Intended for healthcare professionals

Rapid response to:

Education And Debate

Monitoring clinical trials—interim data should be publicly available

BMJ 2001; 323 doi: https://doi.org/10.1136/bmj.323.7310.441 (Published 25 August 2001) Cite this as: BMJ 2001;323:441

Rapid Response:

Interim Data v. Interim Analyses

Lilford et al [1], make a number of important points about the need
to release interim results from clinical trials. In discussing this need,
however, they write of it as "interim data", not clarifying the separation
between making the results of the interim analyses known and releasing the
actual interim data.

There is an enormous reluctance on the part of researchers to release
their actual data even after they have published the results of their
research.[2] Given this, it seems highly unlikely that they would ever
consider releasing the data that were the basis of any interim analyses.

The release of the actual data should, in the long term, however, be
considered at least as important as the release of interim analyses.

REFERENCES

1. Lilford RJ, Braunholtz D, Edwards S, Stevens A. Monitoring
clinical trials - interim data should be publicly available. BMJ 2001;
323:441-442.

2. Reidpath DD, Allotey PA. Data sharing in medical research: an
empirical investigation. Bioethics 2001; 15: 125-134.

Competing interests: No competing interests

27 August 2001
Daniel Reidpath
Senior Lecturer -- Social Epidemiology
School of Health Sciences, Deakin University