Intended for healthcare professionals


Reporting harms more transparently in trials of cancer drugs

BMJ 2018; 363 doi: (Published 01 November 2018) Cite this as: BMJ 2018;363:k4383

Response to Dr. Barton et al. Re: Reporting harms more transparently in trials of cancer drugs

I would like to thank Barton et al. for their comments on our paper. It is unfortunate that they disagree with the CONSORT statement on reporting harms because their statement that "we do not agree that descriptive terms (such as acceptable, manageable, feasible or tolerable) should be eliminated from oncology trial publications" is in clear contradiction to the CONSORT recommendation. We have explained at length in our paper, in the box and in the podcast why the use of such terms downplays toxicities and may incorrectly influence the risk-benefit trade-off decisions for the patient, and I do not wish to reiterate the same here.

The authors of the letter cite treatment discontinuation rates, dose escalation rates, etc., to make a point that the drugs were indeed "acceptable, tolerable or manageable"; however, we cite the percentages of severe, serious and fatal adverse effects. The main point of our paper is that it should be only the patients who decide whether the toxicities are acceptable. Neither we, the authors of the BMJ paper nor the authors of the letter nor the treating physicians can label toxicities that patients experience as acceptable; it's always the patients' call. However, I again firmly disagree that even the drugs that have fatal adverse effects can be considered as having "manageable toxicities" as the authors of the letter point out using the example of liposomal irinotecan. The very fact that some patients died due to side effects from the drug proves that those side effects were not "manageable".

The other point made by the authors of the letter that the top journals wouldn't have allowed these papers to pass through if they were not accurate is a big question on the journals, that probably the journals should introspect. I agree with the final point that the harms shouldn't be considered in isolation. Throughout our paper, we discuss about the risk-benefit trade-offs. Again, all these judgments have to be made by the patients and not anybody else. We have even provided two solutions in our paper about how we can address this issue.

Thank you for the opportunity to clarify our points. I have no conflicts of interest to disclose.

Competing interests: No competing interests

06 December 2018
Bishal Gyawali
Research Fellow
Brigham and Women's Hospital
1620 Tremont Street, Boston