Abstract：
:Assessing the probability that a Phase III clinical trial will demonstrate clinically relevant efficacy based on Phase II data is an important topic in clinical drug development. An accurate estimate of how likely a Phase III trial will succeed based on available data will inform the decision on whether to move an experimental medicine forward to Phase III testing. Bayesian and likelihood methodologies have been developed in the literature to assess the probability of reproducibility in clinical trials for parametric models. A class of approaches that combines the Bayesian and likelihood approaches is proposed to evaluate the success probability of a Phase III trial based on Phase II data, which applies to the parametric, semi-parametric, and non-parametric settings and includes the Bayesian and likelihood approaches as special cases.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Su Zdoi
10.1016/j.cct.2010.08.008subject
Has Abstractpub_date
2010-11-01 00:00:00pages
620-3issue
6eissn
1551-7144issn
1559-2030pii
S1551-7144(10)00152-7journal_volume
31pub_type
杂志文章abstract：BACKGROUND:Individuals with serious mental illness (SMI) smoke at disproportionately higher rates than those without SMI, have lifespans 25-32 years shorter, and thus bear an especially large burden of tobacco-related morbidity and mortality. Several recent studies demonstrate that smokers with SMI can successfully qui...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2019.06.001
更新日期：2019-08-01 00:00:00
abstract：BACKGROUND:Unlike conventional time-to-event analysis of composite endpoints in clinical trials, the "win ratio" method allows for flexibility in prioritizing their components. Here, we compare the EVOLVE trial findings using the win ratio with those from time-to-event analysis. METHODS: EXPOSURE:Randomization to cin...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2016.04.001
更新日期：2016-05-01 00:00:00
abstract：:Phase IIA clinical trials are commonly conducted as pilot studies to evaluate efficacy and safety in selected populations of patients with the disease or condition to be treated or prevented. The efficacy objective is to find preliminarily evidence of the effectiveness or ineffectiveness of study treatments. Go/no-go ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2012.07.006
更新日期：2012-11-01 00:00:00
abstract：BACKGROUND:Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.cct.2019.105859
更新日期：2019-12-01 00:00:00
abstract：:Transitional care programs have been widely used to reduce readmissions and improve the quality and safety of the handoff process between hospital and outpatient providers. Very little is known about effective transitional care interventions among patients who are uninsured or with Medicaid. This paper describes the d...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2017.12.003
更新日期：2018-02-01 00:00:00
abstract：:As a convention, a p-value is often computed in hypothesis testing and compared with the nominal level of 0.05 to determine whether to reject the null hypothesis. Although the smaller the p-value, the more significant the statistical test, it is difficult to perceive the p-value in a probability scale and quantify it ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2015.07.001
更新日期：2015-09-01 00:00:00
abstract：BACKGROUND:The translation of research evidence into practice is facilitated by clinical trials such as those sponsored by the National Cancer Institute's Community Clinical Oncology Program (CCOP) that help disseminate cancer care innovations to community-based physicians and provider organizations. However, CCOP part...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2012.08.008
更新日期：2012-11-01 00:00:00
abstract：INTRODUCTION:Focal therapy offers the possibility of cancer control, without the side effect profile of radical therapies. Early single centre prospective development studies using high intensity focused ultrasound (HIFU) have demonstrated encouraging genitourinary functional preservation and short-term cancer control....
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究
doi：10.1016/j.cct.2013.06.005
更新日期：2013-09-01 00:00:00
abstract：BACKGROUND:The FEVER (Frail Elderly Vibration Exercise Response) study aims to address a paucity of research focusing on the use of Whole Body Vibration (WBV) by frail elderly who, with the highest levels of dependence and fall-related hospitalisation/mortality, potentially stand to benefit most from such accessible ex...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2015.08.008
更新日期：2015-09-01 00:00:00
abstract：BACKGROUND:New approaches are needed to better monitor blood pressure (BP) between physician visits, especially for patients in rural areas or for those who lack transportation. We have developed a custom-built bi-directional texting platform for home BP measurements that can then be managed by clinical pharmacists loc...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2020.106169
更新日期：2020-11-01 00:00:00
abstract：BACKGROUND:In a recent publication, the International Guidelines for Groin Hernia Management by the European Hernia Society (EHS) recognized the need to individualize and tailor the surgical approach for hernia repair. There may be different opportunities for optimization of the surgical technique for surgeons performi...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究
doi：10.1016/j.cct.2019.105853
更新日期：2019-11-01 00:00:00
abstract：BACKGROUND:Thousands of people die annually from prescription opioid overdoses; however there are few strategies to ensure patients receive medication risk information at the time of prescribing. OBJECTIVES:To compare the effectiveness of the Emergency Department (ED) Electronic Medication Complete Communication (EMC2...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2017.05.003
更新日期：2017-08-01 00:00:00
abstract：BACKGROUND:Early pregnancy through the first year of life represents an important period for family health promotion and obesity prevention. Overall, preventive interventions in pregnancy and infancy have insufficiently engaged fathers. We describe the rationale and design of First Heroes, an intervention to improve pe...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2020.106253
更新日期：2020-12-17 00:00:00
abstract：BACKGROUND:Colorectal cancer (CRC) screening by annual fecal immunochemical test (FIT) is an accessible and cost-effective strategy to lower CRC incidence and mortality. However, this mode of screening depends on follow-up colonoscopy after a positive FIT result. Unfortunately, nearly one-half of FIT-positive patients ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2019.105920
更新日期：2020-02-01 00:00:00
abstract：PURPOSE:African-American women (AAW) are more likely to be metabolically unhealthy than White women (WW). Metabolic syndrome (MetS) is associated with increased breast cancer risk and mortality from breast cancer is greater in AAW compared to WW. Data show MetS affects health-related quality of life (HRQoL). Exercise s...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2018.02.005
更新日期：2018-04-01 00:00:00
abstract：INTRODUCTION:The increasing complexities of conducting multiregional trials and an evolving regulatory environment contribute to unprecedented new challenges for use of patient-reported outcome measures (PROMs)(1) within clinical trials. This paper presents these challenges and potential solutions. METHODS:Real-world ...
journal_title：Contemporary clinical trials
pub_type： 临床试验,杂志文章
doi：10.1016/j.cct.2013.02.006
更新日期：2013-05-01 00:00:00
abstract：:Obesity prevalence is higher in rural compared to urban residents. Rural health clinics offer a potential venue for delivery of weight management. However, traditional programs require travel to attend on-site meetings which is impractical or inconvenient for rural residents. Clinic staff in most rural settings are un...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2018.02.006
更新日期：2018-04-01 00:00:00
abstract：BACKGROUND:Evaluation of new therapies for cancer has suffered a paradigm shift in the last years. The use of innovative and more efficient designs is a priority for the scientific community; nevertheless, the use of this kind of design is not yet wide spread. PURPOSE:In this paper will examine the effectiveness of ad...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,评审
doi：10.1016/j.cct.2011.09.017
更新日期：2012-01-01 00:00:00
abstract：:Breast cancer is the most common invasive cancer among women in developed countries. Obesity is a major risk factor for breast cancer recurrence and mortality in both pre- and postmenopausal women. Co-morbid medical conditions are common among breast cancer survivors. The Exercise and Nutrition to Enhance Recovery and...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2012.12.003
更新日期：2013-03-01 00:00:00
abstract：OBJECTIVES:To review current publications to examine safety of tai chi (TC). DESIGN:Cochrane Library, EBSCO host and MEDLINE/PubMed were searched for randomized controlled trials (RCTs) including TC as the core intervention and reporting adverse events (AEs). Data were extracted considering active vs. inactive control...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,meta分析
doi：10.1016/j.cct.2019.06.004
更新日期：2019-07-01 00:00:00
abstract：:Traumatic brain injury (TBI) often leads to immediate and chronic functional impairments that affect care partners, or those providing physical and/or emotional support to individuals with TBI. The many challenges associated with being a care partner often lead to caregiver burden and can compromise the well-being and...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2019.03.004
更新日期：2019-05-01 00:00:00
abstract：BACKGROUND:Atorvastatin and metformin are known energy restricting mimetic agents that act synergistically to produce molecular and metabolic changes in advanced prostate cancer (PCa). This trial seeks to determine whether these drugs favourably alter selected parameters in men with clinically-localized, aggressive PCa...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2016.06.014
更新日期：2016-09-01 00:00:00
abstract：UNLABELLED:Despite short-term efficacy, many weight loss studies demonstrate poor long-term results and have difficulty recruiting men. Cost-effective treatments that help men achieve long-term weight loss are required. Using a two-phase, assessor-blinded, parallel-group randomised controlled trial design this study wi...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2013.11.004
更新日期：2014-01-01 00:00:00
abstract：BACKGROUND:Chronic Obstructive Pulmonary Disease (COPD) frequently coexists with other diseases. Whereas COPD action plans are currently part of usual care, they are less suitable and potentially unsafe for use in the presence of comorbidities. This study evaluates whether an innovative treatment approach directed towa...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.cct.2013.06.003
更新日期：2013-09-01 00:00:00
abstract：:Major depressive disorder (MDD) is the most common mental illness and the leading cause of disability worldwide. Electroconvulsive therapy (ECT) is the most effective treatment for MDD and the gold-standard therapy for treatment-resistant depression (TRD), yet it remains underutilized due to factors such as limited av...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2018.12.009
更新日期：2019-02-01 00:00:00
abstract：BACKGROUND:Despite widespread use of learning collaboratives in health care, few randomized trials have evaluated their effectiveness. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervent...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.cct.2019.105816
更新日期：2019-09-01 00:00:00
abstract：BACKGROUND:Multiple sclerosis is a chronic progressive neurological disease. Evidence attests to the benefits of exercise, guidelines for exercise in multiple sclerosis are available. Remote-delivery of exercise adherence programmes based on the exercise guidelines require urgent testing. AIMS:The design, and outcomes...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2021.106281
更新日期：2021-01-12 00:00:00
abstract：BACKGROUND:In 2007, we commenced the Healthy Beginnings Trial (HBT) Phase 1 study, which is the first randomised controlled trial (RCT) to test the effectiveness of an early childhood obesity intervention in children aged up to 2 years. The results were promising with significant improvements in infant feeding practice...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.cct.2011.11.008
更新日期：2012-03-01 00:00:00
abstract：:Double-blinded trials are often considered the gold standard for research, but significant bias may result from unblinding of participants and investigators. Although the CONSORT guidelines discuss the importance of reporting "evidence that blinding was successful", it is unclear what constitutes appropriate evidence....
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2004.11.020
更新日期：2005-02-01 00:00:00
abstract：:Establishing a holistic approach for the enrollment of subjects into clinical trials that includes strategies for the recruitment of non-traditional and minority populations has been an elusive task. The existence of such a design, that is understood and embraced by investigators and the target communities, would stre...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2007.11.003
更新日期：2008-07-01 00:00:00
