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Seminars in Oncology Nursing Apr 2020To describe the increasing complexity and scope of clinical trials research, convergent research, and the clinical nurse roles and responsibilities to ensure safe... (Review)
Review
OBJECTIVES
To describe the increasing complexity and scope of clinical trials research, convergent research, and the clinical nurse roles and responsibilities to ensure safe patient care and study data integrity.
DATA SOURCES
Textbooks, journal publications, federal regulations, US Food and Drug Administration documents, clinical practice guidelines.
CONCLUSION
The immune system, genetics, and molecular pathology are not new in the context of oncology treatments. The reliability and clinical validation of in vitro diagnostic medical devices is, however, becoming increasingly more important in the development of marker driven targeted therapies, immunotherapy, and adoptive T-cell transfer. Protecting patients and preserving the integrity of clinical trials is of utmost importance.
IMPLICATIONS FOR NURSING PRACTICE
The role and scope of oncology and research nurses will intersect and shift as clinical care continues to involve high-acuity patients who participate in complex in vitro diagnostic and therapeutics clinical trials. The expertise of oncology nurses may vary in skills and knowledge domain; however, all scopes of practice are underpinned by the nursing code of ethics to ensure accountability for all aspects of patient care.
Topics: Biomedical Research; Clinical Trials as Topic; Ethics, Nursing; Genetic Testing; Humans; Neoplasms; Oncology Nursing; Research Personnel
PubMed: 32265167
DOI: 10.1016/j.soncn.2020.151002 -
Cardiovascular Revascularization... Jun 2020
Topics: Humans; Cardiology; Clinical Trials as Topic; Congresses as Topic; Diffusion of Innovation; Heart Diseases; Treatment Outcome
PubMed: 32349943
DOI: 10.1016/j.carrev.2020.04.003 -
Contemporary Clinical Trials Mar 2021This paper describes the need to prepare for the development of antiviral therapeutics for the next pandemic. Preparation would consist of a stockpiling of best...
This paper describes the need to prepare for the development of antiviral therapeutics for the next pandemic. Preparation would consist of a stockpiling of best practices for clinical trial design, analysis and operations during the current SARS-CoV-2 pandemic as well as continuous development of treatments and methodology between pandemics. This development would be facilitated by a global clinical trial pandemic reserve similar to the military reserves consisting of medical and quantitative methods professionals who would remain engaged between pandemics. Continuous identification of potential antiviral drugs and diagnostic methods would also be needed. Specific methodology addressed includes the importance of large simple trials, follow up time, efficacy endpoint, appropriate estimands, non-inferiority trials, more sophisticated patient accrual models and procedures for data sharing between clinical trials.
Topics: Antiviral Agents; COVID-19; Clinical Trials as Topic; Diagnostic Techniques, Cardiovascular; Drug Development; Humans; Pandemics; Research Design; SARS-CoV-2; Time Factors; COVID-19 Drug Treatment
PubMed: 33515783
DOI: 10.1016/j.cct.2021.106292 -
Journal of Nuclear Medicine : Official... Jun 2021This article explores basic statistical concepts of clinical trial design and diagnostic testing, or how one starts with a question, formulates it into a hypothesis on... (Review)
Review
This article explores basic statistical concepts of clinical trial design and diagnostic testing, or how one starts with a question, formulates it into a hypothesis on which a clinical trial is then built, and integrates it with statistics and probability, such as determining the probability of rejecting the null hypothesis when it is actually true (type I error) and the probability of failing to reject the null hypothesis when it is false (type II error). There are a variety of tests for different types of data, and the appropriate test must be chosen for which the sample data meet the assumptions. Correcting type I error in the presence of multiple testing is needed to control the error's inflation. Within diagnostic testing, identifying false-positive and false-negative results is critical to understanding the performance of a test. These are used to determine the sensitivity and specificity of a test along with the test's negative predictive value and positive predictive value. These quantities, specifically sensitivity and specificity, are used to determine the accuracy of a diagnostic test using receiver-operating-characteristic curves. These concepts are briefly introduced to provide a basic understanding of clinical trial design and analysis, with references to allow the reader to explore various concepts at a more detailed level if desired.
Topics: Clinical Trials as Topic; Diagnostic Techniques and Procedures; Humans; Predictive Value of Tests; ROC Curve; Sensitivity and Specificity; Statistics as Topic
PubMed: 33608427
DOI: 10.2967/jnumed.120.245654 -
Neurosurgery Mar 2021Cell therapy has been widely recognized as a promising strategy to enhance recovery in stroke survivors. However, despite an abundance of encouraging preclinical data,... (Review)
Review
Cell therapy has been widely recognized as a promising strategy to enhance recovery in stroke survivors. However, despite an abundance of encouraging preclinical data, successful clinical translation remains elusive. As the field continues to advance, it is important to reexamine prior clinical trials in the context of their intended mechanisms, as this can inform future preclinical and translational efforts. In the present work, we review the major clinical trials of cell therapy for stroke and highlight a mechanistic shift between the earliest studies, which aimed to replace dead and damaged neurons, and later ones that focused on exploiting the various neuromodulatory effects afforded by stem cells. We discuss why both mechanisms are worth pursuing and emphasize the means through which cell replacement can still be achieved.
Topics: Cell Survival; Cell- and Tissue-Based Therapy; Clinical Trials as Topic; Humans; Neurons; Stroke
PubMed: 33370810
DOI: 10.1093/neuros/nyaa531 -
British Journal of Cancer Oct 2019International collaboration in oncology trials has the potential to enhance clinical trial activity by expediting the recruitment of large patient populations, testing... (Review)
Review
International collaboration in oncology trials has the potential to enhance clinical trial activity by expediting the recruitment of large patient populations, testing treatments in diverse populations and facilitating the study of rare tumours or specific molecular subtypes. However, a number of challenges continue to hinder the efficient and productive conduct of both commercial and non-commercial international clinical trials. These challenges include complex and burdensome regulatory requirements, the high cost of conducting trials, and logistical challenges associated with ethics review, drug supply and biospecimen collection and management. We propose solutions to promote oncology trial collaboration, such as regulatory reform, harmonisation of trial initiation and management processes and greater recognition and funding of academic (non-commercial) clinical trials. It is only through coordinated effort and leadership from researchers, regulators and those responsible for health systems that the full potential of international trial collaboration can be realised.
Topics: Antineoplastic Agents; Clinical Trials as Topic; Government Regulation; Humans; Information Dissemination; International Cooperation; Medical Oncology; Multicenter Studies as Topic; Neoplasms; Research Support as Topic; Specimen Handling
PubMed: 31378784
DOI: 10.1038/s41416-019-0532-4 -
Epilepsy & Behavior : E&B Dec 2019Convulsive status epilepticus (SE) is a relatively common emergency condition affecting individuals of all ages. The primary goal of treatment is prompt termination of... (Review)
Review
Convulsive status epilepticus (SE) is a relatively common emergency condition affecting individuals of all ages. The primary goal of treatment is prompt termination of seizures. Where first-line treatment with benzodiazepine has failed to achieve this, a condition known as established SE (ESE), there is uncertainty about which agent to use next. The Established Status Epilepticus Treatment Trial (ESETT) is a 3-arm (valproate (VPA), fosphenytoin (FOS), levetiracetam (LEV)), phase III, double-blind randomized comparative effectiveness study in patients aged 2 years and above with established convulsive SE. Enrollment was completed in January 2019, and the results are expected later this year. We discuss lessons learnt during the conduct of the study in relation to the following: ethical considerations; trial design and practical implementation in emergency settings, including pediatric and adult populations; quality assurance; and outcome determination where treating emergency clinicians may lack specialist expertise. We consider that the ESETT is already informing both clinical practice and future trial design. This article is part of the Special Issue "Proceedings of the 7th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures".
Topics: Adult; Anticonvulsants; Benzodiazepines; Child, Preschool; Clinical Trials as Topic; Diagnostic Tests, Routine; Double-Blind Method; Emergency Service, Hospital; Female; Humans; Levetiracetam; Male; Status Epilepticus; Treatment Outcome; Valproic Acid
PubMed: 31653603
DOI: 10.1016/j.yebeh.2019.04.049 -
Current Neurology and Neuroscience... Jul 2019Multimodal CT imaging (non-contrast CT, NCCT; CT angiography, CTA; and CT Perfusion, CTP) is central to acute ischemic stroke diagnosis and treatment. We reviewed the... (Review)
Review
PURPOSE OF REVIEW
Multimodal CT imaging (non-contrast CT, NCCT; CT angiography, CTA; and CT Perfusion, CTP) is central to acute ischemic stroke diagnosis and treatment. We reviewed the purpose and interpretation of each component of multimodal CT, as well as the evidence for use in routine care.
RECENT FINDINGS
Acute stroke thrombolysis can be administered immediately following NCCT in acute ischemic stroke patients assessed within 4.5 h of symptom onset. Definitive identification of a large vessel occlusion (LVO) requires vascular imaging, which is easily achieved with CTA. This is critical, as the standard of care for LVO within 6 h of onset is now endovascular thrombectomy (EVT). CTA source images can also be used to estimate the efficacy of collateral flow in LVO patients. The final component (CTP) permits a more accurate assessment of the extent of the ischemic penumbra. Complete multimodal CT, including objective penumbral measurement with CTP, has been used to extend the EVT window to 24 h. There is also randomized controlled trial evidence for extension of the IV thrombolysis window to 9 h with multimodal CT. Although there have been attempts to assess for responders to reperfusion strategies beyond 6 h ("late window") using collateral grades, the only evidence for treatment of this group of patients is based on selection using multimodal CT including CTP. The development of fully automated software providing quantitative ischemic penumbral and core volumes has facilitated the adoption of CTP and complete multimodal CT into routine clinical use. Multimodal CT is a powerful imaging algorithm that is central to current ischemic stroke patient care.
Topics: Brain Ischemia; Clinical Trials as Topic; Computed Tomography Angiography; Humans; Multimodal Imaging; Reperfusion; Stroke; Thrombectomy; Tomography, X-Ray Computed
PubMed: 31352585
DOI: 10.1007/s11910-019-0978-z -
Transplantation Jan 2020
Review
Topics: Clinical Trials as Topic; Data Interpretation, Statistical; Humans; Organ Transplantation; Research Design; Treatment Outcome
PubMed: 31365474
DOI: 10.1097/TP.0000000000002865 -
Tomography (Ann Arbor, Mich.) Jun 2020The Clinical Trial Design and Development Working Group within the Quantitative Imaging Network focuses on providing support for the development, validation, and... (Review)
Review
The Clinical Trial Design and Development Working Group within the Quantitative Imaging Network focuses on providing support for the development, validation, and harmonization of quantitative imaging (QI) methods and tools for use in cancer clinical trials. In the past 10 years, the Group has been working in several areas to identify challenges and opportunities in clinical trials involving QI and radiation oncology. The Group has been working with Quantitative Imaging Network members and the Quantitative Imaging Biomarkers Alliance leadership to develop guidelines for standardizing the reporting of quantitative imaging. As a validation platform, the Group led a multireader study to test a semi-automated positron emission tomography quantification software. Clinical translation of QI tools cannot be possible without a continuing dialogue with clinical users. This article also highlights the outreach activities extended to cooperative groups and other organizations that promote the use of QI tools to support clinical decisions.
Topics: Clinical Trials as Topic; Clinical Trials, Phase III as Topic; Diagnostic Imaging; Humans; Neoplasms; Positron-Emission Tomography; Radiation Oncology; Randomized Controlled Trials as Topic; Tomography, X-Ray Computed
PubMed: 32548281
DOI: 10.18383/j.tom.2019.00022