On May 20, 1747, James Lind pioneered a scurvy trial on board the HMS Salisbury. Providing some crew members with two oranges and one lemon per day, while others were given cider, vinegar, sulphuric acid or seawater, along with their normal rations, Lind’s experiment is ranked as one of the first clinical trials in the history of medicine. More than 250 years later, the anniversary of his groundbreaking work is celebrated as International Clinical Trials Day. Held annually by the National Institute of Health Research, the principles of Lind’s work still form the basis of modern clinical trials.
In a commentary for Trials, Dr David Sackett offers his perspective on more recent developments in clinical …
International Clinical Trials Day is celebrated around the world on the 20 May to commemorate the day in 1747 when James Lind started one of the very first trials in history. It provides an opportunity to raise awareness about the importance of clinical research in healthcare and to encourage involvement in clinical trials. It is timely that the recently created Health Research Authority (HRA) – whose mission is ‘to protect and promote the interests of patients and the public in health research’ - has announced its plans to increase transparency and reporting of clinical trials in the UK.
BioMed Central welcomes the HRA proposals ‘to make the registration of clinical trials within an agreed timeframe a condition of ethics …
The decrease in cost and increase in efficiency of genome-scale studies means we can enjoy fast-paced generation of genomic data. In the clinic, this growth has attracted a lot of attention and many randomized clinical trials are using genomic data. During the course of a particular trial, clinicians may stumble upon genetic findings that could have health implications, but which are of no interest to the investigation in progress – so called incidental findings. The return of these incidental findings to patients has important ethical and practical considerations, but the fast pace in the genomics field has not been matched by the publication of recommendations on how best to handle them.
The Genomics and Randomized Trials Network (GARNET) analyzes …
The introduction of digital object identifiers (DOIs) to all ISRCTN records in the Current Controlled Trials database, announced today, is an essential part of achieving the aims of the Threaded Publications initiative – making the medical literature more transparent and better connected.
Prospective trial registration should be the first step in transparently disseminating all scientifically relevant information about a clinical trial. Trials can be very expensive to carry out, involve large numbers of subjects and investigators, and generate large amounts of data potentially constituting several scientific articles. The articles from the third International Stroke Trial are a case in point. But unfortunately many clinical trial-related articles are not published, leading to bias in …
Current Controlled Trials (CCT) has introduced digital object identifiers (DOIs) to all ISRCTN records. DOIs issued by the organisation CrossRef are unique alphanumeric ID assigned to a digital object, such as an electronic journal, article, report, thesis or a clinical trial record. A DOI serves as a stable, persistent link to the full-text of an electronic item on the internet. The journal or article website address can change over time but a DOI is permanent. DOIs are widely used by academic publishers for helping to ensure the permanence, discoverability and citability of scholarly content published on the web.
A trial ID such as the ISRCTN uniquely identifies a clinical trial. Introduction of a DOI (made …
BioMed Central in collaboration with an Ottawa-based researcher has received the Committee on Publication Ethics (COPE) research grant for a timely project which aims to facilitate wider sharing of clinical research data.
In the last few weeks GlaxoSmithKline and Medtronic have made public commitments to share data from clinical trials they have sponsored, the BMJ have strengthened their policy on data sharing for clinical trial submissions, and Ben Goldacre‘s latest book, Bad Pharma, is causing something of a stir. These are significant and much-needed developments in transparency in clinical research.
Researchers working with human subjects are amongst the least likely to share their data, and the practicalities and legalities of sharing clinical data while …
A new Current Controlled Trials (CCT) advisory board has been appointed as of October 2012, whom we are looking forward to working with on guiding the future development of our trial registration and related publishing services.
Some members have been helping us promote and improve the quality of prospective clinical trial registration for many years:
Gerd Antes (German Cochrane Centre), Maurizio Bonati (Mario Negri Institute for Pharmacological Research), Kay Dickersin (Johns Hopkins Bloomberg School of Public Health), Jeffrey Drazen (New England Journal of Medicine), Richard Lilford (University of Birmingham), Elizabeth Wager (Publications consultant) and we thank them for their past contributions, and for renewing their commitment to the service.
Also, we welcome new members who are specialists …
Authors of study protocols in Systematic Reviews are now entitled to a 20% discount on the article processing charge (APC) for publication of the results of the same systematic review in the journal.
Publication – and public registration in PROSPERO – of information about proposed or ongoing systematic reviews is increasingly common, and Systematic Reviews regularly publishes protocols.
To encourage authors to report the results of their research regardless of the outcome – whether positive, negative or no difference – we offer an APC discount on publication in a number of journals.
Financial incentives for transparent reporting of all components of a research project are one part of BioMed Central’s Threaded Publications initiative. See our protocol publication …
The UK Clinical Trials Gateway (UKCTG) launched in 2011 and is an initiative from the Department of Health. UKCTG is supported by BioMed Central and Current Controlled Trials and is designed to provide easy to understand information about clinical trials running in the UK. The trial data are sourced from the ISRCTN register and ClinicalTrials.gov. To improve patient care and encourage participation in future clinical trials, it is crucial that the potential participants are aware of research relevant to them. All trial records on the UKCTG have a dedicated lay summary field to include a plain English summary. The UKCTG has been striving to make the clinical trial …
The first edition of the Current Controlled Trials quarterly newsletter was published in April 2012, and we hope that our users find this newsletter informative. If you missed it, you can register to receive future editions. We encourage you to share these updates with friends and colleagues and to send any feedback you may have on the current issue or on content that you would like to see in future issues.
The ISRCTN register works closely with the Department of Health and has been involved in a national initiative, ‘UK Clinical Trials Gateway (UKCTG)’, which aims to bring clinical trials to the attention of …