Questions about clinical research

[libraryismyhome]

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(1) I am aware that it is possible to write a protocol and publish multiple papers from it. But, is it possible to do vice versa? Multiple protocols culminating in one paper?

(2) If I am intending to obtain "clinical score" of outpatients and try to juxtapose with the data I am using, but I am not a medical professional and only have administrative, privacy, and research law clearances. Is it possible for my "PI," who is a physician to provide me with his or her patient info?

(3) If I submit my paper to peer-reviewed journals(moderate impact factor) and receive rejections or feedbacks couple of times, approximately, how many months would I need to spend?


Thank you in advance!

 

[gmcguitar4]

1) why would you do it this way? multiple papers from one study is the way to go.

2) If you are doing your own study at that hospital and using in-patient data, I feel like it should be approved by the IRB. I would consult your PI. What type of study are you planning on doing? Is it prospective or retrospective?

3) how many months would you need to spend doing what?

 

[libraryismyhome]

1) why would you do it this way? multiple papers from one study is the way to go.

2) If you are doing your own study at that hospital and using in-patient data, I feel like it should be approved by the IRB. I would consult your PI. What type of study are you planning on doing? Is it prospective or retrospective?

3) how many months would you need to spend doing what?

First of all, thank you for your reply!! 🙂

(1) i am just concerned about the possibility of not getting accepted, but you are absolutely right.

(2) Again you are right. Guess I would need to finish writing protocol first. I would be doing both pros and retro. But if I separately write a retro, I thought that it would take less time to approve.

(3) Once I finish writing my first paper then submit it to a peer-reviewed journal and assume that I get feedbacks or rejections like 3 times, how many months or weeks it will take for me to be published?

 

[gmcguitar4]

well, if you write a decent protocol and your IRB isn't crazy strict like mine is then that would be great. Considering studies can be over a year or more, I would try focusing on getting one or two studies instead of multiple. I have some great ideas too but when it comes down to it, some studies can take up all of your time and you just can't do too many.

You should concentrate on getting 1 down though and have your PI help you when he/she can. The paperwork can be a miserable process, as well as screening.

So if you do a study..it usually takes a while before you can get anything worth publishing out of it. You need substantial data to back your theory or w/e you are trying to do. That is why I am stressing to concentrate one maybe 1 or 2 studies because you will want to get as many candidates as possible. The studies I work on are backed by huge pharma companies and they recruit hospitals from all over the world. Even then, it takes about a year or two for them to collect enough data.

How big is your hospital? in a city?

 

[LizzyM]

Rejections can take as little as a week or as much as eight weeks. Once a paper is accepted, it can take months and months for it to appear in print.

A retrospective chart review often qualifies for a waiver of informed consent so the process is streamlined. If you are doing prospective research, you need to get informed consent from each subject or justify why it isn't practical to do so. Research on dead people is most efficient because they are not human subjects for the purposes of research (but their data is covered by HIPAA).

 

[libraryismyhome]

well, if you write a decent protocol and your IRB isn't crazy strict like mine is then that would be great. Considering studies can be over a year or more, I would try focusing on getting one or two studies instead of multiple. I have some great ideas too but when it comes down to it, some studies can take up all of your time and you just can't do too many.

You should concentrate on getting 1 down though and have your PI help you when he/she can. The paperwork can be a miserable process, as well as screening.

So if you do a study..it usually takes a while before you can get anything worth publishing out of it. You need substantial data to back your theory or w/e you are trying to do. That is why I am stressing to concentrate one maybe 1 or 2 studies because you will want to get as many candidates as possible. The studies I work on are backed by huge pharma companies and they recruit hospitals from all over the world. Even then, it takes about a year or two for them to collect enough data.

How big is your hospital? in a city?

My hospital is a large one definitely but it's in a suburban college town. There are big cities taking about 1~2 hours by car.
But what do you mean by IRB being strict? I am using a retrospective protocol template made by another school, so would this work?

Rejections can take as little as a week or as much as eight weeks. Once a paper is accepted, it can take months and months for it to appear in print.

A retrospective chart review often qualifies for a waiver of informed consent so the process is streamlined. If you are doing prospective research, you need to get informed consent from each subject or justify why it isn't practical to do so. Research on dead people is most efficient because they are not human subjects for the purposes of research (but their data is covered by HIPAA).

Right! so I should focus on one or two studies and try to separate between retro and prospective components and go from there. and research on dead people? haha good insight I gained today! 😀

 

[gmcguitar4]

You don't always need consent for a prospective registry. It depends on whether its observational or interventional. I am doing an observational one now and the IRB waved us from getting consent. Makes things so much easier. All we need is data from the charts of patients that are eligible, the doctors aren't even supposed to know so that they don't think about the study when tending to patients.

Well my IRB just takes a long time to review things and are pretty meticulous..I am not sure if thats how it is everywhere.

 

[LizzyM]

You don't always need consent for a prospective registry. It depends on whether its observational or interventional. I am doing an observational one now and the IRB waved us from getting consent. Makes things so much easier. All we need is data from the charts of patients that are eligible, the doctors aren't even supposed to know so that they don't think about the study when tending to patients.

Well my IRB just takes a long time to review things and are pretty meticulous..I am not sure if thats how it is everywhere.

It is that way everywhere.... figure on things taking weeks to months to be approved and being expected to jump through many hoops. Most likely the IRB will hold you to the Code of Federal Regulations called "The Common Rule". It applies to federally funded research but some institutions apply the same rule to all research at the institution regardless of funding. There is a similar set of rules promulgated by the FDA that apply to studies of drugs & devices. For the common rule see:

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html