Clinical Trials and Practice – Open Journal最新文献

Patient and Surgeon’s Concerns with Post-Mastectomy Nipple Reconstruction: An Alternative to Traditional Nipple Reconstruction 患者和外科医生对乳房切除术后乳头再造的关注：传统乳头再造术的替代方案

Clinical Trials and Practice – Open Journal Pub Date : 2023-12-29 DOI: 10.17140/ctpoj-6-124

Gerald L. Klein, Roger Morgan, William Heim, Nicholas Pashos

{"title":"Patient and Surgeon’s Concerns with Post-Mastectomy Nipple Reconstruction: An Alternative to Traditional Nipple Reconstruction","authors":"Gerald L. Klein, Roger Morgan, William Heim, Nicholas Pashos","doi":"10.17140/ctpoj-6-124","DOIUrl":"https://doi.org/10.17140/ctpoj-6-124","url":null,"abstract":"Aims The aim of this paper is to determine what women who undergo reconstructive surgery after mastectomy (due to breast cancer) are seeking. It also answers the question, how plastic surgeons are attempting to fill this need. Methods A survey was undertaken of 84 plastic surgeons and 70 of their patients who underwent recent mastectomy and reconstruction surgery. All the material was deidentified before analysis. Results The majority of the women wanted their breasts and nipples to be natural and have the same appearance (or sometimes to be more attractive) or similar appearance. Conclusion Women undergoing this type of surgery frequently develop a decreased quality-of-life (QoL) which also affects their feeling of femininity, sexuality, and psychological well-being. The post-surgery time period and the additional necessary treatments are extremely stressful events. The importance of their breast post-operative aesthetics correlated with their self-esteem and body image. It is important for plastic surgeons to take these factors into consideration, when planning their reconstructive surgery","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":" 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139144098","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Importance of an Unbiased Safety Review Board in Phase I Clinical Trials 无偏见的安全审查委员会在 I 期临床试验中的重要性

Clinical Trials and Practice – Open Journal Pub Date : 2023-12-29 DOI: 10.17140/ctpoj-6-e002

Gerald L. Klein, Roger Morgan

引用次数: 0

Combat Pandemic: Coronavirus Disease-2019 Vaccines Production, Clinical Trials and Global Partnerships 抗击大流行:冠状病毒病-2019疫苗生产、临床试验和全球伙伴关系

Clinical Trials and Practice – Open Journal Pub Date : 2022-12-30 DOI: 10.17140/ctpoj-5-123

Pratima Malekar

{"title":"Combat Pandemic: Coronavirus Disease-2019 Vaccines Production, Clinical Trials and Global Partnerships","authors":"Pratima Malekar","doi":"10.17140/ctpoj-5-123","DOIUrl":"https://doi.org/10.17140/ctpoj-5-123","url":null,"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.","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":"20 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129992530","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Potential Errors and Corrections in Early Phase Drug Development 早期药物开发中的潜在错误和纠正

Clinical Trials and Practice – Open Journal Pub Date : 2022-12-30 DOI: 10.17140/ctpoj-5-122

Gerald L. Klein, R. Morgan

{"title":"Potential Errors and Corrections in Early Phase Drug Development","authors":"Gerald L. Klein, R. Morgan","doi":"10.17140/ctpoj-5-122","DOIUrl":"https://doi.org/10.17140/ctpoj-5-122","url":null,"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.","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129972152","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Design and Statistical Methods for Handling Covariates Imbalance in Randomized Controlled Clinical Trials: Dilemmas Resolved 随机对照临床试验中处理协变量不平衡的设计和统计方法:难题解决

Clinical Trials and Practice – Open Journal Pub Date : 2021-12-31 DOI: 10.17140/ctpoj-4-121

B. Egbewale

{"title":"Design and Statistical Methods for Handling Covariates Imbalance in Randomized Controlled Clinical Trials: Dilemmas Resolved","authors":"B. Egbewale","doi":"10.17140/ctpoj-4-121","DOIUrl":"https://doi.org/10.17140/ctpoj-4-121","url":null,"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.","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":"2014 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127457346","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Coronavirus Disease-2019 Clinical Trial Case Studies Within the Biotechnology and Clinical Research Organizations Industry 2019冠状病毒病-生物技术和临床研究机构行业内的临床试验案例研究

Clinical Trials and Practice – Open Journal Pub Date : 2021-12-31 DOI: 10.17140/ctpoj-4-118

Melanie K. Pearce, Nathanael E. Hughes

引用次数: 0

The Importance of Teaching and Fostering Clinical Research in Primary Health Care 初级卫生保健教学与促进临床研究的重要性

Clinical Trials and Practice – Open Journal Pub Date : 2021-12-31 DOI: 10.17140/ctpoj-4-119

G. Klein, Mark Brown

引用次数: 0

The Promise of Small Data for Telemedicine in Chronic Condition Management: A Real-World Case Series 远程医疗在慢性病管理中的小数据前景:一个真实世界的案例系列

Clinical Trials and Practice – Open Journal Pub Date : 2021-12-31 DOI: 10.17140/ctpoj-4-117

S. Schwartz, B. Byrd, H. Dempster, Tim Payne

{"title":"The Promise of Small Data for Telemedicine in Chronic Condition Management: A Real-World Case Series","authors":"S. Schwartz, B. Byrd, H. Dempster, Tim Payne","doi":"10.17140/ctpoj-4-117","DOIUrl":"https://doi.org/10.17140/ctpoj-4-117","url":null,"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.","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":"308 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134450883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Case for Digital Pill Use in Clinical Trials 在临床试验中使用数字药片的案例

Clinical Trials and Practice – Open Journal Pub Date : 2021-12-31 DOI: 10.17140/ctpoj-4-120

G. Klein

{"title":"The Case for Digital Pill Use in Clinical Trials","authors":"G. Klein","doi":"10.17140/ctpoj-4-120","DOIUrl":"https://doi.org/10.17140/ctpoj-4-120","url":null,"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","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":"70 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127360032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Beyond Placebo: Alternative Options to the Randomized Control Trial Design in Rare Disease Studies 超越安慰剂:罕见疾病研究中随机对照试验设计的替代方案

Clinical Trials and Practice – Open Journal Pub Date : 2020-12-31 DOI: 10.17140/ctpoj-3-110

P. Sriram

引用次数: 2