27 February 2006

My fellowship begins, finally

So, the next few posts will be an attempt to describe my family's visit to Mali. Words and pictures cannot do justice to such an incredible journey, but it will be an attempt. Inshallah (God Willing).

In other news, I am happy to say that after 6.5 months of anxious waiting, I can officially say that my fellowship has started. Feb 13 we had our initial investigator meeting to discuss the protocols and processes for the upcoming Phase I/II malaria vaccine trial in children 2-3 years old in Doneguebougou and Bancoumana. Briefly, clinical trials are set up as follows:
Phase I are the safety studies, to ensure that the vaccine/drug is safe and will not cause harm to the individuals who receive the vaccine/drug. for international studies, this usually starts with giving the drug/vaccine of interest to healthy volunteers in the country from which the drug/vaccine is sponsored (in our case, the US.) If the research shows that the vaccine/drug is safe, then it is tested in people who are exposed to the illness on a continuous basis (i.e. a malaria endemic country like Mali). Here, we have already conducted Phase I studies of this vaccine in adults in Doneguebougou, and the results show that it is promising. The purpose of this Phase I study is to make sure that it will be safe for the future recipients of this vaccine, children. Typically, these studies involve few participants (30-40) so if the vaccine/drug is not safe, we will not be causing too much harm.

Phase II studies are efficacy studies, meaning we want to make sure that the vaccine/drug does what it is supposed to do. In our case, we want to ensure that the vaccine will mount a proper immune response against our particular vaccine target, which is common to all the malaria parasites that cause the most illness here in Mali, Plasmodium falciparum. These studies involve greater numbers of individuals, to ensure that the vaccine will have an effect in a larger population.

Phase III studies are really a combination of Phase I and II on a massive scale, typically hundreds to thousands of participants. In general, malaria vaccines are no where near this point yet for a variety of reasons. Typically, assuming the results are favorable, the vaccine/drug of interest can then be marketed and distributed en masse.

Phase IV studies are surveillance/follow-up/post-marketing trials to ensure that the vaccine/drug is still safe. For the most part, once a drug/vaccine passes the Phase III stage, it will remain on the market for a while. Occassionally though, the drug/vaccine may be pulled, due to deleterious side effects that where unknown or not demonstrated in earlier trials. The most notable and recent example of this invovled the pain relievers Vioxx and Celebrex, which were initially noted to be wonder drugs, and after further research (i.e. Phase IV studies) shown to be associated with cardiac arrythmias in patients who took those drugs.

so, normally there is a long gap between each phase of the process, sometimes as long as 2 years between Phase I and Phase I studies. In our case, we are combining the phases in a unique clinical trial that will piggy-back a Phase II study on top of a Phase I trial, pending favorable safety results of the Phase I trial. It is a complicated structure that I am not allowed to discuss for confientiality and security reasons, but suffice it to say that if all goes well, we will essentially have results 2 years earlier that using the traditional system. Inshallah.

So, with that boring lessone over with, let's get back to the official beginnings of my research fellowship. So, the Monday we had our investigator meeting, I was battling the beginnings of some type of cold/flu/bug, which made this 8 hour day unbearable. The next 5 days were then spent recuperating from my illness and waiting for the green light to start the consent process of the villagers who would participate in our study. In true Malian fashion, I got word Friday night that we would start the consent process Saturday morning. I quickly packed a bag and headed out to Doneguebougou early the next morning. Since my knowledge of Bambara is essentially nill, my role was really as an observer, to see the process in action. I was impressed with the teams efforts at maintaining the integrity of the consent process in a manner that is consistent with studies that I have participated in the U.S. However, the process took 45 minutes to an hour in some cases to cover the 7 page consent form. But, in the world of clinical research, all of that information sharing is necessary.

We had finished consenting our first group by Sunday afternoon, and now were waiting to start the screening process. The purpose for screening is to determine which potential participants meet our inclusion and exclusion criteria for the study. All potential participants who have given their consent must undergo a thorough past medical history and physical examination, laboratory testing, and other sampling to ensure that their general health is intact. We were told initially that this process would start that Monday. But again, this is clinical research and this is Africa, so we waited for 4 days before we were given the green light to start the process. Now mind you that this is an African village about an hour outside of Bamako. There is no internet, cell phone service that is limited to a 5 square meter area near the vaccine clinic, one television station, and no other research activities going on. So needless to say that those 4 days were spent chillin' Mali village style. I read a book, wrote some of my upcoming blog entries, listened to BBC Africa on the radio, and did not much else. So by the time Thursday rolled around, I was eager to start screening.

My role in the screening process was that of "study clinician." I was partnered with my friend Guindo, one of the Malian study clinicians. It was our job to perform the past medical history and physical examination on each potential participant. Since our vaccine will be administered to children between 2-3 years old, the examination is made more difficult with mostly uncooperative kids. Given my interest in pediatrics as a career, I was up to the task. Without getting into specifics for confidentiality reasons, I am happy to say that my medical training at Tulane was key in my diagnosis of some cardiac and intestinal maladies in the children that we screened (I plan on talking more about this later in a future blog entry). After an exhausting 2 days of screening, I was happy that my fellowship is finally happening.

The next step is vaccination. Right now we really do not know when this will start, Inshallah this week. When it does, rest assured that I will be right in the thick of things when it does. In the meantime, I will be back out in the village, chillin' Craiger in Mali style.

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