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:

Extending openess

Dear Sir,
I commend the authors call for increased transparency in the reporting of
trial results.

I would like to call for this openness to be extended to the
registration of all pharmaceuticals. In brief, Pharmaceutical companies
submit a confidential dossier of data on a drugs purported efficacy,
safety and mechanism of action. This data is independently scrutinised
and a decision is then made as to whether and under what circumstances a
drug is to become available to the public. Making this data available for
scrutiny, perhaps after a drug has been approved, would allow for public,
academic and commercial scrutiny.

Thus there would be an additional layer of review, which should allow
for earlier detection of any flaws in the provided data.

Competing interests: No competing interests

27 August 2001
Alastair Mander
Physician & Geriatrician
Barwon Health