Clinical Trials and Practice – Open Journal (CTPOJ)

Recently Published Articles

2021, November

original research

Design and Statistical Methods for Handling Covariates Imbalance in Randomized Controlled Clinical Trials: Dilemmas Resolved

Bolaji E. Egbewale*
DOI: http://dx.doi.org/10.17140/CTPOJ-1-121

PDF 432.92 KB

Full-Text (HTML)

2021, August

review

The Case for Digital Pill Use in Clinical Trials

Gerald L. Klein*
DOI: http://dx.doi.org/10.17140/CTPOJ-1-120

PDF 739.81 KB

Full-Text (HTML)

2021, April

opinion

The Importance of Teaching and Fostering Clinical Research in Primary Health Care

Gerald L. Klein* and Mark A. Brown
DOI: http://dx.doi.org/10.17140/CTPOJ-1-119

PDF 302.16 KB

Full-Text (HTML)

2021, January

mini review

Coronavirus Disease-2019 Clinical Trial Case Studies Within the Biotechnology and Clinical Research Organizations Industry

Melanie K. Pearce and Nathanael E. Hughes*
DOI: http://dx.doi.org/10.17140/CTPOJ-1-118

PDF 290.07 KB

Full-Text (HTML)

2021, January

case series

The Promise of Small Data for Telemedicine in Chronic Condition Management: A Real-World Case Series

Steven M. Schwartz*, Brigid Byrd, Helen Dempster and Tim Payne
DOI: http://dx.doi.org/10.17140/CTPOJ-1-117

PDF 578.99 KB

Full-Text (HTML)

2020, November

case study

Role of Low-Level Laser Therapy as an Adjunct in the Management of Diabetic Ulcer

Shijina Koliyath, Ravi K. Chittoria*, Chirra L. Reddy, Padmalakshmi B. Mohan. Imran Pathan, Neljo Thomas and Nishad Kerakada
DOI: http://dx.doi.org/10.17140/CTPOJ-1-116

PDF 328.58 KB

Full-Text (HTML)

2020, July

original research

The Role of Negative Pressure Wound Therapy with Instillation and Dwell Time in the Preparation of Wound Bed

Nishad Kerakada, Ravi K. Chittoria*, Saurabh Gupta, Chirra L. Reddy, Padmalakshmi B. Mohan, Imran Pathan, Shijina Koliyath and Neljo Thomas
DOI: http://dx.doi.org/10.17140/CTPOJ-1-115

PDF 419.26 KB

Full-Text (HTML)

2020, July

commentary

How a Network Came Together to Manage a Large Research Program During the Pandemic

Tamara Friedman*, Elli G. Paleoudis, Avery Freed, Susan Adler, Cheryl Fittizzi and Ihor Sawczuk
DOI: http://dx.doi.org/10.17140/CTPOJ-1-114

PDF 300.51 KB

Full-Text (HTML)

2020, July

perspective

Innovation in Clinical Trials is Possible: The Hidden Opportunity in the Coronavirus Disease-2019 Emergency

Valeria L. Scarano* and Davide Smaldone
DOI: http://dx.doi.org/10.17140/CTPOJ-1-113

PDF 341.84 KB

Full-Text (HTML)

2020, June

review

Diversity and Recruitment of Minorities in Clinical Trials: An Unmet Need

Nathalie Vives*
DOI: http://dx.doi.org/10.17140/CTPOJ-1-112

PDF 338.00 KB

Full-Text (HTML)

2020, June

original research

The Digital Stethoscope in Telemedicine: A Health Camp Study

Imran Pathan, Ravi K. Chittoria*, Saurabh Gupta, Chirra L. Reddy, Padmalakshmi B. Mohan, Shijina Koliyath, Nishad K and Mohamed Ishaq Z
DOI: http://dx.doi.org/10.17140/CTPOJ-1-111

PDF 438.72 KB

Full-Text (HTML)

2020, March

mini review

Beyond Placebo: Alternative Options to the Randomized Control Trial Design in Rare Disease Studies

Preethi Sriram*
DOI: http://dx.doi.org/10.17140/CTPOJ-1-110

PDF 289.55 KB

Full-Text (HTML)

2019, October

commentary

Remote Consent Clinical Research

Preethi Sriram*
DOI: http://dx.doi.org/10.17140/CTPOJ-1-109

PDF 281.37 KB

Full-Text (HTML)

2019, October

case report

Role of Bactiguard Infection Technology in Preventing Catheter-Associated Urinary Tract Infections

Shijina Koliyath, Ravi Kumar Chittoria*, Abhinav Aggarwal, Saurabh Gupta, Chirra Likhitha Reddy, Padmalakshmi Bharathi Mohan and Imran Pathan
DOI: http://dx.doi.org/10.17140/CTPOJ-1-108

PDF 351.27 KB

Full-Text (HTML)

2019, September

opinion

Clinical Research: The Future of Medicine Stuck in the Digital Past

Elizabeth Del Mastro Benincasa*
DOI: http://dx.doi.org/10.17140/CTPOJ-1-107

PDF 250.67 KB

Full-Text (HTML)

2019, August

original research

Role of Sound Enhancer Device in Teleconsultation

Shijina Koliyath, Ravi Kumar Chittoria*, Vinayak Chavan, Abhinav Aggarwal, Saurabh Gupta, Chirra Likhitha Reddy, Padmalakshmi Bharathi Mohan and Imran Pathan
DOI: http://dx.doi.org/10.17140/CTPOJ-1-106

PDF 329.78 KB

Full-Text (HTML)

2019, July

mini review

Latest Results from Immunotherapy Clinical Trials in Triple Negative Breast Cancer

Alexios Strimpakos*, Konstantinos Tsigaridas and Maria Avgoustidou
DOI: http://dx.doi.org/10.17140/CTPOJ-1-105

PDF 469.61 KB

Full-Text (HTML)

2019, February

original research

The Effectiveness of Transcutaneous Electrical Nerve Stimulation Versus Carbamazepine in Trigeminal Neuralgia: A Randomized Controlled Trial

Rebecca Millan-Guerrero*, Rebecca Isais-Millan, Gabriel Castillo-Varela, Gabriel Ceja-Espíritu and Martha Alicia Higareda Almaraz
DOI: http://dx.doi.org/10.17140/CTPOJ-1-104

PDF 538.47 KB

Full-Text (HTML)

2017, October

mini review

Cluster Randomized Controlled Trials: A Quick Update on Concepts and Types

Bolaji Emmanuel Egbewale*
DOI: http://dx.doi.org/10.17140/CTPOJ-1-103

PDF 348.57 KB

Full-Text (HTML)

2017, October

review

Clinical Investigations on Medical Devices, after the New European Regulation (2017/745)

Salvatore Bianco*, Alfredo Nunziata and Giacomo Pozzoli
DOI: http://dx.doi.org/10.17140/CTPOJ-1-102

PDF 387.89 KB

Full-Text (HTML)

2017, March

original research

Distribution and Conduct of Clinical Trials Involving Music Therapy: Registered Clinical Trials in the Lost 15 Years

Keiko Yukawa, Hitoshi Fuji and Hajime Sato*
DOI: http://dx.doi.org/10.17140/CTPOJ-1-101

PDF 491.29 KB

Full-Text (HTML)

2016, June

editorial

Model Based vs. Rule Based Designs in Phase I Dose Finding Clinical Trials

Yunfei Wang and Jichuan Wang*
DOI: http://dx.doi.org/10.17140/CTPOJ-1-e001

PDF 330.16 KB

Full-Text (HTML)

About the Journal

Aims and Scope

Article in press

2021, January

case series

The Promise of Small Data for Telemedicine in Chronic Condition Management: A Real-World Case Series

Steven M. Schwartz*, Brigid Byrd, Helen Dempster and Tim Payne
DOI: http://dx.doi.org/10.17140/CTPOJ-1-117

Provisional PDF 578.99 KB

Full-Text (HTML)

Abstract [+]

Connected care is defined as the “real-time, electronic communication between a patient and a provider, including telehealth, remote patient monitoring, and secure email communication between clinicians and their patients” (Alliance of Connected Care). Connected care can create a high-value interaction strategy with patients when it makes thoughtful use of commercially available digital health technologies with demonstrated both clinical and economic effectiveness. Karantis360™, is a home sensor technology that enables real-time tracking, data analytics and predictive care for personal (at home) care powered by IBM Watson Health. IndividuALLyticsTM is a telemedicine platform driven by a patent-pending an N-of-1 analytical engine and related digital dashboards that provides individual, patient level evaluation of treatment response. The underlying technology combines disparate digital health technology data with the best evidence-base guidelines with N-of-1 methodology. The output allows for creation of personalized treatments empirically tested at the patient level over time (aka over the course of care). When aggregated both within and across persons,
the time-ordered data can build predictive pathways of behavior and ensure the relevant care and medical treatments are in place to support effective medical and self-management of chronic illness. This case-series report describes the implementation of a joint home sensor technology (big data) and an N-of-1 analytic engine (small data) with three elderly consented volunteer customers-patients of Karantis360™. Each person underwent successive, 2-week behavioral change treatment phases to determine usability, utility regarding medical and self-management and any proximal effects on health risks.
Keywords
Telemedicine; Small data; n-of-1; Internet of things; Chronic conditions; Self-management; Predictive analytics.

2021, January

mini review

Coronavirus Disease-2019 Clinical Trial Case Studies Within the Biotechnology and Clinical Research Organizations Industry

Melanie K. Pearce and Nathanael E. Hughes*
DOI: http://dx.doi.org/10.17140/CTPOJ-1-118

Provisional PDF 290.07 KB

Full-Text (HTML)

2021, April

opinion

The Importance of Teaching and Fostering Clinical Research in Primary Health Care

Gerald L. Klein* and Mark A. Brown
DOI: http://dx.doi.org/10.17140/CTPOJ-1-119

Provisional PDF 302.16 KB

Full-Text (HTML)

2021, August

review

The Case for Digital Pill Use in Clinical Trials

Gerald L. Klein*
DOI: http://dx.doi.org/10.17140/CTPOJ-1-120

Provisional PDF 739.81 KB

Full-Text (HTML)

Abstract [+]

Medication adherence in clinical trials is significantly overestimated through every phase of drug development. This can cause a reduction in statistical power, potentially resulting in incorrect conclusions regarding efficacy, safety, tolerability, and dose-response relationships, in addition to major cost overruns. Digital pill systems enable adherence measurement through an embedded ingestible sensor paired with an external receiver. An oral pharmaceutical product is over-encapsulated by a pharmaceutical-grade shell containing a biocompatible sensor. Upon exposure to gastrointestinal fluid, the shell dissolves and the sensor is activated. Medication ingestion data is transmitted via a digital signal. Clinicians and researchers use this data to track, in real time, when and if a medication was taken. These systems have demonstrated a 99.4% rate of accuracy, and have over 15-years of supporting
experience and safety data. Spurred by the accelerated adoption of technology in healthcare and in everyday life, patients have become tech-savvy. They quickly adapt to these devices, and are able to use them safely and effectively. Digital pills can be implemented in most types of studies. In early-stage trials such as pharmacokinetic and pharmacodynamic studies, or dose-finding studies, accurate information on maximum-tolerated dose levels is essential and cannot be established unless study participants are highly adherent. In later-stage pivotal trials, effective medication adherence tracking can strengthen the dataset and confidence in the study results. Significant nonadherence may generate results that do not meet statistical or clinical significance for the critical endpoints, resulting in at worst, a failed trial, or at best, the need to enroll additional patients at substantial additional cost. Most clinical trials fail to achieve statistical significance, and poor medication adherence is often an important contributor. A digital pill system can ensure the quality and integrity of adherence data, increase confidence in the overall study data, and improve clinical trial efficiency.

2021, November

original research

Design and Statistical Methods for Handling Covariates Imbalance in Randomized Controlled Clinical Trials: Dilemmas Resolved

Bolaji E. Egbewale*
DOI: http://dx.doi.org/10.17140/CTPOJ-1-121

Provisional PDF 432.92 KB

Full-Text (HTML)

Abstract [+]

Introduction
In practice, between groups baseline imbalance following randomization not only opens effect estimate to bias in controlled trials, it also has certain ethical consequences. Both design and statistical approaches to ensure balanced treatment groups in prognostic factors are not without their drawbacks. This article identified potential limitations associated with design and statistical approaches for handling covariate imbalance in randomized controlled clinical trials (RCTs) and proffered solutions to them.
Methods
A careful review of literatures coupled with a robust appraisal of statistical models of methods involved in a way that compared their strength and weaknesses in trial environments, was adopted.
Results
Stratification breaks down in small sample size trials and may not accommodate more than two stratification factors in practice. On the other hand, minimization that balances for multiple prognostic factors even in small trials is not a pure random procedure and in addition, could present with complexities in computations. Overall, either minimization or stratification factors should be included in the model for statistical adjustment. Statistically, estimate of effect by change score analysis (CSA) is susceptible to direction and magnitude of imbalance. Only analysis of covariance (ANCOVA) yields unbiased effect estimate in all trial scenarios including situations with baseline imbalance in known and unknown prognostic covariates.
Conclusion
Design methods for balancing covariates between groups are not without their limitations. Both direction and size of baseline imbalance also have profound consequence on effect estimate by CSA. Only ANCOVA yields unbiased treatment effect and is recommended at all trial scenarios, whether or not between groups covariate imbalance matters.
Keywords
Randomization; Covariate imbalance; Stratification; Minimization; Change score analysis; ANCOVA.

NOTE: The DOIs of the In-Press Articles will only function after the final publication of the articles and once they are uploaded to the Current Issues.

×

Previous Issue

Home

Authors Instructions

Submit Manuscript

Reviewer Registration

Contact Us

Article in press

Current issue

Previous issue

Archive

Archive

Connect with us

Advertisement

Recently Published Articles

Design and Statistical Methods for Handling Covariates Imbalance in Randomized Controlled Clinical Trials: Dilemmas Resolved

PDF 432.92 KB

The Case for Digital Pill Use in Clinical Trials

PDF 739.81 KB

The Importance of Teaching and Fostering Clinical Research in Primary Health Care

PDF 302.16 KB

Coronavirus Disease-2019 Clinical Trial Case Studies Within the Biotechnology and Clinical Research Organizations Industry

PDF 290.07 KB

The Promise of Small Data for Telemedicine in Chronic Condition Management: A Real-World Case Series

PDF 578.99 KB

Role of Low-Level Laser Therapy as an Adjunct in the Management of Diabetic Ulcer

PDF 328.58 KB

The Role of Negative Pressure Wound Therapy with Instillation and Dwell Time in the Preparation of Wound Bed

PDF 419.26 KB

How a Network Came Together to Manage a Large Research Program During the Pandemic

PDF 300.51 KB

Innovation in Clinical Trials is Possible: The Hidden Opportunity in the Coronavirus Disease-2019 Emergency

PDF 341.84 KB

Diversity and Recruitment of Minorities in Clinical Trials: An Unmet Need

PDF 338.00 KB

The Digital Stethoscope in Telemedicine: A Health Camp Study

PDF 438.72 KB

Beyond Placebo: Alternative Options to the Randomized Control Trial Design in Rare Disease Studies

PDF 289.55 KB

Remote Consent Clinical Research

PDF 281.37 KB

Role of Bactiguard Infection Technology in Preventing Catheter-Associated Urinary Tract Infections

PDF 351.27 KB

Clinical Research: The Future of Medicine Stuck in the Digital Past

PDF 250.67 KB

Role of Sound Enhancer Device in Teleconsultation

PDF 329.78 KB

Latest Results from Immunotherapy Clinical Trials in Triple Negative Breast Cancer

PDF 469.61 KB

The Effectiveness of Transcutaneous Electrical Nerve Stimulation Versus Carbamazepine in Trigeminal Neuralgia: A Randomized Controlled Trial

PDF 538.47 KB

Cluster Randomized Controlled Trials: A Quick Update on Concepts and Types

PDF 348.57 KB

Clinical Investigations on Medical Devices, after the New European Regulation (2017/745)

PDF 387.89 KB

Distribution and Conduct of Clinical Trials Involving Music Therapy: Registered Clinical Trials in the Lost 15 Years

PDF 491.29 KB

Model Based vs. Rule Based Designs in Phase I Dose Finding Clinical Trials

PDF 330.16 KB

About the Journal

Aims and Scope

Article in press

The Promise of Small Data for Telemedicine in Chronic Condition Management: A Real-World Case Series

Provisional PDF 578.99 KB

Abstract [+]

Coronavirus Disease-2019 Clinical Trial Case Studies Within the Biotechnology and Clinical Research Organizations Industry

Provisional PDF 290.07 KB

The Importance of Teaching and Fostering Clinical Research in Primary Health Care

Provisional PDF 302.16 KB

The Case for Digital Pill Use in Clinical Trials

Provisional PDF 739.81 KB

Abstract [+]

Design and Statistical Methods for Handling Covariates Imbalance in Randomized Controlled Clinical Trials: Dilemmas Resolved

Provisional PDF 432.92 KB

Abstract [+]

Current Issue

Model Based vs. Rule Based Designs in Phase I Dose Finding Clinical Trials

PDF 330.16 KB

Distribution and Conduct of Clinical Trials Involving Music Therapy: Registered Clinical Trials in the Lost 15 Years

PDF 491.29 KB

Abstract [+]

Clinical Investigations on Medical Devices, after the New European Regulation (2017/745)

PDF 387.89 KB

Cluster Randomized Controlled Trials: A Quick Update on Concepts and Types

PDF 348.57 KB

The Effectiveness of Transcutaneous Electrical Nerve Stimulation Versus Carbamazepine in Trigeminal Neuralgia: A Randomized Controlled Trial

PDF 538.47 KB

Latest Results from Immunotherapy Clinical Trials in Triple Negative Breast Cancer

PDF 469.61 KB

Abstract [+]

Role of Sound Enhancer Device in Teleconsultation

PDF 329.78 KB

Abstract [+]

Clinical Research: The Future of Medicine Stuck in the Digital Past