Clinical Trials and Practice – Open Journal (CTPOJ)
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Recently Published Articles
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Combat Pandemic: Coronavirus Disease-2019 Vaccines Production, Clinical Trials and Global Partnerships
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582.94 KB Full-Text (HTML)
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Design and Statistical Methods for Handling Covariates Imbalance in Randomized Controlled Clinical Trials: Dilemmas Resolved
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433.79 KB Full-Text (HTML)
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The Importance of Teaching and Fostering Clinical Research in Primary Health Care
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303.67 KB Full-Text (HTML)
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Coronavirus Disease-2019 Clinical Trial Case Studies Within the Biotechnology and Clinical Research Organizations Industry
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291.78 KB Full-Text (HTML)
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The Promise of Small Data for Telemedicine in Chronic Condition Management: A Real-World Case Series
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578.86 KB Full-Text (HTML)
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Role of Low-Level Laser Therapy as an Adjunct in the Management of Diabetic Ulcer
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343.13 KB Full-Text (HTML)
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The Role of Negative Pressure Wound Therapy with Instillation and Dwell Time in the Preparation of Wound Bed
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420.00 KB Full-Text (HTML)
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How a Network Came Together to Manage a Large Research Program During the Pandemic
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307.84 KB Full-Text (HTML)
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Innovation in Clinical Trials is Possible: The Hidden Opportunity in the Coronavirus Disease-2019 Emergency
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392.92 KB Full-Text (HTML)
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Diversity and Recruitment of Minorities in Clinical Trials: An Unmet Need
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347.49 KB Full-Text (HTML)
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Beyond Placebo: Alternative Options to the Randomized Control Trial Design in Rare Disease Studies
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296.26 KB Full-Text (HTML)
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Role of Bactiguard Infection Technology in Preventing Catheter-Associated Urinary Tract Infections
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373.67 KB Full-Text (HTML)
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Latest Results from Immunotherapy Clinical Trials in Triple Negative Breast Cancer
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529.07 KB Full-Text (HTML)
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The Effectiveness of Transcutaneous Electrical Nerve Stimulation Versus Carbamazepine in Trigeminal Neuralgia: A Randomized Controlled Trial
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573.26 KB Full-Text (HTML)
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Cluster Randomized Controlled Trials: A Quick Update on Concepts and Types
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380.63 KB Full-Text (HTML)
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Clinical Investigations on Medical Devices, after the New European Regulation (2017/745)
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402.32 KB Full-Text (HTML)
About the Journal
Clinical Trials and Practice – Open Journal will discuss all fields related to clinical research, practice and the trials that help achieve results in clinical research.
Clinical Trials and Practice are experiments done in clinical research. These biomedical experiments and related research studies help in achieving new interventions and subsequent treatments in different aspects of human medicine.
The main objective of Openventio is to maintain the information that relates to Clinical Trials and to bring information from all the authors and diverse sources in a uniform way through our well-designed open access domain.
Aims and Scope
Clinical Trials and Practice – Open Journal is designed to answer all open ended questions about clinical trials from inception of a particular research study to final product or treatment roll outs.
CTPOJ covers a wide array of subjects as given below
- Latest trials and practice
- Investigators in clinical trials
- Clinical research and ethics in public health
- Volunteers and research centers
- Medical product testing rules
- Questionnaire
- Antifungal medicines in clinical trials
- ONSTEP hernia repair
- Residual pain and chronic pain
- Recurrence
Submissions for this Journal are accepted from fundamental research to detailed public health plans.
The audience of CTPOJ includes surgeons, physicians, pharmacists, registered nurses, pharmaceutical manufacturer’s adjunct healthcare professionals, housekeepers, policy makers, volunteers, practitioners, government watchdogs, students of various universities and general communities from different parts of the world.
The Journal welcomes all types of articles such as original research, review, case-report, mini-review, editorial, short-communication, book review, opinion, commentary, letter to the editor, conference proceedings, technical report, errata, illustrations etc.
We are open to receive comments or any corrections from any potential scientists to improve the quality of our Journal.
Article in press
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Potential Errors and Corrections in Early Phase Drug Development
Provisional PDF
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Abstract [+]
Many foreign and small companies trying to enter the United States biopharmaceutical market make avoidable errors in their early clinical phase drug development and clinical trials. They need to first understand the risks that they must endure with patent law, regulatory hurdles, the complexity and duration of the necessary clinical trials, and the large cost of drug development, which often necessitates raising substantial capital from investors. If appropriate capital for these clinical studies must be raised, then the company must be able to clearly articulate a realistic expected return on investment to these individuals. So, they must also understand the market, its exclusivity, and the competition. This must all be put together in a sleek pitch deck. Early errors frequently begin with too few, inadequate, or poorly constructed patents. These and other risks and errors may be prevented by the use of an experienced product development team. Many of these errors could be avoided if companies used more experienced drug development professionals to assist them in selecting the optimum patent strategy, regulatory plan, budget, contract research organization (CRO), clinical investigators, and etc. It is hoped that this opinion piece will help make early clinical trials more effective and save time and money.
Keywords
Clinical trials; Drug development; Biotechnology; Contract research organization (CRO); Principal investigators.
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Combat Pandemic: Coronavirus Disease-2019 Vaccines Production, Clinical Trials and Global Partnerships
Provisional PDF
582.94 KB Full-Text (HTML)
Abstract [+]
The advent of coronavirus disease-2019 (COVID-19), in March 2020, has forced the entire world into continuously changing dimensions, the emergence of variants has put forward a challenge to scientists and doctors, indeed the entire world to cope with it. A lot of clinical research was done, starting with the use of Chloroquine, an anti-malarial drug to treat COVID-19, antivirals and indeed entire world experienced havoc and a death toll due to the coronavirus which led to the emergence of various vaccine platforms developed against changing variants of coronavirus and in this pandemic messenger Ribonucleic acid (mRNA) and nanotechnology added new dimensions to vaccine development. Vaccines may induce additional cellular or humoral immune regulations, including The cell (helper T-cell) responses and germinal center responses, and form relevant memory cells, which in turn enhance their efficiency. As the benefit outweighs the safety issues with vaccination so far, the World Health Organization (WHO), has approved a total of ten vaccines, to use in emergencies, including 3 Indian vaccines (Covovax™, Covaxin® and Sputnik V). The first part, of this mini-review highlights vaccine production, and the clinical trials landscape, and the second part discusses the emergence of global partnerships, and the equity of vaccines to all, taken together, combating pandemics.
Keywords
Pandemic; Immunogen; Adenovirus; Vaccines; Clinical trials; Global partnerships.
Current Issue
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The Promise of Small Data for Telemedicine in Chronic Condition Management: A Real-World Case Series
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578.86 KB Full-Text (HTML)
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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.
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The Case for Digital Pill Use in Clinical Trials
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697.92 KB Full-Text (HTML)
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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.
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Design and Statistical Methods for Handling Covariates Imbalance in Randomized Controlled Clinical Trials: Dilemmas Resolved
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433.79 KB Full-Text (HTML)
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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.
Previous Issue
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Beyond Placebo: Alternative Options to the Randomized Control Trial Design in Rare Disease Studies
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296.26 KB Full-Text (HTML)
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.
The Digital Stethoscope in Telemedicine: A Health Camp Study
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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.
Diversity and Recruitment of Minorities in Clinical Trials: An Unmet Need
PDF 347.49 KB
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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.
Innovation in Clinical Trials is Possible: The Hidden Opportunity in the Coronavirus Disease-2019 Emergency
PDF 392.92 KB
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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.
How a Network Came Together to Manage a Large Research Program During the Pandemic
PDF 307.84 KB
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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.
The Role of Negative Pressure Wound Therapy with Instillation and Dwell Time in the Preparation of Wound Bed
PDF 420.00 KB
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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.
Role of Low-Level Laser Therapy as an Adjunct in the Management of Diabetic Ulcer
PDF 343.13 KB
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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.
