Monday Media: Episode 2, 22nd October 2018

Last week’s Media Monday blog post seemed to go down pretty well, so I’m bringing it back today. As I said last week, it might not turn out to be a weekly occurrence; selfishly though, I think it’s a good post for me to write – it forces me to take a step away from my own research and read about what others are doing.

Letter: Comprehensive literature search for animal studies may have saved STRIDER trial

This is an important letter, and one that I wish had seen earlier – it was published last week and usually I see BMJ opinion pieces doing the rounds on Twitter, but this didn’t crop up.

The letter discusses the recent announcement that the STRIDER (sildenafil therapy in dismal prognosis early onset fetal growth restriction) trial has been halted after 11 babies died. An interim review of the trial data showed that lung complications were more common in the babies born to women assigned to take sildenafil (also known as viagra) than those that were assigned to the placebo. The main focus of this piece is not the early closure of the STRIDER trial, but the fact that the trial ever went ahead in the first place. The authors, Prof Michael Symonds and Prof Helen Budge, argue that a more comprehensive literature search during the trial planning stages could have prevented the infant deaths. One study that was published in 2009 demonstrated ‘adverse effects of sildenafil including hypotension, reduced fetal oxygen supply, and further fetal growth reduction. It concluded that sildenafil “should be used with caution in [intrauterine growth retardation] because of its detrimental effects on uteroplacental perfusion and on the fetus.”‘ Why that study was omitted in the rationale for the STRIDER trial is unclear; this reinforces the need for up to date, comprehensive systematic reviews to be conducted before a trial begins.

This response to the letter makes some important points too: Isn’t it the right time for librarians to officially join clinical trial teams?

Publishing:  BioMed Central journals launch new pre-print platform

BioMed Central has launched a pilot pre-print platform that gives researchers the option to share their work in a citeable way at the point of manuscript submission. The peer review process will still go ahead as normal, but the manuscript will be publicly accessible for those submitting to BMC Anesthesiology, BMC Neurology, BMC Opthalmology and Trials. If the manuscript is ultimately rejected, all information corresponding to the journal will be removed, but the article itself will remade available online along with any revisions that have been submitted too. Personally I think this is a fantastic step forward in the world of publishing, and I am glad to see efforts being made to reduce the time between manuscript submission and dissemination. Find out more about In Review, here.

In a blog post later this week I will be doing a ‘publication explainer’ for a manuscript that we’ve just submitted to Trials, which is now available on the In Review platform, so I’ll talk a bit more about it then.

Opinion: How one pharmaceutical company is reinventing the clinical trial
Janssen Logo. (PRNewsFoto/Janssen Research & Development, LLC)

This piece is written by Andreas Koester, MD; the Vice President and Global Head of Janssen Clinical Innovation. The company that the title is referring to is Janssen Clinical Innovation, which is part of Janssen Research & Development LLC, and therefore the information held within it should be read with that in mind.

This article was published in STAT News in September, but I’ve only just seen it now and thought it worth drawing attention to. The piece rightly highlights how common issues with participant recruitment to clinical trials are, as well as the problem of ensu

ring that those participants remain in the trial right to the end. It then goes on to describe several projects that Janssen Clinical Innovation are running, that all aim to improve trial design in some way. Described in the main body of the article are three projects;

  1. The mHealth Screening to Prevent Strokes study – a collaboration between Janssen, Scripps Translational Science Institute, Aetna, and iRhythm Technologies, that aims to ‘bring the trial to the patient’ by incorporating wearable devices for data collection.
  2. The Global Trial Community – an initiative that allows patients to have access to some of their data during trials in a way that does not compromise the integrity of the research. This aims to ’empower patients by giving them what they want: their health data’.
  3. The Integrated Smart Trial & Engagement Platform – a digital technology platform that works to combat many of the administrative and logistical challenges that are common within the lifetime of clinical trials. The platform, called iSTEP for short, uses scanners to track when medication kits arrive and are returned, sends patients customised information like dosing instructions and tutorial videos, and includes electronic drug labels that are tailored to the patient’s preferred language. The aim of the platform is to ‘use technology to enable more efficient clinical trials’.

Now, I’m the type of person that wants evidence of the difference that these new initiatives and platforms make – it could be that Janssen is spending huge amounts of money implementing all of these changes, but participant recruitment and retention is still not improving. That said, Janssen are a huge pharmaceutical company with funding behind them that allows this sort of ‘try it and see’ approach; in the academic world that would never work, we don’t have the resources for it. I’ll be watching these developments closely over the coming years, hopefully they will be rigorously evaluated at some point!

Monday Media: Episode 1, 15th October 2018

I’ve talked before on this blog about how I do some freelance writing projects along side my full time job, and today I want to start a new series of blog posts that originate from a conversation I had with a client a while ago. One of the regular projects that I work on is a weekly recap of news; every single week (through thesis write up and everything!), I write a news recap piece for Synthego. Synthego are based in Silicon Valley, and they have a product portfolio spanning software and synthetic RNA kits that are designed to support scientists and researchers with CRISPR gene editing processes. I’ve worked with Synthego for over 2 years now, and this little recap of news has become a normal part of my week. I find these types of posts really interesting to write even though I don’t work in a lab or have anything to do with CRISPR or gene editing day-to-day, so I figured it might be good to make a little news recap of my own each week.

I’m not sure if this will be a weekly thing just yet (let’s see if anyone actually reads it first…), but I’m going to use these posts to highlight new research, interesting articles and other forms of media (blog posts, podcasts, YouTube videos etc) that are related to things I find interesting – primarily trials and trial methods, but likely a bit of public engagement/involvement and research integrity thrown in there too.

So, here goes! Let me know what you think and whether you’d like to see these types of posts become a regular thing on the blog.

Research Paper: The effect of optimised patient information materials on recruitment in a lung cancer screening trial: an embedded recruitment trial

Full disclaimer on this one – I know some of the team behind this paper; one of them was (I just had to go back and delete the word ‘is’, it’s still very strange to not be a PhD student anymore) my PhD supervisor, and I’ve been lucky enough to work with a few of them on other projects too. Even so, it’s still interesting and it’s still useful.

This study focusses on the content of participant information leaflets; these are the leaflets that people are given when they are approached to take part in a trial, it should contain all the information they need to make a decision about trial participation, and it should be presented in a format that is accessible and easy to digest. In reality, a lot of participant information leaflets are super long, very text-heavy, and often make people (myself included) groan just thinking about reading them. The team behind this study designed and conducted an embedded study (also called SWATs or studies within trials – I mentioned them in a previous blog post here), looking at participant information leaflets used within a host trial that aimed to assess the effectiveness of a new test in reducing the incidence of patients with late-stage lung cancer at diagnosis compared with standard care. Potential participants approached for participation in the host trial were randomised to receive the original participant information leaflet and accompanying letter (control group) or optimised versions of these materials which had undergone user testing and a process of re-writing, re-organisation and professional graphic design (intervention group). The primary outcome was the number of patients recruited to the host trial, and the secondary outcome was the proportion of patients expressing an interest in participating in the host trial (just a note – I’ll be doing a post all about outcomes soon as that’s what my next research project will focus on, keep an eye out for it over the coming months!).

The results of this embedded study suggest that optimised patient information materials made little difference to the proportion of patients positively responding to a trial invitation or to the proportion subsequently randomised to the host trial. I’m interested as to why this is – personally I think it’s something to do with the verbal information that potential participants get alongside these leaflets, but I guess that’s a question for a future study! Read the full paper here.

Research paper: Global public attitudes about clinical research and patient experiences with clinical trials

A new study published in JAMA from researchers at The Center for Information and Study on Clinical Research Participation in Boston, Massachusetts, caught my eye this week. The team surveyed 12,427 people in 2017 about their attitudes and understanding of clinical research, these individuals represented 68 countries and included 2,194 clinical trial participants.

The survey found that 84.5% of respondents perceived clinical research to be very important to the discovery and development of new medicines, but 59% were unable to name a place where studies were conducted. 90% believed that clinical research is generally safe, but 44.9% reported that clinical trials are rarely considered as an option when discussion treatments or medications with their physician. Perhaps unsurprisingly, clinical trial participation was perceived as inconvenient and burdensome; 49% of respondents expressed that their clinical trial participation disrupted their daily routine.

Clearly, there is a lot of work to be done in terms of normalising trial participation, and improving trial design to minimise burden and/or disruption for participants. Read the full paper here.

Webinar: Health Care Improvement Scotland’s QI Connect Global WebEx Series presents ‘Too much medicine… winding back the harms of medical excess’ with Fiona Godlee
Fiona Godlee is Editor-in-Chief of the BMJ, she’s a qualified doctor and hugely intelligent and inspirational woman. I’ve seen her speak a few times, and each time I’ve been left feeling galvanised to do something to help solve the problems

she’s highlighted. She’s spoken at length about the harms of having ‘too much medicine’, and whilst at the BMJ she’s been heavily involved in their Too Much Medicine campaign. This webinar promises to be an interesting look at the problem of medical excess, and hopefully some ideas on how we can prevent the continuation of over-medicalisation.

This webinar takes place on October 31st 4-5pm (UK time), and you can register for free here.

Opinion: How to fulfil China’s potential for carrying out clinical trials

Some researchers believe that China has the potential to become one of the world’s most favoured sites for performing clinical trials. Largely, this is because China is home to ~20% of the world’s population, as well as a pattern of morbidity and mortality that is increasingly similar to Western countries – it has been suggested that doing trials in China could solve the recruitment issues we see so often in trials conducted elsewhere. Currently, China has 32 national centres for clinical medicine research, and has formed a collaborative innovation network of more than 2100 medical institutions in 260 cities. Another attraction is that – for the time being at least – trials conducted in China cost half or less compared to those conducted in Europe and North America because it has larger numbers of medical staff and a lower cost base.

That said, moving all trials to China isn’t a viable option right now; the country’s trial experience is very much in its infancy, and it’s important that we ensure that trials are of a high quality. This article published in the BMJ provides some initial ideas of how the wider trials community can help to ensure that China is able to fulfil its potential for carrying out high quality clinical trials.