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 adaptive designs compared with traditional designs in phase II clinical trials. METHODS:We reviewed a group of abstracts records between 1980 and 2008 and extracted data regarding statistical design, year of publication, kind of evaluated product, localization, sample size and results of the trials. RESULTS:Nine hundred and eighty-nine clinical trials were identified and from them 333 traditional designs and 19 adaptive designs were included in the review. Two hundred statistical papers were located and 16 were included in the review. The most frequent designs were Standard up and down designs, continual reassessment methods and its variation and designs with Bayesian approaches. More than 80% of the studies evaluated different schemes of chemotherapy. Adaptive designs evaluated only drugs and not any kind of treatment combination and the most often localizations evaluated in both designs were lung, haematology malignancies, and colon cancers. CONCLUSIONS:Adaptive designs are more efficient from the statistical point of view but they are not yet widely used because of complex and computationally intensive methods needed, substantial effort for planning the trials and lack of regulatory guidance.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
López MF,Dupuy JF,Gonzalez CVdoi
10.1016/j.cct.2011.09.017subject
Has Abstractpub_date
2012-01-01 00:00:00pages
223-7issue
1eissn
1551-7144issn
1559-2030pii
S1551-7144(11)00253-9journal_volume
33pub_type
杂志文章,评审abstract::Thirty percent of all military personnel smoke cigarettes. Because of the negative health consequences and their impact on physical fitness, overall health, and military readiness, the Department of Defense has identified the reduction of tobacco use as a priority of US military forces. This study aims to evaluate the...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.04.009
更新日期:2012-09-01 00:00:00
abstract::An instrumental variable (IV) estimator has been widely used to estimate causal effects among compliers in randomized trials with noncompliance. The estimator of complier average treatment effect can be expressed as a ratio of two unbiased estimators but the ratio estimator is not unbiased. The bias of IV estimator ca...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2012.03.013
更新日期:2012-07-01 00:00:00
abstract:PURPOSE:Black breast cancer survivors have high rates of obesity and low physical activity levels. Little is known about the acceptability and feasibility of interventions in this population. OBJECTIVE:A two-arm RCT was launched to assess the efficacy of a culturally targeted 12-week multimodal lifestyle intervention ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2015.12.005
更新日期:2016-01-01 00:00:00
abstract:BACKGROUND:We evaluated the association of demographic and clinical characteristics with participation in an epidemiologic study of diabetes mellitus among youth. METHODS:SEARCH for Diabetes in Youth is a multicenter study of physician-diagnosed diabetes in youth under the age of 20 comprising a surveillance and a coh...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究
doi:10.1016/j.cct.2008.05.008
更新日期:2008-11-01 00:00:00
abstract:BACKGROUND:The Covid-19 pandemic has caused fear and panic worldwide, forcing healthcare systems to disregard conventional practices and adopt innovation to contain the infection and death. Globally, there has been a rapid proliferation of research studies and clinical trials assessing risks, infectivity and treatment....
journal_title:Contemporary clinical trials
pub_type: 杂志文章,评审
doi:10.1016/j.cct.2020.106106
更新日期:2020-09-01 00:00:00
abstract::Low/no-income, African American men are disproportionally burdened by chronic disease resulting from a complex interplay of systemic, sociocultural, and individual factors. These disparities are related to poverty, racism, gender role strain, high levels of stress, low levels of physical activity, and malnutritious di...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106240
更新日期:2020-12-07 00:00:00
abstract:PURPOSE:The aims of the study protocol are to investigate different adapted physical training programs in patients with advanced lung cancer undergoing palliative chemo- or radiotherapy and to evaluate their effects on physical performance, quality of life, symptom burden, and efficacy of oncologic treatment. METHODS:...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2013.11.013
更新日期:2014-01-01 00:00:00
abstract:INTRODUCTION:Robotic assistance during laparoscopic surgery for pelvic organ prolapse rapidly disseminated across the United States without level I data to support its benefit over traditional open and laparoscopic approaches [1]. This manuscript describes design and methodology of the Abdominal Colpopexy: Comparison o...
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.2012.05.007
更新日期:2012-09-01 00:00:00
abstract:OBJECTIVES:Community Health Workers (CHWs) have been recommended to reduce diabetes disparities, but few robust trials of this approach have been conducted. Limitations of prior studies include: unspecified a priori outcomes; lack of blinded outcome assessments; high participant attrition rates; and lack of attention t...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2011.10.013
更新日期:2012-03-01 00:00:00
abstract:BACKGROUND:Research demonstrates a link between migraine and obesity. Obesity increases the risk of frequent migraines and is associated with migraine prevalence among reproductive-aged women. These findings are substantiated by several plausible mechanisms and emerging evidence of migraine improvements after surgical ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2013.03.004
更新日期:2013-05-01 00:00:00
abstract::Interactive voice response (IVR) technology is a robust method of data collection that has been underutilized in behavioral medicine and clinical pharmacotherapy research. While it is clear that there is an increasing interest in this technology, published research in the medical field has not described its implementa...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2007.02.007
更新日期:2007-09-01 00:00:00
abstract:BACKGROUND:The 9-valent human papillomavirus (HPV) (9vHPV) vaccine targets the four HPV types (6/11/16/18) covered by the licensed quadrivalent HPV (qHPV) vaccine and five additional types (31/33/45/52/58). A large outcome trial of 9vHPV vaccine was conducted. METHODS:An active control (qHPV vaccine) was used because ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究
doi:10.1016/j.cct.2015.02.009
更新日期:2015-05-01 00:00:00
abstract:INTRODUCTION:Youth in disadvantaged urban areas are frequently exposed to chronic stress and trauma, including housing instability, neighborhood violence, and other poverty-related adversities. These exposures increase risk for emotional, behavioral, and academic problems and ultimately, school dropout. Schools are a p...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2019.105895
更新日期:2020-03-01 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::We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol...
journal_title:Contemporary clinical trials
pub_type: 更正并重新发布的文章,已发布勘误
doi:10.1016/j.cct.2020.106128
更新日期:2020-10-01 00:00:00
abstract::Knee osteoarthritis (OA) is a leading cause of late life pain and disability, and non-Hispanic black (NHB) adults experience greater OA-related pain and disability than non-Hispanic whites (NHWs). Recent evidence implicates psychosocial stress, cognitive-attentional processes, and altered central pain processing as co...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106159
更新日期:2020-11-01 00:00:00
abstract:OBJECTIVE:Our goal is to test the efficacy of a family-based, multi-component intervention focused on infants of African-American (AA) mothers and families, a minority population at elevated risk for pediatric obesity, versus a child safety attention-control group to promote healthy weight gain patterns during the firs...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.06.002
更新日期:2017-09-01 00:00:00
abstract::Smokers are at high risk for oral disease. As a result, they represent an important target group for population-level, public oral health promotion efforts. While dental health professionals often address smoking with their patients, no systematic efforts have been made to offer smokers an intervention to improve thei...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.04.003
更新日期:2017-06-01 00:00:00
abstract:BACKGROUND:Mindfulness-based relapse prevention (MBRP) is a method that combines cognitive behavioral relapse prevention with mindfulness practice. Research suggests that MBRP can effectively reduce withdrawal/craving in people with substance use disorder (SUD). An important part of MBRP is to practice mindfulness medi...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.04.006
更新日期:2018-07-01 00:00:00
abstract:PURPOSE:By 2020, 70% of people living with HIV in the United States will be greater than 50 years of age. As many as 37% of sexually active older people living with HIV (OPLWH) engage in HIV transmission sexual behaviors. In spite of repeated calls for secondary prevention interventions to reduce condomless sex in OPLW...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106047
更新日期:2020-08-01 00:00:00
abstract:BACKGROUND:Current guidelines recommend behavioral intervention to achieve a modest weight loss (e.g., 3-5%) as a first-line obesity treatment. Online behavioral obesity treatment, delivered via the Rx Weight Loss (RxWL) program, produces clinically significant initial weight losses. However, the program's pragmatic ut...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2019.05.003
更新日期:2019-07-01 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:BACKGROUND:Many studies on the health effects of the glycemic index (GI) are confounded by differences in the intakes of other macronutrients and fibre. Little data exist about the within- and between-subject variability of the GI. OBJECTIVE:Our objectives were therefore (i) to calculate the GI of eight commonly used ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2009.08.001
更新日期:2010-01-01 00:00:00
abstract::Traditionally, children presenting with appendicitis are referred for urgent appendectomy. Recent improvements in the quality and availability of diagnostic imaging allow for better pre-operative characterization of appendicitis, including severity of inflammation; size of the appendix; and presence of extra-luminal i...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2019.06.013
更新日期:2019-08-01 00:00:00
abstract:PURPOSE:This article describes the protocol for a Hybrid Type I cost-effectiveness and implementation study of interpersonal psychotherapy (IPT) for men and women prisoners with major depressive disorder (MDD). The goal is to promote uptake of evidence-based treatments in criminal justice settings by conducting a rando...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.01.013
更新日期:2016-03-01 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::Home-based telemedicine (HBT) is a validated method of evidence-based treatment delivery for posttraumatic stress disorder (PTSD), and justification for its use has centered on closing gaps related to provider availability and distance to treatment centers. However, another potential use of HBT may be to overcome barr...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.03.004
更新日期:2016-05-01 00:00:00
abstract:BACKGROUND:Lifelong antiretroviral therapy (ART) (Option B+) is recommended for all HIV-infected pregnant/postpartum women, but high adherence is required to maximize HIV prevention potential and maintain maternal health. Mobile health (mHealth) interventions may provide treatment adherence support for women during, an...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.03.007
更新日期:2017-06-01 00:00:00
abstract::Double-blinding is an important and widely implemented feature of clinical trials although its success is rarely assessed. In a randomized, placebo-controlled trial of tea tree oil, an aromatic essential oil, for the treatment of recurrent herpes labialis (RHL), or cold sores, deception was used to prevent volunteers ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2007.04.006
更新日期:2008-01-01 00:00:00
abstract::Recruitment of patients for clinical trials is one of the major hurdles on the way to successful completion of any human research study. Direct comparison of recruitment activity in different sites and projects is not easy due to lack of a unified measure of recruitment efficacy. The author introduces a new variable, ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2005.05.001
更新日期:2005-10-01 00:00:00