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Wednesday, September 2, 2015

Outsourcing Clinical Trials to Uganda

By Esther Nakkazi
(NB; I first published this piece on the-newshub https://www.the-newshub.com/science/outsourcing-clinical-trials-to-uganda)

Doing research is like going on a long journey into the unknown. Research is expensive and it is also a long, tedious process for countries to clear and allow it among communities.

Uganda wants to make this process faster by reducing it from 10 to eight weeks. This was revealed by Julius Ecuru, the Assistant Executive Secretary at Uganda National Council for Science and Technology (UNCST). 

I was attending the 7th Annual National Research Ethics Conference (ANREC) held from 7 - 8 July in Kampala, themed ‘understanding vulnerabilities in research.’

One of the reasons research studies like clinical trials take long to be cleared in Uganda is because they have to be cleared by the office of the President. Apparently, this was instituted because some researchers wanted to do it in unsafe regions and had to be guided. But now that Uganda is safe, Ecuru said, this can be minimised.

Henry Tumwijukye, the Country Director, Amsterdam Institute for Global Health and Development while presenting a paper on law and bioethics in research during this meeting pointed out that clearing a research study in Uganda was far too long with so many players, which increases to the already expensive cost of conducting that research.

For instance, if you want to do a clinical trial in Uganda, the protocol is presented to the Community Advisory Board (CAB) by the Principal Investigator.

It is then cleared by the Data safety and Monitoring Board (DSMB) that is appointed by the study sponsor. It then proceeds to an independent Ethics Research Committee or Institutional Research Board (IRB) for scientific and ethical review. There are 17 of these that have been accredited in Uganda by the UNCST and they are listed on their website.

You then register it with the UNCST for quality assurance, if it is a drug or a vaccine it proceeds to the National Drug Authority (NDA), or to the Uganda National Health Research Organisation (UNHRO) and finally it is cleared by the Research secretariat in office of the President.

This definitely increases the cost of research because each of these regulatory bodies charges a fee. Tumwijukye who says there is ‘over regulation’ proposes that these bodies should be helped to get grants from Government or elsewhere, to mitigate the cost of research.

“The time, cost and interplay within these institutions,” said Tumwijukye, "does not make much sense". The roles of these institutions need to be harmonised, he advised.

There are other problems, the conference heard. Most Principal Investigators do not read all the research materials, most are sub-awardees in the north-south collaborations and have no intellectual input. The poorly facilitated and incapacitated ethics committees are also not monitoring research adequately.

But the knock out was that most African researchers do not even know their national research laws, most rely on US regulations. But who can blame them, African governments do not finance research!

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