Whitehall pharmaceutical blog
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A study conducted by the US Food and Drug Administration and European Medicines Agency found that the agencies are identifying the same types of deficiencies in clinical investigations submitted in … more
In our latest blog post, we demystify Good Clinical Practice training with a detailed breakdown of what it is and who it’s for while highlighting the benefits of a GCP certification from … more
For clinical practitioners across all sectors, maintaining GCP compliance is always paramount. With changes to the Good Clinical Practice Framework on the horizon, it isn’t surprising that … more
ICH’s planned GCP revisions are aimed at enabling researchers to maximise the potential of new technologies, reduce costs and improve patient protection.
The steps to revision. … more
Today’s news that the AstraZeneca/Oxford Covid-19 vaccine trial has been paused because a participant fell ill will polarise opinion.
Some will see it as another manifestation of the … more
Depending on where you are in the world, reported infection rates range from over 20% (New York) to 6% (Geneva).
What is going on?
Are researchers in simply in too much of a hurry … more
Clinical trials have always been hampered by under-representation for certain key groups, and this is particularly a problem with children. A recent study published in the European Journal of Cancer … more
The invention of vaccinations is often regarded as one of the greatest breakthroughs in modern medicine. Vaccinations currently prevent 2-3 million deaths a year, and this figure could increase to a … more
Mental health is increasingly on the agenda for policy makers and health practitioners, but one group of society seems to be at an ever-increasing risk of developing mental health problems, students. … more
Problems with a new type of pacemaker, first implemented in the UK in 2014, have sparked a debate over the effectiveness of medical device testing.
Back in 2014, Maureen McCleave felt lucky … more
NHS Digital has just published the results of its latest survey on the mental health of children and young people in England – the first since 2004.
The latest survey was the first to … more
It is no secret that advances in technology and the advent of social media have impacted almost every aspect of our lives - and are continuing to do so. However, what is less well-known is the … more
When my Mother was receiving care at home, one of the main problems was a sense of lack of control. She and I never knew exactly when the carer would arrive or precisely who would attend. The … more
In 2017-18 at least 55,000 referrals to children’s mental health services (Camhs) were rejected or considered inappropriate. In the same year, there were almost 200,000 referrals in total … more
Some say that the first 200-year old has already been born. It's hard to imagine that in the future we might think of our lives in terms of centuries, but one thing is certain – we are living … more
The NHS is 70 years old on 5th July this year. According to a study by the King’s Fund, 90% of people in the UK support the founding principles of the NHS – to provide a healthcare system … more
Blockchain could revolutionise recruitment to clinical trials.
According to an article in the Canadian Journal of Surgery, as few as 16% of patients are aware of clinical trials … more
According to figures obtained by the NSPCC, the number of schools seeking professional help for students was 34,757 in 2017-18 (up 38% on 2014-5). In almost one-third of referrals where data was … more
The Learning Disabilities Mortality Review was published today and highlights some severe health inequalities faced by those with learning disabilities. People with learning disabilities die … more
There are over 850,000 people living with dementia in the UK, and their care costs around £26 billion a year, according to Whitehall Training’s course on Dementia Awareness.
… more
The Care Quality Commission (CQC) found that 72% of clinics offering residential services for people withdrawing from drugs or alcohol had breached regulations of the Health and Social Care Act. … more
Statistical analysis of over 5,000 published trials has highlighted 90 that contain dubious data.
This is equivalent to around 2% of the trials examined using statistical tools to identify … more
Three US women have been left blind following an experimental treatment that they believed was part of a drug trial.
According to The New England Journal of Medicine, the women suffered … more
The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust have warned that the discovery of new drugs to treat childhood cancers is at risk because of EU legislation intended to … more
According to the World Health Organisation, 25% of deaths of children under 5 are at least partially down to air pollution. Even “safe” levels of air pollution may increase rates of … more
The first modern epinephrine autoinjector, the EpiPen, was invented in the mid-1970s. Since then, many versions have been introduced but the market is still dominated by a single design, sold by … more
Drug discovery is a time-consuming process in any country – trials that follow the proper rules of Good Clinical Practice take a lot of time and money. And that is before you consider the … more
According to two UK cancer charities, thousands of NHS patients could be missing out on cancer treatments they would receive in other “similar” countries.
Breast Cancer Now and … more
Recent US legislation has sought to increase the number of paediatric clinical trials. The aim is partly to increase the number of medicine proven to be effective against primarily childhood ailments. … more
Researchers from John Hopkins University, claim that over a quarter of a million US deaths are down to medical errors every year. This worrying figure is only eclipsed by heart disease and cancer. … more
An article published last week in Science Translational Medicine weighed up the pros and cons of various incentives used to encourage participants to enrol in clinical trials.
The incentives … more
Today, a new weapon in the fight against AIDS was unveiled in South Africa.
Over seven million South Africans are living with AIDS – the largest number anywhere in the world. Poor … more
It goes without saying doesn’t it – the search for new drugs is becoming harder and harder. Why then does the percentage of successful trials seem to be growing?
Bucking the … more
This seems like an odd question, but a recent survey of more than 1,500 consumers and nearly 600 physicians conducted on behalf of Memorial Sloan Kettering Cancer Center (New York), revealed that only … more
Nowadays, the idea of trial data sharing does not seem as far-fetched as it did a few years ago. The all-trials initiative’s call for full disclosure of trial data has been answered by many … more
At the moment in the UK, pregnant women are offered screening at 10-14 weeks to detect whether there is an elevated risk of Down’s syndrome and a couple of other chromosomal conditions. This … more
Antibiotic resistance is a massively high-profile issue. I know I can’t visit the doctor without seeing signs telling me that antibiotics can’t cure all ills and that over prescribing is … more
Is it ethical NHS patients to be bumped down the queue for surgery if they are unwilling/unable to lose weight or stop smoking?
A recent report from the Royal College of Surgeons shows that … more
Chinese healthcare has been rocked by the revelations that for years, many of the vaccines given by state hospitals may have been incorrectly stored or been past their expiry date.
The fraud … more
The Government of Malawi and UNICEF have been testing drones as a way of drastically cutting waiting times for infant HIV tests.
These drones are controlled from a mobile app and crucially; … more
A recent report in JAMA Oncology has espoused the hidden benefits of negative trials results – and this view seems to have been endorsed in new draft guidance from the EMA.
Negative … more
Up to 4% of emergency hospital admissions in the US are caused by adverse reactions to prescription drugs, claims a recent paper from the New England Journal of Medicine.
Are there … more
As the entry price point plummets – I ask, are robot companions an ethical way to meet the emotional needs of vulnerable elderly patients?
My seven year old son would love Paro … more
Cancer Research UK has today announced a breakthrough that could theoretically lead to a new treatment for some cancers within the next five years.
Newly-published research into the genetics … more
Britain is debating how to regulate scientific experiments involving human/animal hybrids or “chimeras” amid concerns about a negative backlash and accusations of Frankenstein science. … more
A recent article in UK journal Nature suggests that published trial results may not always match the original trial designs.
One of the very first things any child learns about science is … more
The earliest lesson of the recent French Trial Tragedy is that it’s dangerous to leap to conclusions.
The trial in question was of a drug intended to treat anxiety and mood disorders … more
One of the things that has pretty much united the pharmaceutical world is the deep dislike of ex-fund manager, Martin Shkreli. He shot to fame in mid-2015 by hiking the price of the 65-year old … more
For those of you who missed the interview with Dr Leann Fieldstad, Vice President, Global Pharmacovigilance Operations, PAREXEL, published earlier this month in Clinical Leader, I thought it was worth … more
The Chinese Food and Drug Administration (CFDA) has issued for comment its proposed revisions to the good clinical practice (GCP) rules for Chinese clinical studies. If the changes pass into law, they … more
