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Alliance for Clinical Trials in Oncology (Alliance) coordinated trials utilize Medidata Rave® (Rave) as the primary clinical data capture system. A growing number of ... and complex cancer care delivery research ...
Despite the problem of inadequate recruitment to randomised trials, there is little evidence to guide researchers on decisions about how people are effectively recruited to take part in trials. The PRioRiTy st...
The Commentary to this article has been published in Trials 2018 19:584
The Alliance for Clinical Trials in Oncology (Alliance) trial A191901 is an ongoing, four-arm ( ... plus MI, or enhanced usual care) randomized clinical trial that tests the efficacy and effect of ... the Pillsy ...
One of the top three research priorities for the UK clinical trial community is to address the gap in evidence-based approaches to improving participant retention in randomised trials. Despite this, there is l...
Acute myeloid leukemia (AML) is the most common acute leukemia in adults and has an unacceptably low cure rate. In recent years, a number of new treatment strategies and compounds were developed for the treatment...
This study will implement a multilevel intervention with patient and clinician components as a NCORP Cancer Care Delivery Research (CCDR) trial within the Alliance for Clinical Trials in Oncology Research Base (Alliance
The stratified model of care has been an effective approach for the treatment of low back pain. However, the treatment of patients with low risk of psychosocial-factor involvement is unclear. The addition of t...
Motivation and a therapeutic alliance are crucial for successful therapy. It is assumed that dogs can increase motivation and help support therapeutic relationships. This is one of the reasons for including do...
Prioritisation of clinical trials ensures that the research conducted meets the needs of stakeholders, makes the best use of resources and avoids duplication. The aim of this review was to identify and critica...
Couple relationship distress is common and associated with poor physical, psychological, and relational outcomes for both partners. Emotionally Focused Therapy for couples (EFT) is a short-term structured appr...
This article is part of a Supplement: Volume 18 Supplement 1
The Correction to this article has been published in Trials 2018 19:99
The translation of evidence from clinical trials into practice is complex. One approach to ... translation is to consider the ‘implementability’ of trials as they are designed and conducted. Implementability of trials
Clinical trial evidence underpins evidence-based medicine and the improvement of healthcare worldwide. In Australasia, a significant proportion of clinical trials are conducted by geographically dispersed and ...
This article is part of a Supplement: Volume 20 Supplement 1
Rotavirus is a primary infectious virus causing childhood diarrhoea and is associated with significant mortality in children. Three African countries (Nigeria, the Democratic Republic of Congo, and Angola) are...
The Editor has invited me to mark the occasion with a few words “on the development and/or impact of randomised trials over the last decade, or perhaps some thoughts about the future.” I do so here by citing s...
Cognitive behavioural therapy (CBT) has been found to be effective in reducing fatigue severity in MS patients directly following treatment. However, long-term effects are inconsistent leaving room for improve...
The improvement of psychological treatments for depression in young adults is a pressing issue highlighted in the literature. Its relevance is determined not only because young adults are underrepresented in r...
The IREM-Freq trial is an international multicenter randomized clinical trial conducted in mental healthcare centers across Australia, ... . Process measures include memory, learning, therapeutic alliance, motiva...
Clinical Trial Networks in which trialists work collaboratively enable multi-site, large-scale, high-quality clinical trials to be efficiently run. Although the benefits of Clinical Trial Networks are largely kno...
The investigation of mindfulness-based interventions (MBIs) in cognitive-behavioral therapy has greatly increased over the past years. However, most MBI research with youth focuses on structured, manualized gr...
Continuous feedback on patient improvement and the therapeutic alliance may reduce the number of dropouts and ... There are, however, only three published randomized trials on the effect of feedback on the ... in...
Growing use of cloud computing in clinical trials prompted the European Clinical Research Infrastructures Network, a European non-profit organisation established to support multinational clinical research, to ...
We assessed the prevalence, and potential impact of, trials of pharmacological agents for acute stroke that were completed but not published in full. Failure to publish trial data is to be deprecated as it set...
Major depressive disorder (MDD) is a leading cause of disease morbidity. Combined treatment with antidepressant medication (ADM) plus psychotherapy yields a much higher MDD remission rate than ADM only. But 77...
Evidence generated from partnering with parents to design and conduct research together may be used to refine, adjust, and modify future research approaches. This study aimed to describe the initial approaches...
New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional r...
People with psychosis have high rates of trauma, with a post-traumatic stress disorder (PTSD) prevalence rate of approximately 15%, which exacerbates psychotic symptoms such as delusions and hallucinations. Pi...
Interventional clinical studies conducted in the regulated drug research environment are designed using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E6 (R2) Good Clinical Pr...
Poor recruitment to, and retention in, clinical trials is a source of research waste that could be reduced by more informed choices about participation. Barriers to effective recruitment and retention can be w...
Routinely collected electronic health records (EHRs) have the potential to enhance randomised controlled trials (RCTs) by facilitating recruitment and follow-up. Despite this, current EHR use is minimal in UK ...
Given the complex nature of opioid addiction treatment and the rising number of available opioid substitution and antagonist therapies (OSAT), there is no ‘gold standard’ measure of treatment effectiveness, an...
Hundreds of youth psychotherapy randomized trials have generated scores of helpful empirically supported treatments (ESTs). However, the standardized structure of many ESTs and their focus on a single disorder...
Impairment in social functioning is a key component of personality disorder. Therefore psycho-education and problem solving (PEPS) therapy may benefit people with this disorder. Psycho-education aims to educat...
It has been demonstrated that cognitive behavioural therapy (CBT) has a moderate effect on symptom reduction and on general well being of patients suffering from psychosis. However, questions regarding the spe...
Despite being preventable, suicide is a leading cause of death and a major global public health problem. For every death by suicide, many more suicide attempts are undertaken, and this presents as a critical r...
The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to...
Obsessive-compulsive disorder (OCD) is a debilitating psychiatric disorder which affects up to 3% of children and adolescents. OCD in children and adolescents is generally treated with cognitive behavioural th...
Increasingly, it is argued that clinical trials struggle to recruit participants because they do not respond to key questions or study treatments that patients will be willing or able to use. This study explor...
This trial is an investigator-initiated single-center randomized clinical superiority trial of short-term (20 weeks) compared ... personality functioning, attachment, borderline symptoms, group alliance, and ment...
The Update to this article has been published in Trials 2021 22:497
Urologic chronic pelvic pain syndrome (UCPPS) encompasses several common, costly, diagnoses including interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome that are p...
There is a lack of high-quality evidence underpinning many contemporary clinical practice guidelines embedded in the healthcare systems, leading to treatment uncertainty and practice variation in most medical ...
Depression is estimated to become the leading cause of disease burden globally by 2030. Despite existing efficacious treatments (both medical and psychotherapeutic), a large proportion of patients do not respo...
This article provides a description of the rationale, design, and methods of a multisite clinical trial which evaluates the potential benefits of an evidence-based psychosocial treatment, STAIR Narrative Thera...
Psychotherapy is highly effective and widely acknowledged for treating various mental disorders. Nevertheless, in terms of methods for teaching effective psychotherapeutic approaches and competencies, there ha...
Patient and public involvement is increasingly common in trials, but its quality remains variable in a lot of settings. Many key decisions in trials involve numbers, but patients are rarely involved in those d...
Major depression is a common mental disorder that substantially impairs quality of life and has high societal costs. Although psychotherapies have proven to be effective antidepressant treatments, initial resp...
Psychodynamic psychotherapy is frequently applied in the treatment of social phobia. Nevertheless, there has been a lack of studies on the transfer of manualized treatments to routine psychodynamic practice. O...
This article is part of a Supplement: Volume 14 Supplement 1
Treatment guidelines recommend behaviour therapy (BT) for patients with Tourette syndrome (TS) and chronic tic disorder (CTD). However, BT is rarely accessible due to limited availability of trained therapists...
The Correction to this article has been published in Trials 2022 23:541
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