Hi, nanonug and caledonia.
Thank you for your support and confidence in me.
This does look like an interesting way to raise financial support for research, and cost is of course one of the main limiting factors in doing research.
I do want to note, though, that there are other factors that come into play, also, and they have to be worked out as well. I'll comment on some of them, so you will understand what I mean.
First, we are talking about research that involves human beings. This raises some important issues. One is legal liability. There is always the possibility that something can go wrong in treating people, or someone can decide to bring a lawsuit because they believe they have been harmed. So there needs to be provision to protect against this, such as with insurance and a legal staff prepared to defend. This is one reason that human research is best done in an institutional setting.
Also, as a result of what came out of the Nuremberg trials and the Helsinki accords, research involving humans is subject to the requirement that there must be an institutional review committee that is separate from the researchers who review the planned research and decide whether it conforms to guidelines for protecting the people involved. Institutions set up such committees. If research is done outside an institution, there are independent institutional review committees, and they charge several thousand dollars to do a review. If such a review is not done, many medical journals will not publish the research results. This is another reason that it's best to do the research within an institution, such as a university or medical school, or private foundation.
Next, in order to write the research plan that will be reviewed by the institutional review committee, it is necessary to have an appropriate team of people involved. This may include a Ph.D., it must certainly involve one or more licensed physicans to deal with the patients, usually a statistician to help plan a study that is likely to give statistically significant results and to do statistical analysis and interpretion of the data when they have been collected, nursing support if it is a clinical trial, and administrative support to keep the records and make sure the research plan is followed. Enough patients must be included to achieve statistically significant results, including provision for some estimate of how many will drop out. If it is a multicenter study, then the physician, nurse and administrator must be duplicated at each site. Usually, all of these people must be paid for their work, unless some are in a position to donate it.
Then the research plan must be written, and it must include things like the criteria for patient selection, how the existing meds and supplements that the people are taking will be handled, the detailed treatment plan, the lab testing plan, how the data will be collected and handled, how informed consent will be obtained from the patients before participation, and other things. There must be plans for the facilities to be used, and a cost estimate must be put together, with provision for contingencies. A source of funding must be found to cover the costs.
Patients must be recruited, and if there is a control group, healthy normals must also be recruited. If it is a placebo-controlled study, it must be decided whether there will be a separate placebo group, or whether it will be a crossover study, and if so, enough time must be allowed for washout and two treatment durations.
Then the clinical work must be done, and it must be done carefully and in accordance with the plan. If it is a blinded study with placebo, which is pretty much required in order to reach conclusions about the effectiveness of the treatment, appropriate placebos as well as the treatment to be given must be put together.
The clinicians must use judgment about how much coaching they do to potential dropouts. Does the person just need encouragement, or are there real issues that should cause them to drop out of the study? The clinicians must keep track of adverse effects, and record them.
The duration of treatment must be long enough for the treatment to be able to have measurable effects.
Then comes the analysis of the data. This should involve the designer of the study, the physicians, and the statistician, so as to do the most accurate job and to get as much as possible from the data.
Then comes the writing of the paper. The format will depend on which journal it will be submitted to. Some journals have page charges, and they must be covered.
Then the paper is submitted to the editor of the journal. The editor submits it to some anonymous, voluntary, unpaid reviewers. They review it and send back their comments. They can recommend that it be published with some changes, or that it be rejected. If the editor decided to go ahead with it, he or she requests changes from the authors. If they can work things out, the paper is eventually published. If it is rejected, the authors can try submitting the paper to another journal, which may have a different format, and if so, the format will need to be changed before it is submitted. This process can go on through several journals, one at a time, if the paper is not accepted. It isn't allowed to submit to several journals at the same time.
That's basically it. As I think you can see, there is quite a lot involved.
I would like to see a rigorous, publishable clinical trial run on some type of methylation treatment in ME/CFS. Before that can be done, though, I think I will need to find someone who is properly situated and motivated to do it. I'm not affiliated with an institution, and I don't have the formal credentials in the biomedical sciences that will give me credibility with institutional review committees, editors and reviewers, or funding sources.
So, I want to thank you for thinking of me, but I think that quite a few ducks will have to be put in a row before this would be a viable thing to do.
Best regards,
Rich