Putting empathy front and centre is crucial for improving both recruitment and retention in clinical trials. This was the key message from Vicky DiBiaso, Global Head, Patient Informed Development & Health Value Translation at Sanofi. By delving into patient experiences across the entire lifecycle of a trial, Vicky and her colleagues are better able to empathise with the patient journey and make meaningful changes to the study design, benefitting both patients and those running the trials. In a recent webinar, “Putting the patient at the heart of clinical trials”, run by A Life in a Day, Vicky shared her insight on exactly how to put this patient-centred thinking into practice.

Empathise from the start

By delving into the lived in experience of being on a clinical trial or trying to empathise with a family member or carer of someone on a clinical trial, this can help us understand what really matters to them and ensures relevant patient data is not missed.

Rethink study design

Stop and look at the study design right at the start i.e., think about the psychological and physical burdens that are being asked of participants. For example:

  • Types of procedures and tests they are being asked to have
  • of times they are being asked to come to the clinic
  • The burden on family members with regards to transportation or childcare

If these examples are better planned for, then the trial can be made fit for purpose, and in turn this can positively impact recruitment and retention rates.

Provide flexibility

By making sure clinical trials fit within the lives of participants, we may make recruitment a little easier. By using decentralised models or designs which allow remote patient monitoring, we can make taking part in a clinical trial easier for the participants and increase retention.

Think about diversity earlier.

To really understand the patient population, we need to look at real world evidence, research the patterns of disease and uncover the social determinants of health. From this we can then determine which sites are needed to ensure that specific population is captured in the clinical trial.

Look at belief systems

People take part in clinical trials for many different reasons. By looking at their belief systems and the drivers that decide their choice, we can help make the clinical trials fit for purpose and take away the fear they may experience.

Collect data that matters

Does the data being collected, really matter to the patient? We need to think about patient reported outcomes and whether they will make a difference to their lives in the future. Making sure QoL is always first on the list. Patient prioritisation is key.

Think beyond clinical trials

We also need to think beyond clinical trials and to the future. Will this experimental treatment make the difference the patients really need? Will an inhaled version make life easier for the patient or more stressful? Afterall, clinical trials are obsolete unless they have the potential to make a marked improvement on people’s quality of life, well after the trial is completed.

In summary, empathy is key to everything, whether is it in clinical trials or beyond. By involving patients from the very start we can really understand their needs, expectations and how we as an industry, can help.


To read more articles like this from our PM Society Patient Engagement Interest Group, Visit the webpage here. If you’re interested in joining the Patient Engagement Interest Group then do not hesitate to get in touch.