Patient-led Clinical Trials

May 8, 2017 - May 9, 2017, London

Where patients and pharma join forces to deliver empowered trials

Transparency & Outreach Critical to Trial Enrollment

To boost trial recruitment companies must optimize technology to give patients a place at the table.

Pharma has to start making more use of online outreach to engage patients and it must do better when it comes to providing transparency on trial results - these were two of the key messages highlighted during eyeforpharma’s webinar on optimizing new technologies to boost trial recruitment.

Over 500 people tuned in live to hear how Sanofi and AstraZeneca were leveraging different technologies to get patients onto their trials.

Enhancing enrollment

Engaging patients requires a number of elements. Potential patients need to see quickly whether they might be eligible for a trial, and it is important that it is easy for them to understand and respond – for instance by using a call feature via Google Voice built in to an online advertisement. As with any other form of communication, messaging must be tailored to the way the patient wants to receive it and it also makes sense to use a variety of different channels – not ignoring traditional ones.

Companies are rightly wary of regulatory strictures but need to find new ways of getting patients on board. Above all, pharma needs to demonstrate empathy by speaking to patients in a language they understand. This has not always been the case in the past but, the webinar speakers suggested, things may be changing for the better.

Building trust

Webinar participants answered a series of poll questions about enhancing enrollment: to kick off, they were asked what approaches their companies or clients had taken to better engage patient communities and the public in clinical research. Responses were split between those who used social media (42%), study-specific online portals (61%), traditional advertising (57%) and direct engagement with patient advocacy groups (49%).

Patricia Roselle, Assistant Director, Patient Network Manager at Sanofi said the latter finding was important since building trust with the public and patient groups comes directly from giving patients an equal seat at the table and hearing from them. This means that “the message – regardless of channel – has the patient voice embedded in it”.

Dragnet approach

While there was surprise that more people are not using social media, Jenny Skogsberg, Clinical Development Manager at AstraZeneca, suggested that companies were likely to be using all four methods. Roselle said that this ‘dragnet’ approach made sense when you consider that demographics and differing disease areas mean that it is necessary to engage patients in different ways. 

Putting our patients first means we have to have multiple options available.

To illustrate this, she described how Sanofi ran patient panels for diabetes patients and found that Type 1 patients, who were typically adolescent, wanted a Bluetooth-enabled glucometer whose data could be uploaded into e-diary – but Type 2s, who tended to be older, preferred a paper diary. “Putting our patients first means we have to have multiple options available,” she added.

Roselle went on to explain exactly how Sanofi was attempting to improve trial enrollment. “There is great opportunity for patients to participate but they’re not getting the reach or understanding they need,” she began. To address this, Sanofi has established a network across 60 countries of patient advocacy group leads. “We align our stakeholders within Sanofi – medical advisers, marketing etc. – and initiate outreach at local level to understand unmet needs,” she went on. Sanofi gets feedback from patients on study design or in areas such as whether there are particular difficulties in engaging with different ethnic communities. “It’s about getting more entrenched with patients,” she concluded.

Asset evaluation

Patient groups seek to influence access and pricing, and Sanofi is keen to hear from them earlier in the development continuum. The company recently met with diabetes patients before study design, at the stage it calls asset evaluation, and asked them what a perfect treatment would look like. For instance, would injecting insulin once a month be easier and how could the fear of hypoglycaemia be eliminated? “They feel valued, they want to participate in your clinical trial,” says Roselle. “That helps drive recruitment and retention.”

“It is important to really understand what the patient wants and what we can do to create that product for the patient,” Skoksberg agreed. “We’ve done similar exercises to understand the patients’ needs – it makes them feel valued, gives them an influence when we’re designing trials and products.”

Thorough information

AstraZeneca has been using online recruitment for trials with study-specific web pages, connecting them to Google and Facebook advertising and co-operating with advocacy groups on email address lists and using their Facebook pages. “These web pages are a good way of getting thorough information about the study when compared to newspaper advertising,” she explains. “It gives the patient the information they need to take the decision.”

They feel valued, they want to participate in your clinical trial. That helps drive recruitment and retention.

Skoksberg was surprised to find that nearly a third of webinar participants had never seen a clinical study ad online. “But this is going to change,” she said. “In 5-10 years’ time there will be a lot of visibility of clinical research on the web. This could speed up recruitment, of course, but could also be a good patient retention initiative.”

They make it easier for patients to show relatives what they are doing, for one thing – and it would help companies put their message across. “In the worst cases, patients would find negative information from some blogger – not the informative information that we would want to give – so it’s important every study has a webpage,” she added.

Room for improvement

One key area where webinar participants clearly felt there was massive room for improvement was the question of how well pharma displays ongoing research to the public. Nearly 90% said the industry did this badly.

“As an industry, we’ve not provided trial results to patients very well at all”, agreed Roselle. “If you try on to make head or tail of that information, it’s not consumer friendly,” she acknowledges. “The return of results in lay language is key. We’ve had internal discussions about how to do that – a password-protected portal for example.”

“We’re working a lot on this right now,” suggested Jenny Skogsberg. “Within one or two years the reality will look quite different.

More wearables

Another webinar poll found that 80% of clinical professionals are not utilizing – or even planning to use – wearable health tracking devices in their trials in the next year. Skogsberg agreed that while it represents a huge opportunity within clinical research, “we’re only starting to explore it”. But many patients are interested in understanding how their bodies work so may be happy to use them, and “it would give us quite a lot of information for free in addition to the information you are already collecting”. 

The reliability of the data from wearables is the main problem, says Patricia Roselle at Sanofi. “When you go to file product registration, you are going to be challenged by the regulator. They will ask how confirmable is the data on which a decision would be made which could affect the general public.”

Google is working on projects designed to ease data quality doubts, she said. If these bear fruit then more companies will be emboldened to use wearables.

As eyeforpharma Chairman Paul Simms said, summing up, “This is the beginning of a conversation, not the end.”

Patient-led Clinical Trials

May 8, 2017 - May 9, 2017, London

Where patients and pharma join forces to deliver empowered trials