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Consortium publishes new principles for transparency in clinical trials/The Guardian debate on public engagement in research
So, this has been fairly well-reported already. But in a show of my utmost commitment to the transparency agenda here is a link to the news release on the Royal College of Physicians (RCP website) about yesterday’s launch by the Ethical Standards in Health and Life Sciences Group (ESHLSG) (a consortia of professional, medical and commercial organisations) of: Clinical Trial Transparency Principles and Facts.
The first step towards transparency would have been for RCP to have published the thing on their website alongside the news release (big sigh). But at least they are well-ahead of the ABPI which hasn’t even got a mention of it on their site as far as I can see.
Such is life. Here are the principles enshrined in the document for everyone’s consumption:
• Investigators should ensure that the methods and plans for their clinical study or trial are recorded on a publicly accessible register within 21 days of initiation of patient enrolment, and that this information is kept up to date.
• With commercial pharmaceutical trials, investigators should make available the methods and results of the trial within one year of the product gaining marketing authorisation and being available on the market in any country worldwide.
• Where a product fails to secure to marketing authorisation but the trial results are “of significant medical importance”, they should be made available within one year of the trial being completed, through a publicly accessible website or journal.
• For all other studies or trials, investigators should make available the methods and results within one year of completion through a publicly accessible website or journal.
• Investigators should report the trial “fully and transparently”, following appropriate reporting guidelines, and in particular the recommendation in the current version of the CONSORT (Consolidated Standards of Reporting Trials) statement.
• Investigators should ensure that no “important aspect” of trial results has been omitted, and that any deviations from the study protocol are explained.
• Investigators should ensure that any interpretation of their clinical trial accurately reflects the research questions, study design and results, and is without bias.
• Investigators should report their clinical trial in enough detail to allow other researchers to extract the trial design and data for use in meta-analyses and systematic reviews.
• Investigators listed as authors on publications arising from clinical trials are responsible for all of the content and should ensure that they adhere to the ICMJE (International Committee of Medical Journal Editors) guidelines in terms of qualifying for authorship.
Great online debate about public engagement today, hosted by The Guardian. You can see the feed here. Still digesting and might reflect publicly in due course.
I am not sure what made me think about and look for this report: ‘N=1: Why people matter in medicines.’
Perhaps it was all the talk last week about the Department of Health’s 11th report to parliament on the Pharmaceutical Price Regulation Scheme (PPRS) - in essence the way in which drug prices are set – and the steps being taken to introduce a new system called ‘value-based pricing.’ Or the paper also published last week suggesting that the design of clinical trials is often inherently flawed and ultimately unhelpful to clinicians because studies look to answer the wrong question. That is, rather than looking at the benefits of one treatment compared to another, they compare the treatment against placebo. Or the fact that the Royal College of Physicians will be much in the news today for other reasons.
It certainly wasn’t this post on ‘Scrubbing Up’ on the BBC site and which I only heard about today. Although the article made me feel very angry indeed, after taking a step back I realised that it only served to prove my point in this blog that we are not thinking through the issues around medicines development and use. As follows.
‘N=1: Why people matter in medicines’ is the report of the sub-group of the Royal College of Physicians Medicines Forum. This working party was brought together to look at the medicines pipelines from a patient perspective.
Chaired by Harry Cayton, its members included patients, regulators, health professionals, academics. We took evidence from people such as Ben Goldacre, Fiona Fox from the Science Media Centre, Boots the chemist, charities and others. We also went out in the field visiting a GP surgery and a hospital pharmacy.
The report was completed last June and press released in September but it is quite hard to find on the College’s website unless you are looking for it. Nor did it get much coverage anywhere else as far as I can tell. So, I thought I would post its recommendations here for good measure (see below).
The overall conclusion will not be a surprising one for many people: that the way in which medicines are developed and prescribed could be more effective and efficient if designed around the needs of patients. That it is not, can be pointed to as a key reason for the current inefficiencies in prescribing practice; why many patients do not keep to their medicines regime Reform of the system has to be approached in a radically different way that focuses on making the system work holistically from a patient point of view as opposed to being preoccupied with making ‘disobedient’ patients more compliant. Instead of ‘concordance,’ think coherence.
And the report did propose some radical new approaches: every GP practice should have access to a local pharmacy adviser to whom patients could be referred for help and support; the better use of IT for prescribing; development of a patient formulary for the public to help them find better information about medicines and their impact; and the need to listen more closely to the way in which patients talk about their experiences of medicines and find ways of translating this into clinical practice so that patients and doctors are speaking the same language.
This might not be the right day for this blog, but there is no time like the present as they say.
Before I go, a quick mention of the fact that Harry Cayton will be chairing the new Public Engagement and Involvement Committee at the MHRA which should be up and running some time this year. Good news.
Recommendations for more effective engagement
The pharmaceutical industry, medicines regulators, commissioners and prescribers need to capture and appreciate what patients say about medicines more thoroughly and comprehensively, and to understand the stories that people tell about medicines: how they use them; the benefits they experience; and the adverse reactions that can arise, so that we can make the most of this area of healthcare.
Start the process with a collection of patient terms and descriptors, collected throughout the medicines system: in clinical trials; regulatory decisions; technical appraisals; the consulting room; the pharmacy, in order to help health professionals work with patients to get the most from a medicine they have decided to take.
Create new opportunities to capture and react to patients’ views and experiences about medicines. The current opportunity to report suspected adverse drug reactions through the Yellow Card Scheme needs greater use and a higher profile. We need to explore other options to report – for example developing a patient formulary and using initiatives like healthtalkonline.
The Expert Patients Programme should explore how it could further develop expert medicine users to provide support and advice to people about their medicines.
To build further on existing achievements, more sustained effort needs to go into the quality and design of medicine information leaflets, addressing a range of needs, and using a range of formats and approaches – including exploiting opportunities offered by new communication tools.
Recommendations for service improvement
GP consortia in collaboration with local networks of pharmacists, nurses and other healthcare professionals should introduce a proactive system of aftercare to allow patients to be contacted in the first few weeks after starting a new medicine. Some people may need longer-term support. We welcome the planned introduction of the Department of Health’s ‘new medicines service’ which may be an opportunity to improve the management of medicines use.
Every GP practice in the country should have access to a local pharmacist adviser, to whom they can refer patients with medication problems, and who can be used as a source of advice for both patients and GPs on medication related issues.
Patients should control access to their care record and, if they wish, allow pharmacists and other healthcare professionals to access and input into their electronic NHS patient record.
There should be a better use of information technology in general practices to assist the public in requesting and obtaining prescriptions.
Recommendations for improving research for the benefit of the public
Reporting guidelines on patient and public involvement in medicines research should be developed to: improve standards of reporting of patient and public involvement (PPI); strengthen the evidence base for PPI in medicines research; and encourage its inclusion in research design and conduct. These guidelines should be primarily aimed at scientists writing up their research for publication or involved in peer review, and at academic journals.
Health departments across the UK should collaborate and fund initiatives to improve public awareness and understanding of the importance and role of research in delivering quality care. We would like to see public involvement in health research extended to include their involvement in the development of new medicines.
The new National Institute for Health Research (NIHR) School for Public Health Research and NIHR Policy Research Unit on Behaviour and Health to be established as part of the government’s white paper proposals on public health should investigate public health-orientated approaches to the use of medicines, alongside conventional applications of pharmaceutical technologies.
Regulatory approaches should also support consideration of the population benefits of medicines use. The outcomes of regulatory decisions should be evaluated in terms of population health benefit, together with an evaluation of the acceptability of such an approach to the public.
Yesterday I spoke at a meeting of the Royal College of Paediatrics and Child Health (RCPCH). There was an outstanding presentation before mine by Kate Baker, a young academic paediatrician, about what inspired her to go into research. She talked about the importance of charismatic role models in attracting young doctors to science. But also highlighted the importance of doctors being given time and money (and not necesarily a lot!) to pursue research. And it is not just at the beginning of their career but further along too, I learnt.
Today the normally mild-mannered Royal College of Physicians took a potshot with its blunberbuss at the increasing pressures on the NHS that would be caused by the growing demand for its services and the lack of a strong consultant workforce to help cope with this challenge.
But more pertinent still was the BMA statement also today about pressurised NHS organisations squeezing the amount of support they give to doctors to pursue what are known as professional activities not directly related to clinical care (what they call SPA time) including research.
The BMA has produced an excellent booklet called ‘Quality Time’ which gives a host of examples of how doctors have used this time to improve services, for research, and to improve the knowledge and understanding of colleagues and patients. I particularly liked this quote:
‘One of the problems with decreasing consultants’ SPA time is that they won’t have time to innovate.’
‘Medics’ will be gathering in Scotland this week for a 5-day meeting at the Royal College of Physicians of Edinburgh to discuss the medical breakthroughs that have done most to shape and indeed saved lives over the past fifty years.
Scotland on Sunday have a report today previewing the meeting. The article includes a list of the top 20 advances as voted by over 600 ‘docs.’ Antibiotics came top and Scotland has a link to 8 of the top 20; interesting also to see things appear in the list such as randmized clinical trials.
But Office for National Statistics data published earlier in the weekend shows that Scotland still has mountains to climb in combatting the biggest killers in society – cancer, heart disease and stroke. (Note the very important health warning on the stats though given by the British Health Foundation).
The challenge is that it will require not just new medical breakthroughs such as stem cell treatments or stratified medicine but also changes in people’s behaviour as well if we are to truly win the battle against them, And that is what will probably mark the next 50 years out from the previous 50 in many respects.
So, I have been following with interest the House of Lords Science and Technology Sub-Committee Inquiry into behaviour change that is underway. The committe have already taken evidence from members of No 10’s so-called ‘nudge unit’ and Government departments and I think witnesses from MRC and other science organisations are up before the committee on 30th November.
This committee may be going quietlyand efficently about its business outside of the glare of media attention but sometimes a ‘nudge nudge, wink wink’ can speak volumes.
It has been one of those weeks!
But I got a bit of a fillip with the Chief Medical Officer (CMO), Sir Liam Donaldson’s, annual report on Tuesday.
Apart from being a good read, the CMO’s annual address on the state of the nation’s health can give voice and momentum to an issue within the Department of Health and Government.
I well remember when at the Royal College of Physicians, how Sir Liam’s words and support ensured the campaign to ban smoking in public places had a strong tailwind within Whitehall. The rest is history.
So it was significant that this year, among other things, he should choose to focus on rare disorders. You’ll recall that many of AMRC’s members represent and fund research into rare disorders and there is growing concern about the lack of attention given to their agenda (See my post in September 2009).
Sir Liam puts forward an action plan for the future including a National Clinical Director, he training of more specialists to improve service provision, greater public awareness, and measures to strengthen research.
I couldn’t see a response posted on Rare Diseases UK’s website but it sounds like an agenda we can all rally behind.