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：:This study was set up to test an ecological intervention using a pragmatic cluster randomised controlled design (RCT) aimed at increasing physical activity (PA) within the community in a deprived inner-city area in the UK. The research will provide a detailed mapping (using Graphical Information Systems GIS) of the en...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2008.03.005
更新日期：2008-09-01 00:00:00
abstract：BACKGROUND:Risk factors for cardiovascular disease (CVD) not only increase the risk for clinical CVD events, but also are associated with a cascade of neurophysiologic and neuroanatomic changes that increase the risk of cognitive impairment and dementia. Although epidemiological studies have shown that exercise and die...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2012.09.004
更新日期：2013-01-01 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：BACKGROUND:Functional dyspepsia (FD) is a common problem affecting up to 10-25% of individuals. FD accounts for significant health care costs and affects quality of life but has no definitive treatment. OBJECTIVES:The Functional Dyspepsia Treatment Trial (FDTT) aims to test whether treatment with an antidepressant (am...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2012.02.002
更新日期：2012-05-01 00:00:00
abstract：BACKGROUND:Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured muc...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2020.106177
更新日期：2020-12-01 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：:Modified Zelen's approach is a randomization technique useful in multi-center trials where balance in treatment assignments within a center is desired. It has great balancing properties in a study with equal allocation to several treatment arms. This technique can also be used in studies with unequal allocation, where...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,评审
doi：10.1016/j.cct.2011.08.006
更新日期：2011-11-01 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：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: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: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：:The Medication Adherence and BP Control Trial (ABC Trial) is a randomized, controlled, multi-site, medication adherence and blood pressure (BP) control trial in an economically disadvantaged and multi-cultural population of hypertensive patients followed in primary care practices. To date, no other such trial has been...
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.2007.01.003
更新日期：2007-07-01 00:00:00
abstract：BACKGROUND:Formation of diet and physical activity habits begins during early childhood. However, many preschool-aged children in the United States do not achieve recommendations for a nutritious diet or active lifestyle. Two important spheres of influence, home and child care, could ensure that children receive consis...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2017.11.007
更新日期：2018-01-01 00:00:00
abstract：BACKGROUND:In the past 20-30 years, the prevalence of atopic diseases, particularly among children in the Western world, has increased. It has been suggested that Western lifestyle may have reduced the overall exposure to microbial stimulation early in life. The role of the gut flora in this connection has been studied...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2006.02.009
更新日期：2006-08-01 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
abstract：BACKGROUND:Despite significant advancements in psychopharmacology, treating major depressive disorder (MDD) is still a challenge considering the efficacy, tolerability, safety, and economical costs of most antidepressant drugs. One approach that has been increasingly investigated is modulation of cortical activity with...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2010.09.007
更新日期：2011-01-01 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：:Determining the quality of a randomized clinical trial (RCT) is necessary for decision-makers to determine the believability and applicability of the trial findings. Issues that are likely to affect the utility of RCT evidence include issues of bias, random error and applicability. In this article we focus primarily o...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,评审
doi：10.1016/j.cct.2015.07.019
更新日期：2015-11-01 00:00:00
abstract：:Researchers have long sought to find combinations of cancer drugs that might achieve synergy. However, while observed in some preclinical tumor models, synergistic effects are rarely seen in clinical trials. In fact, growing evidence in clinical trial data shows that the treatment effect of most approved combination t...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2020.106126
更新日期：2020-11-01 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：: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：:Parents of young children with type 1 diabetes (T1D) experience unique, developmental challenges in managing their child's T1D, resulting in psychosocial distress. Only a small portion of young children reach glucose goals and adherence to diabetes devices that help improve T1D management have historically been low in...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2019.05.008
更新日期：2019-07-01 00:00:00
abstract：:Several randomized trials have found behavior change programs delivered via text messaging to be efficacious to improve preventive health behaviors such as physical activity and stopping smoking; however few have assessed its value in skin cancer prevention or early detection. The HealthyTexts study enrolled 678 parti...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2013.03.009
更新日期：2013-05-01 00:00:00
abstract：INTRODUCTION:Many low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aim...
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.2015.10.006
更新日期：2015-11-01 00:00:00
abstract：OBJECTIVE:Endometriosis is a chronic, estrogen dependent condition that affects 5-10% of reproductive aged women and is associated with pelvic pain and infertility. As the approach to therapy shifts from surgical ablation to pharmacological control, a non-surgical mode of diagnosis would be desirable. The ENDOmarker st...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2018.03.002
更新日期：2018-05-01 00:00:00
abstract：BACKGROUND:Bipolar Disorder (BD) is a common and severe form of mental illness. Pharmacotherapy is the main treatment offered, but has limited effectiveness, and there is increasing evidence that people with BD respond well to psychological interventions. Inequalities in access to face-to-face psychological interventio...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2012.02.011
更新日期：2012-07-01 00:00:00
abstract：:Foundational elements of lifelong health are formed during the preschool years. Child care attendance has nearly doubled in the past 5 years making child care centers an ideal setting to establish healthy habits that prevent pediatric obesity. Despite the promising evidence of efficacy of child care-based obesity prev...
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.2019.105849
更新日期：2019-11-01 00:00:00
abstract：:Pediatric primary care is an important setting in which to address obesity prevention, yet relatively few interventions have been evaluated and even fewer have been shown to be effective. The development and evaluation of cost-effective approaches to obesity prevention that leverage opportunities of direct access to f...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2013.06.017
更新日期：2013-09-01 00:00:00
abstract：INTRODUCTION:Breast cancer survivors face dual challenges: long term sequelae of treatment, and risk of recurrent disease. Obesity and a sedentary lifestyle complicate both challenges. The WISER Survivor trial assessed the effects of exercise and/or weight-loss on lymphedema, biomarkers of breast cancer recurrence, and...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2017.07.017
更新日期：2017-10-01 00:00:00
abstract：:This paper proposes a method for balancing prognostic variables between treatment and control groups in design of clinical trials. It assumes that some of prognostic variables are continuous and others are categorical and that they are independently distributed. The proposed method uses the Kullback-Leibler divergence...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2006.05.002
更新日期：2006-10-01 00:00:00
