FAQs & Internal Notes

Question 1

How do you calculate patients per site per month?

Answer 1

We have enrollment information on the study level (not the site level). However, given the number of sites in each country, we are able to estimate the average patients enrolled at each site.

Question 2

Where do you get information on delayed studies & studies finished ahead of schedule?

Answer 2

Through the clinical trial registries, sponsors will include their estimated start and end dates in the future for current studies. As the planning and execution progresses, start dates and end date may get pushed back by the sponsor.

Question 3

Where do you get information on studies terminated due to slow patient recruitment?

Answer 3

This is sponsor submitted for the most part through a variety of public sources including clinical trial registries, SEC filings, and press releases. In addition, our journalists are interviewing company executives on their pipeline strategies and sometimes they may disclose why certain studies failed.

Question 4

Where do you get information on study issues on the investigator/site level

Answer 4

• While we know if a study fails due to slow accrual, we do not have this information on the individual investigator level.
• We take that into account in our BPC Smart Scoring and won’t dock an investigator points if they’ve been involved in a couple failed studies where the issues may not have anything to do with that individual.
• Instead, we weigh this field accordingly – if an investigator has been involved in 10 studies with recruitment issues where those studies only had a handful of sites, it’s probably too significant to be a coincidence.

Question 5

Users looking for Specific Data

Answer 5

There may be some people looking at the tool that only work in the planning or selection phases (ex. Investigator Selection). In these cases you should still create a project to show them the reports within a project profile because they have new data points (i.e. studies failed due to slow accrual), easier workflow, and more obvious value prop. This will give you an opportunity to quickly show them the other reports that will be valuable to other groups at their company. Although that individual may not work directly with that piece of clinical operations, everyone will still recognize the value of it and this may open doors to other individuals at that company. If needed, you can always open the relevant search pages to demonstrate the hundreds of search parameters, etc.