by IainBate
24. May 2012 15:40
The ABPI, a host of Royal colleges and other major healthcare organisations have created a set of principles in order to drive best practice in clinical trial reporting.
The Ethical Standards in Health and Life Sciences Group’s (ESHLSG) Clinical Trial Transparency Principles and Facts outlines standards including publishing study outcomes within 21 days and releasing significant data.
Dr Clare Gerada, Chair of the Royal College of GPs, said the document provides “much-needed clarity, as well as setting new standards for transparency and best practice”.
The ESHLSG principles are the first time that leading healthcare bodies and senior pharma representatives have agreed on a joint approach on clinical trial data and outcomes.
Deepak Khanna, co-chair of the group and President of the ABPI, said that clinical research is an “essential part of the medicine development process” and the results are a “source of information” to all researchers.
He commented: “Scientists can examine, question and utilise trial data, and that can only benefit the healthcare community and patients. I’m delighted that so many healthcare leaders are involved in this project – we will be far more effective in finding the right solutions if we work together.
“It is in all of our interests to be transparent, and it is incredibly encouraging to see the collaborations that have brought about this conference and the publication of the Principles document.”
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Tags: ABPI, royal colleges, clincal trial, clinical trial reporting, clinical trial data, ESHLSG, Dr Clare Gerada, RCGP, Royal College of General Practitioners, ESHLSG clinical trial principles, Deepak Khanna, ABPI President, research, scientists
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by JoelLane
13. January 2012 15:50
Many clinicians and scientists engaged in UK clinical research are doctoring the data, according to a new BMA survey.
Of 2782 UK-based doctors and scientists who responded to a short questionnaire, 354 (13%) said they had direct experience of their colleagues “adjusting, excluding, altering or fabricating data”.
In addition, 163 respondents (6%) said they were aware of cases where research misconduct had not been properly investigated by the relevant clinical or academic body.
The survey follows a recent BMJ editorial claiming that under-reporting of clinical trial data by pharmaceutical companies is widespread and poses “a threat to the integrity of evidence-based medicine”.
Now, showing the other side of the coin, the BMJ has stated that research misconduct is “alive and well" in the UK.
The questionnaire was sent to 9036 UK-based clinicians and scientists, of which 2782 (31%) responded. The BMJ report noted that some response bias was likely: “Those with cases to report may have been more liable to respond.”
“While our survey can't provide a true estimate of how much research misconduct there is in the UK, it does show that there is a substantial number of cases and that UK institutions are failing to investigate adequately, if at all,” said Dr Fiona Godlee, BMJ Editor in Chief.
Dr Elizabeth Wager, Chair of the Committee on Publication Ethics (COPE), commented: “This survey chimes with our experience where we see many cases of institutions not co-operating with journals and failing to investigate research misconduct properly.”
The report calls into question the superiority of ‘pure’ clinical and scientific research over industry-sponsored research in terms of the reliability of its conclusions.
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Tags: clinical research, doctors, clinicans, scientists, research misconduct, medical data, fake medical data, Dr Fiona Godlee, BMA, British Medical Association, BMJ, British Medical Journal, COPE, Dr Elizabeth Wager
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by emma
7. November 2011 11:51
A single ‘superjab’ offering lifetime immunisation against flu has been developed by scientists.
According to developers, SEEK, once-in-a-lifetime Flu-v fights could start to be used on patients in three to five years, against all strains of the virus, including the deadly avian, swine and seasonal variants.
Gregory Stoloff, SEEK, said: “Our aim is for the flu vaccine to become more like the mumps and measles vaccine – where you need it once and you get protection for a long time.”
The NHS spends £100 million on vaccinations every year, but the changing virus means that vaccines have to be updated, so the new jab could cut this cost down considerably.
But upon vaccination with Flu-v, the immune system is said to detect and fight a part of the virus that is present in all strains.
Results of clinical trials have found that healthy volunteers who were vaccinated with Flu-v had less of the virus in their blood.
Professor John Oxford, of trial constructors Retroscreen Virology, said: “It clearly has a biological effect worthy of further investigation, particularly with respect to the broadness of the response.”
Last winter, 600 people in Britain were killed by flu.
The DH has said that it is too early to comment on Flu-v.
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Tags: flu, influenza, superjab, super jab, jab, shot, vaccine, vaccination, immune system, immunisation, lifetime immunisations, scientists, SEEK, Flu v, flu vaccine, avian, swine, seasonal flu, Gregory Stoloff, mumps, measles, NHS, budget, costs, spending, new jab, clinical trials, Retroscreen Virology, virus, illness, DH, Department of health
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by emma
2. November 2011 11:33
A potential multi-cancer drug is to be tested in a human trial to see if it can treat a number of solid tumour cancers.
The drug, L-NNA could be used in the treatment of solid cancers such as those of the bowel, breast or lung.
Professor Peter Hoskin, from the Mount Vernon Cancer Centre in London, said: “Scientists across the world are looking for ways to prevent cancer cells from receiving the supplies they depend on to grow and divide. It's very exciting to launch this trial of a new drug which in future may provide a new approach to treat a wide range of cancers.”
The drug constricts blood vessels leading to tumours, cutting of blood supply by acting on the enzyme, nitric oxide synthase (NOS).
“All cancers rely on the delivery of vital nutrients and oxygen through blood vessels. Without a blood supply, a tumour can't grow beyond the size of a pin head,” added Professor Hoskin.
Scientists at the Mount Vernon Cancer Centre in London are in the process of recruiting 40 patients for the Phase I trial. The study will focus on establishing the correct dose of drug and will be funded and managed by Cancer Research UK’s drug development office.
Other medicines have already been developed that block tumours from forming their own networks of blood vessels, a process called angiogenesis.
Dr Nigel Blackburn, Director of Drug Development at the charity, said: “This is a promising area of research. We're looking forward to the early trial results of this new drug with great interest.”
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Tags: multi-cancer drug, human trials, clinical trials, cancer drugs, cancer, L-NNA, treatment, solid cancers, bowel cancer, breast cancer, lung cancer, Peter Hoskin, Mount Vernon Cancer Centre, London, scientists, cancer cells, new cancer drug, blood supply, blood, nitric oxide synthase, NOS, pharma, pharmaceuticals, drugs, medicine, medication, therapy, blood vessels, drug dose, patients, Nigel Blackburn, drug development, charity, angiogenesis, tumours, Cancer Research UK, solid tumour cancers
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by emma
12. October 2011 15:02
Seven medical devices, diagnostics and healthcare IT have been named in Cleveland Clinic’s Top 10 Medical Innovations for 2012.
The list of medical devices and therapies was chosen by a panel of physicians and scientists at Cleveland Clinic, named one of “America’s Best Hospitals” by the US News & World Report survey.
The annual list recognises new techniques, therapies and approaches to treat medical conditions.
The selection criteria for qualifying in the Top 10 Medical Innovations required nominations to:
- Have significant potential for short-term clinical impact (either a major improvement in patient benefit or an improved function that enhances healthcare delivery)
- Have a high probability of success
- Be on the market or close to being introduced
- Have sufficient data available to support its nomination.
The Top 10 Medical Innovations for 2012 are:
10. Genetically Modified Mosquitoes to Reduce Disease Threat
9. Novel Diabetes Therapy: SGLT2 Inhibitors
8. Harnessing Big Data to Improve Health Care – Health care data requires advanced technologies to efficiently process it. Analytics can be applied to better hospital operations and tracking outcomes for clinical and surgical procedures.
7. Active Bionic Prosthesis: Wearable Robotic Devices
6. Implantable Device to Treat Complex Brain Aneurysms
5. Increasing Discovery with Next-Generation Gene Sequencing
4. Medical Apps for Mobile Devices
3. Concussion Management System for Athletes – Patient management tools can instantly detect brain injuries at the moment of contact.
2. CT Scans for Early Detection of Lung Cancer
1. Catheter-Based Renal Denervation to Control Resistant Hypertension
Cleveland Clinic is a non-profit academic medical centre that integrates clinical and hospital care with research and education.
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Tags: medtech, med tech, medical technology, medical devices, diagnostics, healthcare IT, Cleveland Clinic, Medical Innovations, 2012, therapies, physicians, scientists, USA, US, America's Best Hospital, US News and World Report, techniques, approaches, treatment, medical conditions, treat, therapy, patient benefit, success, market, mosquitos, diabetes therapy, SGLT2 inhibitors, healthcare, health, health care, technologies, analytics, hospital, clinical, surgical procedures, bionic prosthesis, wearable robotic devices, implant, implantable devices, brain aneurysms, discovery, gene sequencing, medical apps, mobile devices, concussion management system, brain injuries, concussion, CT scans, lung cancer, detection, catheter, renal denervation, hypertension, medical centre, research, education
Medtech News
by emma
2. September 2011 14:59
Former Pfizer employees have established a research networking firm to be based at their previous workplace in Sandwich, Kent (pictured).
Seven ex-Pfizer staff members will be part of The Research Network, “a bit like a dating agency for scientists”, as described by its CEO, Andrew McElroy.
He explained that the company would help biotech and pharmaceutical companies connect with partners for outsourcing research productivity.
“We are a talented team of experienced drug discovery scientists who have a broad knowledge of the scientific services market place, what things cost, how long projects will take and who provides the best service.”
Pfizer put the site up for sale in June, with the Government naming the Discovery Park as an Enterprise Zone.
Kent County Council has previously warned that financial recovery in the area could take up to a decade, but MPs have since begun campaigning for investment interest in the site.
Significant interest has been shown in the site, hoping to attract around 190 businesses, which will in turn create around 2,500 new jobs, replacing the 2,400 lost when Pfizer decided to close the plant in February.
The drug giant was previously criticised for its lack of support to those who were made redundant, and only retained 350 employees at the plant until it vacates the premises by the end of 2012.
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Tags: ex, staff, employees, Pfizer, closure, Sandwich, Kent, location, plant, site, research networking firm, workplace, staff members, The Research Network, dating agency, scientists, Andrew McElroy, drug, pharma, pharmafield, pharma field, pharmaceutical, sales, medical sales, pharmaceuticalfield, pharmaceutical field, medical, health, healthcare, health care, medication, prescription, medicine, biotech, Enterprise Zone, Kent County Council, giant
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