Clinical Intelligence Analytics - Trends by Study Attributes

In the last post, we looked at the growth trends of studies registered, initiated, completed and posted results over the period of last 20 years. We looked at yearly trends and then drilled down at quarterly and monthly trends and compared the growth in current year with the previous year.
In this post, we will see the growth trends of registered studies by study attributes like study type, study phase, Drug/Device and DMC flag over the period. I have filtered out the studies where the study attributes were not specified.

Figure 2.4

This dashboard (Figure 2.4) is an extension of growth trends:
1. Study Submission Trend by Study Type-
The chart shows the trend of studies submitted for interventional and observational types.
The share of interventional studies have decreased. In early 2000's, there were around 90-93% interventional studies and 7-10% observational studies. In last few years, the share of observational studies have increased to 21%.

2.  Study Submission Trend by FDA oversight-
The chart shows the trend of studies by the oversight of the FDA, if the study is for FDA regulated drug or a device. 
Until 2008, the share of the studies for FDA regulated devices was less than 10% which has increased to around 25% now.

3. Study Submission Trend by Study Phase-
 Phase 3 studies are important studies since sponsors apply for FDA approval after that. 
Study type NA are the studies that do not have a phase of a study, and I guess it is mainly for the device related studies. These studies share have increased significantly over the period and I think its because the device related studies share have increased as we observed in the previous chart.
There is a slight drop in the share of phase 1 studies. The share of Phase 2 studies in green has decreased from 43% in 2003 to 12% in 2018. Phase 3 studies have also followed the same trend with the share reducing to just 7% in 2018 from 25% in 2005. Phase 4 are post marketing studies and the share has reduced from 16% in 2005 to 7% in 2018.

4. Study Submission Trend by DMC-
The DMC flag tells if the study has a Data Monitoring Committee appointed or not. There were many studies that did not mention if they have DMC or not. As I mentioned in the beginning, the chart is the representation of only studies that has the data and others were filtered out.
The share of DMC appointed studies increased in the first few years and then start to drop until 2008 after which it picked up again a bit and maintaining the 40% level until 2013 but falling down a bit to 34% in 2018.
Feel free to share your thoughts.
See you soon in the next post.