Everyone who has been involved in the planning of a clinical trial knows the difficulty of considering every stakeholder. Keeping a good balance for your trial success is like juggling. So, why would you want to add another “ball” in the air?
It depends on the “ball” you add to the game.
Patient advocates and patient groups have been overlooked for a long time by the clinical research industry. They are typically not familiar with clinical trials and their potential benefits for patients. Plus, it is labor-intensive to find the right person in each country, and establish a fruitful collaboration.
Overall, this path seems more complicated than attractive when you are busy working on your country selection.
However, it might be worth investing your time. I will highlight some points that might make you consider involving patient groups as early as possible. In this article, I am also offering alternative ways to receive invaluable patient insights without the need for direct contact. Although, if you’d like to get in touch with patient organizations in any given country, TrialHub can help with that.
Let’s look at patient advocates and why they are crucial to successful clinical trial planning. Patient advocates are representing a certain group of patients in a specific region or country. This means, they
- Are familiar with the healthcare landscape – i.e. current standard of care, best hospitals, best doctors, etc.
- Know which patients are more likely to join a study in the first place
- Can highlight the best way/channel to reach the patients (not only via your selected sites)
FOR SPONSORS: If a patient advocate is convinced that you are doing something good for the patients, they might be an even stronger supporter for getting your drug reimbursed, adopting your treatment, and providing ideas of the best patient support programs.
But…can they replace KOLs or site surveys? No, they are complementing them and can provide even more relevant insights:
1. Patient advocates and KOLs:
As discussed in my previous article about Patient Recruitment Prediction it’s important to consider the current standard of care and the specific patient challenges per country. Traditionally, companies ask KOLs.
However, they are not always fully aware of what patients really need. It is easy to forget that patients make decisions based on all aspects of their lives and not just their health. Their journey is not limited to the doctor’s office – it continues with the pharmacy, colleagues, family members, daily routines, and more. And normally, patient advocates are very aware of the Big Picture.
NB! Patient advocates are a rich source of patient insights. Nonetheless, there are other ways to receive in-depth patient insights in a specific country. Many pharma companies and CROs have started using social listening as a method to gather insights while planning their clinical trials. In the last few months, my team and I decided to combine these methods with thousands of other reliable data sources in TrialHub.
2. Patient advocates and Site Surveys:
Site surveys are used to assess a site’s past experience with clinical trials in a specific indication, and whether they have the capabilities and capacities of conducting your new trial. This is hard to replace, as the requirements change and depend on the team and hospital equipment.
Patient advocates, on the other hand, can tell you more about how patients feel about a hospital and its structure. For the main question, does the site have enough patients to reach my patient recruitment target, patient advocates can help too. They know the First-Choice hospital that patients seek and trust after being diagnosed. And sometimes, they are more aware of numbers and demographics than the hospitals.
IDEA: Sometimes, arranging an hour meeting with a KOL or receiving a response from a site might just take forever. Patient advocates can help here too. Often, they are already close to the hospitals and the doctors in the field. If they are on your side, they can give you part of the required information or even arrange a call or meeting for you.
Are patient advocates nice-to-have or a must-have?
Patient advocates are rising stars in the clinical research industry. At the moment, their know-how has been primarily used for protocol development and patient insights. I think they have been underestimated for a long time.
However, this starts to change and forward-thinking and innovative companies are finding new ways to engage with patient advocates and listen to what they have to say. In this increasingly competitive landscape, being innovative is no longer nice-to-have but a true necessity for survival.