From Approval to Publication: Study Types and Timeframes Using the UK Clinical Practice Research Datalink

OBJECTIVES: Timely access to reliable real-world data is critical to inform decision making. However, accessibility and usability of databases varies. This research aimed to investigate the types of studies conducted using the UK Clinical Practice Research Datalink (CPRD) and the time from their approval to publication.

METHODS: CPRD protocols approved between January 2019–December 2021 were matched with publications in the CPRD bibliography. December 2021 was selected as a cut-off to allow sufficient time for subsequent publication. Protocols and publications were manually matched using technical summaries and approval IDs. For each publication, research type and disease area were extracted, and time from approval to publication calculated.

RESULTS: 295 approved protocols were matched with publications; 433 could not be matched. Clinical and epidemiological research were most frequent (53.7% and 35.7%, respectively), while economic research was less common (10.5%). Publications in endocrine and cardiovascular research were most common (18.0% and 16.6%, respectively). Other areas included oncology (9.8%), neurology (9.2%), respiratory (8.1%), mental health (6.4%), musculoskeletal/orthopedics (5.8%) and COVID-19 (4.8%). The mean (standard deviation) time from approval to publication was 2.2 (1.0) years, with little variation between study types, ranging from 2.1 (1.0) to 2.4 (0.8) for epidemiological and economic studies, respectively. During COVID-19 (March 2020–December 2021), a spike in mental health protocols was observed.

CONCLUSIONS: CPRD data support clinical and epidemiological research in disease areas that reflect health priorities of the UK. Completing studies that utilize CPRD data can be a lengthy process. Average times presented are likely underestimated, as ongoing studies could not be matched. While reasons for delays are not reported by CPRD, delays during study execution and data access post CPRD-approval could be contributing. Greater transparency regarding average times for review, approval and data release may be beneficial to inform study planning.