groups » Global Health Research Process Map » Is there also an applicable trial termination map?

Dear Sam

I find this excerpt of an article by Prof Jimmy Withsworth a thought provoking one, and with his many hears of experience in directing clinical research programmes in Uganda, he in this absract asks many questions which I find it useful to discuss.

Find the excerpt below

It is considered best practice for successful interventions to be made available once a trial is over, but major practical issues surround implementation of guidelines on after-trial provision of care. Whose responsibility is this? Is it the investigators, sponsor, funder or national government? Who should benefit? The trial participants or the community from which they were drawn? How wide is 'the community'? Some guidelines encourage grant applicants to consider before a trial is conducted how post-research access can be ensured.The National Institute of Allergy and Infectious Diseases (NIAID) suggests researchers should submit a plan for after trial care, but note that NIAID itself would not normally foot the bill ('Science', May 2003). The Wellcome Trust takes a similar position, but will assist applicants with the instigation of processes with different stakeholders prior to the research being carried out. Who should decide what is 'best treatment' and when a successful experimental intervention should be provided routinely? Some argue that provision of health care is ultimately the responsibility of national governments.

Collateral healthcare benefits arising as a by-product of conducting a trial need to assessed carefully to ensure that they do not adversely affect the local research environment, amount to coercive or undue influence to participants, and should be of a standard that can be sustained after the research is over.

Although these questions are basically ethical in nature, is there a way of smoothly terminating trials that should be incorporated in the initial design?


  • srpfranzen Sam Franzen 11 Feb 2013

    Hi Innocent

    That's a really interesting and important question. Also a very complex one and i think very much depends on the circumstances and the intervention. I think the key thing is making sure the intervention is important to the local community and is feasible for implementation, post trial. In my personal opinion, the solution is to ensure early engagement with the local health system before the trial begins, to negotiate these terms and issues. If there is early horizontal engagement, the findings are more likely to influence policy and in my opinion working with local stakeholders and government bodies in a horizontal rather than vertical fashion is generally the best way forward in most circumstances. Finding the funding for post trial access is a different issue though, as research funders usually don't have the money to provide this, as their main business is research funding. Since funding is now even scarcer, this is a problem. Once again, early planning for the exit strategy may help, perhaps by working with local government to help them find funding to provide for the intervention if it proves successful. I do not think it is ever sufficient just to do the research and not be concerned with how it is implemented. Perhaps this should be one of the outcomes by which research is assessed for funding in the future? The problem is that researchers can be so busy, and are not experts in all areas such as policy implementation. If this is the case a collaborative and inclusive strategy that involves concerned expertise may help.

    What do others think?

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