Abstract:
:International calls for registering all trials involving humans and for sharing the results, and sometimes also the raw data and the trial protocols, have increased in recent years. Such calls have come, for example, from the Organization for Economic Cooperation and Development (OECD), the World Health Organization (WHO), the US National Institutes of Heath, the US Congress, the European Commission, the European ombudsman, journal editors, The Cochrane Collaboration, and several funders, for example the UK Medical Research Council, the Wellcome Trust, the Bill and Melinda Gates Foundation and the Hewlett Foundation. Calls for data sharing have mostly been restricted to publicly-funded research, but I argue that the distinction between publicly-funded and industry-funded research is an artificial and irrelevant one, as the interests of the patients must override commercial interests. I also argue why it is a moral imperative to render all results from all trials involving humans, also healthy volunteers, publicly available. Respect for trial participants who often run a personal and unknown risk by participating in trials requires that they--and therefore also the society at large that they represent--be seen as the ultimate owners of trial data. Data sharing would lead to tremendous benefits for patients, progress in science, and rational use of healthcare resources based on evidence we can trust. The harmful consequences are minor compared to the benefits. It has been amply documented that the current situation, with selective reporting of favorable research and biased data analyses being the norm rather than the exception, is harmful to patients and has led to the death of tens of thousands of patients that could have been avoided. National and supranational legislation is needed to make data sharing happen as guidelines and other voluntary agreements do not work. I propose the contents of such legislation and of appropriate sanctions to hold accountable those who refuse to share their data.
journal_name
Trialsjournal_title
Trialsauthors
Gøtzsche PCdoi
10.1186/1745-6215-12-249subject
Has Abstractpub_date
2011-11-23 00:00:00pages
249issn
1745-6215pii
1745-6215-12-249journal_volume
12pub_type
杂志文章相关文献
Trials文献大全abstract:BACKGROUND:Irritable bowel syndrome (IBS) is reported by one in ten of the population accounting for up to 40% of new referrals to gastroenterology outpatients. Patients characteristically have abdominal discomfort and disturbed bowel habit. Diarrhoea-predominant IBS is characterised by frequent loose stools with assoc...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-14-10
更新日期:2013-01-09 00:00:00
abstract:BACKGROUND:Autism spectrum disorder (ASD) is found in approximately 1% of the population and includes core symptoms that affect general and social development. Beside these core symptoms, it is suggested that up to 60% of children with ASD suffer from comorbid anxiety disorders which may further affect educational, soc...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2591-x
更新日期:2018-04-02 00:00:00
abstract:BACKGROUND:Nursing home residents are frequently affected by joint contractures, which impacts their participation and daily activities. A complex intervention, the Participation Enabling Care in Nursing (PECAN), was previously developed and pilot tested to address their needs. Its effectiveness and safety will be eval...
journal_title:Trials
pub_type: 杂志文章,多中心研究
doi:10.1186/s13063-019-3384-6
更新日期:2019-05-29 00:00:00
abstract:BACKGROUND:Tackling neonatal mortality is essential for the achievement of the child survival millennium development goal. There are just under 4 million neonatal deaths, accounting for 38% of the 10.8 million deaths among children younger than 5 years of age taking place each year; 99% of these occur in low- and middl...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-11-58
更新日期:2010-05-17 00:00:00
abstract:BACKGROUND:Trials of complex interventions are associated with high costs and burdens in terms of paperwork, management, data collection, validation, and intervention fidelity assessment occurring across multiple sites. Traditional data collection methods rely on paper-based forms, where processing can be time-consumin...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-016-1674-9
更新日期:2016-11-17 00:00:00
abstract:BACKGROUND:Research shows that more than half of the people taking medication for a chronic condition are non-adherent. Nonadherence hinders disease control with a burden on patient quality of life and healthcare systems. We developed a tool that provides insight into nonadherence risks and barriers for medication-adhe...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-016-1393-2
更新日期:2016-06-03 00:00:00
abstract:BACKGROUND:Despite the promise and popularity of advance care planning, there is insufficient evidence that advance care planning helps patients to meet their end-of-life care preferences, especially in Asian settings. Thus, the proposed study aims to assess whether patients with advanced heart failure who are receivin...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-016-1414-1
更新日期:2016-06-10 00:00:00
abstract:BACKGROUND:Evidence for benefit of high positive end-expiratory pressure (PEEP) is largely lacking for invasively ventilated, critically ill patients with uninjured lungs. We hypothesize that ventilation with low PEEP is noninferior to ventilation with high PEEP with regard to the number of ventilator-free days and bei...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2640-5
更新日期:2018-05-09 00:00:00
abstract:BACKGROUND:Medically unexplained symptoms (MUS) are highly prevalent and pose a burden both on patients and on health care. In a pilot study psychosomatic therapy delivered by specialised therapists for patients with MUS showed promising results with regard to patient's acceptability, feasibility and effects on symptom...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3913-3
更新日期:2019-12-09 00:00:00
abstract:BACKGROUND:Post-stroke depression (PSD) is the most common psychiatric complication after a stroke. The most frequently used antidepressants are selective serotonin receptor inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs), however, these exhibit a series of side effects. Traditional Chin...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2633-4
更新日期:2018-05-10 00:00:00
abstract:BACKGROUND:Bone microarchitecture is a significant determinant of bone strength. So far, the assessment of bone microarchitecture has required bone biopsies, limiting its utilization in clinical practice to one single skeletal site. With the advance of high-resolution imaging techniques, non-invasive in vivo measuremen...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-9-19
更新日期:2008-04-13 00:00:00
abstract:BACKGROUND:Individuals with spinal cord injuries (SCI) are prone to pressure ulcers (PUs) because of the loss of sensorimotor function involved as well as increased skin moisture. Treatment of PU after SCI is complicated, involving different specialties and with need for long-lasting follow-up. This study should identi...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3185-y
更新日期:2019-01-24 00:00:00
abstract:BACKGROUND:Maternal and perinatal mortality are major problems for which progress in sub-Saharan Africa has been inadequate, even though childbirth services are available, even in the poorest countries. Reducing them is the aim of two of the main Millennium Development Goals. Many initiatives have been undertaken to re...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-10-85
更新日期:2009-09-18 00:00:00
abstract:BACKGROUND:Glaucoma is a chronic eye disease associated with irreversible visual loss. In Africa, glaucoma patients often present late, with very advanced disease. One-off procedures, such as laser or surgery, are recommended in Africa because of lack of or poor adherence to medical treatment. However, acceptance of su...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-149
更新日期:2014-04-29 00:00:00
abstract:BACKGROUND:Depression Care for People with Lung Cancer is a complex intervention delivered by specially trained cancer nurses, under the supervision of a psychiatrist. It is given as a supplement to the usual care for depression, which patients receive from their general practitioner and cancer service. The third Sympt...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-10-92
更新日期:2009-09-30 00:00:00
abstract:BACKGROUND:Delirium prevalence in the intensive care unit (ICU) is high. Numerous psychotropic agents are used to manage delirium in the ICU with limited data regarding their efficacy or harms. METHODS/DESIGN:This is a randomized controlled trial of 428 patients aged 18 and older suffering from delirium and admitted t...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-12-139
更新日期:2011-06-06 00:00:00
abstract:BACKGROUND:The per-protocol effect is the effect that would have been observed in a randomized trial had everybody followed the protocol. Though obtaining a valid point estimate for the per-protocol effect requires assumptions that are unverifiable and often implausible, lower and upper bounds for the per-protocol effe...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-1056-8
更新日期:2015-11-30 00:00:00
abstract:BACKGROUND:A commonly reported problem with the conduct of multicentre randomised controlled trials (RCTs) is that recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. The aim of this study was to ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-7-9
更新日期:2006-04-07 00:00:00
abstract:BACKGROUND:Postpartum haemorrhage (PPH) is a major cause of maternal morbidity. Bleeding is caused by a combination of physical causes, such as failure of the uterus to contract or operations, and is made worse by impairment of the blood clotting system. A number of studies have shown that low levels of the blood clott...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0670-9
更新日期:2015-04-17 00:00:00
abstract:BACKGROUND:There are more than a quarter of a million individuals aged ≥ 65 years who are resident in care homes in England and Wales. Care home residents have high levels of cognitive impairment, physical disability, multimorbidity and polypharmacy. Research is needed to ensure there are robust, evidence-based interve...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-018-2915-x
更新日期:2018-10-03 00:00:00
abstract:BACKGROUND:Most people who stop smoking successfully for a few weeks will return to smoking again in the medium term. There are few effective interventions to prevent this relapse and none used routinely in clinical practice. A previous exploratory meta-analysis suggested that self-help booklets may be effective but re...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-13-69
更新日期:2012-05-30 00:00:00
abstract:BACKGROUND:Multiple pregnancies are one of the major safety concerns of in vitro fertilization (IVF) due to the increased risk of maternal and neonatal complications. Single embryo transfer is the most effective way to reduce the risk of multiple pregnancies. Selection of the embryo and optimization of the implantation...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-017-1993-5
更新日期:2017-06-05 00:00:00
abstract:BACKGROUND:The application of artificial intelligence (AI) in healthcare is an area of immense interest. The high profile of 'AI in health' means that there are unusually strong drivers to accelerate the introduction and implementation of innovative AI interventions, which may not be supported by the available evidence...
journal_title:Trials
pub_type: 信件
doi:10.1186/s13063-020-04951-6
更新日期:2021-01-06 00:00:00
abstract:BACKGROUND:Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality worldwide. In Denmark 2% of parturients receive blood transfusion. During the course of bleeding fibrinogen (coagulation factor I) may be depleted and fall to critically low levels, impairing haemostasis and thus worsening the ongoing...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-13-110
更新日期:2012-07-17 00:00:00
abstract:BACKGROUND:Attention-deficit hyperactivity disorder (ADHD) is a mental disorder beginning in childhood, and about half of patients have symptoms lasting into adulthood. Adult ADHD causes various impairments of emotional, self-esteem, and executive function and life quality aspects. Furthermore, adverse outcomes include...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0686-1
更新日期:2015-04-14 00:00:00
abstract:BACKGROUND:Three decades of research suggests that prevention of iron deficiency anemia (IDA) in the primary care setting may be an unrealized and unique opportunity to prevent poor developmental outcomes in children. A longitudinal study of infants with IDA showed that the developmental disadvantage persists long term...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-015-0635-z
更新日期:2015-04-02 00:00:00
abstract:BACKGROUND:It is reported that nursing is one of the most vulnerable jobs for developing depression. While they may not be clinically diagnosed as depressed, nurses often suffer from depression and anxiety symptoms, which can lead to a low level of patient care. However, there is no rigorous evidence base for determini...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-015-0554-z
更新日期:2015-01-31 00:00:00
abstract:BACKGROUND AND AIMS:The standard whole-colon tests used to investigate patients with symptoms of colorectal cancer are barium enema and colonoscopy. Colonoscopy is the reference test but is technically difficult, resource intensive, and associated with adverse events, especially in the elderly. Barium enema is safer bu...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-8-32
更新日期:2007-10-27 00:00:00
abstract:BACKGROUND:Immunologic derangement may be the critical pathophysiologic mechanism in sepsis, and immunotherapy might be a potential new treatment. Si-ni-tang (SNT), an ancient Chinese herbal formula documented in Shanghan Lun, has been used for treating severe sepsis for thousands of years. Research shows that it may h...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3646-3
更新日期:2019-08-28 00:00:00
abstract:BACKGROUND:Sharing interim results by the Data Safety Monitoring Board (DSMB) with non-DSMB members is an issue that can affect trial integrity. It is unclear what should be shared. This study assesses the views of professionals to understand what interim information should be shared at interim, with whom and why. MET...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2655-y
更新日期:2018-05-21 00:00:00