“I was lucky,” says Sharpe, “I was aware of clinical trials thanks to my experience in the pharmaceutical industry as a young project manager. I wanted the best chance to live, I wanted to see my family grow up. So, I did my homework and realised there were other options out there for me.”
He now sees it as his responsibility to help other patients through their own cancer journeys and has long advocated for the complicated clinical trials landscape to be modernised.
“Many patients have great difficulty finding a suitable trial and are therefore denied life-saving treatment,” he says. “Information is often scattered across numerous different registries, exclusion/inclusion criteria is hard to understand, and there is so much complicated medical language.”
Janssen shares Sharpe’s desire to modernise the trials process. The Janssen Global Trial Community initiative aims to help patients gain access to the latest treatment options and to improve their experience, including returning data to patients while they are still in the trial, while also finding ways to keep clinicians more up to date about trials.
The value of a community
It is part of a drive to improve the clinical trial process for all stakeholders including trial sites, investigators and the healthcare industry at large, says Caroline Feys, Janssen’s clinical innovation project leader.
Janssen’s Global Trial Community aims to improve patient engagement during clinical trials as well as to enable patients to stay connected with the sponsor company and the investigator, as well as with other trial participants after a trial, says Feys.
Sharpe’s experience is a salutary example of the challenges patients face navigating the complexities of the treatment and clinical trial process and of the value that a patient community for trials can have.
Sharpe spent hours, alongside his friend and his brother, researching promising new drugs and the latest treatments, obtaining second opinions and talking to the best researchers he could find. He was eventually to enrol on a pilot feasibility trial combining ipilimumab with lymphodepletion and chemotherapy, TIL (tumour infiltrating lymphocytes) infusion, and high dose interleukin-2, at the Moffitt Cancer Centre in Tampa Florida.
But the trial was not a success and already six months post diagnosis he was back at square one. “I was extremely fortunate,” he explains, “that the Melanoma Research Foundation found me the one trial that was going to have the best result for me. I was struggling to understand what was going on and although I could have navigated through clinicaltrials.gov I would not necessarily have found that particular trial.”
Feys says up to two thirds of patients find themselves in a similar position to Sharpe and look to move on to a second trial while still in the first. Being part of the Global Trial Community is a great way to stay informed about new studies, she says.
“The programme helps us to stay in contact with our patients before, during and after the trial and enables investigators to build long-term relationships with patients. Before a trial a lot of patients are not aware of what a clinical trial even is. We inform them, we educate them and we ask for input into our trial design to build studies that suit them better. It is about taking them on the journey with us, empowering them.”
Data access for patients
As part of the Global Trial Community, Janssen is also running a pilot scheme where patients in trials can now view and download certain clinical trial data and share them with others, such as their primary care physician. “We believe patients own their data, so why should we hide it from them? It’s all about creating more openness and trust,” says Feys.
The Janssen Global Trial Community is being piloted in five studies in the US, Asia-Pacific and Europe in neuroscience, oncology and immunology. By early 2020, says Feys, it is a goal for all clinical trials run by Janssen in all therapeutic areas to have access to the programme and they will continue expanding to all countries included in the clinical trials.
Janssen has also started a consortium with other pharma companies to create an industry standard to share data back to patients. Called the Patient Data Access Initiative it helps companies to implement data sharing with patients while they are still participating in the clinical trial.
These are just the first steps for Janssen. The ultimate goal is to bring patients into contact with each other during a trial but there are still many legal and regulatory implications to navigate, says Feys. “We know patients are currently looking for each other on social media so our ultimate aim is to be able to facilitate that too.
But legitimate concerns must be addressed first, she adds. “We do not want patients to influence each other and jeopardise the integrity of the study. We must ensure the results are not biased.”
Sharpe believes that peer-to-peer contact during trials should become standard practice. “The real-time feedback you get from patients is often just as valuable, if not more valuable, than what you get from your physician,” says Sharpe. “There is a recognition now that anything that can help a patient is beneficial, but the industry as a whole is still having a hard time understanding how to do it.
“I got real-time information from other patients who were on the same trial as me, they told me about side-effects, they advised a good night’s sleep before a treatment. That’s not information you normally get on a standard clinical trial but it is so helpful. Patients connecting with each other should be the norm and where there are exceptions they should be justified and there should be a legitimate medical reason why the connections are not allowed.”
Sharpe has been cancer free since August 2017 when he completed a four-year trial of pembrolizumab (Keytruda). He understands better than most the value of creating a community to enable patients to access treatment options that could save their lives.
“Thanks to melanoma research, I have been given the double blessing of time and opportunity; I use both to help the next patient walking this journey,” he says.