Clinical Intelligence Analytics - Primary Sponsor

Primary Sponsor Dashboard

Primary Sponsor dashboard (Figure 5.1) provides us insights into the study activities by primary or lead study sponsors. Primary sponsor is an important stakeholder in the clinical trials that has the primary responsibility of initiating, study design and study conduct. In simple terms, we can say that the primary sponsor is the owner of the clinical study. The sponsor can be an individual, a company or an institution, and they can be from industry (commercial) like pharmaceutical or Biotech companies or public non-industry (non-commercial) institutions like government or research institutions. 

 In this dashboard we will look at various aspects of study activities of sponsors.

Figure 5.1

1. How many sponsors have registered clinical trials in the US? How many of them are from the Industry (Commercial)? How many studies have they registered? For how many studies did the sponsors from commercial sector have posted the results for the studies?
The tiles on the top provides few sponsors related summary metrics to answer some of the questions mentioned above.
There are a total of 313,345 studies registered by 28,068 lead or primary sponsors in the US till date. Out of 28,068 sponsors, 8,717 sponsors are from commercial sector with 81,169 studies registered and the remaining 19,351 sponsors are from non-commercial sector with 232,176 studies registered. 
There are 4,545 sponsors with at least one study result posted and 1,680 of them are from Industry. 

2. What percentage of studies were registered by sponsors from industry as compared to the non-industry? 
About 26% of studies were sponsored from the industry or commercial sector. A small percentage 3.31% and 1.16% are contributed by NIH (National Institute of Health) and US government respectively. The raw data did not provide further classification into the non-industry sector. The data is transformed to figure out if the non-industry sponsor is a Hospital or University/Institute/School. The shows that Universities have been a major source of sponsored studies with almost 45% share and Hospitals having 9% share.

3. What's the growth in number of studies sponsored by study as compared to the non-industry sector over the last few years?
Except 2008 and 2014, the number of studies registered by Industry sponsors have largely remained stable around 5,500 mark. In contrast, the studies registered by non-industry sponsors have grown rapidly. Notice the size of the steps in the chart. Also notice the increasing gap between the two lines.

4. What percentage of registered studies have some participation from industry?
The pie chart named Industry Participation shows the share of studies where either the primary sponsor is from industry or at least one of of the collaborators is from industry. About 33% of the studies has some participation from industry.
 
5. Who are the top performing industry sponsors?
The tabular chart shows the primary sponsors from industry sector ranked based on the number of studies registered. The chart also display metrics like number of countries they have recruited patients, number of recruiting facilities, studies in completed state, studies where the recruitment has not yet started, studies that are currently recruiting and studies where results are posted. The success ratio compares the studies that were registered minus the studies that have not yet started or are in progress with the completed studies.
GlaxoSmithKline(GSK) is the top performer with 3351 studies and 91% success ratio followed by Pfizer and Novartis. Pfizer has recruited patients in 105 countries. Sanofi is another sponsor that recruited patients in 107 countries. 

6. Who are the top performing sponsors from non-commercial sector?
National Institute of Health Clinical Center, National Cancer Institute and M.D Anderson Cancer Institute are top 3 performers. The non-industry sponsors have recruited patients in fewer countries as compared to the top sponsors from commercial sectors.
The dashboards can answer many other questions by simply slicing and dicing the data by different dimensions.
If you get any questions in your mind that you want to share, please post them in comments and I will try to address them.
Till next time.  

Clinical Intelligence Analytics - Study Trends

Study Trends

Study Trends dashboard (Figure 4.1) gives us insights into the tends in recruiting country, average registration to enrollment duration and average study duration over the past 2 decades.

Figure 4.1

The data legends are shared between the charts on the first row. Similarly, the legend is same for the 2 charts on the bottom row.
The data is aggregated on a study level and a study is classified as an International (Both US and non-US), US-only and non-US only study based on the countries of patient recruitment. The analysis excludes studies that does not have any recruiting country information which could be for various reasons such as the recruitment might not have started or the study may not have any enrollments yet.
An international study means that it has recruited patients in the US and at least one other country. 
A non-US only study means that the study has recruited the patients in countries other than the US and no patient was enrolled in the US.
For the other 2 charts on the bottom row, the numbers with a minus sign are positive numbers but are shown as negative numbers just for the display purpose as they are on the opposite side. However, this is not intended. The vertical lines are the average lines to show the distance.

The dashboard can provide insights into the following trends:

1. What's the share of studies by recruiting country?
55% of the studies registered in the US have recruited the patients only from countries other than the US. The share of studies that recruited the patients only inside the US is 39%. International studies are just 6%.


2. What is the trend in the study registration by their location of recruitment?
Now that we know something about the share of the studies based on where the patients were recruited, let's take a look at how it has changed over the last 2 decades. The share of international studies has reduced to less than 5% now from 15% in early 2000's. The trend of US-only studies have also declined sharply from lower 90% in early 2000's to 30-35% level now. The trend of non-US studies have increased consistently in past 2 decades from 44% in year 2005 to 66% in 2019.  
Remember that the share of the studies registered in the past years can change based on the studies that are still recruiting or may recruit in future. Hence, the current trend is the snapshot.

3. How has the average time taken study registration to enrollment changed over the last few years?
The chart shows the trend in the time taken from study registration to patient enrollment or study initiation. The chart also compares side-by-side the duration for studies sponsored by industry or non-industry sponsors.
There are many studies that were registered retrospectively, meaning the studies were registered after they were already started (the first patient was already enrolled). Such retrospective studies were excluded from the analysis. Only for the prospective studies, the registration to enrollment duration is calculated in days.  
It appears that it usually took longer, sometimes 1.5-3 times, for non-industry sponsored studies to begin a study after they are submitted. The trend for non-industry sponsored studies is following a parabolic curve. The average registration to enrollment duration for the non-industry sponsored studies is 125 days which is higher than the overall industry average of 107 days. For the most part, the yearly trend is close to the average line except in year 2010 having an average of 145 days, which is also the highest in recent years.
On the other hand, the industry sponsored studies are initiated quickly and the study initiation duration has improved slightly overall. The average for industry sponsored studies is around 80 days which is well below the industry average of 107 days. The average for the last few years has been consistently near the average line.   

4. How has the average study duration changed over the last few years?
The non-industry sponsored studies takes longer to complete as compared to industry sponsored studies. The average study completion duration for non-industry sponsors is close to 3.5 years which is considerably much higher than the overall industry average of 2.6 years. On the other side, the average for industry sponsors is little above 2 years. The good news is that both type of sponsors have made a significant improvement is past 15 years to bring down the average completion duration to lower levels, possibly signalling great improvements in overall operational efficiency in study conduct.
With that positive note, see you till next time. 

Clinical Intelligence Analytics - Study

Study Dashboard

In study dashboard (Figure 3.1), we will look at certain aspects of study at aggregated level as well as at a study level. 

Figure 3.1

The study dashboard will try to answer following questions:

1. What is the average study completion duration for sponsors from Industry and non-Industry?

For all types of studies (All), the sponsors from Industry completed the studies in about 1.9 years. In comparison to that, sponsors from non-industry took almost 3 years to complete the study.

The observational studies (Obs) took longer to complete. The Industry sponsors with an average of 2.3 years performed fairly better than the non-industry sponsors with an average of 3.2 years.

For interventional type of studies (Int), the average study took 1.8 years for Industry sponsor as compared to 2.9 years for non-industry sponsors.

We may further want to look at the study duration by the phase of the study. Phase 3 studies are large scale and complex in nature and hence, it should take longer to complete when compared with phase 1 and phase 2 studies. Let's see what we find. Only interventional studies go through the drug development phases. If you take a look at Avg Study Duration by Phase chart, Phase 2 studies took longest among all the study phases with an average of 3.3 years. Phase 3 studies took an average of 2.9 years to complete where as phase 4 studies took 2.4 years. Early phase 1 studies took longer than the phase 1 studies.

2. What is the share of sponsors from industry and non-industry in interventional or observational studies?

Almost 80% of studies were interventional studies. 56% of 80% which 70% of total interventional studies were sponsored by non-industry sponsors. The industry sponsors have greater share in interventional studies as compared to its share in observational studies.

3. What percentage of studies were completed between 0 to 3 years or between 8 to 10 years?

40% of the studies were completed between 1 to 3 years. Around 29% studies were completed in less than 1 year. 

4. Which studies took the longest to complete?

There are 44 studies (0.02%) that took more than 30 years to complete. The study that took longest was sponsored by Johnson & Johnson to evaluate the efficacy of oral Levofloxacin in the treatment of chronic Bronchitis. This study took 63 years to complete starting in 1931 and completing in 1994 and has enrolled 367 patients. 

5. At study level, how many medical conditions a particular study is conducted?

See the tabular report to view the number of enrollment, medical conditions and the number of study sites and countries of subject recruitment.

6. In how many countries and facilities did a study recruited patients?

See the tabular report.

The dashboard will show the description of the selected study.