Different countries will require different forms of communication and we now have a host of different levels of technology. Among all of this, is trust still a major factor?
Trust is and will always be a major factor in successful clinical trial patient recruitment and retention. When it comes to technology, the advances that we are seeing can help us to reach and engage with clinical trial patients as well as run clinical research. However, the human factor will remain a linchpin to successful clinical trial patient recruitment and retention.“I think at the end of the day, we’re still going to have to have that human interaction to make it all work. I don’t think we can ever be completely virtual in the sense that we’re emojis on a computer. I just don’t see that happening.” – Helen Andrews, Avillion
Engagement with clinical trial participants must also be tailored to each geographical area as patient experience will be different from state to state and country to country. It is no good consulting patients in the US and then using their insight to roll out a trial in Indonesia. Good, consistent engagement where patients feel heard and valued will go a long way in securing trust. And if people trust you, they will be more likely to get involved with clinical research and tell others.
How would you keep reinforcing the importance of human involvement in clinical studies?
The human touch is always important when it comes to building relationships and fostering trust. This is no different for clinical trial patient recruitment and retention. Having someone knowledgeable about all aspects of the trial you are participating in and is just a phone call or email away is essential for a patient’s confidence and a positive clinical trial journey. As Mental Health First Aiders, each one of our Patient Navigators can also provide emotional support and reassurance.
“The human touch is essential for providing patient-centered care, understanding individual needs, addressing any concerns, ensuring that patients are treated with empathy and respect. And that’s something that the Patient Navigator can provide. While digital tools and AI can assist in data analysis and decision support, they can fully replace the compassion and personalized care that…humans can provide.” – Amy Lopez, former Patient Navigator for Innovative Trials.
What would you use in your approach to clinical trial patient recruitment for rare disease research?
For clinical trials that are investigating potential treatments for rare and ultra-rare diseases, it’s more important than ever to build those studies around the patient. Engaging with them early on to understand their perspective and lived experience – to essentially walk in their shoes – is key to designing accessible trials. This patient-centred approach is also crucial for clinical trial patient recruitment. We need to think about how, where and when patients like to be approached, the language and terminology they prefer and any potential enrolment barriers. And of course, we need to consider how we continue to support these patients once they officially become clinical trial participants.
“At that point, retention is huge. You know, we want to retain these patients, we want to make sure that they’re feeling comfortable.” – Kari Reilly, Innovative Trials’ Site Operations Lead
How common is it for patients to be the architects of clinical trial design and how much resistance is there within the industry in terms of patients getting involved in clinical trial design?
As an industry, we are becoming more open to this. We are seeing a shift where large sponsors are including patient groups in clinical trial protocol design and getting feedback at regular checkpoints throughout the study itself, which is a positive step forward. This data can then be utilized to inform and improve future studies.
“Can we listen to patients more? We absolutely can. But we are seeing more of that involvement with patients as active partners…and I think that’s what’s really important.” – Laura Burt, Director of Operations, Innovative Trials
Do you think the COVID-19 pandemic has led to more knowledge of clinical trials among patients generally?
The coronavirus pandemic inevitably thrust the drug development process into the limelight, illuminating the importance of clinical research. What we are seeing now is a shift in the pharma industry when it comes to community engagement approaches, which is an important step forward. Making clinical trials accessible for all appropriate patient populations will improve participant diversity and help ensure results are more robust. It will reduce the burden of clinical trial participation, which will make it easier to recruit clinical trial patients and retain them for the duration of the study. They will also be more likely to report a positive clinical trial experience and share that with their family and friends, spreading their knowledge further and educating others.
“If we can continue that education piece. Then we’re going to start to see that snowball make real traction in the community and the world of clinical research.” – Laura Burt
What are the challenges of raising awareness of and demystifying clinical trials among the public?
The COVID-19 pandemic took a major toll on all of us globally, but it also highlighted the importance of clinical research and the impact it can have on so many people’s lives. However, the public’s understanding of clinical trials is still limited. We need to look at how we educate communities about the benefits of clinical research and continue talking to people about why it’s important to participate.
“We know that there are stigma, still in many communities about the impacts of clinical research…[We need to make sure] the people that go into those communities are representative of those communities. That the education materials we produce…resonate with those communities.” – Laura Burt
Clinical trial community outreach is extremely important. It is an opportunity to educate the public and different patient populations, but it is also a chance to educate ourselves. The more we understand the patient perspective, the more patient-centric we can make protocol design, clinical trial patient recruitment and strategies for effective patient retention.
There are obvious concerns these days about confidentiality and data. Where are we getting the data? Where is it ending up? And how are you securing it?
For our Navigator team, we use a HIPAA-compliant platform to manage all patient-related data. Everything that comes into that platform stays on that platform, so patient confidentiality is protected at all times. The data for each study typically comes from a sponsor’s platform. We work with them to make sure we get the data we need as early as possible.
‘Getting involved from the very beginning to…think out the process of how it’s all going to work is really crucial.” – Kari Reilly
How can we convince healthcare professionals to refer suitable patients and direct them into these trials as valuable stakeholders and potentially unlock medicine access?
There is a general trend for healthcare providers to want to hold onto their patients and not necessarily refer them to a clinical trial. As well as educating the public about the value of clinical research, there should be an education piece for healthcare professionals. This includes physicians, nurses, physician associates (PAs) and healthcare assistants. Not only will they be able to follow their patients’ clinical trial journey, but they can absolutely continue their care after the trial is complete.
“I think it’s easier with some providers than others absolutely, but I think it’s one of those things [where] consistency is key and you just have to keep going at it and, you know, keep trying to raise awareness.” – Laura Burt
What have we learned about patient recruitment and what are the keys to igniting it?
One of the key things is the conversation with patients. You sometimes need to have difficult conversations, but what matters most is how the conversation with that patient ends, and how they feel. Through our Navigator service, it is our goal to make sure that any issues they have during the recruitment phase, or the clinical trial itself, are resolved quickly and efficiently.
The human element in building relationships between sites and clinical trial patients will continue to be important. Over the next few years as technology continues to advance, we anticipate the increased use of artificial intelligence (AI) in clinical trials and patient support. This may be able to help in some cases, but we should never underestimate the power of the human touch as a support tool. Patients will always value the ability to speak to another person about concerns or questions they have, and we should never lose this from our clinical trials.
“I think our biggest takeaway is just understanding that everyone’s situation is very different…it’s diverse patient populations with different backgrounds and different priorities.” – Laura Burt
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