Longitudinal trends and subgroup analysis in publication patterns for preclinical data of newly approved drugs

Abstract

Having observed a large variation in the number and type of original preclinical publications for newly registered drugs, we have explored whether longitudinal trends and/or factors specific for certain drugs or their manufacturers may explain such variation. Our analysis is based on 1954 articles related to 170 newly approved drugs. The number of preclinical publications per compound declined from a median of 10.5 in 1991 to 3 in 2011. A similar trend was observed for the number of in vivo studies in general, but not in the subset of in vivo studies in animal models of disease. The percentage of compounds with studies using isolated human cells or cell lines almost doubled over time from 37 to 72%. Number of publications did not exhibit major differences between compounds intended for human versus veterinary use, therapeutic areas, small molecules versus biologicals, or innovator versus follow-up compounds; however, some companies may publish fewer studies per compound than others. However, there were qualitative differences in the types of models being used depending on the therapeutic area; specifically, compounds for use in oncology very often used isolated cells and cell lines, often from human origin. We conclude that the large variation in number and type of reported preclinical data is not easily explained. We propose that pharmaceutical companies should consistently provide a comprehensive documentation of the preclinical data they generate as part of their development programs in the public domain to enable a better understanding of the drugs they intend to market.

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2021

“…Each novel drug is classified based on its innovation status as defined above (Table 1 ) and on the type of agent (small molecule, antibody, and peptide, and DNA/RNA-related: Table 2 ). As observed previously (Koster et al 2016b , 2016a ), we found a very heterogeneous reporting of data on novel entities in the peer-reviewed literature with regard to type and quantity of data being disclosed and to the number of publications. For ease of reading, we have organized our subsequent discussion by therapeutic areas.…”

Opportunities and Challenges for Drug Development: Public–Private Partnerships, Adaptive Designs and Big Data

“…In a systematic analysis of non-clinical publications presumably reflecting work performed concomitant with commercial drug development, 75% of all such publications had a corresponding author from academia (Köster et al, 2016b). Thus, project-based collaborations between pharmaceutical companies and individual academic groups are an important component of translational drug development, but the specific needs and approaches may vary considerably between projects, even within a company (Köster et al, 2016a). …”