Philadelphia, PA – In 2015, Novartis made a bold declaration for what patients should expect from the company in areas ranging from clinical trials to access to medicines. To bring that vision to life, Novartis put people like Cathryn Clary in key leadership areas. Her title is Global Head, Patient Affairs and Policy, Chief Medical Officer; her charge is nothing short of bringing the patient voice into every aspect of drug development.
Novartis starts over 90 trials a year. Its goal is fueling every one with patient insight at every step from setting priorities to communicating impact, following the patient involvement roadmap they co-created with DIA and others. (See page 3)
Clary started by talking to the investigators and trail leads. She asked: are you involving patients? About 40% said yes in some way. For those that weren’t, the key challenges included:
- They didn’t know how and there was no framework to help them
- Fear about regulatory restrictions (they asked: does the FDA want us to do this?)
- Discomfort. Could they meet the expectations of patients? Especially with barriers around health literacy and bridging the science-human divide in communications
- Lack of resources (real handcuffs in Novartis’ intricate budgeting process for trials)
- And, just as simple as the patient voice not being top of mind
From there, it was time to both foster cultural change and build process change. The funnel of change that has had an impact at Novartis started at the very top. Here’s Clary’s blueprint:
- Secure senior management endorsement (and have them speak it clearly)
- Diagnoses the obstacles to change
- Map how to overcome them
- Change processes. Clary said, “If patient engagement isn’t in the processes it probably isn’t going to happen. You can change the culture, but you also have to change the processes”
- Identify tools at each step of the process
- Change policies and governance frameworks
- Develop metrics and process for ongoing feedback
- Invest in culture change
One example of a process change is in the clinical development plan. It’s put together after the drug is past proof of concept and it aligns the frontline team and senior leadership around every aspect of how they’ll develop the product going forward.
As of September, every clinical trial team at Novartis has to complete a patient engagement plan as part of that overall document.
A patient engagement champions network focuses on culture change. They’re clinicians in every clinical area who spend a minimum of 10% of their time getting to better understand the tools of patient engagement and how they can drive change.
Another culture shift is actively creating empathy for real-life experience. In preparation for the launch of a drug for chronic heart failure, the team learned the patient journey as a team simulation. Some people were whisked off to an ER. Others wore heavy vests to feel how hard it would be to breath, or sorted up to 20 medicines to make a personal plan. Some were told they had died. Clary said it was a profound experience that informed how they engaged the patient.
Clary also borrowed a simple set of questions from Pfizer to fuel better conversations between senior management and trial designers about how to engage patients:
- What do we know from the patients’ perspective about our development plan or trial?
- How are we incorporating patient knowledge in experience into our development plan or trial?
- What’s the value to patients for our project?
Novartis believes that patient voice can bring more relevant products and evidence to market. Clary shared one example of a cardiac drug that’s data showed a reduction in mortality and hospitalization. But the patient reported outcomes in social media and primary research were much more about symptom relief. That’s what’s really meaningful to them. And what we might better focus trials on in the future.
*Disclaimer: Mentions contained in these posts do not indicate any association between the products and companies and INC Research/inVentiv Health. All details, statistics and figures are taken from the noted presentation.