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Oncology
Research
Publication of interventional phase 3 and 4 clinical trials in radiation oncology: an observational study
  1. Jaime Pérez-Alija1,
  2. Pedro Gallego1,
  3. Isabel Linares2,
  4. Eva Ambroa3,
  5. Agustí Pedro1
  1. 1 Radioterapia i Oncología, Hospital Plato, Barcelona, Spain
  2. 2 Radiotherapy, Institut Catala d' Oncologia, Barcelona, Spain
  3. 3 Medical Physics, Consorci Sanitari de Terrassa, Barcelona, Spain
  1. Correspondence to Dr Pedro Gallego; pedro.gallego{at}hospitalplato.com

Abstract

Objectives Clinical trials produce the best data available for decision-making in modern evidence-based medicine. We aimed to determine the rate of non-publication of interventional phase 3 and 4 clinical trials involving patients with cancer undergoing radiotherapy.

Setting The ClinicalTrials.gov database was searched for interventional phase 3 and 4 trials in radiotherapy with a primary completion date before 1 January 2013. We determined how many of these registry entries have not published the compulsory deposition of their results in the database and performed a systematic search for published studies in peer-reviewed journals.

Results Of 576 trials, 484 (84.0%) did not deposit a summary result in the registry. In addition, 44.9% of them did not publish their results in a peer-reviewed journal. Similar percentages were found for most cancer subtypes: brain (41%), breast (38%), cervical (66%), colorectal (38%), lung (48%), prostate (45%), bladder (56%), head and neck (56%) and lymphoma (33%).

Conclusion Our results show that most trials in radiation oncology did not report the results in the registry. Almost half of these trials have not been published in the biomedical literature. This means that a large number of study participants were exposed to the risks of trial participation without the supposed benefits that sharing and publishing of results would offer to future generations of patients.

  • oncology
  • radiation oncology
  • clinical trials
  • health economics
  • medicine evidence based

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-016040

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    Footnotes

    • Contributors JP-A and PG conceptualised and designed the study. JP-A and PG wrote the first draft of the manuscript. IL, EA, JP-A and PG conducted and analysed registry and peer-reviewed journal searches. AP reviewed the manuscript and helped with the interpretation of the data. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement All data used in this research are publicly available from Clinicaltrials.gov, with the inclusion criteria cited in the text.