As a follow up to our recent webinar, “The ’Power of We’: A Practical, Collaborative Approach to Implement and Deliver Clinical Trials Predictably,” we wanted to share the questions and answers, including those for which we did not have time during the webinar.
1. How many principal investigators (PIs) do you [Clinerion] have access to in your research network?
Barıs Erdogan, Vice President, Clinerion: The majority of the hospitals in our network are general hospitals, of which the majority are teaching hospitals, which have a great research focus. This helps to identify PIs for trials. When a site is selected in the Patient Network Explorer, we show the past performance data of the site, and process-wise, we connect trial sponsors directly to the clinical trial center of the sites The rest of the PI engagement process goes under their administration.
2. How reliable is your [Captario’s] simulation?
Magnus Ytterstad, Head of Decision Analytics, Captario: Since we are using ranges when we do the outputs, I’d say we can have any level of confidence when we put a forecast out there. And, as we get more and more information, that will narrow the ranges so that the forecast will be very accurate once the study has started and it’s progressing. And another way to make the forecast more accurate is to calibrate the prediction and setup of all of the variables by looking at what has happened earlier in previous trials of the same type with the same setup.
3. In your [Trialbee’s] outreach to the public, how can you drive diversity to studies?
Robert Molander, Chief Commercial Officer, Trialbee: It’s really the power of our data and the overall approach that I discussed earlier, where we are able to synthesize real-world data with consumer-based behavioral data such that we can target sub-cohorts or minorities in a very targetable way. And it’s interesting, we’ve actually done this most recently in the support of patient recruitment for COVID-19 trials, where we are able to focus on ethnic minorities, socioeconomically disadvantaged groups, as well as individuals working in specific fields. And I think we certainly feel that our model is specifically well-suited for those types of initiatives.
4. I believe that everything starts with the quality of the data at hospitals. Systems presented here are very supportive if the data quality is high. Especially concerning rare diseases, patients are present more in developing countries where data quality is not as high. Do you [Clinerion] have any plan or support to establish the European Rare Disease Registry Infrastructure or ERDRI-like systems in developing countries in collaboration with the local pharma industry?
Baris: We agree that data quality is extremely important. We see that many health care organizations are taking this seriously and are trying to increase the quality of their data. We are already collaborating with pharma in conducting rare disease projects to leverage data to identify underdiagnosed or misdiagnosed rare disease patients. To do this, we use both structured and unstructured (like doctor notes or family history) data. So as technology evolves, we get less dependent on structured data because we can now use artificial intelligence and machine learning algorithms to increase the analytics capability for unstructured data. So, with this said, we are open to collaborate with all organizations to help the patients.
5. What is the quality of leads that you [Trialbee] drive to the site and how willing is the site to work with you?
Robert: The quality of the leads are driven by the fact that we have a 3-step qualification. And I think, from our experience, the sites have really gotten to appreciate the fact that it is the combination of our advanced targeting, patient self-assessment, and the practitioner interview by the Trialbee nurses that is enabling us to vet these participants very, very thoroughly before they’re even presented to the site.
And, of course, then we work very closely with the site to make sure that, prior to that interview or conversation, they have all of the historical information about the participant. Then, we have a well-defined tracking mechanism to make sure that participants are followed up in a timely manner and eventually, of course, randomized into a study. So, it’s worked well so far. This is the challenge: We always seek to focus on sharpening the saw, if you will, but it’s really the multiple qualification approach that is enabling us to make sure that these participants are “trial-ready.”
6. I am just wondering how this [Clinerion] is applicable in other countries where electronic health records (EHR) are not so interoperable or easily available?
Baris: Over the years, Clinerion has accumulated huge experience in connecting with very different types of systems. We have integrated with state-of-the-art systems as well as legacy systems. We are quite flexible in interfacing with systems and we have proprietary, built-in connectors. If there’s structured data, we can certainly find a way to get it in.
7. How many countries and hospitals are contracted with Clinerion?
Baris: Clinerion is operational in 25 countries and has over 200 contracted hospitals.
8. Do you [Clinerion] have hospitals involved in MENA?
Baris: Yes, we currently have 1 hospital in UAE and 2 hospital groups in the Kingdom of Saudi Arabia, making a total of 11 hospitals.