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Friday, August 3, 2018

Recap! - Exploring the intriguing details of International Clinical Research in Uganda

By Prosperity Eneh

I have continued to learn and grow since Dr. Nicol and the 4th year students (Sara and Kunkun) went back to Minnesota. I have had the opportunity to focus more on clinical practice and research with the meningitis team here at IDI and Mulago/Kirrudu general hospital. I have also had the ability to dive deeper into organizing and finalizing logistics for the post-mortem drug distribution research study in HIV patients (learn more).

Preparing items for the post-mortem research study with Paul and Carol
I head back to Minnesota today and for this final reflection, I will break it down into the various aspects of international research work that were most intriguing to me for the past 10 weeks;

International clinical research - collaboration between institutions is vital for sustainability 

It has been very interesting to be plugged into a team that conducts clinical trials on a large scale. In the past when I have read published papers on big studies that have the potential to affect and change national guidelines, it is often hard to imagine the work that goes into ensuring that these clinical studies goes successfully. I have come to understand the intricacies of this sort of work and the level of organization, team work and perseverance that leads to success. The clinical research team in Uganda is often a mix of international and local partners with various roles to play. The team I worked with consisted of medical doctors, nurses, lab assistants, pharmacy personnel, clinical officers, administrative assistants, research assistants, and a few others. The partners in this team include personnel from Uganda, USA and London. Currently the team is preparing for about 3/4 major studies to start and there has been many training sessions. It is rewarding to contribute to these discussions from a pharmacy perspective but I would say more than the contributions, I have learned so much. 

Clinical rounds and its immediate patient benefits

The research team also conducts clinical rounds at the Mulago/Kirrudu General Hospital where patients with suspected or confirmed cryptococcal or tuberculosis meningitis are referred to. They see these patients in the infectious disease ward. During ongoing trials/studies, the patients can be consented and enrolled in trials if eligible, and when there is no ongoing trial, the patients are still seen and treated. It is however an interesting point to be made about availability of necessary supplies during studies versus when there isn't any studies ongoing. I refer to this as immediate benefits for the patients. In a previous post, I mentioned the lack of medications, labs and various other medical supplies needed for patients in the government hospitals. Often, patients are also unable to fund themselves to receive these vital medical supplies. However, when there are ongoing studies, the team often has funds available to provide these essential labs, medications and other medical supplies to the patients free of charge. Both those enrolled in the study and those that are not enrolled get to benefit from this supply. The impact can be life-saving. Prior to each day of clinical rounds, the team with the latest information on the patients, hands off to the clinical team for the day via phone discussions of the patients. The team is  also available in the infectious disease ward for questions regarding other non-meningitis patients.

Sub-projects, data analysis and publications

While there is often some bigger longer term studies ongoing with the clinical team, there are also opportunities for sub projects and other smaller data analysis projects. These offer opportunities for trainees to use data from large cohorts to answer other clinical questions. As one goes on clinical rounds and sees other potential research questions, it is common to see sub projects come out of these observations. The MN Uganda team has been a great training facility for many students, residents and fellows from various healthcare professions. There is often something for everyone that is dedicated to finding answers to questions. This has also led to very many publications that has come out of this group. During the weekly team phone call, sub-projects are also discussed and trainees are able to get mentorship and direction from the team on the direction of the various ongoing projects. During my stay in Uganda, we worked on a case report now submitted for publication involving a patient with concomitant HIV-Malaria and TB meningitis as this presented a unique case of drug-drug interaction in the management strategy. This is one example of how various activities can stem out of the bigger studies. It provides so many opportunities for the team to continue to add to the literature in this area. 

Regulatory bodies (IRB, NDA, UNSCT, SRC) - Ethical conduct of research is a big deal

There are many acronyms as you see above for the various regulatory bodies. In Uganda, I have noticed that ethical conduct of research is extremely important. While the process can often be tedious and discouraging, it is vital and ensures that patients are not taken advantage of in the research that is conducted. There are some policies that are strict and there are others that can take a long time to process. However, it is still all done as a way to weed out research that only benefits the researcher and not the local population. Changes to the protocol and other sub projects also have to go through the approval bodies as needed. I spent some time ensuring that our regulatory binder for the post-mortem drug study is up to date and while this was challenging, it was also very rewarding.  

Pharmacist role as part of the team - Drug-Drug interactions, medication management and unique perspectives

As pharmacists, we are trained to be the drug experts. I think the biggest contribution to the clinical research team comes from being knowledgeable about the medications. I found it hard at first, as the medications often have different names and I needed time to look up the generic name. However, as I got comfortable with the names of the drugs and their use in this patient setting, it became easier to make medication related recommendations to the medical officers. Furthermore, in my fellowship and Master’s program thus far, I have also been exposed to more extensive research principles which helped me tremendously in being a part of the research team. We spent many hours reviewing data collection instruments for upcoming studies. Providing the pharmacist perspective in relation to research instruments that will be used for the collection of medication information was unique. Also, as mentioned above, sub projects often stem from larger studies. One of the projects that I will be working on moving forward will involve looking at the large data collected from hospitalized patients enrolled in two previous studies and highlighting likelihood for drug-drug interactions and strategies to mitigate them in the future. I am excited to be able to collaborate with the Ugandan pharmacist and medical officer on this project. 

In conclusion

Goodbye lunch!
I will definitely miss Uganda! It has been such an amazing experience in all aspects. I hope to start making plans to visit again soon. I had a chance to meet up with the pharmacists I worked with while I was in Uganda for a goodbye lunch. They were great to work with and I am glad for their continued friendship moving forward. I am heading back to Minnesota for a while and then off to Glasgow, Scotland in September for the International Pharmaceutical Federation (FIP) Annual Conference!