Clinical Summary Dashboard
Summary Dashboard gives an overall picture of clinical trials in a summarized form at a high level.
Below (Figure 1.1) is a picture of the dashboard without any data filters. If I make any selection or filter, I will call it out and mention it.
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| Figure 1.1 |
The Dashboard tries to answer some basic questions to start with, and then we start looking at things from different angles and dimensions.
The summary Dashboard can answer some of the following questions:
1. How many studies have been registered so far in the US?
This the total number of studies registered in the database. As on 09-Aug-2019, there are 313,345 studies registered in the US.
2. How many studies did actually started?
A study is considered to be started when it enrolls its first patient. It's an important milestone in the entire clinical trial process. 291,364 out of 313,345 which is around 93% of the studies did actually start by enrolling a patient.
3. How many studies did actually completed?
Another important milestone is when a study completes and the patients who participated in the study stops receiving the drug. Of the 291,364 studies that started, 167,511 studies were completed, which is 58%.
4. For how many studies did the sponsors posted the results?
Once the study is completed, the data collected is analyzed and the results are posted. Results Database was initiated in 2008 whereas the study registration began in 2000, so there might be studies without posted results. 38,127 studies have results posted out of 167,511 completed studies which is 23%.
5. How many studies are currently recruiting patients?
A study recruits patients as study facility location called study sites. These study locations could be in many countries. 54,968 studies are presently enrolling patients including the ones that are enrolling only by invitation. This means 19% studies of the 291,365 studies that were started are still recruiting patients.
6. How many patients were recruited in the past?
There were few enrollment values such as 99999999 that were converted to 0. About 490 Million people participated in the clinical trials across the globe from 210 countries. As per the recent United Nations estimate, the would population is 7.7 billion. We can say that 6.4% of world population has participated in clinical trials of the US. Other countries may have their own clinical trials registry.
7. What is the average duration of study completion?
Duration is the difference in the start and completion date of the study. 2.62 years is the average duration for a study to complete. Phase 3 trials are large scale studies and takes longer than phase 1 and 2, but we will look at that later. We can say that it will take around 8 years for a new drug to complete all the phases of clinical trials before it can apply to FDA for approval. Add another year or 2 for pre-clinical testing of the drug on laboratory animals. Now I understand how lengthy, complex and risky is the entire process of drug development. I will not go into the drug pricing strategies but you got a sense why those drugs are so un-affordable, even with insurance sometimes.
8. How many total sponsors registered the studies?
28,068 sponsors from both industry and non-industry (government agencies etc) have registered studies. We will see the ratio and proportions later.
9. What share of registered studies were interventional or observational?
Almost 80% of the studies are interventional studies where some kind of therapy is given to the participant.
10. What percentage of registered studies were sponsored by industry and non-industry sponsor?
Non-Industry sponsors leads with 3/4th of studies sponsored by them.
11. Top 10 sponsors who registered the most studies?
GSK is the leader. Pfizer and Astrazeneca are other sponsors from pharmaceutical industry following with a close margin. National Cancer Institute, a non-industry sponsor, is at a second position.
12. What are the top medical conditions for which the studies were registered?
Surprised to see obesity at number 2. Asthma and depression are in top 10. I never thought they were so important but I guess our lifestyle changes are responsible for their growth. Breast cancer is the most studied medical condition.
13. What is percentage share by the overall status of the study?
Only a small portion of the studies were withdrawn and suspended, however, 5.65% studies were terminated which could be a cause of concern.
14. What are the top 10 countries that recruited the patients?
US has recruited about 18% of the total participants.
Taiwan at no 2 surprised me. I found it enrolled around 67 million participants for an observational study but Taiwan's total population is around 25 million. The enrollment number is an outlier to me, however, I did not change it. Cambodia too has a study that enrolled 15 million participants for an observational patient registry sponsored by non-industry sponsor French National Institute.
Since observational studies enroll large population of participants, let's look at who are the top countries who recruited for interventional studies only (Figure 1.2). Almost 82 million participants have been enrolled so far and US once again leads the chart with a contribution of little over 13% and China closing the gap at second position.
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| Figure 1.2 |
You can always slice and dice the analysis to look at things from different perspective in a dashboard. It's real fun to create your own questions in your mind and then try to find out the answers yourself.
See you till next time.
