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Can we do Clinical trial for new MDR-TB in Africa? What are ways to step forward.

By Akshaya Bhagavathula | 11 Jul, 2017

Dear GHD members,

Greetings,

I am Dr. Akshaya Srikanth Bhagavathula, working as Asst.prof of clinical pharmacy at University of Gondar, Ethiopia from past 5 years. Being health professional, my focus in MDR-TB became extremely important due to their poor outcomes especially in HIV co-infected patients.

I want to seek advise from the experts in the group to know what are basic things need to be fulfilled in order to conduct a clinical trial on MDR-TB patients in African settings. With a team of experts from UK, USA and Australia we developed a new method of drug formulation like skin patches for cutaneous route of administration and a oral inhaler for treating MDR-TB. I would like to see the extent of its possibility to take this research into next phase of efficacy studies in Africa, especially in Ethiopia. I will be happy if anyone can guide me to answer the following:
1. Regulatory aspects: Whom to approach to register the IND in Ethiopia in order to conduct a Phase 1 clinical trial.
2. Registry of clinical trial: where to register the trial if wanted to conduct in different SSA countries.
3. Health research ethics to be followed
4. Where to submit the Protocol
5. Ethical clearance committee for clinical trials
6. Safety reporting of suspected unexpected serious adverse reactions (SUSARs)
7. Protocol amendments

Please provide your support to conduct a ethical research in MDR-TB patients for a saving lives tomorrow.

Replies

 

Abdi Isaak Replied at 7:54 AM, 11 Jul 2017

A good starting point is U of Gondar ethics board and they'll be your one stop resources of research registration info

Manager, health & Family; prenatal to five

jeetesh singh Replied at 10:38 AM, 11 Jul 2017

i think you can please try the UNION , they will be able to guide you in a structured way , please give it a try .

regards

jeet

Akshaya Bhagavathula Replied at 11:55 AM, 11 Jul 2017

Thanks to Dr. Abdi and Jeetesh for their support. I will try to approach
both. If anything to add, Please advise me.

Donald Catanzaro Replied at 8:23 PM, 11 Jul 2017

Good Day,
Some things you should consider:

(1) Most of your questions can and should be answered by your institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB). So wherever you are working (hospital, university, etc.) there should be an IRB and they will be both the first people to ask and the final arbiters of what you are required to create, submit, and file.

If your institution does not have an IRB or is not willing to take on this responsibility, you would simply move the IRB oversight to one of your partners. So your cooperators in the UK, USA and Australia likely have IRB's at their institutions so you could have their IRB take the lead on this clinical trial

However, fundamentally, the IRB that you select to take the lead will be the one that decides all the answers to your questions 1-7.

(2) The setting up of a clinical trial can take some time and quite a bit of planning so start early!

(3) First look at other clinical trials that are underway first with MDR-TB then in Africa. A good place to start is https://clinicaltrials.gov/ a free site from the US National Library of Medicine (an institute within the US National Institutes of Health (NIH)). A search of Condition=tuberculosis,MDR reveals 57 trials and you can click "On Map" to see where (22 are in Africa for instance)

(4) Also look at the TB Alliance (see https://www.tballiance.org) which is a not-for-profit product development partnership (PDP) that assists in TB drug development and clinical trials.

(5) Consider other US NIH informational sources and/or training such as: https://www.nih.gov/research-training/clinical-trials which has a wealth of great information for you to review.

(6) Realize that the community is not necessarily unified with respect to MDR-TB and trials. For some competing viewpoints see:
The political and ethical challenge of multi-drug resistant tuberculosis. (available here https://www.ncbi.nlm.nih.gov/pubmed/25630591)
The ethics of a clinical trial when the protocol clashes with international guidelines (https://www.ncbi.nlm.nih.gov/pubmed/26393009)
Justifying research risks in a clinical trial for treatment of multidrug-resistant tuberculosis. (https://www.ncbi.nlm.nih.gov/pubmed/21932482)
The ethics of clinical and epidemiological research. (https://www.ncbi.nlm.nih.gov/pubmed/21740656)
The ethics of non-inferiority trials (https://www.ncbi.nlm.nih.gov/pubmed/18342678)
Conducting clinical trials on tuberculosis in resource-poor countries: imposed science or equally-shared efforts (https://www.ncbi.nlm.nih.gov/pubmed/16158884)

(6) If you have questions and/or need assistance in the planning of your clinical trial there are plenty of experts out there but if you want to email me off the list my address is

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