Generating valid clinical research outside an academic setting (1 Viewer)

[cosjobs]

I'd like to conduct a 60-90 day controlled study with 15 subjects with complete control/monitoring of their diet.

I would like the results to be "publishable" in peer reviewed litereature.

There would be no pharmacological component, but we would have MDs and PhDs involved in the design, implementation and analysis of the implemented diet.

Would it be possible or feasable to conduct such a study and expect to get the results published ?

I know the these studies are under the jurisdiction of the FDA, but since there is no medicine or unusual therapy involved, would they even care? Or would thry likely disallow me from conducting such a thing because it is a non-traditional setting? (The setting would be a 15 bed liscensed group home- we would set up the staffing and monitoring required to assure that all subjects were completely compliant with the program. It would be an "in-patient" situation.)

Any advice, website or boiok recommendations much appreciated.

 

[cosjobs]

From what I can find out so far, its looking pretty good. But most everything I find pertains to drug trials. I need some guidelines for behavior/diet or other non-medicinal/device protocols.

 

[NCCommish]

15 subjects is an awful small sample size. Still I would think if the MDs or PhDs have any clinical research experience they should be able to run it in such a way as to make it suitable for publishing. It's not like you are using drugs or anything not sure the FDA would care unless you make claims to sell something for dieting, treatment of disease, those kinds of things.

 

[cosjobs]

15 subjects is an awful small sample size. Still I would think if the MDs or PhDs have any clinical research experience they should be able to run it in such a way as to make it suitable for publishing. It's not like you are using drugs or anything not sure the FDA would care unless you make claims to sell something for dieting, treatment of disease, those kinds of things.

For most nutritional studies, 15 would be a very small number. But in nearly all those studies, the subjects are "self-reporting." In the study I want to do,it would be "in-patient," so there would verifiably be full compliance with the protocols. In a study the size of the one I want to do, as few as six subject could possibly be sufficient. I think. That's one reason I am writing in here to try and get some clarification/input.

 

[Ilov80s]

Who are you hoping publishes it?

 

[xulf]

Are you looking for a model that has an effect on vitals or one that has an effect on outcome (a logistic regression model with outcome of yes/no or the like)?

 

[The Z Machine]

Are any of the MDs or PhDs affiliated with a university or research institution?

Typically, you need to get institutional review board (IRB) approval from that research institution before performing any research involving human subjects, even if you are only interviewing them, let alone altering their diet.

If you don't have IRB approval, I could see it being a problem for publication. The IRB approves these things from an ethics standpoint, and as far as I know the FDA doesn't care about such things, but everyone will care about the study being conducted ethically.

 

[SoBeDad]

The Department of Health and Human Services (DHHS) has regulations about research studies involving human subjects. The basis for the protection of human subjects in research comes from the Helsinki Declaration, the Nuremberg Code and the Belmont Report. This was meant to prevent the kind of abuses in research studies that occurred in Nuremberg and Tuskegee (black men with untreated Syphilis). Some studies are exempt from review by a human rights board - such as some education studies and food quality evaluation - here's more from the Johns Hopkins IRB. I don't think your study is exempt, so you should get it reviewed by an IRB. At my hospital, the cost of an initial IRB review is $2,000.

Diet is very complex and its effect on outcomes such as cholesterol has been modest. What type of diet do you plan to study.

 

[The Z Machine]

The Department of Health and Human Services (DHHS) has regulations about research studies involving human subjects. The basis for the protection of human subjects in research comes from the Helsinki Declaration, the Nuremberg Code and the Belmont Report. This was meant to prevent the kind of abuses in research studies that occurred in Nuremberg and Tuskegee (black men with untreated Syphilis). Some studies are exempt from review by a human rights board - such as some education studies and food quality evaluation - here's more from the Johns Hopkins IRB. I don't think your study is exempt, so you should get it reviewed by an IRB. At my hospital, the cost of an initial IRB review is $2,000.

Diet is very complex and its effect on outcomes such as cholesterol has been modest. What type of diet do you plan to study.

Are you affiliated with JHH?

I have no real basis on this guess, but I bet that cosjobs intends to study the effect of changes in diet (such as casein-free diet) on the behavior of autistic or other related illnesses treated at group home type facilities.

I'm not a researcher, but my wife is, and has to go through IRB approval for every study she works on. I have no idea how to get IRB approval if no one is affiliated with a research institution. Are there outside IRBs that will evaluate the ethics of independent research?

 

[cosjobs]

Who are you hoping publishes it?

There are scores, if not hundreds and I have not yet dialed in which would be best.

 

[SoBeDad]

The Department of Health and Human Services (DHHS) has regulations about research studies involving human subjects. The basis for the protection of human subjects in research comes from the Helsinki Declaration, the Nuremberg Code and the Belmont Report. This was meant to prevent the kind of abuses in research studies that occurred in Nuremberg and Tuskegee (black men with untreated Syphilis). Some studies are exempt from review by a human rights board - such as some education studies and food quality evaluation - here's more from the Johns Hopkins IRB. I don't think your study is exempt, so you should get it reviewed by an IRB. At my hospital, the cost of an initial IRB review is $2,000.

Diet is very complex and its effect on outcomes such as cholesterol has been modest. What type of diet do you plan to study.

Are you affiliated with JHH?

I have no real basis on this guess, but I bet that cosjobs intends to study the effect of changes in diet (such as casein-free diet) on the behavior of autistic or other related illnesses treated at group home type facilities.

I'm not a researcher, but my wife is, and has to go through IRB approval for every study she works on. I have no idea how to get IRB approval if no one is affiliated with a research institution. Are there outside IRBs that will evaluate the ethics of independent research?

Many multi-site studies have a central IRB that approves the studies for local sites. Western IRB may be the biggest - their fees are steep. I work at a hospital in Miami and we are required to use our local hospital-based IRB. Western IRB would likely review such a study. If there are vulnerable populations involved, then the consent process gets more complicated. The investigators should take an online course in the protection of humans in research studies, such as the CITI Program course.

This study is probably under-powered. When the protocol is written, a thorough review of similar studies should be done. Many investigators are naive or grandiose about their ideas.

 

[cosjobs]

Are you looking for a model that has an effect on vitals or one that has an effect on outcome (a logistic regression model with outcome of yes/no or the like)?

We will measure all kinds of things, esp. including - weight, body fat, bone density (dexascan), lipid panel, fbg, other glucose, bp (daily), etc. Many of these metrics will be measured daily.

We will completely control the diet of the aprticipants for 4-12 weeks (depends on funding) and track the progress (regress) of the metrics.

The hypothesis is that following a Paleo/Prima/Ancestral diet/lifestyle will lead to lower weight and greater health.

I want 15 overweight, post-menopausal women who are likely to have or currently face diabetes/cholesterol/metabolic disorders, but are currently under no medications for those. (I am told that doing only men or only women will have greater statistical signifigance.)

We will do the metrics daily/weekly/ start/end depending how most appropriate. Possibly do a longitudinal follow-up with self reporting.

 

[cosjobs]

The Department of Health and Human Services (DHHS) has regulations about research studies involving human subjects. The basis for the protection of human subjects in research comes from the Helsinki Declaration, the Nuremberg Code and the Belmont Report. This was meant to prevent the kind of abuses in research studies that occurred in Nuremberg and Tuskegee (black men with untreated Syphilis). Some studies are exempt from review by a human rights board - such as some education studies and food quality evaluation - here's more from the Johns Hopkins IRB. I don't think your study is exempt, so you should get it reviewed by an IRB. At my hospital, the cost of an initial IRB review is $2,000.

Diet is very complex and its effect on outcomes such as cholesterol has been modest. What type of diet do you plan to study.

Are you affiliated with JHH?

I have no real basis on this guess, but I bet that cosjobs intends to study the effect of changes in diet (such as casein-free diet) on the behavior of autistic or other related illnesses treated at group home type facilities.

I'm not a researcher, but my wife is, and has to go through IRB approval for every study she works on. I have no idea how to get IRB approval if no one is affiliated with a research institution. Are there outside IRBs that will evaluate the ethics of independent research?

Many multi-site studies have a central IRB that approves the studies for local sites. Western IRB may be the biggest - their fees are steep. I work at a hospital in Miami and we are required to use our local hospital-based IRB. Western IRB would likely review such a study. If there are vulnerable populations involved, then the consent process gets more complicated. The investigators should take an online course in the protection of humans in research studies, such as the CITI Program course.

This study is probably under-powered. When the protocol is written, a thorough review of similar studies should be done. Many investigators are naive or grandiose about their ideas.

I'm really appreciating your input here.

I am in a unique position where I could do an in-house study with complete control of the participants.

My position would enable me to do it much faster and far less expensive than the traditional models.

While there have been many papers about this dietary protocol, there has never been one directly measuring the results from a completely controlled environment.

 

[SoBeDad]

Are you looking for a model that has an effect on vitals or one that has an effect on outcome (a logistic regression model with outcome of yes/no or the like)?

We will measure all kinds of things, esp. including - weight, body fat, bone density (dexascan), lipid panel, fbg, other glucose, bp (daily), etc. Many of these metrics will be measured daily.

We will completely control the diet of the aprticipants for 4-12 weeks (depends on funding) and track the progress (regress) of the metrics.

The hypothesis is that following a Paleo/Prima/Ancestral diet/lifestyle will lead to lower weight and greater health.

I want 15 overweight, post-menopausal women who are likely to have or currently face diabetes/cholesterol/metabolic disorders, but are currently under no medications for those. (I am told that doing only men or only women will have greater statistical signifigance.)

We will do the metrics daily/weekly/ start/end depending how most appropriate. Possibly do a longitudinal follow-up with self reporting.

I work at the hospital in Miami where the South Beach diet was born. You don't need a lot of science to promote a big idea.I'm not saying that the South Beach diet or paleo diet aren't good. The South Beach diet gained traction in Miami via a local TV station which had regular updates on some participants. If you don't collect data for "research", you may not even need to get the study approved by an IRB. The investigator behind the South Beach diet was a well-respected cardiologist with good academic credentials on a national level - Arthur Agatston.

 

[cosjobs]

Are you looking for a model that has an effect on vitals or one that has an effect on outcome (a logistic regression model with outcome of yes/no or the like)?

We will measure all kinds of things, esp. including - weight, body fat, bone density (dexascan), lipid panel, fbg, other glucose, bp (daily), etc. Many of these metrics will be measured daily.

We will completely control the diet of the aprticipants for 4-12 weeks (depends on funding) and track the progress (regress) of the metrics.

The hypothesis is that following a Paleo/Prima/Ancestral diet/lifestyle will lead to lower weight and greater health.

I want 15 overweight, post-menopausal women who are likely to have or currently face diabetes/cholesterol/metabolic disorders, but are currently under no medications for those. (I am told that doing only men or only women will have greater statistical signifigance.)

We will do the metrics daily/weekly/ start/end depending how most appropriate. Possibly do a longitudinal follow-up with self reporting.

I work at the hospital in Miami where the South Beach diet was born. You don't need a lot of science to promote a big idea.I'm not saying that the South Beach diet or paleo diet aren't good. The South Beach diet gained traction in Miami via a local TV station which had regular updates on some participants. If you don't collect data for "research", you may not even need to get the study approved by an IRB. The investigator behind the South Beach diet was a well-respected cardiologist with good academic credentials on a national level - Arthur Agatston.

THis diet has very good national traction, but there is no single study (other than self-reporting or case studies) on the results/benefits.

We ahve a number of PhDs or MDs who would support us and likely work on the study, but what about using these names that have already demonstarted a bias toward the diet? Would it be better to have someone less reknown, but no baggage?

 

[The Z Machine]

When you say, "using these names," what do you mean?

 

[Sand]

I'd like to conduct a 60-90 day controlled study with 15 subjects with complete control/monitoring of their diet.

Oh, good luck with that.

 

[Ilov80s]

Who are you hoping publishes it?

There are scores, if not hundreds and I have not yet dialed in which would be best.

Do you have a connection anywhere? Any reason to think any of them would publish your research?

 

[cosjobs]

Who are you hoping publishes it?

There are scores, if not hundreds and I have not yet dialed in which would be best.

Do you have a connection anywhere? Any reason to think any of them would publish your research?

yes, probably

 

[cosjobs]

When you say, "using these names," what do you mean?

Having advocates of the protocols doing the actual study.

 

[cosjobs]

This guy thinks it may be feasible

 

[Ilov80s]

Who are you hoping publishes it?

There are scores, if not hundreds and I have not yet dialed in which would be best.

Do you have a connection anywhere? Any reason to think any of them would publish your research?

yes, probably

You should fall to that person.