SORAMIC clinical tria

I thought this may be of interest.

Firstly in relation to the way clinical trial data is collected , as was discussed on HC a few weeks back.

And secondly, and far more interesting, are the words in BOLD, below (my bold).

CAFA's rose tinted specs on again, but MAY suggest that SIRT is having an impact, or maybe just more non sirt pts moving to France
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http://www.soramic.de/assets/NewsletterPDFs/2015-11-05SORAMICNewsletter5-15.pdf

Second Interim Analysis
Magdeburg, 2015-11-05


Dear Friends and Colleagues, We are preparing for our second interim analysis of the primary endpoint in the palliative arm. In preparation for this analysis, at the next monitoring visit, your CRA will be collecting outstanding CRFs for all patients randomized before 1 June 2015 and all patient visits before 1 September 2015.

It is very important that you be available at the time of this visit, so that you can sign these CRFs at that time. In addition, please remember that we need endpoint information (i.e., the date of death) for patients who withdraw from active study participation in the palliative arm of the study. Please follow up your patients even after withdrawal.

There are more early withdrawals in the sorafenib-only group, which leads to an imbalance in the data that we acquire.

For most of you, your CRA visits about every 2 months, so we expect to have all of the data for the second interim analysis in hand by early next year.

Kind regards, Jens Ricke Peter Malfertheiner