AD is the most common form of dementia in older people and is characterized by behavioral disorders and a progressive decline in memory function. Genetic studies have provided the best evidence for cause and effect relationships in AD, and recent years have seen tremendous progress in genetics technology to allow for full individualized genomic screening across populations and within individuals.

Examples of the advances include identification of mutations in APP, PSEN1 and PSEN2 genes, which provided a link to the characteristic amyloid plaques seen in AD brains and supported the amyloid cascade hypothesis. Also, ...

Read more]]> This week is the Alzheimer’s Society’s Dementia Awareness Week and Alzheimer’s Research & Therapy is talking about the impact of genetic variants on Alzheimer’s disease (AD).

AD is the most common form of dementia in older people and is characterized by behavioral disorders and a progressive decline in memory function. Genetic studies have provided the best evidence for cause and effect relationships in AD, and recent years have seen tremendous progress in genetics technology to allow for full individualized genomic screening across populations and within individuals.

Examples of the advances include identification of mutations in APP, PSEN1 and PSEN2 genes, which provided a link to the characteristic amyloid plaques seen in AD brains and supported the amyloid cascade hypothesis. Also, studies of the apolipoprotein E (APOE) gene indicated that mutations of the ε4 allele are responsible for approximately one-third of the population-attributable risk for the disease.

Very recently, two large consortiums demonstrated that rare variants in the TREM2 gene (a type 1 membrane receptor protein primarily expressed on microglia in the central nervous system that has been shown to regulate phagocytosis and activation of monocytes) confers significant risk for AD. The association of TREM2 variants with AD highlights innate immunity’s role as a significant factor in AD pathogenesis.

In a new review published today for Alzheimer’s Research & Therapy, Editor-in-Chief Todd Golde highlights TREM2’s importance: “With the spotlight firmly placed on TREM2’s role in AD, research advances will likely be quite rapid, and the emerging data will likely enable a more unified understanding of the function of innate immune signalling in AD.

TREM2 never reached genome-wide significance in the published genome-wide association studies. Thus, combining biological inference with whole exome or whole genome sequencing strategies is likely to yield a treasure chest of novel genetic variants in innate immune signalling factors that influence risk for AD. Hopefully, these will not only tell us more about AD pathogenesis, but will also reveal tractable therapeutic targets”

Continue the discussion – comment on this blog post or contact the Editorial Office at editorial@alzres.com

For more information on Alzheimer’s Research & Therapy, or to submit a manuscript, please visit the journal website or contact the Editorial Office. To access all subscription content, including peer-reviewed reviews, commentaries and debates, register for a free online trial to the journal. To keep up to date with the latest articles published in the journal, sign up for Article Alerts and follow us on twitter.

Read more]]> Clinical oncology in Western countries is currently characterized by preventative programs (which include early diagnosis), combined treatments (radio-chemo-surgery), reconstructive surgery, and, more recently, by tailored treatment with monoclonal antibodies or specific inhibitors based on newly identified cancer biomarkers. Clinical oncology in the rest of the world, which represents 85.3% of the Earth’s population, has different priorities, strategies and aims, which are often difficult to compare. Major differences are not only due to the different socio-economical conditions and the national health programs, but also to disparities in cancer burden and their etiopathogenesis, as well the population-based genetic susceptibility. A further major difference is the age-distribution of the population. In the Western world, the population is very much aged, with people aged 65 and over representing 13.5% of the total in USA, 16.4 in Canada and 17.9% in Europe in 2013. On the contrary, in Africa and Asia, which together hold 60% of the total global population, over-65s represent less than 3% or less than 8%, respectively. For these reasons it is critical to highlight the clinical oncology peculiarities of those non-Western regions and let colleagues share their experiences, describe their strategies and express their opinions.

Within the global oncology field, a peculiar position is held by the African countries. Besides the young age of the population, the tropical climate, limited presence of environmental/chemical carcinogens and presence of wild animals determine the occurrence of specific diseases and infections. The factors contribute to a peculiar pattern of cancers, including Burkitt lymphoma and Kaposi’s sarcoma, which have been considered paradigmatic of those regions. Changes in the socio-economical settings and, in particular, the urbanization of an ageing population with later marriages and fewer pregnancies, exposure to chemical carcinogens and a better control of infections are heavily contributing to a new pattern of cancers. The African oncological community must rapidly adapt to the changes, taking advantage of their Western colleagues’ experiences, who could at the same time learn from these changes.

It is for these reasons that Infectious Agents & Cancer is launching a new ‘Clinical Oncology’ section. Edited by Serigne Magueye Gueye and Jan B. Vermorken, this will represent an opportunity to share experiences and information among worldwide oncologists and to identify and develop diagnostic, as well as therapeutic protocols, that are globally valid in the current community. The section will also feature a subsection on African cancers, edited by Henry Wabinga and Twalib Ngoma, which will allow African oncologists to describe the current oncology issues along with their findings/achievements for those “tropical” cancers, such as EBV-related Burkitt lymphoma and schistosomiasis-related bladder cancer, that are considered rare in the rest of the world.

Please submit your manuscript to the section via the online submission system for the journal. Before submitting your manuscript, please read the ‘Instructions for authors’. Please direct any questions regarding journal selection or the series in general to editorial@infectagentscancer.com.

Dr Scheltens is Professor of Cognitive Neurology and Director of the Alzheimer Centre at the VU University Medical Centre in Amsterdam, which he founded in 2000. Dr Scheltens is active in the field of biomarkers and clinical trials, with his main clinical and research interests including Alzheimer’s disease, vascular dementia, frontotemporal dementia, ...

Read more]]> We are delighted to welcome Dr Philip Scheltens to his new position as one of the Editors-in-Chief of Alzheimer’s Research & Therapy, joining Dr Douglas Galasko (University of California, San Diego, USA) and Dr Todd Golde (University of Florida, USA). Dr Scheltens is replacing Dr Gordon Wilcock (University of Oxford, UK), who is stepping down from this role after many valuable years of guidance as Editor-in-Chief.

Dr Scheltens is Professor of Cognitive Neurology and Director of the Alzheimer Centre at the VU University Medical Centre in Amsterdam, which he founded in 2000. Dr Scheltens is active in the field of biomarkers and clinical trials, with his main clinical and research interests including Alzheimer’s disease, vascular dementia, frontotemporal dementia, magnetic resonance imaging, PET imaging and biomarkers.

This wide-ranging research knowledge compliments Dr Galasko’s and Dr Golde’s expertise, and we are looking forward to working with Dr Scheltens to continue the success and growth of the journal.

Dr Scheltens commented, “I am excited to join my esteemed colleagues to lead the journal. The field of Alzheimer’s disease is going through a very interesting and exciting phase and the journal is rightly positioned to make some important contributions to this field.”

As a major forum for translational research into Alzheimer’s dementia and other neurodegenerative diseases, Alzheimer’s Research & Therapy is dedicated to publishing international peer-reviewed articles at the forefront of scientific breakthroughs in this field. The journal is affiliated to Alzheimer’s Disease International and the Editors-in-Chief are supported by a world-renowned Editorial Board.

The journal will be receiving its first Thomson Reuters (ISI) Impact Factor next month. In addition to the bibliographic databases that articles published in Alzheimer’s Research & Therapy are currently included, such as CAS, Embase, PubMed, PubMed Central and Scopus, the journal will also be indexed in Science Citation Index Expanded, Journal Citation Reports and Current Contents.

For more information on Alzheimer’s Research & Therapy, or to submit a manuscript, please visit the journal website or contact the Editorial Office. To keep up to date with the latest articles published in the journal, sign up for Article Alerts and follow us on twitter.

Annals of Occupational and Environmental Medicine (AOEM), edited by Professor Sang Baek Ko and supported by an expert editorial board,  is an open access, peer-reviewed, online journal that considers original contributions related to the field of occupational and environmental medicine.

“It is ...

Read more]]> Today marks the launch of Annals of Occupational and Environmental Medicine, the first Korean society journal to be published by BioMed Central. It is the official journal of the Korean Society of Occupational and Environmental Medicine (KSOEM) and is the successor of Korean Journal of Occupational and Environmental Medicine.

Annals of Occupational and Environmental Medicine (AOEM), edited by Professor Sang Baek Ko and supported by an expert editorial board,  is an open access, peer-reviewed, online journal that considers original contributions related to the field of occupational and environmental medicine.

“It is vitally important that occupational and environmental medicine researchers and professionals have an international forum through which they can share their work and experiences,” noted Professor Yangho Kim, the President of KSOEM, in his congratulatory message,  “especially when such information could help save or improve lives.”

AOEM is aimed at clinicians and researchers in the wide-ranging discipline of occupational and environmental medicine. The journal covers topics relating to the interactions between work and health, including, subjects like occupational and environmental epidemiology, toxicology, hygiene, diagnosis & treatment of diseases, management, organization and policy.

All articles and the launch editorial from the Editor-in-Chief are now available online. Visit the journal’s website and sign up for article alerts.

It’s commonly discussed how each of our genomes contains a story documenting the migration by our ancient ancestors.  This is most certainly true in that it is apparent we all originated from Africa and migrated to other continents from there. A study published today in Investigative Genetics proposes that some of the genetic diversity we commonly assume to be ancient may in fact be due to recent demographic events within the last 2000 years.

This study analyzed single nucleotide polymorphisms (SNPs) in 999 individuals at 54 sites across the Netherlands. The authors studied this population in the expectation that the ancient genetic signatures from Paleolithic and Neolithic times, such as the Southeast to Northwest cline observed across Europe, ...

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It’s commonly discussed how each of our genomes contains a story documenting the migration by our ancient ancestors.  This is most certainly true in that it is apparent we all originated from Africa and migrated to other continents from there. A study published today in Investigative Genetics proposes that some of the genetic diversity we commonly assume to be ancient may in fact be due to recent demographic events within the last 2000 years.

This study analyzed single nucleotide polymorphisms (SNPs) in 999 individuals at 54 sites across the Netherlands. The authors studied this population in the expectation that the ancient genetic signatures from Paleolithic and Neolithic times, such as the Southeast to Northwest cline observed across Europe, would not be detectable in the contemporary Dutch gene pool.

After analysis, the results demonstrated a subtle but very apparent genetic substructure across the country, dividing the population into four main genetic groups, and resembling the variation across Europe. Further to this, the observed pattern clearly correlated with geological and archaeological records for genetic discontinuities within the country. The authors therefore concluded that it is much more likely that this pattern in the gene pool was due to recent population movements.

The findings from this study suggest it is important for future genetic epidemiology studies that we clarify the contributions of both ancient and recent events to genetic diversity in populations. If further research were to confirm that recent demographic events are responsible for genetic diversity, this could provide useful investigative information to help profile unknown individuals in forensics, and also change the way we currently look at population genetics.

You can read the full article on the website, where you can also sign up for article alerts from the journal. For more information on Investigative Genetics, or to submit a manuscript, please visit the journal website or contact the Editorial Office.

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 ...

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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 trials, evaluating the changes that have taken place over the last decade, and contemplating the future of trial practice. One noticeable change, Dr Sackett notes, is that patients are becoming ever more informed and demanding: ‘Patient groups are increasingly holding trialists’ feet to the fire and forcing us to honour our obligations to them and their diseases, illnesses, predicaments, and other patient-relevant outcomes, rather than focusing only on our interests and those of the drug and device industries.’ The commentary also highlights the growing number of trials conducted in the developing world by trialists hailing from those regions, and the higher levels of recognition this research is receiving.

The  future of clinical trials looks positive, not least in the way trial results are used. Just as registering clinical trials has become the norm, there are calls for the publication of all trial results (regardless of outcome) to be an established practice. The AllTrials initiative, launched in January 2013, is gathering pace, gaining support from the European Medical Agency, many patient groups, and ‘big pharma’ giants, most notably GlaxoSmithKline which is now dedicated to releasing all of its trial results online. The shift towards publication of all results is an important one in the eyes of many researchers. A combination of journals dedicating publication space to more interesting positive findings, and reticence on the part of researchers to publish unwelcome results has led to publication bias and a wider distrust among doctors and patients as to whether the interventions they are prescribing and taking are really the best for the patient.  In a Q&A with Biome, the new online magazine from BioMed Central, Dr Ben Goldacre a co-founder of the AllTrials initiative, discusses the campaign, and how it can dramatically change the landscape of trial reporting. Dr Goldacre comments that ‘doctors, patients, payers, and researchers need access to all the results, of all the trials that have been conducted on a treatment, in order to make informed decisions about which is best. The idea that trial results should be withheld is ludicrous, it simply breaks evidence based medicine, and exposes the medical profession to justified mockery.’

The shift towards publication of all results can be seen as part of a wider move towards making research more available to an increasingly educated public, as well as those researchers and clinicians that directly use results from such research.  Last year, the UK government commissioned the Finch report, which advised parliament to demand that all research funded by public money be published as either ‘green’ or ‘gold’ open access. Universities and science minister, David Willets, promptly made the announcement that £10 million would be earmarked to aid the introduction of such a policy.

As a pioneer of open access, BioMed Central has seen the benefits that opening up research can bring. Tapping into the need for more transparency in clinical trails, the journal Trials and all other BioMed Central journals that publish trials and trial protocols, demand that authors register their clinical trials as a condition of submission. To that end, BioMed Central runs Current Controlled Trials on the behalf of ISRCTN, the UK’s trial registration service. To date, the register holds records of over 11,500 trials. BioMed Central also welcomes the HRA proposals ‘to make the registration of clinical trials within an agreed timeframe a condition of ethics approval’ and ‘to work with publishers to dispel the myths and perceptions about the difficulties in publishing results’.

The publication of negative results is gaining more attention among researchers, and trialists in particular. Trials journal supports the publication of negative results, alongside Journal of Negative Results, established for the sole purpose of publishing unexpected results, or results that go against the current understanding.

Today, billions of people across the globe will take drugs  – from paracetamol tablets to anti retrovirals – that are life saving and life enhancing, and that have all been through a lengthy process of intense testing. Over a quarter of a millennium researchers have refined this process, and continue to do so today, ensuring that the work James Lind began on the HMS Salisbury endures.

Female strawberry poison dart frogs can be non-choosy when it comes to finding a mate concludes research published in Frontiers in Zoology today. In a population with a strongly biased sex ratio and low trait variance between males, females receive no benefit from expending energy and  effort  searching out the ‘fittest’ mate. Instead they lose no time in seeking out the male in the closest proximity as a partner.

Ivonne Meuche, from the University of Veterinary Medicine Hannover, and her team continuously observed mating behaviour of 20 female Oophaga pumilio frogs, during the time period between two successive ovipositions. In parallel, they measured surrounding males’ behaviour and spatial distribution in order to establish what was important ...

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Female strawberry poison dart frogs can be non-choosy when it comes to finding a mate concludes research published in Frontiers in Zoology today. In a population with a strongly biased sex ratio and low trait variance between males, females receive no benefit from expending energy and  effort  searching out the ‘fittest’ mate. Instead they lose no time in seeking out the male in the closest proximity as a partner.

Ivonne Meuche, from the University of Veterinary Medicine Hannover, and her team continuously observed mating behaviour of 20 female Oophaga pumilio frogs, during the time period between two successive ovipositions. In parallel, they measured surrounding males’ behaviour and spatial distribution in order to establish what was important to females when choosing a male to mate with.  In most lek mating systems, where a number of males are present and thereby may compete for female attention, females will chose males based on heritable traits or assumed parenting skills. However, Meuche found that in this population, there was no correlation between mating success of a given male and any physical or acoustic trait measured, or territory size. Unusually, in this system, females selected males purely based on proximity.

The function of male display characteristics and behaviours is a well discussed topic of research for behavioural and evolutionary biologists. This study demonstrates an interesting example of an unusual female sampling tactic whereby females will  accept the closest male as a mate. The authors suggest that in this system, this is an optimum tactic due to low fecundity and low benefits of intensive mate sampling – hence there is little to gain by being a picky female. Further investigation is required to discover whether all strawberry poison dart frogs show these levels of indifference towards their mate choices.

Read more]]> Mental health is a tricky branch of medicine – psychiatrists deal with significant diagnostic and research challenges, and some patients struggle with the stigma they may face socially due to having a mental disorder. In a bid to educate the public about psychiatric conditions, Mental Health Awareness Week, which this year runs from 13th–19th May, is focusing on raising awareness about how exercise can positively affect mental health. In fact, there is increasing focus on modifying key lifestyle factors as primary prevention strategies for mental health disorders, and in a recent opinion article published in BMC Medicine, Felice Jacka and colleagues argue that depression and anxiety should be ranked amongst prevalent medical conditions affected by poor diet and physical inactivity. In another opinion article, Almudena Sanchez-Villegas and Miguel Martínez-Gonzalez discuss how diet may help prevent depression, and recommend that observational studies and clinical trials need to be carried out to confirm the association.

Psychiatry is also very topical this week due to the imminent release of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) by the American Psychiatric Association. This has been undergoing revision for some time, and although greatly anticipated, has also led to much debate, with some arguing that the DSM-5 should not be heralded as the ultimate guide in diagnosing psychiatric disorders. To focus on the many controversies in this area of medicine, a new article collection, Current Controversies in Psychiatry, has been published in BMC Medicine to address the current challenges in psychiatry from diagnosis to co-morbidities.

As Michael Berk discusses in an editorial to launch our article collection, the debate on diagnostic categories in mental health based on DSM-5 is disproportionate to what the changes will actually mean. He highlights that while the modifications in diagnostic criteria are useful, the limitations should also be kept in perspective amongst clinicians and regulators, and warns that adhering too tightly to imperfect criteria will hamper progress in research.

In a debate article, Ian Hickie and colleagues argue that the diagnostic criteria can be improved by developing new approaches that identify pathways underlying the illnesses rather than using broad categories to describe psychiatric disorders. However, in another debate article, Victoria Cosgrove and Trisha Suppes highlight that boundaries between the diagnosis of bipolar disorder I, schizophrenia and schizoaffective disorder are preserved in the DSM-5 criteria, as there is not yet enough data to justify a continuous model of psychosis.

It should be noted that the DSM diagnoses are based on consensus guided by clinical symptoms, and are not derived from any quantifiable research measures. Another closely related diagnostic guideline is the tenth edition of the International Classification of Diseases (ICD-10) developed by the WHO, which is also undergoing revision (the ICD-11 is due for release in 2015); some argue that the two sets of guidelines, although developed for use by different branches of health professionals, suffer from similar limitations.

In an attempt to produce a more informative set of diagnostic guidelines, the National Institute of Mental Health (NIMH) launched the Research Domain Criteria (RDoC) project in 2009, which aims to incorporate genetics, neuroimaging and cognitive science to develop a new classification system. In a debate article, Bruce Cuthbert and Thomas Insel argue that future psychiatric nosologies will be informed by the RDoC, which will help achieve precision medicine for mental disorders. Thomas Insel expands on this project further in his NIMH blog. The move towards focusing on a more personalized approach to psychiatric research is also highlighted in a review article by Charles Nemeroff and colleagues, where the genetics, epigenetics, biomarkers, treatment response and environmental factors of mood disorders and schizophrenia are discussed, with particular emphasis on the impact of neuroimaging on personalized medicine in psychiatry.

The patient’s perspective in all this should also not be forgotten, and as Dan Stein and Katherine Phillips point out, the fifth DSM revision incorporated public feedback for the first time. Stein and Phillips both worked as part of the subgroup for the obsessive compulsive and related disorders criteria, and in a commentary describe the importance of taking patient opinion into account.

One thing that cannot be underestimated is the impact psychiatric conditions have on overall health. In particular, depression has been associated with obesity and cardiovascular diseases (CVD), and in a review article Brenda Penninx and colleagues examine the biological pathways and the dysregulation between depressive symptoms and somatic health. Additionally, Peter de Jonge and colleagues argue that although there is a link between coronary heart disease (CHD) and depression, this association is confounded by heterogeneity, such that depression is a non-causal risk factor for CHD. However, Kenneth Freedland and Robert Carney dispute that depression predicts CHD but admit that better methods are required to ascertain whether depression is a causal risk factor for CHD, which could help determine treatment strategies for CVD prevention.

Further articles will be added to this series to focus on some of the controversies and open questions in psychiatry, so keep an eye out for developments in our article collection. In the meantime, we wish you good mental health!

The problem of antibiotic resistance, recently described as “apocalyptic” by Sally Davies, Chief Medical Officer of the UK, is getting worse and cannot be expected to get better quickly. In a Question and Answer article in BMC Biology, Gerard Wright explains the reasons for the worsening situation, and why, despite the acute need, there are few new antibiotics on the horizon.

Antibiotic resistance is a natural and ancient phenomenon, and the emergence and spread of resistance in human pathogens inevitable, he argues, though widespread clinical and agricultural use of antibiotics makes it much worse; and the problem can only be met by the development of new drugs.

The point that antibiotic resistance predates our development of antibiotic drugs was ...

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The problem of antibiotic resistance, recently described as “apocalyptic” by Sally Davies, Chief Medical Officer of the UK, is getting worse and cannot be expected to get better quickly. In a Question and Answer article in BMC Biology, Gerard Wright explains the reasons for the worsening situation, and why, despite the acute need, there are few new antibiotics on the horizon.

Antibiotic resistance is a natural and ancient phenomenon, and the emergence and spread of resistance in human pathogens inevitable, he argues, though widespread clinical and agricultural use of antibiotics makes it much worse; and the problem can only be met by the development of new drugs.

The point that antibiotic resistance predates our development of antibiotic drugs was made in an earlier Q&A in which Wright explored the mechanisms and origins of antibiotic resistance – it is prevalent in bacteria that live in the environment, for example in the soil microbes from which almost all of our antibiotic products are derived. He can now cite a more recent study confirming that the resistance genes we see in human pathogens are the same as those found in environmental bacteria, presumably as a defence against antibiotic products of their microbial neighbours – the very same products that are exploited by us for antimicrobial drugs. And the antiquity of resistance is illustrated by his own recent finding of resistance genes in the microbial community of a cave sealed from the surface 4 million years ago. The news that multi-resistant bugs have been found on American supermarket shelves thus clearly does not necessarily (as pointed out by the US FDA) imply a disease outbreak in the making – pathogens do not have a monopoly of resistance genes.

So if antibiotic resistance genes are everywhere, and can spread easily – what can we do about it? Wright’s answer, to which he has effectively devoted his career, is to keep discovering new antibiotics, or new ways to make old ones effective again. The problem here, he explains, IS manmade. Not a shortage of good ideas, or new compounds with drug potential, but a regulatory and incentive structure that is ill adapted to support the development of these drugs and get them quickly to the pharmacy. Perhaps most important is a bias towards the development of broad spectrum drugs, which has served the industry well in the past, but which limits the number of suitable lead compounds and – it can be argued – has helped promote both the spread of resistance and undesirable side-effects such as antibiotic-induced colitis, due to an indiscriminate effect on the patient’s microbiome.

Despite his conclusion that things will get worse before they can get better again, Wright points to some glimmers of hope. The Generate Antibiotic Incentives Now (GAIN) Act passed in in the US in 2012 has special provisions for antibiotics against resistant bacteria as well as measures designed to help fast-track new drugs. More recently, further reforms to clinical trial requirements have been proposed by the pharmaceutical industry. There are already some drugs that are benefiting from the GAIN Act, including two new drugs that will treat Clostridium difficile, bacteria that are notoriously causing complications after treatment with broad-spectrum antibiotics in a hospital setting.

Seventy years after antibiotics were first brought to market, it is hard to imagine where we would be if they cease to be effective. The erosion of their efficacy is ongoing, but Wright gives us reason to believe that the inevitable problem of resistance can be successfully met.

BioMed Central welcomes the HRA proposals ‘to make the registration of clinical trials within an agreed timeframe a condition of ethics ...

Read more]]> 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 approval’ and ‘to work with publishers to dispel the myths and perceptions about the difficulties in publishing results’.

Services for trial registration are already widely available. Under the aegis of the World Health Organization which has developed standards for trial registration, a growing number of registers worldwide help researchers reduce wasteful duplication of research and the potential for patients to be put at unnecessary risk in redundant trials.

In the absence of national legislation that would mandate public registration, responsibility for registration and results reporting ultimately lies with investigators and their sponsors or employers. A growing number of health research funders make public registration a condition of their grant application process. Ethical approval is another stage in the research cycle where public registration could be mandated and the HRA proposal to that effect is a step in the right direction.

BioMed Central has acknowledged that public registration (declaration of existence of research) can be seen as the first step towards transparency and future dissemination of health research outcomes. We administer the ISRCTN trial register which will list both trials awaiting ethical approval and trials with full ethical approval.

Traditional subscription journals often need to be extremely selective about what they can publish and less exciting results from trials can be excluded for reasons of space. Open access journals do not have these space constraints: BioMed Central journals welcome the publication of negative or inconclusive results which are essential in order to get the full picture of the research which has been carried out in any specific field. We publish a number of trials-related journals, including Trials, Systematic Reviews and the Journal of  Negative Results in BioMedicine which focuses on articles that ‘promote the discussion of unexpected, controversial, provocative and/or negative results in the context of current tenets’. The journal BMC Research Notes aims ‘to reduce the loss suffered by the research community when results remain unpublished because they do not form a sufficiently complete story to justify the publication of a full research article’. All journals in the BioMed Central medical portfolio encourage and/or demand adherence to established guidelines on trial reporting, such as CONSORT for trial results, SPIRIT for trial protocols, PRISMA for systematic reviews.  They all require that authors register their trials in a recognised register and provide the relevant reference, whether it is the ISRCTN number or the trial identifier used by another of the WHO-vetted registers.

BioMed Central supports this announcement and we look forward to working with the HRA.

Posted on behalf of Helene Faure