Yesterday, I was invited to speak live with Dan Sfera, the site owner and the expert behind Clinical Trials Guru. We got together to discuss some hot topics concerning sites and people who want to get a job in the clinical research field. Dan is passionate about sharing his insights running a site business with his colleagues and helping them do well too. One of the questions Dan raised was:
How can a site compete for more studies (or as Dan described it How to become a site-fighter?)
He wanted to know what sort of data or capabilities a site should capture in order to have an advantage when a sponsor or CRO reviews them for a new study. At the beginning of course we discussed EHRs data as if available at the site might be an advantage. Yet, EHRs depend on multiple parties and are a lot more complicated.
There is, however, something sites can easily get and funnily enough it is something they rarely if ever get asked about in Site Questionnaires.
Site questionnaires are the number one way to get information on whether a site has the patients, availability, and equipment to run a given study protocol. There are a lot of inefficiencies in these questionnaires, but today I’ll talk about the most surprising one of all:
Lack of Insights by Study Coordinators
Traditionally, it is believed that when you need to ask someone for insights this person should be the investigator as she’s the one in charge of the patients’ treatment.
And it really is the case that doctors know their patients best and will be responsible for them throughout the study. Yet, study coordinators have a key role too.
Doctors focus on the medical aspects in the relationship with the patient but then the coordinators are the ones present when patients share their feelings, challenges, and thoughts. They know best why a patient stayed in a trial despite needing to travel long hours. Why they always come with a husband, a child or alone. What their routine looks like.
This ‘data’ is essential for every study protocol and could make or break successful patient recruitment and retention. Though certain CROs do ask study coordinators about their observations, the majority of site questionnaires are missing these questions.
As of today, the site questionnaire is usually an investigator questionnaire.
You might be wondering what questions you need to include next time to have more successful feasibility. Here are some examples:
- Why did patients with X condition (and some eligibility criteria) decide to participate in a clinical trial?
- Why did patients decide not to? What were their top 3 reasons?
- What made patients feel glad to be a part of a study?
- Why did patients quit in the middle of the study?
- What stopped you from providing great patient support throughout the last study with patients with condition X?
- Looking at the protocol, would you recommend this study to a patient, and if not why?
The last question was actually brought to Dan and me by the audience and it is super relevant.
Sometimes, protocols are done in a way that if you are to work on it you need to go against your conscience in order to refer a patient to the study – no one wants to be in this position. As Dan mentioned, nowadays this happens less frequently than before which is a great step towards Patient Centricity.
I believe the insights of study coordinators can be a great asset to all efforts of patient recruitment and engagement experts. If sites can collect them whether they are asked or not, this can not only position them better in front of new sponsors, but they will then contribute to studies that make more sense to their patients and consider their challenges. As I like to say: WIN-WIN for everyone.
If instead of site questionnaires you are interested in prefeasibility of sites, you can also reach out to my team at TrialHub and they will tell you about the ways you can identify your best champions for the study.