Expectations are my enemy.
For the last two years, I have led a large team preparing to enroll patients in the DON clinical trial. This clinical trial is a safety study of a drug, acronym “DON”, that was tested extensively in the laboratory and found to be possibly effective for decreasing death from cerebral malaria. DON is administered intravenously and is given in addition to standard therapies like antimalarial drugs.
The NIH scientists who tested DON in the laboratory approached our research group about possibly doing human testing in Malawi. We wrote a grant proposal together. Fortunately, it worked. About a year ago we were given the funding to carry out the initial human studies. In addition, the NIH agreed to give us DON, put it in little vials, handle the computerized database, and deal with the United States Food and Drug Administration (FDA). Full speed ahead.
Only…..not so much. Some tasks went quickly, and others have been glacially slow.
Starting in June (if it even happens then) means that I must try to do something nearly impossible, namely find people with malaria when there is not any malaria out there.
We received ethical approval by the Malawi Institutional Review Board relatively quickly. The “fill and finish” and the work with the FDA has been the opposite. A large team, headed by Brittany Riggle has worked tirelessly to get DON into those little glass vials used for intravenous medications, the “fill and finish.” She has exhausted herself mentally, physically, and emotionally, preparing the Investigational New Drug (IND) application for the FDA. But both the fill and finish, and filing the IND, have taken much longer than any of us expected or hoped.
In early January 2022, I rushed to Malawi as we were told we might be able to begin the clinical trial late that month. Then it was February. Then March. Then April. Now June.
Malaria season in Malawi is January-June; there is almost no malaria the remainder of the year. Half the patients we are supposed to enroll in 2022 must have malaria. Each time the start date got pushed back, I became increasingly anxious. Starting in June (if it even happens then) means that I must try to do something nearly impossible, namely find people with malaria when there is not any malaria out there. Every delay made me crazier as it pushed us into non-malaria season. Each squashed expectation made me more upset.
For my own mental health, I had to let it all go. I am now resigned to the Fates. None of this is in my control. I have done my part as best I could. I have worried, gotten very angry, felt very stupid for moving to Malawi in January to start a repeatedly delayed clinical trial, and been increasingly upset. None of this does anyone any good, especially me. Even at my advanced age I am still learning. Stop having expectations. No expectations, no disappointment.
