Together, we make a difference!
We are convinced that INMEST is a treatment that can help a great many patients to a better life. But to get there, studies are needed, and they require funding.
All donations, large or small, go toward INMEST research. Together, we can show the world that INMEST is an effective treatment for all conditions with autonomic imbalance.
You can contribute to the research by clicking the donation button here and following the instructions.
If you’re interested in making a contribution but need more information, feel free to contact us at [email protected]
That’s why studies are so expensive
There are several reasons why medical research is expensive. Ultimately, it boils down to quality requirements – the research must be conducted in a way that ensures the results are reliable.
This means, among other things, that the study needs to be sufficiently large, i.e., conducted on a sufficient number of patients. It also means that the study should be “randomized” and “double-blind.”
“Randomized” means that patients are randomly assigned either the drug or method being tested, while other patients receive an inactive treatment (placebo). The allocation of patients to treatment or placebo is determined by a sort of lottery. This way, the study can show which effects are due to the drug or method, and which are due to chance or the placebo effect.
“Double-blind” means that neither the patient nor the personnel conducting the study know who is receiving the treatment and who is receiving the placebo. This is done to ensure that neither group of patients is treated differently, which could distort the study’s results.
However, achieving double-blind status is not always easy. The placebo treatment must look and feel exactly like the “real deal” for both the treating staff and the patient. If it is not possible to have a placebo group, other possibilities exist. For example, one could identify a group of patients who do not receive the treatment but undergo the same examinations as those who receive the treatment. Such a control group should be “matched”, that is, they should, in addition to having the disease in question, be similar to those receiving active treatment in terms of, for example, age and gender.
As the way INMEST works has become increasingly known over time, a study design with a matched control group is something that we at the foundation consider useful when starting new INMEST studies where patients treat themselves at home.
Finally, blood samples, questionnaires, and so on need to be collected and analyzed. This should ideally be done without direct involvement of the lead researcher or the company behind the treatment. It is preferable that an external party, with no vested interest in the study’s results, performs the analysis and statistical calculations.
In summary, a well-conducted study requires a relatively extensive organization. As a result, the costs can be considerable.
The course of the vagus nerve in the body.
Medical study step-by-step
1. PLANING
The art of formulating a hypothesis
Usually, every study starts with formulating the hypothesis that will be tested. “If our treatment works as we believe, treating disease X should lead to effect Y on outcome measure Z.”
It’s important to decide which disease will be treated, which symptom will primarily be studied, and how this will be measured. The expected effect of the treatment on the most important symptom, the so-called primary outcome variable, also determines how many patients need to be included in the study. Besides disease symptoms, the primary outcome variable can also be, for example, a value that can be measured through a blood test or other equipment.
It’s also very important to clearly describe which patients will be included in the study. These are called inclusion criteria, a list specifying which patients will be included in the study. Age and lifestyle factors are examples of things that may need to be considered. Likewise, one must define which patients are disqualified from being included in the study, the so-called exclusion criteria, such as other diseases the patient may have.
In addition to the primary outcome variable, there is usually one or more secondary outcome variables. These are typically other important disease symptoms, how quickly the disease progresses, or survival.
2. BUDGET
When it has been determined how many patients need to be included in the study, which analyses need to be done, and how long the patients should be followed up, a budget needs to be created. At this stage, quotes are gathered on the costs of conducting the various parts of the study. For example, a CRO (contract research organization) might be hired to coordinate many aspects of the study. One could opt to hire a clinical trial unit to conduct the study there, or another option could be to carry out the study at local clinics, such as Källmarkskliniken, or public institutions like university hospitals.
Once the method of conducting the study, including where it will take place, has been decided, the budget can be finalized. A general rule of thumb is that it costs 100,000 SEK per patient per year of participation in a study. So, if a study is conducted with 30 patients, and each is followed for a total of one year, the study would cost approximately three million SEK to carry out.
Once financing to cover the budgeted costs is secured, the next step can be taken.
3. ETHICS REVIEW
External review of the study
There is a comprehensive system in place to ensure the quality and ethics of medical research. No patient should be exposed to unnecessary or unjustifiable risks. This assessment should not be made by those conducting the study themselves; therefore, the study design must be approved by the Ethics Review Board (Etikprövningsnämnden) and the Swedish Medical Products Agency (Läkemedelsverket). After approval, the study must also be reported to the Biobank Registry and registered on a public website, such as clinicaltrials.gov
4. IMPLEMENTATION
Patients and procedures
The number of patients meeting the inclusion criteria affects how quickly the study can be filled. Often, patients need to be recruited from multiple clinics and/or over a long period.
The length and complexity of the study implementation depend on several factors. However, the patient’s visit to the clinic should proceed in the same way regardless of where or when they participate in the study. Otherwise, results may be influenced by factors unrelated to the treatment itself, which would undermine the entire purpose of the study.
Throughout the study, it must be ensured that patients adhere to their prescribed treatment schedule, meet with doctors and nurses at specified intervals, and provide the required samples as outlined by the study.
5. CONCLUSION
Analysis and article
When the last patient has completed their treatment, it’s time to analyze the results. A research nurse often gathers all raw data, which is then sent to the company responsible for conducting the analysis and compiling the study data.
Once the statistical analyses are completed, the researchers’ work shifts to writing a scientific article. The article is usually published in a medical journal after a “peer review.” This means that some of the journal’s experts review the article to ensure that it—and the research it is based on—meets the required standards. Only after this review is the article published.
Based on the article, other researchers and doctors form an opinion about the drug or treatment method’s benefits and drawbacks. The article often also provides clues about what further studies may need to be conducted.
Become a donor and stay up to date!
On the INMEST Foundation’s website, we will naturally publish the study results from the research as they come, but this happens only after the scientific article has been published. Preliminary results from INMEST studies are sometimes presented at scientific conferences in the form of abstracts. When possible, we will also publish such preliminary results on the INMEST Foundation’s website.
From each according to their ability
How much money each person can contribute to the research varies. We are deeply grateful for all donations, no matter how small or large they may be.
Your contribution makes a difference, regardless of the amount!
Money isn’t everything!
If you believe in INMEST, you can help in ways other than donating yourself. The more people who know about the foundation, the more donors we will get. So feel free to tell your friends and acquaintances about INMEST. Please, share the link to our site on your social channels. It is very valuable to us in the long run. Thank you for supporting us!