Recommendations are now in from the UK expert group that was set up to investigate what happened in the disastrous TGN1412 trial. In that trial, six healthy men were given a monoclonal antibody that had never been tested in humans before, and they all experienced very serious adverse events. One participant ultimately had to have to have multiple amputations and all those involved were critically ill. You can read the full text of the paper describing clinical outcomes in this trial on the NEJM website.
Many of the recommendations make good sense, and highlight the extra caution that should be taken when testing new compounds for the first time in humans. Interestingly a couple of the recommendations focus on data sharing. The expert group proposed that a European database needs to be developed for drug regulators to share information on safety from unpublished preclinical studies. Shouldn’t this be an open access database, which would have the greatest chance of achieving transparency and maximising public confidence?
Well, the group did say “…the ultimate goal should be an open access database, and the feasibility of this needs to be explored…”, but has shied away from taking this bold – but necessary – step. The report also advocated sharing safety data from phase 1 clinical trials, which would probably be based on the EudraCT database. Again, information in this database is only available to the drug regulators. The risk in keeping EudraCT confidential is that scientists, patients, trial participants, and clinicians cannot learn about the risk / benefit profile of drugs in development – Andrew Herxheimer has very cogently argued why this is important.
Perhaps a real opportunity has been missed here? Open access to data from preclinical studies and clinical trials can only help to design better and safer medicines, and ensure better protection for people who take part. It would be fantastic to see the initial recommendations on data sharing strengthened.