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!

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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.

8 Reasons You Should Take Part in a Clinical Trial

I originally wrote this post for the What Culture website when they were first launching the Science section of the website, but I wanted to post it here so that I have it on my own blog too.


Clinical trial participation – probably the easiest way of changing the world.

Clinical trials are a critical part of scientific research; they allow us to make sure new products and devices to manage, prevent, treat or detect disease are beneficial and safe for human use.

Thousands of clinical trials are completed every year spanning hundreds of countries around the world. The results of these trials allow governments to make decisions on health budgets, and doctors to make decisions on which drug or device is best for their patients. Patients can also use the results of clinical trials to make choices about their own healthcare plan. Trials may test drugs or combinations of drugs, surgical procedures or devices, ways to screen patients for diagnosis, and care procedures. Each and every clinical trial requires human participants to take part in the study in order to test these new medicines and procedures, but it’s very difficult to find people to sign up. Trials can be abandoned if enough people don’t sign up to participate, and if that happens then answers to the research question the trial aimed to answer will remain a mystery.

Trials are hugely important to human health and disease; without them we would be unable to move science forward, and ultimately we would be unable to save lives. Why should you be the one to sign up for a trial though, is there any way you can benefit from taking part in a clinical trial? Read on to find out my top 8 reasons to say ‘yes’ to trial participation!

1. It’s a brilliant excuse

Have you had a really busy week at work? Don’t fancy that big night out you’ve got planned and need a decent excuse so your pals will get off your back? They can’t exactly try and twist your arm if you declare you must remain sofa-bound because science said so.

Try, “I’m taking part in a potentially world-changing clinical trial and I must refrain from intense movement (e.g. throwing your usual wild shapes on the dancefloor) and drinking alcohol in excess (e.g. the inevitable 3am jagers you’re known for).”

Other excellent uses for taking part in a trial as an excuse include:

  • Getting out of jobs your partner’s been nagging you about for months (No it’s definitely not ok for you to be doing DIY or unblocking the drains or really anything – much too strenuous)
  • Doing extra stuff outside of work (You can’t possibly stay late, you have a clinic visit to attend)
  • Jury duty (You’re trying to cure cancer and they want you to sit and listen to a minor theft case for 4 days? Nae chance)
2. You can make money!

Each clinical trial is different, and your level of involvement will depend on the type of study, what disease the researcher is working on, and the type of intervention you receive – for example, surgical procedures will take longer than giving you a new type of pill to swallow.

Some trials require very little input from you; you may need to keep a food diary or pop in to see a nurse once every few months. For trials like this where you’re not inconvenienced too much you might get a little treat, a notebook or a few pounds to get yourself a coffee on the way out of the hospital.

For other trials though participants are required to be much more involved; these more intense types of trial can require you to stay in hospital for a few days at a time, attend multiple clinic visits or change the way you live day-to-day. These types of study often pay you a higher sum of money as researchers realise you may need to take time off from work or university. These high paying trials are very popular with unemployed people and students looking to make some extra money.

I will say however, taking part in a trial should not be a decision you take lightly – money is a benefit, not a motivator!

3. You’ll help researchers sleep at night

Trials may test drugs or combinations of drugs, surgical procedures or devices, ways to screen patients for diagnosis, and care procedures. Each and every clinical trial requires human participants to take part in the study in order to test these new medicines and procedures, but it’s very difficult to find people to sign up.

In practical terms, not recruiting enough participants is a Very Bad thing for science. In the very worst cases trials can be abandoned if enough people don’t sign up to participate, and if that happens then answers to the research question the trial aimed to answer will remain a mystery.

Thankfully trial abandonment is rare. In more common cases though, researchers manage to recruit between 60 and 80% of the people they’d hoped to – you’re thinking that’s not so bad, right? It’s not good, that’s for sure; without the target number of participants, the results of a study could actually give us incorrect information. Designing and managing a clinical trial is hard work; there are multiple areas where the study could miss targets and exceed budgets. Recruitment is the most common pitfall; getting you guys involved in their trials is the one thing that keeps researchers awake at night.

Take part in a clinical trial and reduce stress levels of a researcher immeasurably – their families will thank you for it.

4. To find out about your own health

If you’re one of those lucky people who is rarely ill, finding out stuff about your own health can super interesting.

Maybe you’re interested to know what your blood type is; a trial that involves taking a blood sample from participants (a super common thing for trials to ask from their participants) will tell you that, and help advance research at the same time.

Other research can give you more detailed information about your own health. For example trials focussing on genetics often ask to carry out a genetic screen on their participants; this is usually a simple process either using a blood sample or a cheek swab. You could find out if you’re at a high risk of obesity, which could help you turn down that slice of cheesecake you had your eye on for after dinner.

In other cases, trials like this may require more thought before taking part; you could find out you’re more at risk of cancer or neurodegenerative diseases like Alzheimer’s, all from giving a blood sample to a research study. It’s important to note here that genetic trials often offer counselling as well, finding out you are at risk of a certain disease can come as a shock – but it does allow you to implement lifestyle changes and hopefully reduce your risk over time.
5. To improve our NHS

We have all seen shocking headlines about how stretched the NHS budget is, and how likely it is to be stretched further as the UK population ages. Clinical research gives us the opportunity to make the medicines that are paid for by the NHS, and the healthcare procedures we use, more efficient. If we can learn how to make the NHS more efficient, the budget will go much further; magic!

For example, there are lots of different treatments available for diabetes – a growing problem in our society. Which one of these treatments works best though? Trials can answer that question for us. This doesn’t mean we’d stop giving out every other treatment though; each patient is different and certain drugs may work better for some people than others.

What we’d be able to do as a result of a trial like this, is find out which types of people are more likely to benefit from each treatment. Then we would be able to match people up with treatments that are more likely to work more quickly. By preventing the use of trial and error, patients would benefit as their disease would be under control more quickly, and we’d be cutting out waste to free up funds for areas of the health service – everyone’s a winner.

6. To help others

For those of us who are lucky enough to be in good health, we tend to take it for granted until the day we wake up sick. We then promise ourselves we’ll actively appreciate being well again. If you’re lucky enough to never wake up sick, there’s no doubt that you’ll experience someone close to you being given difficult news about their health. I can assure you that this will bring you swiftly back down to Earth.

As a healthy volunteer, clinical trials can give you the opportunity to help others. Healthy volunteers are often the group of people researchers find most difficult to bring in to their trials, mostly because when we’re healthy the problem of poor health seems like a distant problem that we’ll deal with if and when it happens to us. New drugs are tested in healthy people before people suffering from the target disease, this allows researchers to double check that the drug is safe. Without healthy volunteers trials would not be able to run.

So when someone close to you is unfortunate enough to receive an unwelcome diagnosis, don’t spend your time being angry at the world and frustrated because life just doesn’t seem fair; think about signing up to take part in a trial.

7. To take control of your own health

When people are given the news that they have a potentially life threatening disease they go through a mixture of emotions. In some cases they may feel helpless, they may ask ‘why me?’ and be frustrated over their perceived lack of control. Taking part in a clinical trial offers one option of regaining that control.

Being a trial participant does not guarantee that you’re going to be given a new or experimental treatment though – patients are randomly assigned to groups in a trial, so you may end up in the placebo group. A trial can still benefit you as you will be more closely monitored than you would throughout standard care.

Signing up for a clinical trial is not a decision that should be taken lightly; it’s a big decision to make and something that isn’t right for everyone. For others though, they can feel empowered by being a participant in a trial. 1 in 6 cancer patients takes part in a clinical trial in the UK each year, a figure that’s raised from 1 in 26 a decade ago. When asked why they decided to take part in a trial, the majority responded that they wanted to feel in control of their own healthcare, and a trial gave them that opportunity.

8. To advance science

Science is an industry full of unanswered questions, many of which can be answered by completing a clinical trial.

An example of a clinical trial may involve randomly assigning people to 2 groups; giving one group of people a drug you think might prevent heart disease each day, and giving the other group of people a placebo (in this case something that looks like a the drug but which has no effect). The result of the trial will give you information on whether that drug prevents heart disease or not. Other trials may not use placebos at all; in this example one group of people could be given the test drug, and the other group a drug which we already know prevents heart disease. Trials with this sort of design can prevent waste and help science and medical treatments advance – if the test drug prevented heart disease more effectively we could start using that instead of the one already in use.

Isn’t that cool? You could help to answer a huge and important scientific question, and you don’t even have to work in a lab.

What Is Blinding (Or Masking), and Why Is It So Important?

Hoorah! Blogtober day 4, and the resurrection of my Clinical Trials Q&A series.
This is a series where I answer questions about all things trials – this is the third post in this series, previous posts have looked at the first clinical trial, and why you might choose to do a trial in favour of using other study designs (this post explains the concept of randomisation, I’d recommend reading that one if you’re not sure what randomisation is – it’ll help this one make more sense).

This post looks at a concept that’s crucial to the success of trials – blinding.

What is blinding?

Blinding, also referred to as masking, refers to “the concealment of group allocation from one or more individuals involved in the research study“. In practice, that means that if you’re taking part in a trial, you will not know what treatment arm you have been allocated to. Often, your doctor or healthcare professional will not know either.

There are various different types of bias:

Table taken from the European Patients’ Academy

Why is blinding so important?

Blinding serves to avoid bias. Sources of bias can come from participants, clinical staff and/or the trial team that’s interpreting the results.

This is not a bad thing, it’s just a thing. We’re all human, and it’s human nature to be influenced by the things that we know or believe – if we don’t know them then we can’t exert our own biases. Think about it, if you have a headache and you take a pill that says it will make your head feel better, when you do feel better you are likely to attribute it to the actions of that pill. In actual fact your headache might have just lifted of its own accord, but you’re much more likely to believe it was a result of the pill.

This idea translates to clinical trials too – if you take part in a trial that’s aiming to find the best tablets to treat a headache and you are told that you have been allocated a headache-stopping pill, you’re more likely to report that your headaches have reduced since you started taking the pill. If you don’t know what the pill is (maybe it’s a sugar pill that has no medical ability at all, maybe it contains a drug that research think will cure headaches), then you are more likely to report the truth of whether your head is still hurting or not. We are swayed by the information that we have, particularly if that information has the potential to make us feel well or unwell.

Blinding is not only important for participants; clinicians, researchers and the people analysing the trial data can also be influenced by the knowledge of which group a participant has been allocated to. If the person recruiting participants into a trial, or treating people within that trial, knows which group their participants are allocated to, their behaviour may change. These changes are often subtle and completely subconscious, but they could influence the way that the participant views the treatment and therefore influence the results of the trial.

Blinding isn’t always possible

In an ideal world every study would be triple blind – participants, clinicians and researchers would all be blind to the treatment that the participant has been allocated to. The world isn’t ideal though, and lots of the trials that are going on involve complex interventions (i.e. not something as simple as a tablet that you can easily duplicate the look and feel of to ensure allocation remains concealed). Some trials are only able to run if they are single blinded, or completely unblinded- surgical trials for example. Innovative trial designs and techniques are often incorporated in an effort to overcome potential bias in these situations.

Blinding isn’t just important in clinical trials involving humans, lab research involving anything from mice to individual cells can be blinded too! I know that lots of people reading this are involved in laboratory research – if that is you, and you are not currently using blinding to avoid bias in your studies, head to the CAMARADES website.
CAMARADES (Collaborative Approach to Meta-Analysis and Review of Animal Data from Experimental Studies) aims to provide an easily accessible source of methodological support, mentoring, guidance, educational materials and practical assistance to those wishing to embark on systematic review and meta-analysis of data from in vivo studies; that includes providing help and support with things like blinding and randomisation. This resource is a brilliant starting point. If you’re not using techniques like blinding and randomisation in you’re research, you’re not alone. This article from The Scientist earlier this year (original publication here) suggests that more than 95 percent of the preclinical work cited by 109 clinical trial proposals lacked the hallmarks of best practices, such as randomization or blinding. It’s time to change this.

You Can Be Involved in Research Right Now, Wherever You Are

A few months ago I wrote a ‘publication explainer’ post on the PRioRiTy Study. That post focussed on this paper: Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership – the PRioRiTy (Prioritising Recruitment in Randomised Trials) study. Read that post here if you’re interested.

Anyway, back to this post; we are now in the midst of the PRioRiTy II Study. PRioRiTy I prioritised questions about recruitment of participants to trials so that we could provide focus for the research community. PRioRiTy II takes a similar approach, but this time we’re prioritising questions about retention of participants that have been recruited into trials. It makes sense if you think about it; there’s no point in figuring out how to effectively recruit participants into trials if they then go on to drop out later on – we need participants to be recruited and retained in order for trial results to be reliable and useful to patients, members of the public healthcare professionals, researchers and policymakers.

The method that we are using to conduct this project has been used lots of times by the James Lind Alliance (again, more information on that in the publication explainer post I mentioned earlier), and we’re currently in the middle of it.

A few months ago we did an initial scoping survey (I say we, I hadn’t actually joined the team at that point!), that survey generated lots of responses. Those responses were questions and statements about things that people want to know about retention – once this survey closed, I joined the team and worked on data analysis for some of the results.

That data analysis resulted in a list of questions that have now gone on to be included in the ‘interim prioritisation survey’. This is a survey that asks respondents to look at the 27 questions that we currently have, and pick the 10 questions that they think is most important.

If you are:

  • A person who has been asked to take part, or has taken part, in a randomised trial
  • A parent or carer of someone who has been asked to take part, or has taken part, in a randomised trial
  • A person who has taken part in aspects of randomised trials as a partner in the research (eg, helped to get the funding, been on a trial steering committee, commented on patient information such as leaflets, letters etc)
  • A health professional or any member of a research team whose work includes encouraging people to stay involved in randomised trials once they have agreed to take part
  • Someone who has designed, run, analysed, reported on or regulated (eg, ethics committees) randomised trials
  • Someone with experience of the methods of randomised trials (ie, how trials are done)

Then we’d love for you to spare a few minutes to complete that survey – take a look here.
For more information on the PRioRiTy II project, head to the Trial Forge website, and take a look at the video below.

My PhD Project in Detail

Last week I got a comment on one of my blog posts asking what my PhD project is about – I scrolled back through my blog and couldn’t find a post dedicated to explaining it (I’ve clearly been too busy banging on about women in STEM, public engagement, and clinical trials in general terms…), so here’s a blog post focussing on my PhD project to remedy the situation.

Project title

Making clinical trials more efficient: consolidating, communicating and improving knowledge of participant recruitment interventions

Where and when?

The University of Aberdeen’s Health Services Research Unit (HSRU), based with Trial Forge.

Study phases and objectives:

Phase 1: To consolidate existing information on participant recruitment into clinical trials.
This will involve completion of a systematic review of non-randomised evaluations of strategies to improve participant recruitment to RCTs (protocol is published here), involvement in updating the existing Cochrane review on randomised evaluations of strategies to improve participant recruitment to RCTs (the 2010 version is published here, and the update is coming!), and involvement with a new Cochrane review led by NUI Galway which will look at the factors that impact participants’ decisions regarding trial participation using a qualitative evidence synthesis (protocol is published here).

Phase 2: To investigate how best to present and distribute this information for the consumption of clinical trial teams. This phase will comprise of a semi-structured interview study with trial ‘recruiters’ (i.e. people who are actively involved in the process of identifying, approaching and recruiting participants to trials), and ‘designers’ (i.e. the people who are in a position to make decisions regarding the methods that a trial uses to recruit – e.g. the person who decides that using a Twitter post, newspaper article, or radio advert would be a good idea to attract participants to the trial), generation of multiple methods of presenting recruitment evidence, and user-testing of these methods using a think-aloud protocol.

Phase 3: To improve the current knowledge base through facilitation of work designed to fill gaps in evidence. To do this I will be producing protocols for a number of SWATs (studies within trials) specifically designed to fill gaps in knowledge found in the reviews that make up Phase 1 of the project. These protocols will be published on the SWAT repository, encouraging trial teams around the world to fill these gaps in our recruitment knowledge.

Clinical trials are at the core of evidence-based healthcare; because they randomise participants to each arm of the trial, they guard against selection bias and therefore offer the fairest way of evaluating healthcare interventions. In more basic terms, randomising participants to Group A and Group B, then you can make sure that you don’t end up with all of one type of participant (e.g. older people, younger people, more ill people, only one gender etc) in Group A, and none in Group B.

The recruitment of participants into clinical trials is difficult – lots of trials have problems with recruitment, and many require extensions to both time and budget as a result of these recruitment issues. In the worst cases, trials can be abandoned entirely because they can’t recruit enough participants; this causes huge waste. What is surprising then, is that the process of recruitment has very little evidence behind it. Largely, we’re relying on gut instinct, experience, and hope.. none of which seem to be working all that well.

My project aims to begin to tackle the problem of trial inefficiency by getting to grips with how participants are recruited into trials, ultimately aiming to improve recruitment methods in order to alleviate recruitment problems in trials on a global scale.

Why this project?

As part of my undergraduate degree, I did an industrial placement year – I swapped student life for a year working in recruitment. I worked for a recruitment agency that supported clinical research companies in industry to recruit staff (Principal Investigators, Research Nurses, Project Managers etc). Essentially, I spent a lot of time on LinkedIn, a lot of time on the ‘phone, and a lot of time annoying people by calling them after seeing their CV on job sites.. Anyway, as part of that role I set up a bank of Research Nurses for an international clinical research organisation. I hired 15 nurses who would do ad hoc shifts when the trial sites needed some extra pairs of hands. I really enjoyed that part of the job, it was nice to get someone from application through to being hired, and to go on that person’s journey alongside them. What wasn’t so nice though, was when those Research Nurses that I had hired started to get turned away from work. This was because the trials that they were working on didn’t have enough participants – no participants, means no data collection, and therefore no need for my Research Nurses.

When I went back to Uni to finish my degree, I was still searching for ways to recruit participants effectively – I didn’t find much, other than an advertisement for a PhD. I applied, interviewed, and was offered the post the same day. I started a month after graduating from my Undergrad, and I’m still working out how on Earth to recruit participants to trials.. it looks like it might be a career-length question, which is totally fine by me 🙂