Kate Shaw, Chief Executive of Innovative Trials, discusses the need to be patient-centred in clinical trials including clinical trials recruitment, engagement and diversity.
Top 5 Takeaways
- There is a growing need for patient recruitment support in clinical trials.
- Finding eligible patients is a barrier.
- Lack of patient diversity limits opportunities to test drug safety and effectiveness.
- Patient retention is just as important as recruitment.
- The entire patient experience should be considered.
Tell me about yourself and your career history?
Clinical research is a fascinating field. Prior to co-founding Innovative Trials 10 years ago, I worked for a number of large global pharmaceutical companies and at one time was the only patient recruitment specialist for Roche. I established Innovative Trials due to a consistent and growing need for specialist patient recruitment support by pharmaceutical companies and others.
“Industry needs to work together to tackle misconceptions; research should be seen as something positive and not something to be afraid of”
What does Innovative Trials do?
Innovative Trials is a clinical trial patient engagement company. We work globally alongside pharmaceutical clients and clinical research organisations (CROs) to address their patient recruitment and retention needs.
Our approach is patient-centred: we go directly to patients, focus on their needs, communicate with them in ways that truly engage, and make sure they are fully informed. Our core team comes from a pharma background and have run trials themselves, which means we also understand the perspective, and challenges, of our clients.
Which therapy areas do you work in?
At Innovative Trials we work across all therapy areas and support trials for potential treatments and vaccines, particularly those that are more complex and, therefore, more difficult to recruit to. Projects have involved trials relating to oncology, paediatric arthritis and women’s health.
How can industry improve access to clinical trials?
Clinical trials have the potential to make a significant impact on patient care as those participating are likely to receive closer monitoring and best practice care. Despite this, clinical trial recruitment has always been a challenge.
Around four in five clinical trial sponsors say finding eligible patients is a significant barrier1. If trials miss their recruitment target dates, this can prove extremely costly and inevitably lead to delays in treatments coming to market, if at all.
One challenge is how and when industry considers the needs of patients. Trial investigators and sponsors primarily focus on trial design and protocol to ensure research achieves its endpoints and gathers the right data to bring a treatment to market. While this is certainly important, little consideration is traditionally given to patient experience. This can often be overcome by building it into the trial design.
Industry needs to ensure all communication avenues are explored: most clinicians do not always know about open clinical trials, so cannot inform their patients. This subsequently limits recruitment opportunities.
Location can also be a barrier. Traditionally, clinical trials have taken place at large sites and hospitals with patients expected to travel regularly for treatment. If we are to improve access, industry needs to take a more localised approach and involve more community-based hospitals.
How can patients be encouraged to participate?
For patients, the main challenge remains that many still don’t know what clinical research is or what it involves. We often only hear about it in the media when something goes wrong. Industry needs to work together to tackle misconceptions; research should be seen as something positive and not something to be afraid of. Only by educating people about clinical research will it open them up to the possibility of clinical trial participation.
And of course we, as a whole, need to ensure that any patient materials are produced in the most engaging way for that particular audience and answers their most pertinent questions. This doesn’t always happen.
How can industry encourage diversity in clinical trials? Patient recruitment is not just about finding more people, it’s about finding the right people for the right clinical trial. Patient diversity is key and yet is something the sector as a whole struggles to achieve.
Relationships are vital in encouraging more patients of all ethnicities to participate in clinical trials. Many people are introduced to trials through their physician, so strong links with them are necessary. The industry also needs to look at how it is engaging with more locally-based community and patient advocacy groups.
Which groups are currently under-represented?
As an industry we must do more to encourage more people from black, Asian and minority ethnic (BAME) communities to participate in research. Currently, most patients involved with clinical trials are white and middle-class. We know that not all patients will respond to medical treatments in the same way, which means a lack of diversity limits opportunities to test the safety and effectiveness of new treatments in the widest range of patients.
What’s the future for clinical trials?
Clinical trials are becoming more complex, especially with the development of precision medicines for disease subgroups, so increasing patient diversity and addressing issues around patient recruitment will get more pertinent.
Protocols are becoming more demanding for the investigator sites as well as the patients taking part, so study sites will need support to balance priorities. This could be training and coaching staff in patient engagement best practice, helping sites to optimise their performance, or providing practical support to find eligible patients at a local level.
What role can technology play?
We are starting to see technology such as voice-powered and wearable devices being used to capture and track trial data. There is certainly a place for these products in making some processes easier, but not everyone will want to wear a device or wants a device like Google or Alexa in their home. Industry needs to ensure there are a variety of communication options available that are appropriate for the patient population in question.
How can trials ensure patient retention?
Recruiting enough suitable – and ideally diverse – patients into a clinical trial is only one part of the process. Keeping people engaged so that they do not drop out is equally vital. Without enough patients to report meaningful results, trials may fail. This in turn puts medicines at risk.
Despite this, patient retention, like recruitment, is often overlooked. The entire patient experience should be considered from the outset: recruiting patients and keeping them engaged means thinking about the type of information they want and how they want to consume it; how they are spoken to; the way they are looked after during the trial and how their family is looked after and treated.
1 Clinical Trials Transformation Initiative. Moving Recruitment Planning Upstream to Reduce Barriers to Participation: Recommendations from the CTTI Recruitment Planning Project. Presented at SCOPE Summit, 2017