Clinical Trials and Practice – Open Journal (CTPOJ)

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Article in press

2016, June

editorial

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

Yunfei Wang, DrPH; Jichuan Wang, PhD*
DOI: http://dx.doi.org/10.17140/CTPOJ-1-e001

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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

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Abstract [+]

Objective: This study aimed to conduct an evaluation of music therapy clinical trials
worldwide, to understand what trials have been conducted and to show the chronological
changes. Additionally, we sought to clarify issues related to providing clinical trial registration
information.
Methods: We searched the International Clinical Trials Registry Platform (ICTRP) database for
“music therapy,” and identified the disease target for each article found.
Results: A total of 150 clinical trial studies were found in the ICTRP using the term “music
therapy.” In these trials, music therapy was used for improvement of social functioning in
schizophrenia and/or serious mental disorders, anxiety and depressive symptoms, and cancer
symptoms. Twenty-five clinical trials were actively recruiting. Sixteen of the 25 trials were
registered in the United States at ClinicalTrials.gov, of which 9 trials were conducted in the US.
Seven trials were conducted in other countries such as Spain, Taiwan, and China.
Conclusion: A search for music therapy clinical trials retrieved 150 trials from the ICTRP, and
the number of clinical trial registrations has increased yearly. Music therapy is widely used in
patients with various diseases, including Alzheimer’s disease, anxiety, and arthritic pain and
has the potential to improve certain disease outcomes, but there is not enough evidence to
substantiate its efficacy. It is important to enlighten researchers and pharmaceutical companies
on the proper management of the quality of such clinical trial information, as this is an important
issue.

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

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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

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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

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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

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Abstract [+]

Cancer immunotherapy has evolved enormously in the recent years with better understanding of immune reactions, immune microenvironment and immunosurveillance. Breast cancer is characterized by large heterogeneity, a fact which rather complicated the development and the approval of novel therapeutic options in comparison to the majority of other solid tumors since each subtype has required a unique scientific approach and different targets and goals. Triple negative breast cancer (TNBC) is considered the most aggressive of the breast cancer subtypes with limited treatment options and worse outcome compared to others. This article summarizes some of the early clinical studies and the recently presented phase III clinical study of immunotherapy checkpoint inhibitors in this difficult setting.

Keywords: Cancer; Immunotherapy; Triple negative breast cancer (TNBC); Breast cancer.

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

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Abstract [+]

Aim

To study the role of sound enhancer device in teleconsultation.

Methods

This study was conducted in the plastic surgery department in a tertiary care centre in the month of May-June 2019. A sound enhancer device was used with mobile phone for videoconferencing as form of teleconsultation by plastic surgery trainees in operation theatre and outpatient department. At the end of the study feedbacks were taken from the trainees.

Results

It was found that on using the sound enhancer device, the sound quality improved and it was helpful in the teleconsultation sessions using videoconferencing.

Conclusion

The use of sound enhancer is a simple, cost-effective, innovative method of using a simple technology to aid in utilisation of teleconsultation facilities in a very non-sophisticated way.

Keywords

Sound enhancer device; Teleconsultation; Telemedicine.

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

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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

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Abstract [+]

To study the role of bactiguard infection technology (BIP) in preventing Catheter-associated urinary tract infections. This study was conducted in a tertiary care centre in the Department of Plastic Surgery, JIPMER, Pondicherry, India in the month of August 2019. The study subject was a 55-year-old gentleman with Fournier’s gangrene and type 2 diabetes mellitus (DM). The Foley’s catheter with BIP technology was used and its role in preventing urinary tract infections (UTI) was studied over a period of 10-days. During the period of the catheter use in our subject, patient did not develop features of urinary tract infections. BIP technology is claimed to be effective in preventing Catheter-associated urinary tract infections but further studies in more individuals is required to validate the same.

Keywords

Bactiguard infection technology (BIP); Catheter associated urinary tract infection (CAUTI); Biofilm.

2019, October

commentary

Remote Consent Clinical Research

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

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Abstract [+]

Recruitment in clinical research trials can be challenging in trials that are time-sensitive and/or are rare disease and critical care trials. One of the hurdles for recruitment in these types of clinical trials is due to the consent process, and the need to have consent of the patient within a certain timeframe, or the patient unable to consent for themselves. This paper will discuss the usage of the utilization of remote consent options for these trials.

Keywords

Recruitment; e-consent; Remote consent; Clinical trials; Rare disease; Time-sensitive.

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

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Abstract [+]

Unique difficulties and challenges can arise for rare diseases and orphan disease indications within a clinical trial. Some of the challenges encountered by trials that are working on rare diseases can include recruitment and enrollment. One of the explanations for the challenges that are encountered in rare disease trials is because of the trial design of study, where the investigational product is being compared to the placebo. This review paper discusses the usage of placebo and when other options could be taken into consideration while creating the protocol, specifically with consideration to rare disease studies. It is essential for the investigators and those designing the protocol to consider alternative options from the standard randomized controlled trial. The aim of this paper is to review alternative trial design options. The trial designs discussed in this review paper include crossover trials, single arm studies and historical data, and n-of-1 trials.

Keywords

Recruitment; Enrollment; Placebo controlled; Clinical trials; Rare disease; Crossover trials; Single arm study;
Historical data; n-of-1 trials.

2020, June

observational study

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

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Abstract [+]

India is a vast country with limited human resources. People living in remote areas often have limited access to healthcare facilities. To address this need and to increase healthcare awareness, health camps have been established. These camps are often supervised by junior physicians. Telemedicine, and in particular use of a digital stethoscope may provide better diagnosis and better consultation to the patient by senior physicians located remotely. This article highlights the clinical use of a digital stethoscope in such a health camp.

Keywords

Health camp; Telemedicine; Digital stethoscope.

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

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Abstract [+]

Patient centricity has led to the idea that drugs should answer medical needs not only defined by the medical bodies but relevant for the patients themselves. This implies that the diversity of the patients should be represented in clinical trials. Disparities in representation of diverse populations in clinical trials have been well-documented for several pathologies like arterial hypertension, diabetes but also in oncology. Today, Caucasian patients included in clinical trials represent at least 75% of the clinical trials population even in pathologies where minorities are largely more affected than Caucasians. Filling the gap in diversity is an important matter to ensure ethics, good practices, regulatory compliance, patient safety and scientific validity. To achieve their recruitment goals and being patient centric, sponsors and investigational sites need to pay attention of this problem and put in place specific strategies. Mistrust of patients of minority groups toward clinical research is one of the main barriers along with lack of access to clinical trials (low awareness, communication barriers, distance to investigational sites). Adapted communication, community-based strategies are some of the useful strategies directed to the patients. Investigators may not encounter diverse populations in their area or may not be aware of unconscious bias when identifying patients suitable for a clinical trial. Looking for referrals and raising awareness of the risk of bias with training on culturally sounded approaches could help investigators to recruit more diverse populations. Lack of awareness and costs may prevent sponsors to focus on diversity but ethics, benefits of data acquisition and patient centricity should be enough motivators to modify this trend. Patients, investigators and sponsors have their own barriers to tackle the lack of diversity in clinical trials. The cultural background of all stakeholders is an important factor in those barriers. Only multidisciplinary approaches including human sciences would help to define patient recruitment strategies that would mitigate the current lack of diversity.

Keywords

Clinical trials; Patient recruitment; Diversity, Minorities.

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

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Abstract [+]

The coronavirus disease-2019 (COVID-19) emergency has clearly shown the need to discover, test and produce a new vaccine but also in general the fragility of the current chain of clinical trials. Through this emergency, is it possible to look at the current clinical trial processes with new eyes? Is it possible to seize the opportunity for change and to have confidence in the possibility of their improvement? In this short article the authors wanted to give an optimistic answer to this question by pushing on the possibilities of innovation nowadays.
Keywords
Clinical trials; Innovation; Covid-19; Digital transformation.

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

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Abstract [+]

Hackensack Meridian Health, a large New Jersey network comprised of 17 hospitals, a medical school, and 200 ambulatory care centers, executes a large research program with approximately 1000 active human subjects studies. With the arrival of the coronavirus disease-2019 (COVID-19) pandemic, the Office of Research Administration was confronted with a series of challenges. These included minimizing face-to-face contact among research participants and staff, allocating limited resources to handle the influx of COVID-19 related proposals, providing human subjects protection training to the physicians and staff who were needed to run the clinical trials, adjusting bio-repository activities to meet the increased demand for samples, and disseminating all of the new regulatory and operational information to the thousands of researchers in the network. The network’s success in modifying its research program quickly and effectively to adapt to the changing landscape can be attributed, in large part, to the centralized nature of the research administration.
Keywords
Research administration; COVID-19; Network.

2020, July

case study

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

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Abstract [+]

Introduction
Although the negative pressure wound therapy (NPWT) is a time tested method of wound preparation, the role of NPWT with instillation and dwell time (NPWTi-d) in decreasing the downtime of wound preparation needs to be evaluated.
Objective
The objective of this study is assess the role of NPWTi-d in wound bed preparation.
Materials and Methods This study was conducted in a tertiary care center, after getting informed consent and ethical clearance. NPWTi-d was done on a 36-years-old female with no known co-morbidities admitted with infected raw area over the right below knee amputation stump and exposed bone who was not responding well to conventional wound dressing. NPWT was applied with the help of sterile polyurethane sponge and two tubes. The antimicrobial solution used was ionic silver solution, just enough to wet the sponge completely and up to the point when the transparent occlusive covering begins to lift. Negative pressure was applied at 125 mmHg. The wound was bathed with ionic silver solution and it was allowed to stay in the wound for 10-minutes, after every 2-hours of negative pressure application. This was continued for 1-week. The dressing was opened at the end of 1-week, wound irrigated with normal saline, exudate swabs for culture taken and debrided, following which fresh NPWTi-d was applied. This was repeated for the next 3-weeks.
Result
By the end of third week, the wound became clean, fully covered with healthy granulation and the wound bed was ready to undergo the definitive wound cover procedure.
Keywords
Negative pressure wound therapy (NPWT); Negative pressure wound therapy with instillation dwell time (NPWTi-d); Ionic silver solution; Wound bed preparation; Amputation stump.

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

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Abstract [+]

Diabetes mellitus (DM) is a chronic debilitating condition affecting people worldwide and diabetic foot ulcers are also a common problem. The treatment of diabetic ulcers requires a multimodal approach. Adjuvant low-level laser therapy (LLLT) may be useful in lesions with protracted healing course but the evidence is still limited. In this study, we share our experience regarding the use of low-level laser therapy as an adjuvant treatment modality in a patient with diabetic foot ulcer.
Keywords
Low-level laser therapy; Diabetic ulcer.

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

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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

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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

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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 374.58 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 398.09 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

CTNSOJ

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

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

Provisional PDF 330.16 KB

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

Provisional PDF 491.29 KB

Abstract [+]

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

Provisional PDF 387.89 KB

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

Provisional PDF 348.57 KB

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

Provisional PDF 538.47 KB

Latest Results from Immunotherapy Clinical Trials in Triple Negative Breast Cancer

Provisional PDF 469.61 KB

Abstract [+]

Role of Sound Enhancer Device in Teleconsultation

Provisional PDF 329.78 KB

Abstract [+]

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

Provisional PDF 250.67 KB

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

Provisional PDF 351.27 KB

Abstract [+]

Remote Consent Clinical Research

Provisional PDF 281.37 KB

Abstract [+]

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

Provisional PDF 289.55 KB

Abstract [+]

The Digital Stethoscope in Telemedicine: A Health Camp Study

Provisional PDF 398.09 KB

Abstract [+]

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

Provisional PDF 338.00 KB

Abstract [+]

Steven M. Schwartz, PhD
steve@individuallytics.com

Bolaji Egbewale, PhD
beegbewale@lautech.edu.ng