Signing up patients for clinical trials has become a major problem for the pharma sector. At present, the main means of clinical trial recruitment is a poster on a hospital wall. It is therefore little wonder that the Tufts University Centre for the Study of Drug Development has found that 48 per cent of Phase II and III drug trials today are under-enrolled or fail to enrol a single patient.
Clinical trials management and technology specialist Icon Firecrest has developed a new “Patient Portal” which will both improve recruitment on to clinical trials for the global pharmaceutical industry and make many more patients around the world aware of trials which could benefit them.
"People suffering from medical conditions all want a solution," says Firecrest vice-president Frances Abeton. "But only 5 per cent of patients around the world use clinical trials as a clinical option. Some people go to great lengths to discover clinical trials that relate to their condition but the vast majority don't know about the trials and don't know how to go about looking for them. GPs tend not to know about them either.
“The Firecrest Patient Portal innovation is about how we can make the 95 per cent of patients who don’t know about them as well as their primary care providers aware of the clinical trials that might offer them a treatment option.”
“We saw the challenge presented by the 95 per cent of patients who are not coming on clinical trials and developed the Patient Portal to enable them to engage with their GPs and the clinical trial investigators in order to access them,” Ms Abeton says.
Each clinical trial using the solution has its own Patient Portal which patients can find through a simple Google search. They may also have been alerted to it through a patient advocacy group or social media. When the patient goes on to the portal they find all the information they need about the trial and can use this to decide whether the trial may be appropriate for them.
This is where Firecrest's long experience of clinical trials comes in. Established in 2001 in Limerick, the company has been providing innovative technology solutions to the clinical trials sector since then.
Documentation
Ms Abeton explains that the sector is very much paper driven. Each trial has a minimum of three large ring-binders full of documentation to explain what it is about and every person involved in the trial – investigators, doctors, nurses, patients, and so on – has to be given one and understand their contents.
“What we have done is turn these ring-binders into multimedia content which can be accessed online”, she says. “By doing that we improve everyone’s understanding of the content. People are both seeing and listening to what will happen as well as reading about it. Research shows that people retain just 10 per cent of the information they read on paper whereas they can retain between 50 per cent and 60 per cent of what they see on video.”
Having easy to use and understand multimedia presentations are particularly important in settings where multiple trials are taking place. “Take a busy hospital in Dublin”, says Ms Abeton. “A nurse there might be involved in five separate clinical trials and have three patients coming in one morning, each at a different stage of a different trial. We turn all the compliance details into easily accessed information. This enables studies to be started quicker and improves compliance considerably.”
Outcome
She points to simple factors that can affect compliance and therefore compromise the outcome of a trial. “It can come down to simple things like measuring a patient’s waistline – just where is the waistline? Or how do you weigh a patient, with our without clothes or shoes? Our technology reduces errors and increases patient safety.”
It is this technology and expertise that has enabled the development of the Patient Portal. Once the patient has accessed the portal and decided they are interested in the trial it is then up to doctors to assess the patient to decide on their eligibility or otherwise.
Very importantly, the Patient Portal also gives the patient information during the trial offering them a better experience as well as easy-to-use tools for feedback, giving researchers improved methods to collect data, and understand patient conditions. The Firecrest eConsent tool also improves overall compliance and therefore the success rates of clinical trials. Some 5 per cent of all adverse FDA findings are due to consent errors and the Firecrest process is aimed at reducing this significantly.
“A typical consent form is 23 pages long and is a very complex document”, Ms Abeton points out. “We have simplified this and put it online with multimedia content explaining each section of it. The patient can go through it, pause it, ask questions and so on, and at the end give their consent . . . ”
Reaction to the Patient Portal has been enormously positive. “We launched in 2015 and due to huge demand we had to go live with it very quickly,” says Ms Abeton.
