Transparency of herbal clinical research

What is the state of herbal clinical trial reporting?

The Declaration of Helsinki states that  “every research study involving humansubjects must be registered in a publicly accessible database before recruitment of the first subject” (1).

Open When I Feel Like It

Alan Levine Flickr, CC BY-2.0. “Open when we feel like it”.

However it is widely acknowledged that many clinical trials are not registered in a publicly accessible database, and that many results are not published at all  (2). Of 224,000 study records on ClinicalTrials.gov only 23,000 reported results despite an FDA ruling for US research stating that results should be published within a year of completion, ‘The Final Rule’ (3). The #AllTrials campaign, part of the Sense About Science  organisation, advocates for honesty and openness about clinical research and estimates that about half of the clinical trials carried out are never published in a journal, i.e. not only sharing the results but also the finer details of the study participants and methods.

Where to find clinical trial information?

A number of clinical trial registries exist where details of trials are publicly shared, and where the results can be uploaded and links to full publications listed.

https://clinicaltrials.gov (managed by the National Library of Medicine at the National Institute of Health (NIH))

https://www.ukctg.nihr.ac.uk (UK NHS)

http://www.who.int/ictrp/trial_reg/en/ (WHO International Clinical Trials Registry Platform)

http://14.139.60.56:8079/ctri/about-ctri/introduction-ctri (International Clinical Trials Registry India, WHO India)

There are probably others which I’ll list here in due course.

Professional guidelines for researchers

In the UK, professional bodies and societies advocate for transparency in clinical trial reporting. The Association of British Pharmaceutical Industry (ABPI) issued a new code of practice in 2012 on clinical trials transparency encouraging the registry of new trials and publication of results within set timeframes, and provide  useful accompanying toolkits to assist researchers and trial managers.

The British Pharmacological Society ‘Pharmacology Matters‘ bulletin recently shared an article by Sile Lane from #AllTrials explaining how lack of rigor to publishing trial results leads to inaccurate evidence on which vital health decisions are made, and that patients and volunteers on clinical trials are being betrayed as their data is never used or reused.

 

How does herbal clinical research fair?

So for my field of research the golden question is what is the picture for Ayurveda traditional herbal medicine? This area of research is usually under even more intense scrutiny regarding the availability and quality of evidence. Also without pharma-scale investment, each piece of work is precious and adds to a much-needed evidence base.

I looked for all trials relating to ‘Ayurveda’ on ClinicalTrials.gov and sorted for all ‘completed’ reviews. The full dataset was downloaded into Excel as a .csv file (available here –> Ayurveda Clinica Trials BLOG). For this search term there were no results returned from NHS Gateway or WHO international registry.

In total, 18 studies were retrieved ranging from several Phase 2 (small scale human clinical trials) to others that were not categorised. Of the 18 studies that indicated they were ‘completed’, four updated their records accordingly instantly on the date of completion. The average time for records on ClinicalTrials.gov to be updated was twelve months, with the longest time for any further information to be posted being four years.

Only one trial indicated that the entry ‘has data’, meaning the authors have the option to share data on the system and/or provide a link to a full peer-reviewed publication. However, five others had shared results but not updated the system (below).

How many had published their results?

By searching for the unique identifier for each study (the NCTXXXX number) using Google searches and the PubMed database, the results from the clinical trials could be tracked down. In total, six had published their results in peer-reviewed publications. PubMed generally incorporates the identifier within the meta-data for each publication to help with retrieval of clinical trial information. Of these studies, all of the main outcomes were positive findings.

Therefore in this small sample, there was a publication rate of results of 30%, compared to a report rate of 50% estimated by #AllTrials.

Engagement with the clinical trials registry was poor with records updated slowly or not at all, and a tendency to not share study data and outcomes there.

What next?

By searching for the registered names of individual authors, it could be assumed that in a couple of cases, the researchers may have left their institution. Aside from that we do not know the motivations as to why indivituals and their organisations choose not to share the findings of their work.

Further work is needed to understand why researchers do not report their study findings, despite the clinical trials registry platforms such as that run by the NIH, NHS or WHO making the process simple. The question is who is ultimately responsible, the researcher, organisation, and how can full registration and reporting of trials be enforced? Also do all researchers from around the globe have access to technology infrastructure and have digital skills to utilise these systems in an equitable manner?

(1) WMA (2013). WMA Declaration of Helsinki. Available: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

(2) Mayo-Wilson, E., Heyward, J., Keyes, A., Reynolds, J., White, S., Atri, N., … & Ford, D. E. (2018). Clinical trial registration and reporting: a survey of academic organizations in the United States. BMC medicine16(1), 60.

(3) Zarin, D. A., Tse, T., Williams, R. J., & Carr, S. (2016). Trial reporting in ClinicalTrials. gov—the final rule. New England Journal of Medicine375(20), 1998-2004.

Added comments

Useful article
https://www.bmj.com/content/361/bmj.k1452

Useful organisation
@TranspariMED

Teaching and assessing large student groups

Heads of University Bioscience (HUBS) / Royal Society for Biology workshop for early career academics held at the University of Reading School of Agriculture, Policy and Development on Wednesday 21st February 2018.

This was a great day organised by Graham Wright and Julian Park. I covered for Katherine Hubbard and ran a session about working with large student groups.

For the session I prepared a workbook in Google Docs and we added to this during the session. You can access and download the Workshop Resource and Session Planner.

The resource will be shared using a CC-BY-SA license.

Open educators learning from social entrepreneurs

It was an honour to be invited to speak at the International Summit for Social Entrepreneurship held at De Montfort University on 16-17 November. The event was organised by my amazing and inspirational friend Momodou Sallah – Reader in Global Youth Work, National Teaching Fellow, Director of Global Hands and 2015 Times Higher ‘Innovative Teacher of the Year’. In the event, Momodou brought together social entrepreneurs, staff and De Montfort students to understand and discuss the importance of social action and enterprise locally and globally.

Momodou participating in a DMU 24 hour vigil and me wrapped up.

I was inspired by everyone I met. Everyone talked about the importance of people, collaboration and education. As an open educator joining this new community I could see how much our movement could learn from taking more decisive action. I often think we spend far too much energy defining and debating, and not enough energy in actual change.

Practical, Pragmatic and Passionate

It was a joy to hear from Dorothy Francis from Leicester’s Cooperative Social Enterprise Agency (CASE, @CaseCooperative) who are specialist advisors mentoring and transforming people’s ideas into businesses . She talked about taking a “practical and pragmatic approach to changing the earth we live on”. But also the need passion. I learnt from her about the careful choice of words – ‘under-developed countries’ negatively portrays nations that are artistically, architecturally, medically and advanced in so many ways, and I think back to so many lectures I’ve given on global diseases in which I will talk about ‘re-developing countries’ next time. Change is brought about in many ways, not least by the myriad of co-operative groups which she described. The International Cooperative Alliance comprises around 1 billion global people, and reminded me very much of open education and the people it attracts, driven by values rather than profit. It was disappointing to see at the ICA there are 17 men and only 3 women on the board of directors, and it made me wonder how we can affect genuine change and not re-tread old paths if we are not challenging the governance and structures of new ambitious organisations as they emerge.

“If you want to understand today, you have to search yesterday”. (Proverb).

Food for Education – Food for Thought

The next example of social enterprise was mind-blowing in terms of speed and scale. Bhawani Singh Shekhawat is the CEO of the UK branch of Food For Education  which provides free school dinners to children in India – and now the UK – based on Ayurvedic principles and providing much needed nourishment. The group provide 2 million meals a day in India, not surprisingly incentivising attendance and helping children achieve. The group are now providing meals in Brent, UK, and I couldn’t help but think how this model could help provide meals for hospitals and care homes.

Changing The World

There were so many great speakers at the event, this blog post does not do them justice. But one more here achieving great change was Andrew Hunt of Aduna.com. This was a fascinating talk for me having worked in the food industry myself, and seeing Andrew’s example of finding an amazing natural product and bringing it to market. The basis of the company is for social good not profit – and Andrew explained that unlike ‘Fair Trade’ agreements where co-operatives are provided with an income, his model provides money directly to families. The product – Baobab – a tree from the Adansonia genus and gained fame as the ‘Tree of Life’ in the Lion King produces coconut-like fruits with a  nutritious core. Andrew’s prior work in marketing and knowledge of the retail market was essential for negotiating the scene and getting Baobab into key London stores, plus attracting media attention. I was fascinated how this innocent product became ravaged by the media and translated into the skin-healing, detox-sensation and pseudoscientific garbage that so often reflects endemic journalistic lack of understanding of any semblance of basic science. I did wonder whether the pseudo stuff would ultimately risk the reputation of this enterprise.

Open Educators as Social Entrepreneurs?

In my talk, I tried to connect the work of the open education field with that of social entrepreneurship. We have a shared basis of being values-driven, wanting to change our lot be it education or society in general, and being passionate about what we do. I think the two communities can learn from each other, and I am particularly inspired by their ability to have a clear goal, be passionate and pragmatic, and to have a robust business model behind their work.

 

 

 

The Awesome Jo Brand

This has to be the facial expression of the week for me – a mixture of strength and despair from the wonderful Jo Brand (staking a stance about sexual harassment on Have I Got News For You ). Whilst we all probably agree there needs to be more women on comedy panel programmes, I had an interesting conversation that made me think of how our silence has played such an important part on where we are today “constantly under siege” – or rather, where we aren’t in terms equality.

In the latest allegations of inappropriate sexual behaviour, my immediate reaction has been, really? Does this still go on? I think this leads me to part of the problem – generations of mainly but not exclusively women have experienced unwanted inappropriate behaviour from others, but as we develop our armour over the years from those first early jobs, we experience it less? As we develop our armour and confidence presumably we are seen as less easy targets? We remove ourselves from workplaces and situations – I remember a PhD interview where the Professor and Senior Consultant didn’t look me in the eye once. Creep. As we develop our cut-throat witty one liners – it is clear we are not to be meddled with. I’m lucky, I play in bands and drink pints, and I’m pretty convinced that has made my life a lot easier in being one of the blokes and out of the firing line.
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Coming back to the generational thing is important. Only recently my 80+ year old mum started to tell me of what life was like getting the tube to work in London and life in the office in the 1950’s and 1960’s. Gropers and meddlers were abound, and flashers on the tube a regular occurrence. As the older children in the family started work, they were told to look after the younger girls and boys – the boys weren’t immune either. She never told me this before, and I’ve still never shared my experiences. Maybe her own experiences meant that we never talked about this stuff in the home. I always put it down to my parents being very Victorian but now I’m not so sure. The moment something mildly sexual came on the telly, my mother would burst forth with a profuseness of tutting, and hail the scenes as “utter filth”. My dad was a hefty man and this was the days before remote controls, but he could get to the telly and change channels faster than Usain Bolt off the starting blocks.
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I wonder if each generation probably thinks things have changed and therefore remains silent without doing anything about it.
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Of course the problems are more complex than the media portrays, and the rather simplistic binary argument of men versus women is really unhelpful and uncomfortable. I’ve worked in offices with some mortifyingly embarrassing female colleagues, sitting on the knees of directors and going off for private meetings. They were the ones with the power. And as my mum would say “letting the side down”. I’m not surprised that work cultures are confused, although it doesn’t excuse it. We are all complicit in our silence, and society has therefore continued along based on what has not been said.
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So we need to talk about it. Mums, nannies, aunts, sisters, talk to your girls and your boys. Hopefully we’ll get to a point where these matters aren’t comedy fodder for men on panel games, and they’ll be able to talk about it too.