Statistical Analysis of a Clinical Trial in Orthostatic Hypotension -a Nonparametric Approach

1987 ◽  
Vol 26 (01) ◽  
pp. 47-52
Author(s):  
R. Haux ◽  
H. Immich ◽  
M. Schumacher
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Statistical Analysis ◽  
Mathematical Models ◽  
Orthostatic Hypotension ◽  
Nonparametric Tests ◽  
Trial Methodology ◽  
Clinical Trial Methodology ◽  
Nonparametric Approach ◽  
Serial Measurements

SummarySome basic problems and considerations of analyzing clinical trials, in which a large amount of data is recorded on very few patients - mostly in the form of serial measurements -, are highlighted within the framework of a clinical trial in orthostatic hypotension. The method suggested to analyze these kinds of trials renounces the use of complex mathematical models and complicated statistical methods. It is simply based on the derivation of relevant aspects of the patient’s profiles and the use of well-known nonparametric tests and requires only a very simple study design. With this procedure, however, it is possible to satisfy at least the basic requirements of clinical trial methodology.

scholarly journals Clinical trials in the Coronavirus era: management of risks

2020 ◽  
pp. 18-24
Author(s):  
Aleksey Vodovozov ◽  
Keyword(s):  
Risk Assessment ◽  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Trial Methodology ◽  
Ministry Of Health ◽  
Trial Team ◽  
Clinical Trial Methodology ◽  
Regulatory Authorities ◽  
The World

The COVID-19 pandemic has caused unique problems facing the clinical trials (CT) community both in terms of the rapid implementation of CTs of COVID-19 drugs and vaccines, and many ongoing non-COVID-19 CTs that are either suspended or adapted to new realities. The CT organizers have played a key role in decision making, risk assessment and adaptation of trial processes, working side by side with other members of the trial team. Regulatory authorities (FDA, EMA, Ministry of Health of Russia, etc.), which issued initial recommendations for adapting the clinical trial methodology to new conditions as far back as March 2020, and then later on, generalized the experience in the management for clinical trials. The recommendations made based on the reviewed experience can help all CT parties to cope with the risks associated with both COVID-19 itself and anti-epidemic measures in different countries of the world with minimal losses.

scholarly journals Challenges in the development of clinical trials for major depressive disorder: lessons learned from trials in minor depression

2002 ◽  
Vol 4 (4) ◽  
pp. 402-407
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Lessons Learned ◽  
Minor Depression ◽  
Trial Methodology ◽  
Major Depressive ◽  
Clinical Trial Methodology ◽  
Theoretical Assumptions

This paper reviews some of the challenges faced by individuals who design and implement clinical trials of potential antidepressant medications. Particular emphasis is placed on questioning the validity of some of the theoretical assumptions that form the underpinnings of most conventional trials. Work from our group developing clinical trial methodology for minor depression is used as an example of how alternate constructs may be helpful to differentiate drug-placebo differences.

Global Trials, Local Bodies: Negotiating Difference and Sameness in Indian For-profit Clinical Trials

2020 ◽  
pp. 016224392096381
Author(s):  
Sibille Merz
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Trial Methodology ◽  
Clinical Trial Methodology ◽  
Principal Investigators ◽  
For Profit ◽  
Clinical Research Organization ◽  
Cultural Specificity ◽  
Local Biologies ◽  
Trial Participants

Global clinical trials depend on a range of standards in order for research results to be comparable. As standardization is more than a mere technical exercise, tensions can arise when things are not uniform. This paper uses empirical data from interviews with principal investigators as well as Clinical Research Organization and pharmaceutical industry representatives working in India’s clinical trial industry to critically examine the ways Indian researchers navigate quests for standardization. It turns the analytical lens to the often obfuscated work of standardization aiming to transcend the biological and cultural specificity of research participants and research sites. Drawing on the concept of local biologies, it illustrates that the universal body presumed by clinical trial methodology is, in fact, a specifically Euro-American one: Indian participants not only need to be made globally comparable but also aligned with the drugs’ future consumers. Focusing on the tensions between biomedicine’s postulation of bodily universality and trial participants’ local biologies, this paper advances recent interventions problematizing the structural violence undergirding global clinical trials. It also contributes to the literature on local biologies in its discussion of how these are negotiated in Indian for-profit clinical trials.

scholarly journals Master Protocols for Precision Medicine in Oncology: Overcoming Methodology of Randomized Clinical Trials

Life ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. 1253
Author(s):  
Raimondo Di Liello ◽  
Maria Carmela Piccirillo ◽  
Laura Arenare ◽  
Piera Gargiulo ◽  
Clorinda Schettino ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Personalized Medicine ◽  
Clinical Research ◽  
Targeted Therapies ◽  
Randomized Clinical Trials ◽  
Trial Methodology ◽  
Clinical Trial Methodology ◽  
Therapeutic Algorithms ◽  
New Compounds

Randomized clinical trials are considered the milestones of clinical research in oncology, and guided the development and approval of new compounds so far. In the last few years, however, molecular and genomic profiling led to a change of paradigm in therapeutic algorithms of many cancer types, with the spread of different biomarker-driven therapies (or targeted therapies). This scenario of “personalized medicine” revolutionized therapeutic strategies and the methodology of the supporting clinical research. New clinical trial designs are emerging to answer to the unmet clinical needs related to the development of these targeted therapies, overcoming the “classical” structure of randomized studies. Innovative trial designs able to evaluate more than one treatment in the same group of patients or many groups of patients with the same treatment (or both) are emerging as a possible future standard in clinical trial methodology. These are identified as “master protocols”, and include umbrella, basket and platform trials. In this review, we described the main characteristics of these new trial designs, focusing on the opportunities and limitations of their use in the era of personalized medicine.

scholarly journals Knowledge and Perception Regarding Clinical Trials Among Dental Students-A Questionnaire Based Study

2020 ◽  
Vol 11 (SPL3) ◽  
pp. 1626-1633
Author(s):  
Thaslima Nandhini J S ◽  
Vignesh Ravindran ◽  
Jeevitha M
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Undergraduate Students ◽  
Good Clinical Practice ◽  
Dental Students ◽  
Trial Methodology ◽  
Chi Square ◽  
Postgraduate Students ◽  
Clinical Trial Methodology ◽  
Validated Questionnaire

Clinical trials play an important role in improvement of quality on healthcare practice. Good clinical practice is a backbone of conductance of trials. A lack of knowledge may translate to a negative perception towards clinical trials. The study aims to evaluate the awareness of clinical trials among undergraduate dental students in a private dental institute. We have quantified the knowledge and perception of clinical trials by a structured validated questionnaire. The questionnaire was administered to dental students from first year undergraduate to third year Postgraduate. The percentage of questions answered were calculated and tabulated in the excel sheet. Data were analysed using SPSS statistical software and the chi-square test was done. P valve was set as 0.05 as a level of significance. From statistical analysis, postgraduate students (59.2%) had better knowledge than undergraduate students (40.8%). Around (46.7%) had been involved in clinical trial training. Within the limitations of current study, students pursuing postgraduate had a better knowledge of clinical trial methodology than compared to undergraduate students.

Clinical Trial Methodology

1995 ◽  
pp. 407-417 ◽  
Author(s):  
T. L. Munsat ◽  
D. Hollander ◽  
L. Finison
Keyword(s):  
Clinical Trial ◽  
Trial Methodology ◽  
Clinical Trial Methodology

Statistical analysis plan for evaluating different intensities of blood pressure control in the ENhanced Control of Hypertension And Thrombolysis strokE stuDy

2018 ◽  
Vol 14 (5) ◽  
pp. 555-558 ◽  
Author(s):  
Craig S Anderson ◽  
Mark Woodward ◽  
Hisatomi Arima ◽  
Xiaoying Chen ◽  
Richard I Lindley ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Body Weight ◽  
Statistical Analysis ◽  
Lower Risk ◽  
Standard Dose ◽  
Statistical Analysis Plan ◽  
Symptomatic Intracerebral Hemorrhage ◽  
Stroke Study

Background The ENhanced Control of Hypertension And Thrombolysis strokE study (ENCHANTED) trial was initiated as a 2 × 2 partial-factorial active-comparison, prospective, randomized, open, blinded endpoint clinical trial to evaluate in thrombolysis-eligible acute ischemic stroke (AIS) patients whether: (1) Arm A – low-dose (0.6 mg/kg body weight) intravenous (iv) alteplase has noninferior efficacy and lower risk of symptomatic intracerebral hemorrhage (sICH) compared with standard-dose (0.9 mg/kg body weight) iv alteplase; and (2) Arm B – early intensive blood pressure (BP) lowering (systolic target 130–140 mmHg) has superior efficacy and lower risk of ICH compared with guideline-recommended BP control (systolic target <180 mmHg). Arm A was completed in 2016; Arm B is now concluding. Objective To outline in detail and make public the predetermined statistical analysis plan (SAP) for the ‘BP control’ arm of this study. Methods All data collected by participating researchers will be reviewed and formally assessed. Information pertaining to the baseline characteristics of patients, their process of care, and the delivery of treatments will be outlined, and for each item, statistically relevant descriptive elements will be described. For the trial outcomes, the most appropriate statistical comparisons to be made between groups are planned and described. Results A SAP was developed for the results of the BP control arm of this study that is transparent, available to the public, verifiable, and predetermined before completion of data collection. Conclusions We have developed a predetermined SAP for the ENCHANTED BP control arm to be followed to avoid analysis bias arising from prior knowledge of the study findings. Clinical trial registration ClinicalTrials.gov (NCT01422616); ISRCTN Register (ISRCTN82387104); Australian New Zealand Clinical Trial Registry (ACTRN12611000236998); EU Clinical Trials Register (2011-005545-12); and Clinical Trials Registry – India (REF/2017/05/014334).

Clinical trial methodology in rare gynecologic tumor research: Strategies for success

2018 ◽  
Vol 149 (3) ◽  
pp. 605-611 ◽  
Author(s):  
Jubilee Brown ◽  
R. Wendel Naumann ◽  
William E. Brady ◽  
Robert L. Coleman ◽  
Kathleen N. Moore ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Research Strategies ◽  
Trial Methodology ◽  
Clinical Trial Methodology ◽  
Gynecologic Tumor ◽  
Tumor Research ◽  
Strategies For Success
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