Patient-led Clinical Trials

May 8, 2017 - May 9, 2017, London

Where patients and pharma join forces to deliver empowered trials

Active Partners in Research

GSK are tapping into their consumer division's skill of capturing consumer insights - could FMCI (Fast-Moving Consumer Insights) be the way forward?

As companies increasingly integrate patient input into their R&D activities, they are realizing that they must also forge strong partnerships with patients and their families. Yet, how do you transform buzzwords like patient engagement, patient voices, patient partnerships from theory into practice?

It starts with "being more systematic", says Danielle Gerlag, Patient Engagement Lead at GSK. “Over the last 10-15 years, we’ve done a lot to get the patient’s voice heard within GSK - and there are pockets of excellence where we have engaged with patients in different phases of drug development to get their insight and to understand the patient’s journey and their unmet needs. We decided recently to use these pockets of excellence to hard-bake this into our strategy across the rest of the organization.”

So GSK created a new group under the leadership of Dr Andrew Benzie called 'Patients in Partnership'. “We’re getting the patient’s voice better incorporated into the lifecycle from the earliest stage. We’d like to make it a deliberate action for teams; whenever they start developing a drug or designing a clinical study they understand when and how to involve patients and come to understand what to expect from their involvement.”

Addressing unmet needs

The team plays a big role in matching the science of patient input to unmet needs, says Gerlag. “We’d like to encourage patients to become partners in designing studies and get their feedback on the assessments, to really understand if we’re capturing the right data. An example is the recent inclusion of the results from the St George’s Respiratory Questionnaire in the Nucala label. As it is well-known to payers, showing a meaningful impact on this measure is important, enabling more patients to access this important medicine.”

Regulators and patient groups are increasingly interested in capturing the patient perspective, she says. “We’ve seen them ask for it, even in areas where patient-reported outcomes haven’t been used as often, for example, cardiovascular and renal areas. As patients become more internet savvy and connected, we will need to be ready to communicate about these benefits.”

The next frontier: FMCI

GSK is going further, ensuring that perspectives are captured while the patient is using the medication. The company is working with the Clinical Innovation and Digital Platform Performance Unit (PPU), asset teams and external consortia, using digital sensors to collect objective data aimed to corroborate patient benefits and explore novel endpoints.

Ongoing asthma, COPD and rheumatoid arthritis studies include a range of patient-reported outcome (PRO) measures as well as actigraphy (monitoring rest/activity cycles), to more capture experience more holistically, according to Gerlag. “This will enable us to characterize changes in the ability of these severely impacted asthma and rheumatoid arthritis patients to increase intensity and/or duration of daily physical activity, an important goal of managing asthma control.”

Future plans include the application of PRO measurement science to performance outcomes endpoints (for example, activity levels), application of PROs as performance measures in quality measurement of care, greater exploration of treatment preference, greater use of social/digital media methods, and PRO science application to how GSK involve patients in the drug development process.

Digital and beyond

In addition to PROs, GSK still believes in using interviews with patients who complete studies to further characterize the patient experience, says Gerlag. “Patient insights from the exit interviews provide far greater granularity on treatment benefits, side effects, and satisfaction with treatment, than would otherwise be obtainable through clinical and patient-reported outcome measures alone”.

“From these interviews, not only have we learned that the treatment conferred significant benefits in terms of symptom palliation, but importantly how those symptom benefits translated into impacts, such as improved physical function and capacity, enabling patients to perform activities more easily and having a positive impact on their ability to work and fulfil their role within their families.”

The company is also playing a lead role in the validation of such measures. “As part of the EU Innovative Medicines Initiative (IMI) PROactive Consortium, we are developing measures of patient experience of physical activity in COPD. The consortium includes multiple academic institutes and pharmaceutical companies and, most importantly, patient representatives and organizations. The PROactive tools are in the final stages of qualification as novel drug development tools and will be reviewed by the EMA Scientific Advice Working Party this Spring. Once qualified, the tools can be used to measure patient experience of physical activity in clinical development.”

Past experience

Capturing the experiences of past patients through an alumni forum is another area of interest, says Gerlag. “We want patients involved in all phases and have already worked with patient groups on our patient leaflets, patient-informed consent forms etc. to look at the language we are using and how accessible it is to patients. We have developed and tested electronic consent where you can focus on the highlights of the study and click on links to explain difficult terminology (placebo, randomization etc). We have a patient questionnaire at the beginning, middle and end of the study to ask about their experience of the study and what we can do to improve the experience.”

GSK’s consumer health division is a fountain of knowledge, she says. “People in consumer health have a lot of experience of getting customer feedback and using it to develop their products and services – we are tapping into that knowledge to see if we can use it to work with patients to improve their overall experience.”

Danielle Gerlag will be speaking at eyeforpharma's Patient-Led Clinical Trials on 8-9 May 2017.

Since you're here...
... and value our content, you should sign-up to our newsletter. Sign up here

Patient-led Clinical Trials

May 8, 2017 - May 9, 2017, London

Where patients and pharma join forces to deliver empowered trials