Image: Innovative Trials
Q&A: Clinical trials
Q&A: how to find the right clinical trial participants with Innovative Trials
Patient recruitment is one of the biggest challenges in clinical trials. Founder and CEO of Innovative Trials Kate Shaw tells Natalie Healey what sponsors should be doing to ensure they attract and retain the right participants for medical research.
Amy McCleney, research engineer at Southwest Research Institute.
Image courtesy: Southwest Research Institute
Credit: Courtesy of Cognite
he Department for International Trade (DIT) is responsible for promoting international investments and trade in the UK, as well as developing trade policy framework. As new markets are developed and the financial landscape is shifted by changes like Brexit, the DIT works to ensure investments in the UK remain stable and profitable.
In the thick of it is Campbell Keir, Deputy Director of Energy and Infrastructure responsible for the Oil and Gas, Renewable Energy, Civil Nuclear and Infrastructure portfolio.
Innovative Trials works with pharmaceutical companies and clinical research organisations to help them reach their patient recruitment targets. Since it launched in 2010, the company has worked on nearly 200 clinical trials and played a part in six new treatments being approved for patients.
In April, Innovative Trials was honoured with a Queen’s Award for Enterprise for its global reach and impact in helping bring new medicines to market. Founder and CEO Kate Shaw speaks to Natalie Healey about her passion for medical research and ensuring people are fully educated and supported before they participate in a clinical trial.
Natalie Healey: Why did you start Innovative Trials?
Kate Shaw: We started the company ten years ago. Prior to that, I had worked at Roche for 12 years as a global patient recruitment specialist. I felt there was a growing need for patient recruitment expertise, and I thought that the time was right for patient recruitment to be at centre of clinical trials.
We recruited about 40,000 patients into clinical trials and we've been part of the approval process to get new products on the market which has been a huge achievement. I think patient recruitment is finally starting to be seen as a discipline that is really important.
What has brought about that change?
Clinical trials are becoming more and more complex. Around 80% of clinical trials don't recruit on time. People are now realising being proactive on patient recruitment means you’re more likely to get the patients in on time. That means you get the research done on time, which increases the chances of bringing a new product to market.
What are the most challenging elements of patient recruitment?
When clinical trials are set up, it's an incredibly busy time and there are a lot of logistics to sort out, from how you're going to get the drug to market to data collection hurdles. Patient recruitment is a challenge because it can't be controlled in the same way. You’re dealing with people rather than products.
One challenge that's really at the forefront of people's minds at the moment is diversity of trials. Diversity has historically been really low in clinical trials, and some pharma companies are now realising that they need to recruit more patients from BAME populations. There's much more of a focus on recruiting a whole population into the trials, rather than just a certain subset of patients.
How does Innovative Trials help pharmaceutical companies?
One of the things we do is produce patient insight education materials. These might be animations, websites, posters or brochures. We want to make sure patients understand what they'd be doing in the trials. The more education the patients are given, the more likely they are to remain throughout the whole duration of the trial. If patients leave trials early it obviously affects the validity of the trial, which ultimately means all these other patients have given their time and energy and effort to go into trial but then we can't get a result.
To improve diversity for some of the trials, we will go out into the communities and talk to people about the research. We recently worked on an ovarian cancer trial recruiting for BRCA positive women. This faulty gene has a much higher incidence in Ashkenazi Jew populations. We sent information to local synagogues, so the community was aware that they're in a population that has a higher possibility of having this disease. It’s about taking the trial out to the community rather than waiting for people to come in.
What does the pharmaceutical industry need to do to improve patient recruitment?
I think it needs to focus on both recruitment and retention. Make trial design as simple as possible. Being able to collect data where the patient doesn’t have to go into the clinic every time is one way of making trials more appealing. And I think it’s important that pharma only collects the data they really need from the trial. Can you reduce the number of blood tests for participants for instance?
I do think the pharmaceutical industry has got much better at putting the patient at the heart of the trial in recent years. I try and put myself in the patient's shoes, and think if that was me, what would make me not want to do this trial?
How can public trust in clinical research be improved?
People are still scared about clinical research but what we're really trying to do is inform communities that clinical trials are hugely important for the future of medications. And for individuals with certain conditions, a clinical trial could be a really good treatment option for them.
Some populations are even more nervous than others. We have a long way to go in educating people about clinical research. But one positive of the Covid-19 situation is that you hear much more about clinical research on the news. Hopefully, people are now starting to realise how important trials are.
I am an optimistic person, and I like to see the positives in situations. So I think the time is right to really push clinical research. Ultimately what we're trying to do is get the message out there that clinical research is an option for everybody.