David Akirtava

	The Open Payments database provides invaluable information about the US clinical investigator terrain. The US government, through the Sunshine Act, requires that all payments to physicians by the pharmaceutical and medical instruments industries be reported in the Open Payments database. The reported details allow us to establish the actual number of US clinical trials in which an investigator has taken part. The last completed database release included data through December 31, 2016. We examine the three years for which complete data are available.

	The concentration of clinical trial activity is clear. Less than a third, 29%, of clinical investigators took part in an industry sponsored study for the first time in 2016. They may, of course, have taken part in studies before January 1, 2014. However, for the three years covered by these industry data, these investigators appear for the first time in 2016.

	The large number of investigators who average less than two clinical trials a year is noteworthy. Three quarters of the total active US clinical investigator pool fall within this category. Research in a large number of fields demonstrates the value of accumulated learning. This may be expressed in terms such as moving down the experience curve, or simple trial and error. However, a large number of current US clinical investigators have limited clinical trial experience.

Total Number of US Clinical Trials per Investigator (2014-2016)*

for active Clinical Investigators in 2016

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This data analysis takes a look at how much experience US clinical investigators have.

US Clinical Investigator Experience

	Understanding the investigator landscape is essential for drug development professionals. This may range from questions about broad trends to more operational issues such as finding the most appropriate clinical investigators for a specific clinical trial. Data from ClinicalTrial.gov indicate that the United States remains the center of global clinical trial activity, by far the most active of any country. The US clinical investigator arena then remains a critical element in global clinical trial activity. 

	Claims about the number of US clinical trial investigators active in the conduct of industry-sponsored studies are usually based more on subjective judgment than verifiable data. Estimates of active US investigators range from about 20,000 to almost 150,000. 

	The US government, through the Sunshine Act, requires that all payments to physicians by the pharmaceutical and medical instruments industries be reported in the Open Payments database. The reported details allow us to establish the actual number of active, unique, US clinical trial investigators. Over the last two complete years reported in the database, 2015-2016, 39,855 principal and sub-principal investigators took part in industry-sponsored clinical trials. No doubt some investigator may have started clinical trials for the first time in 2017, just as a number of the investigators, active in the two reported years, may have discontinued their clinical trial participation. 

	It is even possible to identify the number of active investigators in any given year by medical specialty. The chart below reports the ten most frequently mentioned specialties. Most investigators appear in both years.   

	Number of Active Clinical Trial Investigators Each Year

	By The 10 Most Frequently Reported Medical Specialty

Estimates of active US investigators range from about 20,000 to almost 150,000.

What is the Actual Number of Active US Clinical Trial Investigators?

	R&D spending, according to a number of sources, continues to grow as biopharmaceutical solutions become integral to a wider range of medical maladies. Phase III clinical trials represent the critical data foundation in the new drug approval process for regulatory authorities around the world. Published data indicate the size and complexity of these Phase III studies has hardly changed over the last few years. Despite some assertions about a growing number of clinical trials, there are no data, which can be verified by third parties, supporting these assertions. In fact, one of the most widely accepted sources of data on clinical trials, ClinicalTrials.gov, points to an opposite conclusion.

	ClinicalTrials.gov is a federal database, mandated since 2007 for all organizations conducting studies under FDA auspices. Missing data for any of the variables is often close to zero, and rarely exceeds three percent. ClinicalTrials.gov has become a widely used tool by drug development professionals and a frequently cited data source for research publications.

	The randomized clinical trial (RCT) model has come under stress as the requirements of conducting RCTs became more demanding. As therapies become more targeted though, the financial calculus might very well make these RCTs even more problematic. Yet to date, the number of industry sponsored Phase III clinical trials continues unchanged. The slight drop in the 2016 reflects a slight lag in reporting. 

	Number of Industry Sponsored Phase III Opened in Each Year

Published data indicate the size and complexity of these Phase III studies has hardly changed over the last few years.

David Akirtava

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US Clinical Investigator Experience

What is the Actual Number of Active US Clinical Trial Investigators?

Industry-Sponsored Phase III Clinical Trial Activity