Four steps for more patient centric trials
Medidata’s general manager & senior vice president EMEA, Christian Hebenstreit, on placing the patient experience at the heart of clinical trials
Clinical trials have long been steeped in technical, clinical language and usually unintelligible to the patients who go through them. They’ve historically been run in a top-down fashion, managed in tightly controlled clinical settings, and governed by heavy regulations. Added to this, a patient is often a passive participant, not clearly informed on the workings of – nor engaged in – the findings of their own trials. Data, too, was kept away from patients and generally flowed from investigators back to the sponsors, thus missing the very people taking part in the trial.
But times are changing rapidly, and patients are increasingly active in challenging these norms. They want, and expect, to be involved in all aspects of their trial. In response to this, organisations are increasingly taking a patient centric approach to the clinical trial process.
Patient centricity can be achieved by capturing every element of a clinical trial that a patient is going through and using these insights to uniquely design each study so that patients can be involved in key decisions about their health and treatments. This helps to minimise their stress and create the best outcome for all parties involved.
The pharma and life science industry has been proactively focusing on patient centricity for some time now; not only to meet patient expectations, but to improve trial success rates and speed up the development timelines of new drugs. This includes gaining patients’ perspectives and better informing them about risks, benefits and disease progression. However, there are still big steps to be taken before we can see a truly patient centric approach across the whole industry.
The steps to becoming truly patient centric
Adopting a patient centric mentality doesn’t just happen overnight. Here are four steps I can share based on my discussions with some of the clinical researchers we work closely with, distilled and filtered through the lens of our own clinical experts, which can help organisations move towards this approach:
1. Addressing company culture: The primary focus for organisations, clinicians and researchers must always be about providing what is most important to patients and families, rather than the business – a fact that must be accepted and championed by all within the company from the very top.
At our recent NEXT Paris event, Thierry Escudier, head of clinical development at Pierre Fabre Medicaments, explained how a potential patient centric leadership structure could work.
“Patient centricity starts with the CEO, whose main task must be to inspire and communicate to the rest of the organisation why they should implement a patient centric approach to everything they do,” he commented. “The overall strategy is then shaped by leaders within traditional functions such as R&D, regulatory compliance and medical affairs (to name but a few), who can play ambassadorial roles and help implement the CEO’s vision.
“This enables the whole organisation to understand and buy in to this direction from the very outset and help ease the implementation of all patient centric activities.”
2. Understanding each patient experience: Patient centricity requires sponsors, chief research officers (CROs) and clinicians to have a clear view of every individual’s experience within a trial. Yet each trial element and burden – from blood tests to invasive procedures or high numbers of hospital visits – is subjective and can vary from one patient to the next.
Obtaining a clear view across the trial process is essential to delivering true patient centricity. This can also help trial leaders to identify and address potential issues amongst patients, in real time, as they happen, thereby reducing dropout rates and contributing to faster, more cost-effective trial results. The nature of more specialised clinical research means it is harder to find patients that meet all the criteria for a trial. Therefore, there is unprecedented competition for patients and a worrying gap in supply and demand – which a patient centric approach can help address.
3. Using technology to enrich and simplify the trial experience: Becoming patient centric also means being open to embracing new ways of working. Technology naturally has an important role to play here and the smart phone has quickly emerged as a champion in this space thanks to its ubiquity, its ability to run unique medial apps, and its onboard biometric and location tracking systems. These can be used to capture vast amounts of data remotely and in real time, in a way that has been shown to be reliable, reproducible and clinically meaningful. Most importantly, it means that patients can often input trial data, or receive trial information, from the comfort of their own home.
4. Clearly presenting information back to patients: Patients involved in clinical trials deserve to have a clear view of what is happening to them at all stages of the trail process. This can only happen if information is presented back to them in a way that they can understand. This means moving away from using heavy legal documents and language, towards multimedia content and electronic informed consent sheets that respectfully explain concepts and terminologies. This modernised process facilitates dialogue between physician and patient and should also increase patient engagement in a trial.
Cancer Research UK’s patient involvement strategy
Cancer Research UK (CRUK) is just one of many great examples of a patient centric approach to clinical trials. At our NEXT Paris event, CRUK’s head of clinical operations and data management, Stephen Nabarro, explained how, for them, patient involvement is at the heart of everything they do.
“From patient sounding boards providing feedback during the first due diligence phase, all the way to patient interviews and focus groups helping to design trial protocols, participants are proactively encouraged to give feedback,” he told attendees. “They’ll also receive cards thanking them for their help thus helping to remind them of the overall goal of the trial.
“It’s this way that we ensure that participants are viewed not as subjects, who merely receive treatments, but as collaborators and co-researchers whose participation throughout the process is vital to the overall success of any trial or project.”
The way forward
There isn’t a single, clearly defined blueprint that an organisation must follow to become patient centric, but the steps outlined above are a good starting place to help the industry reach its goals. The good news is that an increasing number of organisations are taking positive steps today – we see this across our own customer base and beyond.
It is a trend that is already resulting in a transformative impact on the sector and on people’s lives, opening new opportunities for patients and professionals alike and helping to accelerate the drug development process.