The Limited Impact of COVID-19 on US Clinical Trial Activity

Article

Research shows there was no decline in non-COVID related study spending during height of pandemic.

The COVID-19 pandemic has had devasting effects in a broad range of medical, economic and social areas in the United States and many other countries. Just what impact though has COVID-19 had on the volume of US pharma-sponsored clinical trial activity? Public statements have covered the spectrum, from minimal to devasting. However, the Open Payments database actually enables us to answer the question directly; the affect on the total volume of US clinical trial activity has been quite limited. Total pharmaceutical industry spending, as measured by Open Payments, on US patient enrolllment and treatment activities did not decline in the years 2020 and 2021 from the baseline pre-COVID 2019 level.

Open Payments is the result of a federal law, the Sunshine Act. For each year since the end of 2013, pharmaceutical companies with at least one marketed product have had to report all payments, over a low threshold, to physicians and other medical professionals. These Open Payments include two types: general and research. General payments relate to pharmaceutical companies’ payments to medical professionals when marketed products are involved. Research payments though are more restricted, and can be broken down in what is often called clinical grant payments. These cover virtually all clinical investigators and their clinical trial experience across all indications. Other related payment activities, such as consulting, are reported separately and not included in the Open Payments data used for this analysis. All payments must be reported, but the publication of certain research payments may be withheld for up to four years. However, few companies withhold the public release of these data. We estimate that 97% of all US pharmaceutical clinical grant payments are reported, and eventually made public in the Open Payments database.* This report research data only for pharmaceutical company sponsored clinical trials. The Open Payments research (clinical grant) data shown below adjusts for any such delay, even if this reporting delay is minor.

The Open Payments database allows us to measure directly the impact of COVID-19 on US industry-sponsored clinical trial activity through the end of 2021, the most recent year for which these data are currently available. COVID-19 may have negatively affected the launch and execution of clinical trials in two ways. First, COVID-19 clinical trials may have displaced other clinical trial activity. But did this displace non-COVID-19 related clinical trials? Second, the COVID-19 pandemic itself presented major operational challenges to clinical trials of any sort. Recruiting patients, treating these patients, and validating source data are but a few areas where the pandemic must have made the conduct of clinical trials particularly difficult. Since we coded Open Payments data by individual study indication, we are able to answer both questions.

ClinicalTrials.gov shows virtually no decline in the number of US sites opened for Phase II and III clinical trials between 2019, 2020, and 2021. However, opening sites may not adequately capture the level of patient activity taking place. Sites may be opened, for instance, but lag in the recruitment and treatment of patients. There is no way to assess actual activity levels from the ClinicalTrials.gov database. However, Open Payments provides the appropriate data since the payments are predominately associated with patient enrollment and treatment activity.

Open Payments data show a constant, if undramatic, increase in US clinical trials between 2017 and 2021, a trend dating back to 2013 when the database first began. Even if we were to remove COVID-19 related spending from the 2020 and 2021 time period, there is no decline in non-COVID related study spending. Moreover, the total increase strongly rebounded in 2021. The COVID-19 pandemic did not reduce overall US industry-funded clinical trial activity. While COVID-19 studies themselves may have paused, but not due to reduced non-COVID clinical trial activity.

Pharmaceutical company US clinical research spending, reported in Open Payments ($billions)

Pharmaceutical company US clinical research spending, reported in Open Payments ($billions)

Two related questions remain. How did COVID-19 affect commercially funded clinical research outside the United States? And, what will the 2022 data show? Open Payments does not address the question of ex-US clinical trial activity. The data for 2022 will become available in June of 2023.

*A separate analysis of these non-reported data showed that most of these studies were early phase studies from quite small pharmaceutical companies, constituting a very small total share of all commercially sponsored US clinical trial activity.

Harold E. Glass, PhD, managing director, SunshineMD

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