University of Aberdeen requires trial results to be posted within 12 months

28 Mar 2017

The University of Aberdeen’s clinical trial policies require the summary results of some clinical trials to be posted on a registry within 12 months of trial end. However, the policy only covers some types of trials, and the university fails to assume responsibility for auditing staff compliance and publishing audit results.

 

 

Strengths:

 

Clear and time-bound results posting policy:

o   “It is mandatory for the Clinical Trial summary results to be posted in EudraCT within six or twelve months following the end of the trial, depending on the type of trial concerned (six months for paediatric and twelve months for other trials).”

 

Clear allocation of responsibilities:

o    “It is the Sponsor’s responsibility to ensure that the CI posts the Clinical Trial summary results in EudraCT for CTIMPs within the appropriate time frame.”

o   “It is the CIs responsibility to ensure that study findings are published and disseminated in a timely and appropriate manner… The results of all CTIMPs should be appropriately disseminated through publication in peer-reviewed scientific journals.”

 

Includes auditing provisions:

o   “It is the Sponsor’s responsibility to ensure that these processes are appropriately audited by the QA manager (or delegate).”

 

Policy explicitly covers non-completed trials and those with null results

o   “There is an obligation to full and open publication of research project results, whatever the findings. Research projects with null results, those which failed to recruit to target and those which were unexpectedly terminated, all need to be published.”

 

Policy is reviewed at least every 3 years

 

Weaknesses:

 

Many trials are not covered by the policy:

o   Trials other than CTIMPS are not covered

o   CTIMPS in which university staff are involved but that are not (co-)sponsored by the university or the local NHS are not covered

 

Shifts some responsibility to external parties:

o   The trial sponsor (rather than the university itself) is responsible for ensuring that summary results are posted on the trial registry

o   The trial sponsor (rather than the university itself) is responsible for ensuring that relevant processes are audited

 

Weak auditing provisions:

o   The university does not assume responsibility for auditing staff compliance with its own policy (i.e. when the trial sponsor is the local NHS)

o   The university fails to ensure that audit results are made public

·         Authors are only “encouraged” to follow EQUATOR reporting guidelines (rather than being obliged to do so)

 

Link to FOI response

 

Link to relevant policy

 

Note: This blog is based on the university’s response to a Freedom of Information request. In total, I filed identical FOI requests with 17 UK universities. Future blogs will explore the strengths and weaknesses of other universities’ policies.

 

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