Dear GHD members,
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.