Talk:Investigator's brochure

Comments

This article is part of a series of articles trying to provide additional information on several aspects of clinical development (trying to fill some gaps)

Hello, fellow AMWA classmates, I've completed my minor edits to the page. I find it very confusing to follow the Wikipedia style guide. Perhaps someone can correct the way I've edited the references and the external links. Terimedwriter (talk) 23:17, 28 July 2009 (UTC)

Keeping the Investigator's Brochure a Summary of Information, not a Compilation

Question for the Instructor: I have worked on 2 IBs recently and both times have found it difficult to reduce the size of the final documents. New information is added to the IB, but nothing is deleted. Do you have any suggestions on avoiding this scenario? Terimedwriter (talk) 17:30, 29 July 2009 (UTC)

Good question! It is very difficult to persuade people to cut what they previously written. As the development program continues, more clinical data is available. Therefore the nonclinical data is less relevant than the clinical data, and page count should be adjusted correspondingly. Whereas an IB for an initial IND may be all nonclinical, by phase 3 nonclinical data should be 3-5 pages. Janedollie (talk) 19:03, 27 August 2009 (UTC)Jane

Agreed...we try to keep the IB to a certain page size, and summarize earlier data to "make room" for the newer (usually clinical) data.Montybean (talk) 01:22, 2 October 2009 (UTC)

Question for the Instructor: I have written IBs from package inserts when using a currently marketed drug for a different indication. There is little nonclinical information since it is already an approved drug and the nonclinical data is still applicable. Do you have experience with this same type of scenario? If so, did you run into any roadblocks? --Writer1AB (talk) 21:17, 13 September 2009 (UTC)

This is why I need this course. Preparing the annual updates of drugs in late phase development are a big problem for me and all the project teams in my experience. No one is willing or able to take the responsibility for reducing the size of the IB. It seems to just get bigger and less user friendly. How do I handle this? Janka1 (talk) 17:47, 30 September 2009 (UTC)

This is definitely a question of mine also. How is it determined what gets pulled out? Who takes responsibility for this?Kwbaz (talk) 20:22, 1 October 2009 (UTC)

My most recent experience has been that at the point a drug is in late stage development, the IB is huge, and it is a problem getting the appropriate folks to review it and make the changes...even though everyone agrees the document needs to be shortened! My only suggestion is that the writer (or whoever is responsible for updating and coordinating the reviews) has to start the process early enough.... Montybean (talk) 01:22, 2 October 2009 (UTC)

Investigational product properties

Why is the chemical/structural formula necessary for the clinician and could providing such detail cause an intellectual property risk? Rodnator (talk) 19:05, 28 August 2009 (UTC)

That's an interesting point. Intellectual property is usually safeguarded by confidentiality agreements for that very reason. I wonder, though, if the stringency of these agreements tends to change throughout development phases? Seems logical that they would, as the competitive concerns for a first in humans Phase I trial are quite different from, say, a Phase IV trial, but I'm no J.D.... thoughts, anyone? [-JER} Jeruckle (talk) 11:20, 3 October 2009 (UTC)

Hi to the class. I have added some additional text and marked it with a signature so it is easy for you guys to see. Please delete or change anything that is wrong. I have 0% experience with IBs or regulatory writing. Fortunately, I have edited Wikipedia before, but I have never used the talk pages. So this is a doubly good learning experience. Can anyone give a viewpoint about how a physician/investigator actually uses an IB? Are IBs throw-away literature or cherished reference documents? I think it would be helpful to know. TrivialWriter (talk) 03:37, 16 September 2009 (UTC)

In my experience (I admit I'm relatively new to the field), the PI scrutinizes the IB... but most of my work is early in development and with PIs who take a very hands-on approach to their studies. I would suspect that Investigator use of the IB varies widely, depending on how well the drug has been studied, whether or not the Investigator has worked with the compound before, in what population is the drug being studied, whether the Investigator is more of a clinician or more of a researcher, etc. I wonder what others have seen in their experience...? [-JER] Jeruckle (talk) 11:20, 3 October 2009 (UTC)

Hello fellow AMWA members, I also don't have any experience with IBs or regulatory writing--I'm on a steep learning curve. This Wikipedia editing exercise is quite fun. From what I can tell, the IB is a very important document that summarizes everything that is known about the investigational product. It's a document that is compiled early on in the clinical trial, so that decisions can be made about how to run an trial with the safety of the volunteers and/or patients in mind. Please correct me, if I am wrong on this. Grijze poes (talk) 05:49, 28 September 2009 (UTC)

IB requirements for regulated clinical trials vs. non-regulated trials

Question for the instructor: Is an IB required for a clinical trial that is not regulated by FDA? For example, an investigator at NIH may start a clinical trial to evaluate a marketed drug to determine whether there is any association of the drug use with an increase in certain diseases (side effects). Hankipo123 (talk) 20:01, 18 September 2009 (UTC)

Question for the instructor: I have a similar issue where the drug is approved by the FDA however the pharma company is now seeking a new indication. All that is available for nonclinical information is the data from the package insert. No additional non-clinical studies have been conducted. The IB was generated using the package insert. Have you do this before?\--Writer1AB (talk) 14:09, 20 September 2009 (UTC)

Hello Classmates and Question

Question for the instructor:

I added my name to my edits so that you could see they are there. However, it certainly makes the text hard to follow when it's cluttered up with contributors' names. If I remove the tags, would you still be able to tell that I've done my homework?

I also have a question about updates, similar to the question above. If a clinical program is very active, many new studies may need to be incorporated and described. In a new edition, to what extent can the old version of the IB or an approved label be referred to without having to repeat everything that was there before ?

Thanks for this assignment! This is a very interesting exercise, even apart from the stated goal of learning about IBs. Whenever I refer to the guidances, I am always amazed at how general and sketchy they are. From these vague instructions massive piles of requirements arise for the pharma company regulatory documnets I work on.CAS57 (talk) 22:24, 18 September 2009 (UTC)

• Question for the instructor:

IB's are supposed to be updated annually, what happens if the sponsor fails to do this or if the clinical program has been stalled for some reason and no significant updates are necessary within the year from previous update?

I wasn't sure how much editing to do---so I just added some content under 2 sections---pediatric and drug abuse. I'm not sure how to add my user name here? I suppose since I registered, you can see that I edited the page in some way?

School project

Hello,

I have noticed that this appears to be a school project. Might I suggest looking at and signing up at Wikipedia:School and university projects? This page includes some tips and tricks to get new editors started, as well as advice for the instructor to ensure that what they are doing falls within Wikipedia guidelines. For example, it is inappropriate to sign your username in an article (but important to do it on the talk page!). Should the instructor wish to review who has contributed what, all the edits can be found under the "history" tab at the top of the page. Happy editing, shoy (reactions) 01:05, 23 September 2009 (UTC)

Thanks, this is very helpful! TheFifthSmith (talk) 05:06, 30 September 2009 (UTC)

NMSISI edits

Hi all, I added my edits with 3 objectives carefully in mind, because you all did such a good job ahead of me I didn't want to be contributing verbiage without substance. So, I emphasized (1) the role of the IB in maintaining the safety of human subjects in clinical trials; (2) added other guidances IB authors often refer to; and (3) added IB content details taken from the guidances noted as well as from other, more specific guidelines, such as the guideline for deriving a safe dosage in humans.

Best, NMSISI (talk) 11:26, 23 September 2009 (UTC)(talk) 00:57, 23 September 2009 (UTC)

Question regarding AE Tables

What has been your experience with the inclusion of a specific "expected" AE table? This is based on recommendations of the CIOMS VI working group that Development Core Safety Information (DCSI) should be added to the IB and use as the definitive list of expected events for regulatory reporting purposes. I have seen this done by 2 clients so far. I have also seen confusion in this regard!Martha1279 (talk) 20:59, 27 September 2009 (UTC)

Does inclusion or exclusion of AEs become a liability issue for the sponsor? Inclusion of expected AEs certainly seems like it would be valuable information for a PI. Kwbaz (talk) 20:29, 1 October 2009 (UTC)

Subheadings of Undeveloped Content

Question for AMWA Instructor: The current article has numerous subheadings toward the end of the article that seem to go beyond ICH guidance and its suggested outline. Furthermore, those subheadings have no content. Did you put them there and expect your students to develop the content? I ask before I start editing because I'd be inclined to remove them. Thanks for your reply. D Pantelis (talk) 21:02, 28 September 2009 (UTC)D Pantelis

I have the same question. I looked at the history tab and could not figure out who added those headings or when. Only a dozen people have been here recently so perhaps it is to make sure everyone gets to write something. I am adding a bit to several topics based on my knowledge, but as you point out, much of it is does not seem to be covered in the prereading. TheFifthSmith (talk) 05:13, 30 September 2009 (UTC)

I recognized this too - I went ahead and filled in a few of these sections as adapted from content from sample IB documents and in cases where some of the information overlaps with the IND. I also share another author's concern regarding inserting references, more specifically citing a reference that has already been cited (equivalent to inserting a cross reference). I was not able to do this efficiently, certainly several of the references may overlap and this functionality would be useful. I look forward to learning from all of you. Write Bright (talk) 19:18, 30 September 2009 (UTC)

IB Update

Question for AMWA Instructor: Why would the IB need to be updated after a market approval and the drug becomes commercially available? Is this assuming there's another trial going on somewhere? Thanks! Chilirabbit (talk) 06:15, 2 October 2009 (UTC)

An example is where an approved drug is used in combination with other drugs as part of a clinical trial. The IB needs to be kept up-to-date with the latest safety information. I am working on some trials like this now. Wpharm1 (talk) 19:27, 2 October 2009 (UTC)

Question for Jane

Can the IB be submitted electronically or is it by hardcopy submission only?

Question for Jane

Hi Jane,

Can the IB be submitted electronically or is it by hardcopy submission only?

cheers, oki... —Preceding unsigned comment added by Okd007 (talk • contribs) 20:14, 2 October 2009 (UTC)

I have worked on multiple studies and the IB is submitted to the sites/IRB always in PDF format. Sometimes they like to have a Word version with Track Changes to see the changes between the prior version and the current. Wpharm2 (talk) 22:14, 2 October 2009 (UTC)

Question for Jane

What is the general trend for frequency of updates to the IB across development phases (more frequent updates early or late in development)? Jeruckle (talk) 10:49, 3 October 2009 (UTC)

Under what circumstances would new information be so important that it would need to be communicated to the investigators and/or regulatory authorities and/or IRB/IEC prior to inclusion in the revised IB? Seems to me that the language on p. 34 of the EMEA Guideline for GCP (section 7.1, last sentence of 2nd paragraph) is intended to prioritize communication. Is there ever information that should not be included in a revised IB?Jeruckle (talk) 10:50, 3 October 2009 (UTC)

Hard to edit

I am finding that editing the IB through wikipedia is not very user friendly! I am spending more time trying to get things to work than editing. And in editing it is very hard to read; the window is too small. Wpharm2 (talk) 22:16, 2 October 2009 (UTC)

Use of non published references in IB

I am having difficulty with understanding use of references for nonclinical studies of products in early development. Little information may be published as the know body of information is summarized in Technical Reports that are not readily available to Investigators or IRB's. In the absence of information published in public domain, is it of common practice to just provide the technical report number? Mk3521 (talk) 18:53, 11 October 2009 (UTC)

GoCE

--The copyeditor's corner 19:50, 25 May 2011 (UTC)

Proposed new lede

In medical research, an Investigator's brochure (IB) is a summary of previously established facts and information compiled by the researchers to guide the conduct of a drug trial. Goal is to gather the information to ensure that no previously-known dangers are overlooked in planning the study and so that information is on-hand in the event of a overdose or adverse drug reaction requiring rapid intervention. There are national standards for the production and updating of brochures and work being lead by the International Conference on Harmonisation to standardise them internationally.

I also propose eliminating use of term 'IB' in favour of 'brochure' throughout the article.