Aims:
Clinical trials are fundamental for the advancement of cancer treatment. Multi-national phase 3 trials are key enablers and suitable Australian access is important. Clinical trial registries are an important quality control measure, providing oversight of the clinical trial landscape. ClinicalTrials.gov is a large US clinical trials database. It is not exhaustive but is broadly representative of clinical trial activity. The aim of this study was to query the ClinicalTrials.gov database for the characteristics of phase 3 oncology trials listing at least one accrual site in Australia.
Methods:
The ClinicalTrials.gov database of some 350000 trials was queried for all phase 3 cancer trials. The resultant subset of 8045 trial records was downloaded for further analysis. The records were analysed using python and simple descriptive statistics applied.
Results:
Of the 8045 trials 2553 trials ran in 2 or more countries (703 did not contain information related to country and 4789 trials were conducted in 1 country only). The most common tumour types studied in the 2553 trials were breast, lung, leukaemia, prostate, colorectal, myeloma and melanoma with 306, 297, 203, 169, 166, 101, 95 and 79 trials respectively. Australian sites participated in 1000 of these 2553 trials for an overall participation rate of 39%. The rate of participation for the most common trials were breast 35%, lung 43%, leukaemia 44%, prostate 38%, colorectal 36%, myeloma 41% and melanoma 70%. The most common interventions (experimental and standard) in multi-national trials were drugs (61%), biological agents (12%) and radiation (9%). The overall participation rate and frequency of major intervention types was broadly stable across time.
Conclusions:
Australia participates in 39% of multinational phase 3 oncology trials as listed on ClinicalTrials.gov. Trial participation rates across the major tumour types are broadly similar with the exception of the high participation rate for melanoma studies.