THE CAMBRIDGE STATISTICS DISCUSSION GROUP


               Thursday 13th May 2004 7:15 for 7:45



                      Hopkinson Room,
           University of Cambridge Computer Laboratory,
                  Pembroke Street, Cambridge






        Statistical Considerations When Working for a CRO






                       Melanie Cooray,
                    Statwood Partnership,
                          Hitchin


Abstract:
Working for a CRO (Clinical Research Organisation) or pharmaceutical company,
statisticians develop and evaluate the results of clinical trials to determine
 the safety and effectiveness of new medications. The main aspects of being a
statistician are writing the analysis plan and producing accompanying tables,
listings and figures. Issues in statistical analyses include the objective of
the study, primary and secondary endpoints, multiplicity, bias in treatment
comparisons, the patient population, multi-centre trials, assessing
interactions,  adjusting for covariates,  handling missing data, statistical
power and meeting regulatory guidelines. Occasionally further research is
necessary and we have to base our analysis on previous studies. Programming,
sometimes in collaboration with non-statisticians, is important in creating
appropriate output. Clients include medics, clinicians and study investigators.
Our job is to advise the client on the design and analysis of clinical trials
to ensure the data can be analysed.  Depending on the company you work for
there are various processes in place to ensure that good quality information
is passed to the client. Standard documents called SOPs (standard operating
procedures) help to maintain certain standards ensuring working to FDA
guidelines.



Speaker:
After finishing her MSc at the University of Southampton, Melanie began work
for Chiltern International, a small CRO based in Slough.  She then moved back
to Southampton to begin work at PPD Development, a much larger CRO.
Melanie now works in Hitchin for the Statwood Partnership, another small CRO,
where she has been for the past 6 months.


Directions:
Enter the New Museums site through the arch from Pembroke Street.
Turn to the left in front of the building with the brown iron staircase
and pass through the passage way by the tree. Enter the lobby which is
straight in front of you and find the back entrance to the Computer Service
on the left. When inside follow the signs to the Hopkinson Room.
It is not possible to park on the New Museums site in the evening.
The back entrance to the Computer Service will be locked at 7:45.
Arrivals after 7:45 can gain admittance by contacting the secretary on
07761769436.




Provisional Next Meetings:
October - Steve Brooks (Statistical Laboratory).
24th November - Simon Godsill (Dept. of Engineering).

Supper: Some members eat regularly in the University Centre before
each meeting at 6-15pm. Feel free to join them.

Subscriptions: of 4 pounds per member are now due for the 2003-2004 session.

Secretary: Peter Watson, MRC Cognition and Brain Sciences Unit,
15 Chaucer Road, Cambridge CB2 2EF;telephone 01223 355294 Extension 801;
E-mail [log in to unmask]