Globalisation of industry-sponsored clinical trials for breast, lung and colon cancer research: trends, threats and opportunities.

OBJECTIVE

Breast, lung, colon cancers are the 'big killers' in oncology. Access to innovative treatments lags behind in low-income and middle-income countries. We investigated the geographic distribution of industry-sponsored trials; and whether results were reported in clinical trial registries.

METHODS AND ANALYSIS

We conducted a search in ClinicalTrials.gov by: (i) study type: interventional; (ii) condition: breast, lung, colon cancer; (iii) phases: I-IV; (iv) funder: industry. Trials registered as of 30 June 2018 were extracted; for completed trials, a second extraction was performed on 30 September 2022.

RESULTS

We included 4177 trials. Phase I-IV trials involving only high-income countries were 3254/4177 (77.9%), while 923/4177 (22.1%) trials included at least one site in middle-income countries (MICs). Most phase III trials (416/688; 60.5%) involved MICs, including only lower MICs (6/416, 1.4%), only upper MICs (225/416, 54.1%) and lower and upper MICs (185/416, 44.5%). Phase IV trials involved MICs in 45/89 (50.6%) cases. Phase I and II trials included MICs in smaller proportions (72/950, 7.6% and 390/2450, 15.9%, respectively). No trials were run in low-income countries (LICs). Among completed trials, 430 out of 1854 (23.2%) involved MICs. Results had not been entered in the registry in 63.4% (1176/1854) of trials overall and 49.5% (213/430) of trials involving MICs.

CONCLUSION

Trials for breast, lung and colon cancers are increasingly delocalised to countries likely unable to get access to innovative medicines. Furthermore, LICs are not hosting any industry-sponsored trials. Measures are needed to ensure benefit-sharing for trials countries; to improve transparency and to stimulate research addressing the needs of LICs.