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
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;
- 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.
- 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’.
- 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!