The purpose of the clinical trial is to prove that a new treatment/device brings a new or greater value for a certain group of patients. This value can be measured scientifically, as well as behaviorally (for example quality of life). Once Phase 3 of a clinical trial gets completed, the process of bringing the new treatment/device to a wider pool of patients has not finished. Just the opposite!
Phase 3 usually ends with the beginning of the so-called launching phase when the sponsor companies are planning market access. Launching comes with a lot of questions about the payers and their expectations, patients, and their needs and pathway.
One common mistake a lot of biotech and pharma companies make is to answer these questions after Phase 2 – Phase 3. Why is this a mistake?
Here are two reasons why:
Payers request specific health economics and real world data in order to approve and reimburse your treatment/device.
You perhaps see and hear more and more the term Real World Data (RWD). This is so because payers’ main responsibility is to ensure that whatever they will be paying would really make an impact on their clients – the patients.
Having real evidence proving that your new treatment/device contributes to a better lifestyle, longer life, improved patient journey, and easier access to healthcare is a must when speaking with the payers. Guess what? The approval authorities want to see the same type of information too as they also have their main responsibility towards the patients and their caregivers.
At the same time, RWD is not so easy to get access to. In some countries like the USA, companies have used claims data to create Electronic Medical Records showing what the real patient journey is.
→ This is helpful: when you compare the patient journey with the patients’ experience throughout the clinical trial.
For that purpose, you need to know which parameters of the real journey you want to improve and then add them as endpoints to be measured. What this means though is that by the time a company starts planning the launch of a new product, it’s too late to think which are these parameters they will be presenting as improved.
You need to have the data by that time and in order to have it you need to first integrate a mechanism to generate it through the whole trial at the very beginning (even at Phase 1).
→ This is not helpful: The patient journey mapped thanks to EHRs usually represents the clinical pathway of the patient.
But the main outcomes that a sponsor is supposed to represent in front of payers is what happens after treatment, the long-term benefits (and if possible related again to health economics). This is not information you see in EHR as this is usually owned by the patients the moment they go home, go back to work, or whatever their daily routine is.
This means that again Patient Reported Outcomes (PRO) throughout and even after the trial are a must in order to gather these valuable insights on the quality of life and the real impact of the treatment.
If patients are the consumers, you need to understand what they value:
My observations show that though there is much effort spent in planning how to tackle a concrete market for a new treatment/device, clinical trials are still seen as an operational matter. This is also one of the reasons why we often end up having challenges with patient recruitment and retention.
When planning for launching a new product, professionals would usually run market research campaigns to figure out what is the best strategy, messaging etc. to bring patients closer to their products. I wonder what if this market research is done prior to any launch plan?
Clinical trials also need an understanding of the market in order to plan properly:
- Patient recruitment strategies
- Protocol design according to the patients’ and doctors’ values
This is why gathering patent insights about each and every country you are planning to include in your research is so fundamental.
Patient Experience Data (PED) becomes more and more important. The authorities recognize that too. Last week the FDA issued guidance on how they are using PED when deciding on approving a new treatment. I feel this is just the beginning of a wave where patients and their insights will become even more important in a world driven by value-based pricing.
If you are also interested in how we can map the patient journey country-by-country, let me know and I’d love to chat with you.