How Do I start a clinical trial?

[LanceArmstrong]

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How Do I start a clinical trial?

Let's say I want to start a clinical trial for example to test whether labetalol reduces colon caner. Who do I go to to get the project going. What paperwork must I have to start using this drug thats approved for another use in my colon cancer patients. What kind of consent forms do I need. How do I design the study and what must I write before I start, and how do I monitor the study. Most importantly who is an expert in clinical trials that I can go to to get help and answers to all my questions - let's say im in a community hospital thats closely affiliated with a large university and I am an intern or a 2nd year resident.

Thank I advance for your help...🙂

 

[GoinBack2Cali?]

How Do I start a clinical trial?

Let's say I want to start a clinical trial for example to test whether labetalol reduces colon caner. Who do I go to to get the project going. What paperwork must I have to start using this drug thats approved for another use in my colon cancer patients. What kind of consent forms do I need. How do I design the study and what must I write before I start, and how do I monitor the study. Most importantly who is an expert in clinical trials that I can go to to get help and answers to all my questions - let's say im in a community hospital thats closely affiliated with a large university and I am an intern or a 2nd year resident.

Thank I advance for your help...🙂

Identification of “drug”
Establish research bank
Develop “bench scale” production
In-house pilot-scale production
Analytical assay development of bulk product
Evaluation of potency using suitable bioassay
Preparation of cGMP Production Banks
Initiate analysis of cGMP Master and Production Banks
Manufacturing of cGMP bulk product
Performance of CMC related QC tests
Initiate stability study on bulk compound
Formulation of cGMP “compound”
Initiate stability study of molecule
Potency studies
Toxicology study
Initiate draft IND (Investigational New Drug) application
Clinical site preparation
Develop clinical protocol
Submission of IND to FDA
Investigational review board submission of clinical protocol
Patient enrollment
Administration of experimental treatment

 

[tri guy]

Any large institution has an Institutional Review Board (IRB) that is in charge of approving and monitoring any studies that involve humans. Getting IRB approval is a notoriously long and difficult process typically taking many months, even when fast-tracked. To get things rolling I would contact the IRB at the University that the hospital is associated with to see if you could get some general information or to set up a meeting. They should be good about getting you information about consent forms and all the other necessary portions of the project. I would also try to get from them a contact of someone from the hospital who has recently had a project approved so that you could get advice from them. I hope that helps you at least get a start on planning your trials. Good luck!

 

[tri guy]

In regards to the post above, it looks like Lebetalol is already FDA approved so you would only have to complete:

Clinical site preparation
Develop clinical protocol
Institutional review board submission of clinical protocol
Patient enrollment
Administration of experimental treatment

 

[Circumflex]

In addition to the other advice regarding protocols and IRB approval, etc., you need to consult with a biostatistician/epidemiologist to design the study. You need to figure out how many people to enroll, what variables you can measure, confounders that need to be controlled for, what characteristics patients need to be in control vs. study group.

All of these things need to be done to determine the feasibility of your study. You might not have a large enough patient population and it might require a mult-institutional approach. This is why the big clinical trials, like in the NEJM have many centers participating.

 

[LanceArmstrong]

In regards to the post above, it looks like Lebetalol is already FDA approved so you would only have to complete:

Clinical site preparation
Develop clinical protocol
Institutional review board submission of clinical protocol
Patient enrollment
Administration of experimental treatment

I checked out cancer.gov and fda and it looks like if you are using an old drug for a new disease you must still do an IND...am I understanding this correctly?

 

[LanceArmstrong]

Any large institution has an Institutional Review Board (IRB) that is in charge of approving and monitoring any studies that involve humans. Getting IRB approval is a notoriously long and difficult process typically taking many months, even when fast-tracked. To get things rolling I would contact the IRB at the University that the hospital is associated with to see if you could get some general information or to set up a meeting. They should be good about getting you information about consent forms and all the other necessary portions of the project. I would also try to get from them a contact of someone from the hospital who has recently had a project approved so that you could get advice from them. I hope that helps you at least get a start on planning your trials. Good luck!

In that case would it make more sense to do a study at a small hospital without an IRB? And if not the IRB then who else can approve a clinical trial?

 

[Circumflex]

In that case would it make more sense to do a study at a small hospital without an IRB? And if not the IRB then who else can approve a clinical trial?

You can't do studies using humans (even chart reviews) without IRB approval. Some small hospitals may be affiliated with a larger or academic hospital and use their IRB. You are going to have many hoops to go through to start giving cancer patients a treatment approved for hypertension.

For this kind of study, you would never get enough people enrolled at a small center in any reasonable amount of time and obtain any meaningful results.

 

[LanceArmstrong]

I checked out cancer.gov and fda and it looks like if you are using an old drug for a new disease you must still do an IND...am I understanding this correctly?

Nevermind, it does need an IND - a new indication, a new rout of administartion, a new dosage - all these things apparently need an IND for an existing drug:
I found the site: http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm

 

[LanceArmstrong]

You can't do studies using humans (even chart reviews) without IRB approval. Some small hospitals may be affiliated with a larger or academic hospital and use their IRB. You are going to have many hoops to go through to start giving cancer patients a treatment approved for hypertension.

For this kind of study, you would never get enough people enrolled at a small center in any reasonable amount of time and obtain any meaningful results.

Got it. 👍 do you have any info on fast tracking the process, I heard exceptions can be made for compassionate sues of drugs. However definetely IRB first...

 

[Surg Path]

I checked out cancer.gov and fda and it looks like if you are using an old drug for a new disease you must still do an IND...am I understanding this correctly?

That's correct. We're doing that now with an approved prostate ca drug in breast ca at MSKCC.