target motion, patient localization, and heterogeneity corrections.

Defining Endpoints and Biomarkers in Inflammatory Bowel Disease: Moving the Needle Through Clinical Trial Design

Heart failure is a common condition responsible for at least 290 000 deaths each year in the United States alone.1 A small minority of heart failure cases are attributed to Mendelian or familial cardiomyopathies. The majority of systolic heart failure cases are not familial but represent the end result of 1 or many conditions that primarily injure the myocardium sufficiently to diminish cardiac output in the absence of compensatory mechanisms. Paradoxically, because they also injure the myocardium, it is the chronic actions of the compensatory mechanisms that in many instances contribute to the progression from simple cardiac injury to dilated cardiomyopathy and overt heart failure. Thus, the epidemiology of common heart failure appears to be just as sporadic as its major antecedent conditions (atherosclerosis, diabetes, hypertension, and viral myocarditis). Familial trends in preclinical cardiac remodeling2 and risk of developing heart failure3 reveal an important role for genetic modifiers in addition to clinical and environmental factors. Candidate gene studies performed over the past 10 years have identified a few polymorphic gene variants that modify risk or progression of common heart failure.4 Whole-genome sequencing will lead to the discovery of other genetic modifiers that were not candidates.5 The imminent availability of individual whole-genome sequences at a cost competitive with available genetic tests for familial cardiomyopathy will no doubt further expand the list of putative genetic heart failure modifiers. Heart failure risk alleles along with traditional clinical factors will need to be considered by clinical cardiologists in their design of optimal disease surveillance and prevention programs and in individually tailoring heart failure management. The use of individual genetic make-up is likely to have the earliest and greatest impact on managing patients with heart failure by tailoring available pharmacotherapeutics to optimize patient response and minimize adverse effects (ie, the …

Innovation in Health Care: Time for a Gut Check

We as medical physicists have a crucial role to play in ensuring that all patients on radiotherapy protocols are treated comparably. Without this comparability, the validity of outcome results from the pooled patient data may be jeopardized. Advances in radiation therapy technology and delivery techniques have naturally led to the desire to incorporate such new tools into clinical trials, yet standardized quality assurance (QA) procedures are not fully developed and widely practiced. Although several task groups within the AAPM have been formed to set standards for QA for these new technologies, a major challenge is to conduct clinical trials that involve both the old and new technologies without overwhelming individual physicists with additional testing. National and international multi‐institutional clinical trials uniquely challenge the medical physics community to maintain comparability while at the same time requiring or permitting patient treatments that incorporate advanced technologies such as IMRT, image guided radiotherapy, image fusion, and other techniques.The AAPM Working Group on Clinical Trials presents this continuing education symposium in order to discuss the efforts underway to design QA methods for advanced radiotherapy technologies especially in the context of clinical trials with the intent to address the issue of comparability and standardization of protocol data. We will present the work of Task Group 113, an important player in these efforts, on providing guidance as to physics practice standards for QA for radiotherapy clinical trials. The task group's recommendations on QA procedures and reporting methods are intended to facilitate highly consistent protocol treatments and data submission.The Working Group on clinical trials has identified several topics that pose significant challenges with respect to consistency of physics practices: dose calculations with heterogeneity corrections, localization verification, image fusion techniques, and the treatment of moving targets. In this course, the history and the current state of the art will be described for each topic. The discussion about these areas should be of interest whether or not one is involved in clinical trials.Educational Objectives:1. Understand the quality assurance issues facing Medical Physicists using advanced technologies and how these relate to clinical trial data validity.2. Learn what Task Group 113 is doing to address the accuracy and consistency of data we send to quality assurance review centers.3. Understand the problems and potential solutions to controversies in quality assurance measures for image fusion, target motion, patient localization, and heterogeneity corrections.

A valuable new edition of the trusted, practical guide to managing data in clinical trials Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided. While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements. Newly featured topics include: The growing availability of off-the-shelf solutions for clinical trials Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry The increasing use of the Internet in the collection of data and management of trials Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines Development of Standard Operating Procedures for the conduct of clinical trials Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels.

Food Effect on Oral Bioavailability: Old and New Questions.

Three discipline collaborative radiation therapy (3DCRT) special debate: FLASH radiotherapy needs ongoing basic and animal research before implementing it to a large clinical scale.

Radiation therapy quality assurance in clinical trials – Global harmonisation group

From Molecule to Patient and Ways to Get the Dose Precisely Right

Spinal cord injury (SCI) causes irreversible neurological deficits and represents a major global health and socioeconomic burden. Although neural progenitor cell (NPC) transplantation is strongly supported by preclinical evidence through cell replacement, intrinsic neuroregeneration, and broad neurotrophic and immunomodulatory effects, its clinical translation has progressed more slowly than anticipated. In parallel, rapid advances in gene editing, biomaterial engineering, and organoid technologies are reshaping the therapeutic landscape. Therefore, it is timely to systematically re-evaluate the current evidence on NPC-based therapies for SCI and to refine future translational strategies. This review provides an updated and comprehensive overview of NPC therapy for SCI across the full translational continuum. First, we summarize the biological properties, advantages, and limitations of NPCs derived from adult or embryonic neural tissues, embryonic stem cells (ESCs), and induced pluripotent stem cells (iPSCs), highlighting issues such as tumorigenicity, immune responses, and manufacturing standardization. We then focus on efficacy-oriented genetic modifications and engineered delivery systems, including NPCs overexpressing neurotrophic, synaptogenic, or pro-survival factors, as well as combination strategies integrating NPCs with biomaterials, small molecules, or immunomodulatory agents to enhance graft survival, circuit reconstruction, and motor and sensory recovery. Subsequently, we systematically analyze 19 clinical trials of NPC/NSC-based products conducted in 10 countries, covering HuCNS-SC, LCTOPC1, NSI-566, hESC-OPC, and the emerging iPSC-derived product XS228. Trial designs, dosing regimens, routes of administration, safety profiles, and preliminary functional outcomes are compared, and key design principles for next-generation clinical trials and patient selection are proposed. Finally, we discuss organoid-based approaches and artificial intelligence (AI)-assisted decision tools as emerging platforms for disease modeling, protocol optimization, and precision indication refinement. NPC-based therapy for SCI remains at an early but promising translational stage. No NPC product has yet achieved regulatory approval, reflecting persistent challenges in cell source optimization, safety control, graft survival, in vivo tracking, and trial design. Nevertheless, by integrating rigorous cell source selection, rational gene modification, advanced delivery systems, and well-designed clinical trials targeting carefully defined patient populations, NPCs are expected to achieve meaningful-and potentially transformative-clinical benefits for individuals with SCI in the future.

Engaging Underrepresented Patients in Hematology Clinical Trials through the LLS Impact (Influential Medicine Providing Access to Clinical Trials) Research Grant: A Multi-Institutional Effort

The physiochemical properties of nanoparticles (NPs), including surface charge, will affect their uptake, transformation, translocation, and final fate in the environment. In this study, we compared the phytoxoxicity and transport behaviors of nano CeO2 (nCeO2) functionalized with positively charged (Cs-nCeO2) and negatively charged (PAA-nCeO2) coatings. Cucumber seedlings were hydroponically exposed to 0-1000 mg/L of Cs-nCeO2 and PAA-nCeO2 for 14 days and the contents, distribution, translocation, and transformation of Ce in plants were analyzed using inductively coupled plasma mass spectrometry, micro X-ray fluorescence (μ-XRF), and X-ray absorption near-edge spectroscopy (XANES), respectively. Results showed that the seedling growth and Ce contents in plant tissues were functions of exposure concentrations and surface charge. Cs-nCeO2 was adsorbed strongly on a negatively charged root surface, which led to significantly higher Ce contents in the roots and lower translocation factors of Ce from the roots to shoots in Cs-nCeO2 group than in PAA-nCeO2 group. The results of μ-XRF showed that Ce elements were mainly accumulated at the root tips and lateral roots, as well as in the veins and at the edge of leaves. XANES results revealed that the proportion of Ce(III) was comparable in the plant tissues of the two groups. We speculated that Cs-nCeO2 and PAA-nCeO2 were partially dissolved under the effect of root exudates, releasing Ce3+ ions as a result. Then, the Ce3+ ions were transported upward in the form of Ce(III) complexes along the vascular bundles and eventually accumulated in the veins. The other portion of Cs-nCeO2 and PAA-nCeO2 entered the roots through the gap of a Casparian strip at root tips/lateral roots and was transported upward as intact NPs and finally accumulated at the edge of the blade. This study will greatly advance our information on how the properties of NPs influence their phytotoxicity, uptake, and subsequent trophic transfer in terrestrial food webs.