Is there a time frame when we can start to see the first results? It seems everythig pretty good but it goes terribly slowly. Will they release some part results?
The first paper out will probably be from the researcher who led the focus groups on PEM. Twenty patients participated in a total of four phone calls, and those discussions helped guide the design of the second visit of the study (which is explicitly studying PEM after an exercise challenge). She said she's finishing up that paper. As for most of the results, they won't come until all of the volunteers finish their visits. Spinal fluid, for instance, is being pooled. The pools - one from patients, the others from the two control groups - will then be examined for thousands of immune system proteins and compared. That work can't be done until the researchers get spinal fluid from everyone. There are other substudies that also need to wait for everyone to come through.
So far 16 patients have completed visit 1, and I was the second patient to complete visit 2. About the same number of controls have come through. As I posted on Phoenix Rising, myself and others have talked to the study team about ways they can speed things up. They tried running a healthy volunteer and a patient through the protocol simultaneously. It sounds like things got a little hairy, but I think they will try that again. That's the most obvious way to speed up the study.
Running two patients at the same time is not feasible, I was told. Patients need a lot of attention and the team is fairly small - two nurses, two post-bachelor's fellows (who are really helpful - they squire patients around the huge building and collect samples, etc. etc.), a patient coordinator and Dr. Walitt. That's the ME team. Avi Nath does a neuro exam on patients during visit 1 and makes decisions about the protocol when issues arise. Dozens of other physicians and researchers are involved for their expertise, such as the person who does the neurocognitive testing. The protocol uses all kinds of resources around the Clinical Center - the patient rooms, MRI machines, a surgeon to do the muscle biopsy, transcranial magnetic stimulation machines, lumbar puncture under fluoroscope (for some of us, others get a bedside LP), the exercise test room, the metabolic chamber for 5 nights. Coordinating all of that is a big task and those resources are finite and are being used by hundreds of other studies.
I asked about adding more people to the team, but after a discussion about it, I don't think that would speed things up all that much. Each patient spends a total of nearly 4 weeks at the Clinical Center - two weeks for visit 1 and another two for visit 2. Healthy volunteers complete the protocol in about 3 weeks. There are so many tests and procedures being run that those times can't really be compressed. Visit 2, especially, cannot be shortened because PEM is being studied out to 72 hours after the exercise test. And the patient spends week 1 doing pre-exercise tests. Adding staff - say another nurse - will probably lead to a lot of downtime for that person, and idle government workers tend to be a problem. I do hope they try again to run a healthy person and patient through simultaneously to speed it up.
At this rate, I think it will be about three more years before the study is finished. That's a long time. I'm not happy about it, but I understand the trade-offs at play. In-depth = time-intensive. The NIH could have spent a week with each patient, not studied PEM, done a few basic sub-studies, and called it a protocol. Instead, we will have a very comprehensive look at ME from many different angles. I think that the results will be really valuable, but unfortunately it's going to take a while.
