Obopólne korzyści: koncentracja na pacjentach w badaniach klinicznych

Recently, we ran our first clinical trial in hidradenitis suppurativa, a difficult-to-manage lifelong condition that causes small, painful lumps to form under the skin. More than a year before the trial was due to start, we partnered with patient representatives to optimize the trial design and conduct together. 

Some key considerations that came from our collaboration:

• Finding a common language: The participants told us that trial information is often not easily understandable. We worked together to create trial information in easy-to-understand language including visuals.
• Ensuring patient comfort: People living with hidradenitis suppurativa are in a lot of pain. We were planning considering not to allow patients to take pain medication in the trial because it makes it harder to know if the trial drug reduces pain if you have already treated it with separate pain medication. They told us however that it would be hard for them to stop taking pain medication. We wanted to see the benefits of the trial drug but also make trial participants as comfortable as possible, so we found a compromise by allowing certain pain medications to be taken during the trial.
• Agreeing key endpoints: We also learned about the outcomes that truly matter to them, for example pain, and included all outcomes important for patients as endpoints in our trial. 
• Setting clear expectations: The group also told us that not knowing what’s about to happen at a trial visit could cause them anxiety before the visit, which in turn can trigger a worsening of their symptoms. We worked with our patient partners to create visuals that showed what to expect from participation in a trial, from a visit to the hospital, etc. to help them to mentally prepare. When we asked trial participants which communication materials they liked most, it was these co-created visuals.

All these adjustments helped the participants to have a much more comfortable experience during the trial. 

“This is amazing. You’re not just including the patient but memorializing the impact the patient has. This is the first time I’ve seen anything like this. It is the kind of data that pharma companies need. This is the model that every pharma company should have. If you can share this as best practice, it will really help the whole industry.” – Patient representative

We at Boehringer Ingelheim believe in the value of patient-centric clinical development. Building on examples like this one, we are working to integrate patient feedback into how we approach the design and conduct of all our trials.

Patient-centricity is a must. It must go beyond the consideration of patient needs from a sponsor’s perspective to also empower patients to shape their own clinical trial journey. To really build a sense of partnership, this means bringing patients in as early as possible and providing them with the time, resources, and support to get their heads around the highly complex information.  

Transparent communication with the patients is also vital – making clear what is possible, and what’s not. Showing the full picture helps them to stay informed and is another way that we can demonstrate that we are all on the same side.  

This is our vision – and this is the journey we are committing ourselves to. We’re moving from the era of patient centricity to patient design