Tor 7 dec / År 41 / Nr 5 2023

Capture patient experience in clinical trials – be ready when FDA asks

Can you identify all benefits of your investigational drug – without hearing the users? As FDA will start asking pharma to patient experiences of investigational drugs in clinical trials from 2021, it is high time to listen to the patients. Clinical Survey Outcomes ApS can help gathering patients experiences of investigational drugs.

It is obvious when meeting Jens Harald Kongsø, founder of Clinical Survey Outcomes ApS, that here is a person heading up an innovative research organisation with strong insights on hearing patients in clinical trials. Clinical Survey Outcomes will help its clients prepare for the patient experience related questions of from HTAs and regulatory bodies.

Patient-centered research is not a buzz-word
Based in Copenhagen, Denmark, Clinical Survey Outcomes’ team of 20 experienced researchers collect structured feedback of the experiences of patients, carers and healthcare professionals of new medicine in clinical trials. Even though the company is less than a year old, it is already trusted by both large and small pharmaceutical developers in Denmark, Sweden, the UK and the US.
“Many pharmaceutical companies say that they are patient-centred in their drug development. But in most cases, it is often more of a buzzword than actually the case”, says Jens Harald Kongsø. “What we do at Clinical Survey Outcomes is turning patient-centred drug development into a real option and a strong asset for the pharma company”.
After all, patients are the true experts on what they experience when they test a new drug in clinical trials – and the pharma industry can benefit from this insight.

Patient experience does matter
Knowing what patients experience while using a new pharmaceutical drug does matter. For the safety of patients, health authorities have set up a structured process to ensure that the negative experienced effects are reported throughout the clinical trials.
“Interestingly, no such structured reporting process exists for the positive effects experienced by the users. As a consequence, far too often after a new drug has been launched, we may start hearing about additional benefits of the drug or we simply find out that there are some aspects of the product that turned out to mean a lot to the patients. The problem is, that once the product is on the market most of the clinical trials are over. It is hard to convince a project to re-do a trial because a possible new benefit; the marketing material has been made, salesforce has been trained and the price has been set with the payers. This means that any additional benefit does not get added to the value messages and is not phased into the pricing negotiations”.
“As a result of this, companies should stop the guessing what patients might think of a new project. They should instead take a structured approach to patients’ feedback as their experiences can be an important strategic input to optimise the following clinical trials, guiding many stakeholders within the organisation, and eventually to regulatory and HTAs – because they will ask sooner or later. It is such a shame investing hundreds of millions – and not spending the last small amount to hear what the patients experienced and actually think about the product”, Jens Harald Kongsø concludes.

FDA will soon start to ask about patients experiences in clinical trials
The 21st Century Cures Act has directed the American Food and Drug Administration (FDA) to include the patient’s voice in drug development and review from 2021. This means that FDA will start to ask pharma from 2021. Even though it will not be mandatory for Pharma to provide patient feedback to FDA, FDA´s commissioner Scott Gottlieb have publicly stated that “This is becoming an important element in how we evaluate drugs,”.