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As much as the sponsor and research funders are set on a particular main study, what obligations extend to them when a principal investigator develops an auxilliary study piggy backing on the main study. Should this not also fall in the realm of research capacity building, and thus be encouraged? in case the study is multicentre, and the auxilliary study is sound scientifically and ethically, shouldnt the sponsor, funders and PI-consortia be obligated to roll it over the network to make it more robust. What is your take?
Hi Jesse, yours is a good concern and i wish to share my little experience in being part of a multi-center clinical trial. I too think encouraging the sites to come up with auxiliary studies, as long as they do not affect the outcome of the main study, is a good way to build research capacity. In our multi-ceter trials rolling out sub studies to all sites has not always been feasible as it is dependent on 1)site's research interests 2)capacity to run additional studies as this may draw away resources and participants from the main study...among other things. I believe trial (esp multi-center) offers a unique opportunity and an important question can be answered parallel to the main study if the sites have the requisite resources i.e. interested PIs, participants pool or data and there are financial resources to match.
I totally agree with Gogetti's post above. However, the reason many Investigator's use these kinds of chances to run parallel auxilliary studies is their lack of financial resources! Sponsors who hold trully the desire to build capacity do allow and encourage their partner investigators from the "south" to carry out auxilliary studies (If my experience with MRC clinical trials Unit HIV group, is anything to go by).