We have established that patients add a human dimension to the process of drug development. However, the Patient Voice can become tokenistic when it is included without genuinely influencing decision-making or outcomes. Where enthusiasm for patient engagement within CROs and pharmaceutical companies exists, true commitment often starts off with top-level support, but then only achieves limited adoption across the entire organisation. In other words, it is often a top-down initiative that meets resistance by the time it engages with middle management (for this, read VP and lower). This is where new ideas clash with local organisational customs, practices, knowledge management, maintenance and loss. This is illustrated in the following paraphrase of a conversation I had recently with a CRO:

Question from external consultant: Why is the consent form 25 pages long and written in a style that is inaccessible to everybody?

Answer from middle manager: Because we have always used this. It was written by our team of clinical and legal experts.

Question from external consultant: Don’t you think it might be nice to have expert information design input here? We could develop a more accessible version of the consent form. Then we could maybe test it on a small number of lay people to ensure that real patients in the clinical study can understand it.

Answer from middle manager: [after three weeks of internal discussions] No.

How companies communicate with their patients – their supposed consumers and target clients – reveals the extent to which they take the Patient Voice agenda seriously. If you provide sloppy, lazy information, whether this is a consent form, a clinical outcomes assessment, a package leaflet, a medication guide or lay summaries, then you clearly do not care much about your patients.

Other factors that betray tokenism are as follows:

• When there is limited engagement where patients are consulted only at specific stages, such as at the end of the study or development, rather than throughout the development cycle. This is where patient engagement is an afterthought.

  
  

• When patients are only superficially involved, such as in the form of advisory boards where feedback is not seriously sought or is ignored. If feedback is included, then there is no action taken. This is patronising.

  
  

• Where patients are non-representative of typical patient population, such as only from the above-mentioned ‘empowered’ demographic. This means that views from such patients presented through the prism of privilege, not representative and the needs of a diverse patient population are not captured.

  
  

• Patient input in activities such as a readability testing, concept elicitation, content validity, and linguistic validation is framed as Patient Voice initiatives. This is a bit of a cheat, because in most of these activities, patient input is mandatory. Of course, these are opportunities to understand more about the patient’s lived experience, but this depends on how seriously the sponsor takes their input: is it just a checkbox activity or is it an opportunity to learn from patients? In any event, doing only this is not Patient Voice research.

Patient involvement needs to be meaningful, ongoing and integrated into all phases of drug development. Authentic engagement comes from to what extent pharma companies genuinely listen to and act on patient feedback.

Written by Mark Gibson

Cologne, Germany, October 2024