Clinical Trials

2021 ◽  
Author(s):  
Oliver A Cornely ◽  
Cara Lange
Keyword(s):  
Clinical Trials ◽  
Human Subjects ◽  
International Standards ◽  
Scientific Validity ◽  
Vaccine Trials ◽  
Scientific Principles ◽  
Design Selection ◽  
Systemic Symptoms ◽  
Selection Of

Clinical trials (a.k.a. clinical studies) in vaccinology are investigations with humans to assess the immunogenicity, reactogenicity i.e., the expected local or systemic symptoms of the desired immune response, safety and/or efficacy or effectiveness of vaccines. Such investigations must be designed, conducted, and analysed based on scientific principles to get sound answers to specific questions stated in the trial plan. Since Clinical Trials involve human subjects, highest ethical standards need to be applied. In addition, national laws, licensing regulations and international standards, for example Declaration of Helsinki, regulate the procedures and conduct of clinical trials. Vaccine trials can be classified by development phase (phase I-III before licensure; phase IV post-licensure); by purpose; or role of the investigator. The study protocol covers design, selection of study subjects, selection of endpoints, methods to minimize bias, conduct of the study and analysis plan, all aimed at answering the study question with best possible internal scientific validity.

scholarly journals Investigating the role of natural phyto-oestrogens on bone health in postmenopausal women

2003 ◽  
Vol 89 (S1) ◽  
pp. S87-S99 ◽  
Author(s):  
Silvia Valtueña ◽  
Kevin Cashman ◽  
Simon P. Robins ◽  
Aedin Cassidy ◽  
Alwine Kardinaal ◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Trials ◽  
Bone Loss ◽  
Postmenopausal Women ◽  
Bone Health ◽  
Early Stage ◽  
Daily Intake ◽  
Present Knowledge ◽  
Selection Of

Research on the bone effects of natural phyto-oestrogens after menopause is at a relatively early stage. Published studies are few, difficult to compare and often inconclusive, due in part to design weaknesses. Currently, many questions remain to be answered including to what extent a safe daily intake may prevent postmenopausal bone loss. These questions can only be addressed by conducting well-planned, randomised clinical trials that take into consideration present knowledge in the oestrogen, phyto-oestrogen and bone fields. This review is intended to provide hints for critical decision-making about the selection of subjects, type of intervention, suitable outcome measures and variables that need to be controlled.

scholarly journals Evidence for the use of probiotics and prebiotics in inflammatory bowel disease: a review of clinical trials

2007 ◽  
Vol 66 (3) ◽  
pp. 307-315 ◽  
Author(s):  
Charlotte Hedin ◽  
Kevin Whelan ◽  
James O. Lindsay
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Bowel Disease ◽  
Human Subjects ◽  
Specific Patient ◽  
Attractive Therapeutic Target ◽  
Patient Groups ◽  
Inflammatory Bowel ◽  
Mutual Tolerance

Human subjects and their enteric microbiota have evolved together to reach a state of mutual tolerance. Mounting evidence from both animal models and human studies suggests that inflammatory bowel disease (IBD) represents a malfunction of this relationship. The enteric microecology therefore represents an attractive therapeutic target with few side effects. Probiotics and prebiotics have been investigated in clinical trials as treatments for IBD, with conflicting results. The evidence for the use of probiotics in the management of pouchitis is persuasive and several studies indicate their effectiveness in ulcerative colitis. Trials of probiotics and prebiotics in Crohn's disease are less convincing. However, methodologies vary widely and a range of probiotic, prebiotic and combination (synbiotic) treatments have been tested in a variety of patient groups with an assortment of end points. Conclusions about any one treatment in a specific patient group can therefore only be drawn on evidence from relatively small numbers of patients. The present article reviews the role of the intestinal microbiota in the pathogenesis of IBD and addresses the clinical evidence for the therapeutic manipulation of bowel microbiota using probiotics, prebiotics and synbiotics in IBD.

scholarly journals Conflicts among Multinational Ethical and Scientific Standards for Clinical Trials of Therapeutic Interventions

2012 ◽  
Vol 40 (1) ◽  
pp. 99-121 ◽  
Author(s):  
Jacob M. Kolman ◽  
Nelda P. Wray ◽  
Carol M. Ashton ◽  
Danielle M. Wenner ◽  
Anna F. Jarman ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Human Subjects ◽  
International Standards ◽  
Therapeutic Interventions ◽  
Research Subjects ◽  
Medical Sciences ◽  
Professional Groups ◽  
Department Of Health ◽  
Research On Human Subjects ◽  
Scientific Standards

There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences (CIOMS), the International Conference on Harmonization's standards for industry (ICH), and the CONSORT group's reporting norms (Consolidated Standards of Reporting Trials), in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's (FDA) body of regulations, and information sheets by the Department of Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”

scholarly journals Hematopoietic Cell Transplantation for Myelodysplastic Syndromes

2016 ◽  
Vol 12 (9) ◽  
pp. 786-792 ◽  
Author(s):  
Vijaya Raj Bhatt ◽  
David P. Steensma
Keyword(s):  
Clinical Trials ◽  
Cell Transplantation ◽  
Myelodysplastic Syndromes ◽  
Lower Risk ◽  
Hematopoietic Cell Transplantation ◽  
Disease Risk ◽  
Hematopoietic Cell ◽  
Comorbidity Index ◽  
Selection Of

Allogeneic hematopoietic cell transplantation (HCT) offers the only potential cure for patients with myelodysplastic syndromes (MDS). However, with current approaches to HCT, many older patients with comorbidities are poor HCT candidates, and treatment-related morbidity and mortality may offset benefit for patients with lower-risk disease. Consequently, selection of patients with MDS for HCT should take into consideration disease risk category including mutational status, HCT comorbidity index, functional status, donor options, and available institutional resources. Formal geriatric assessment may further guide use of HCT and, if HCT is chosen, selection of conditioning intensity. Patients with higher-risk MDS should be considered for HCT at the time of diagnosis, whereas expectant nontransplant management is more appropriate for those with lower-risk disease. A high blast burden at the time of HCT increases the risk of subsequent relapse; however, the role of pretransplant cytoreductive therapy and the regimen of choice remain controversial. Patients with MDS younger than 65 years and with an HCT comorbidity index ≤ 4 may benefit from more intense conditioning regimens. The presence of complex or monosomal karyotype or mutations in TP53, DNMT3A, or other genes identify patients with poorer outcomes following HCT. Patients with TP53 mutations have particularly poor survival, and should be enrolled in clinical trials whenever possible. Several important HCT studies are ongoing and will better define the role of HCT in MDS as well as the value of pretransplant cytoreductive therapy or post-transplant relapse-prevention strategies. Given the apparent underuse of HCT in eligible patients and low enrollment in MDS HCT clinical trials to date, timely referral of patients with MDS to such trials and HCT programs is critical.

scholarly journals Regulatory Framework for Conducting Clinical Research in Canada

2017 ◽  
Vol 44 (5) ◽  
pp. 469-474 ◽  
Author(s):  
Josmar K. Alas ◽  
Glenys Godlovitch ◽  
Connie M. Mohan ◽  
Shelly A. Jelinski ◽  
Aneal A. Khan
Keyword(s):  
Clinical Trials ◽  
Human Subjects ◽  
Policy Statement ◽  
Institutional Research ◽  
Public Health Agencies ◽  
Clinical Trial Research ◽  
Health Agencies ◽  
Drug Regulations

AbstractResearch in human subjects is at the core of achieving improvements in health outcomes. For clinical trials, in addition to the peer review of the results before publication, it is equally important to consider whether the trial will be conducted in a manner that generates data of the highest quality and provides a measure of safety for the participating subjects. In Canada, there is no definitive legislation that governs the conduct of research involving human subjects, but a network of regulations at different levels does provide a framework for both principal investigators and sponsors. In this paper, we provide an overview of the federal, provincial and institutional legislation, guidelines and policies that will inform readers about the requirements for clinical trial research. This includes a review of the role of the Food and Drug Regulations under the Food and Drugs Act and the Tri-Council Policy Statement (TCPS2), an overview of provincial legislation across the country, and a focus on selected policies from institutional research ethics boards and public health agencies. Many researchers may find navigation through regulations frustrating, and there is a paucity of information that explains the interrelationship between the different regulatory agencies in Canada. Better understanding the process, we feel, will facilitate investigators interested in clinical trials and also enhance the long-term health of Canadians.

scholarly journals Ethical considerations for epidemic vaccine trials

2020 ◽  
Vol 46 (7) ◽  
pp. 465-469 ◽  
Author(s):  
Joshua Teperowski Monrad
Keyword(s):  
Clinical Trials ◽  
Human Subjects ◽  
Effective Vaccine ◽  
Key Factors ◽  
Epidemic Disease ◽  
Vaccine Trials ◽  
The One ◽  
Effective Product ◽  
Economic Considerations

Vaccines are a powerful measure to protect the health of individuals and to combat outbreaks such as the COVID-19 pandemic. An ethical dilemma arises when one effective vaccine has been successfully developed against an epidemic disease and researchers seek to test the efficacy of another vaccine for the same pathogen in clinical trials involving human subjects. On the one hand, there are compelling reasons why it would be unethical to trial a novel vaccine when an effective product exists already. First, it is a firm principle of medical ethics that an effective treatment or vaccine should not be withheld from patients if their life may depend on it. Second, since epidemic outbreaks often emerge in settings with less-resourced health systems, there is a pronounced risk that any trial withholding an effective vaccine would disproportionately affect the vulnerable populations that historically have been exploited for biomedical research. Third, clinical trials for novel vaccines may be at odds with efforts to control active outbreaks. On the other hand, it may be justified to conduct a trial for a candidate vaccine if it is expected to have certain advantages compared with the existing product. This essay discusses key factors for comparing vaccines against epidemic pathogens, including immunological, logistical and economic considerations. Alongside a case study of the development of vaccines for Ebola, the essay seeks to establish a general framework that should be expanded and populated by immunologists, epidemiologists, economists and bioethicists, and ultimately could be applied to the case of COVID-19 vaccines.

Informed consent in a research setting

2016 ◽  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Care Setting ◽  
Human Subjects ◽  
Consent Process ◽  
Vulnerable Groups ◽  
Clinical Trial Research ◽  
Emergency Situations ◽  
Qualified Person

Informed consent is a legal requirement for all clinical trials conducted on human subjects. This chapter summarises the process for obtaining consent for non-clinical trial research and goes on to describe the more highly regulated consent process for clinical trials in investigational medicinal products (CTIMPs). The chapter defines consent and discusses the requirements for consent in capable adults. The process for CTIMP studies is outlined together with the required elements of consent to be documented in the patient information sheet and the process to be followed with withdrawal of consent is also described. Consent, assent and the concept of legal representatives in vulnerable groups is discussed including children and incapacitated adults. How to assess capacity is described along with consent in emergency situations. Formally documenting the consent process and how the information is given to the patient is vital. The role of the research team in consent is outlined. The investigator is advised to describe the process of consent and should identify which registered health professionals will undertake the process. In some situations a medically qualified person will be required to determine eligibility prior to enrolment, to discuss the study and assess capacity if necessary. A participant's decision to consent for research may be influenced by 'the research culture' in the country or the health care setting. Transparency and providing information continuously to participants throughout the study will re-assure them and reaffirm their willingness to continue.

The role of baseline lesion selection on reader performance in oncologic clinical trials.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14082-e14082
Author(s):  
Anu Bansal ◽  
Ninad Mantri ◽  
Paul McCracken
Keyword(s):  
Clinical Trials ◽  
Data Quality ◽  
Response Criteria ◽  
Published Data ◽  
Accurate Representation ◽  
Data Fidelity ◽  
The Mean ◽  
Retrospective Database ◽  
Selection Of

e14082 Background: Blinded independent central radiology review is integral to modern clinical trials in oncology. Based on previously published data based on overall adjudication rates, it is generally accepted that selection of a larger and more complete number of target and non-target lesions at baseline results in greater reader concordance and therefore improved data fidelity. Methods: A retrospective database review was performed across 27 trials spanning 15 clinical indications and 4 response criteria involving a total of 20,942 independent reads across numerous timepoints in 10,471 subjects by 119 readers. Adjudication rates and adjudication selection rates were calculated across and within all trials. Results: Readers selected a mean of 2.3 target lesions and 1.2 non-target lesions in each subject. The mean adjudication rate across all trials was 33%. However, adjudication selection rate should be a more accurate representation of reader performance. Within any one trial, 44% of readers who selected the greatest number of target and non-target lesions at baseline actually had adjudication selection rates below average. Conclusions: Readers who select more target and non-target lesions than their peers at baseline do not demonstrate significantly higher adjudication selection rates. This suggests that the number of lesions chosen at baseline may not be as strong a contributer to reader performance and data quality as previously surmised.

Faculty selection of textbooks: Key variables and the role of teaching experience

2010 ◽  
Author(s):  
Aja Taitano ◽  
Bradley Smith ◽  
Cade Hulbert ◽  
Kristin Batten ◽  
Lalania Woodstrom ◽  
...  
Keyword(s):  
Teaching Experience ◽  
Key Variables ◽  
Faculty Selection ◽  
Selection Of
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