Clinical Trials Commons^™

Do Firms Respond To Peer Disclosures? Evidence From Clinical Trial Disclosures, Vedran Capkun, Yun Lou, Clemens A. Otto, Yin Wang

Research Collection School Of Accountancy

We examine whether a firm’s decision to disclose non-financial proprietary information depends on peer disclosures of similar information. Using a sample of 5,035 unique clinical trials by U.S. pharmaceutical firms over the 2007-2014 period, we find that the firm is less likely to disclose its own clinical trial results if peers have published clinical trial results pertaining to the same medical condition. Conditional on disclosing clinical trial results, the firm is also less likely to disclose the trial results on time when peers have disclosed their clinical trial results. Our cross-sectional tests suggest that proprietary costs of disclosure play an …

Cognitive Effects Of The Bet Protein Inhibitor Apabetalone: A Prespecified Montreal Cognitive Assessment Analysis Nested In The Betonmace Randomized Controlled Trial, Jeffrey Cummings, Gregory G. Schwartz, Stephen J. Nicholls, Aziz Khan, Chris Halliday, Peter P. Toth, Michael Sweeney, Jan O. Johansson, Norman C.W. Wong, Ewelina Kulikowski, Kamyar Kalantar-Zadeh, Kenneth Lebioda, Henry N. Ginsberg, Bengt Winblad, Henrik Zetterberg, Kausik K. Ray

School of Medicine Faculty Research

Background: Epigenetic changes may contribute importantly to cognitive decline in late life including Alzheimer's disease (AD) and vascular dementia (VaD). Bromodomain and extra-terminal (BET) proteins are epigenetic 'readers' that may distort normal gene expression and contribute to chronic disorders. Objective: To assess the effects of apabetalone, a small molecule BET protein inhibitor, on cognitive performance of patients 70 years or older participating in a randomized trial of patients at high risk for major cardiovascular events (MACE). Methods: The Montreal Cognitive Assessment (MoCA) was performed on all patients 70 years or older at the time of randomization. 464 participants were randomized …

Systematic Review Of Polyherbal Combinations Used In Metabolic Syndrome, Amber Hanif Palla, Faridah Amin, Bilqees Fatima, Arooj Shafiq, Najeeb Ur Rehman, Ikram Ul Haq, Anwar-Ul-Hassan Gilani

Department of Biological & Biomedical Sciences

Background: Metabolic syndrome (MetS) is a multifactorial disease, whose main stay of prevention and management is life-style modification which is difficult to attain. Combination of herbs have proven more efficacious in multi-targeted diseases, as compared to individual herbs owing to the "effect enhancing and side-effect neutralizing" properties of herbs, which forms the basis of polyherbal therapies This led us to review literature on the efficacy of herbal combinations in MetS.
Methods: Electronic search of literature was conducted by using Cinnahl, Pubmed central, Cochrane and Web of Science, whereas, Google scholar was used as secondary search tool. The key words used …

Tocilizumab And Covid-19: A Meta-Analysis Of 2120 Patients With Severe Disease And Implications For Clinical Trial Methodologies, Azza Sarfraz, Zouina Sarfraz, Muzna Sarfraz, Hinna Aftab, Zainab Pervaiz

Department of Paediatrics and Child Health

Background/aim: Since the outbreak of the COVID-19, numerous therapies to counteract this severe disease have emerged. The benefits of Tocilizumab for severely infected COVID-19 patients and the methodologies of ongoing clinical trials are explored.
Materials and methods: A systematic search adhering to PRISMA guidelines was conducted in PubMed, Cochrane Central, medRxiv, and bioRxiv using the following keywords: “Tocilizumab,” “Actemra,” “COVID-19.” An additional subsearch was conducted on Clinicaltrials.gov to locate ongoing tocilizumab trials.
Results: A total of 13 studies were included in the meta-analysis comprising 2120 patients. The treatment group had lower mortality compared to the control group (OR = 0.42, …

Confidence Intervals Of Covid-19 Vaccine Efficacy Rates, Frank Wang

Numeracy

This tutorial uses publicly available data from drug makers and the Food and Drug Administration to guide learners to estimate the confidence intervals of COVID-19 vaccine efficacy rates with a Bayesian framework. Under the classical approach, there is no probability associated with a parameter, and the meaning of confidence intervals can be misconstrued by inexperienced students. With Bayesian statistics, one can find the posterior probability distribution of an unknown parameter, and state the probability of vaccine efficacy rate, which makes the communication of uncertainty more flexible. We use a hypothetical example and a real baseball example to guide readers to …

Randomised Trials At The Level Of The Individual, Jay J H. Park, Nathan Ford, Denis Xavier, Per Ashorn, Rebecca F. Grais, Zulfiqar Ahmed Bhutta, Herman Goossens, Kristian Thorlund, Maria Eugenia Socias, Edward J. Mills

Centre of Excellence in Women and Child Health

In global health research, short-term, small-scale clinical trials with fixed, two-arm trial designs that generally do not allow for major changes throughout the trial are the most common study design. Building on the introductory paper of this Series, this paper discusses data-driven approaches to clinical trial research across several adaptive trial designs, as well as the master protocol framework that can help to harmonise clinical trial research efforts in global health research. We provide a general framework for more efficient trial research, and we discuss the importance of considering different study designs in the planning stage with statistical simulations. We …

The Role And Challenges Of Cluster Randomised Trials For Global Health, Louis Dron, Monica Taljaard, Yin Bun Cheung, Rebecca Grais, Nathan Ford, Kristian Thorlund, Fyezah Jehan, Etheldreda Nakimuli-Mpungu, Denis Xavier, Zulfiqar Ahmed Bhutta, Jay J H. Park, Edward J. Mills

Department of Paediatrics and Child Health

Evaluating whether an intervention works when trialled in groups of individuals can pose complex challenges for clinical research. Cluster randomised controlled trials involve the random allocation of groups or clusters of individuals to receive an intervention, and they are commonly used in global health research. In this paper, we describe the potential reasons for the increasing popularity of cluster trials in low-income and middle-income countries. We also draw on key areas of global health research for an assessment of common trial planning practices, and we address their methodological shortcomings and pitfalls. Lastly, we discuss alternative approaches for population-level intervention trials …

B36: Comparing The Nephrotoxic Effects Of Cisplatin In Combination With Docetaxel Or 5-Fluorouracil, Ria Lei Marie Natividad

Annual Research Symposium

No abstract provided.

B35: Development And Validation Of A Stability Indicating Hplc Method For Quantification Of Estriol In Compounded Glycerinated Gelatin Troches, Tayler Hutto

Annual Research Symposium

No abstract provided.

B30: Identifying New G Protein Coupled Receptor Kinase 6 Substrates Among Proteins Closely Linked To Prognoses Of Pancreatic Cancer, Christine Taing, Jelena Jovanovic, Nicole Khalil, Christopher So

Annual Research Symposium

No abstract provided.

B29: Exploring The Role Of G Protein Coupled Receptor Kinases In Modulating Behaviors To Fluoxetine Using Caenorhabditis Elegans As An Experimental Model, Victoria Pang

Annual Research Symposium

No abstract provided.

B28: Evaluating The Chemotherapeutic Effects Of The Fac Regimen In Mda Mb 231 Breast Cancer Cells With Reduced Beta Arrestin 2 Expression Levels, Angelina Marcee

Annual Research Symposium

No abstract provided.

B27: Evaluating The Chemotherapeutic Effects Of The Fac Regimen In Mda Mb 231 Breast Cancer Cells With Reduced G Protein Coupled Receptor Kinase 2 Expression, Samantha Bodan

Annual Research Symposium

No abstract provided.

B24: Efficacy Of Scaffold Mediated Localized Chemotherapy In Cancer: A Systematic Review, Archana Gupta

Annual Research Symposium

No abstract provided.

B21: Exposure To Vape Smoke Enhances Sperm Mitochondrial Respiration In Mature Mice., Jeremy Y. Saito

Annual Research Symposium

No abstract provided.

B14: Angiogenic Potential Of Oral Cavity Derived Mesenchymal Stem Cells And Its Secretomes: A Systematic Review, Madhura Rajendra Shekatkar

Annual Research Symposium

No abstract provided.

B2: Presence Of Immunosuppressive Drugs Affect Innate Immune Response And Monocyte Differentiation In Lung Transplant Patients, Inayat Kaur Oms Iii, Ryan Wang Oms Ii, Amy E.L. Stone

Annual Research Symposium

Lung transplant patients are administered Immunosuppressive Drugs (ISDs) to prevent transplant rejection, but this also puts them at constant risk of infection due to the decreased ability of the immune system to respond to subsequent infections by viruses, bacteria etc.

Purpose

This paper focuses on the effect of ISDs on the innate immune response. We are using different parts of viruses and bacteria and allowing them to represent the organism as a whole.

Methods

As representatives of the innate immune system, we are going to be testing monocyte, macrophage, and dendritic cell lineages. We are hypothesizing that the presence of …

C43: Telehealth In The Emergency Department: Impact On Wait Times, Alexander Romero, Carmela Bautista, Gabriella Kelley, Mackenzie Hazen, Rebecca Pullen, Vicente Lujan

Annual Research Symposium

Undergraduate nursing students investigated if implementing telehealth in the Emergency Department (ED) can help reduce wait times.

C41: Treating Proctitis And Pouchitis: A Systematic Review Of Clinical Trial Data, Sarah Tesfaye

Annual Research Symposium

No abstract provided.

C37: Evaluation Of The Diagnostic Efficacy Of Saliva For Detection Of Dengue Antibodies- An Elisa Study, Vidya Gurram Shankar

Annual Research Symposium

No abstract provided.

C36: Clinical Evaluation Of Bupivacaine Liposomal, Samaya Cristina (Shuput)

Annual Research Symposium

No abstract provided.

C34: A Review Of Neurogenic Cardiomyopathy In Subarachnoid Hemorrhage And The Prognostic Implications Of Cardiac Biomarkers, Dushawn Harley, Md

Annual Research Symposium

No abstract provided.

C33: Covid Encephalitis Resulting In Focal Seizures With Subsequent Changes On Mri Imaging, Adena Shahinian

Annual Research Symposium

No abstract provided.

C30: A Comparison Of Cbct Soft Tissue With Bellus3d Facial Scan Superimposition, Gerald Sherrick

Annual Research Symposium

Research Symposium

C29: Epilepsy Partialis Continua With Transient Post-Ictal Changes On Mri, Trusha Mehta Do

Annual Research Symposium

No abstract provided.

C28: Acute Encephalopathy As A Presenting Sign Of Suspected Lupus Cerebritis, Jasmine Chopra

Annual Research Symposium

No abstract provided.

C22: Eravacycline Versus Best Previously Available Therapy In Adults With Pneumonia Due To Drug-Resistant Acinetobacter Baumannii, Courtney Jane Scott, Rebecca Jayakumar, Elizabeth Zhu, Velliyur Viswesh

Annual Research Symposium

There are no published studies documenting outcomes with the use of eravacycline against drug-resistant Acinetobacter baumannii. The purpose of this study is to assess the efficacy of eravacycline use, in comparison to best previously available therapy, in patients with drug-resistant Acinetobacter baumannii pneumonia.

C20: A Comparison Of Heparin Vs Bivalirudin In Patients Undergoing Percutaneous Coronary Intervention (Pci) In Achieving Therapeutic Activated Clotting Time, Priyanga Radjassegarane, Ragini Bhakta, Joanne Dominguez

Annual Research Symposium

No abstract provided.

C17: Programmed Cell Death Ligand- 1 Expression As A Prognostic Indicator In Oral Squamous Cell Carcinoma, Dr. Samar Saeed Khan

Annual Research Symposium

No abstract provided.

C16: On-The-Spot Transport Media For The Freshly Biopsied Soft Tissue Specimen: A Comparative Study, Snehashish Ghosh

Annual Research Symposium

No abstract provided.