One thing I like about working in patient recruitment for clinical trials is that no two trials are the same. Every study brings new challenges to overcome, resulting in new learning opportunities. One challenge that can be particularly daunting is drafting study recruitment materials for multiple institutional review boards (IRBs), or the independent ethics committees that approve the use of materials in clinical trials. Normally, inconsistent requirements happen when you are dealing with a central IRB and at least one local IRB. Local IRBs, functioning in support of academic institutions, generally have differing standards when it comes to messaging, terminology and tone. In most cases, any differences are very minor and attributed to simple word choices (think clinical trial vs. clinical study).
This can be an issue when you are drafting centralized materials or advertisements designed to support multiple sites in a research study. How do you standardize your copy so that it can be approved by all regulatory bodies? Following are a few hints on how to avoid IRB issues that can stall production of key recruitment materials.
1) Write any copy like it is being reviewed by the most conservative local IRB
The most important consideration when designing materials that will be reviewed by multiple IRBs is to ensure you do not take too many risks with your writing. Edgy copy might be inspiring to the reader, but could wind up passing through a central IRB while being scrutinized by a local one. While not a universal truth, it is usually the local IRB that will push back aggressively on any language that might be too speculative or promissory.
This is truly the worst-case scenario, because as we often find, academic centers traditionally are activated after dedicated clinical trial sites during study start-up. In that case you may have already had your materials approved by a central IRB and produced (which, in the case of a TV ad can be a significant investment), only to find that a local IRB has a problem with some of the wording. It is much better to write your copy to the most conservative review you can think of so that this is never an issue.
Ultimately, here are a few general tenets to adhere to when drafting copy for patient recruitment ads or materials:
2) Make your materials format as flexible as possible
It pays to have materials that can be easily reformatted to accommodate variable content, should you run into a situation where IRB standards conflict. This is not always easy, especially when it comes to broadcast ads. A good rule of thumb here is to always avoid live action commercials where you have actors with speaking parts. I know that very few clinical recruitment campaigns employ such a sophisticated level of ad, but the cost of reshooting a live action ad would most certainly be prohibitive for a sponsor. Even when using lower cost mediums (print ads, flyers, etc.), it is smart to make sure your creative files can be easily edited by a third-party designer, should you need to have something reformatted on the fly.
3) Communicate with your IRB if there are discrepancies
IRBs can sometimes seem like intractable, soulless bodies that rule with heavy-handed authority. However, if you find an IRB is mandating an edit that contradicts something another body has approved, it might be worthwhile to reach out to the reviewer and discuss the recommendation. Showing an IRB that another IRB has approved copy they are not comfortable with can sometimes result in a change in the ruling.
I recently ran across a situation where two different reviewers at the same IRB had different opinions about the same phrase used in a study flyer. One reviewer approved it, while a few months later, a different reviewer recommended a change. So, even within the same IRB, sometimes you can find variable standards. Ultimately, it never hurts to inquire about a specific decision, especially if not questioning it would result in having to reproduce materials at a significant cost to a sponsor.
Variable decisions by IRBs are something that everyone runs into at some point or another. Poor planning for unexpected deviations in approvals are an easy way to incur unexpected costs in for a study. Make sure you plan accordingly so that any surprise IRB issues don’t derail your recruitment budget or timeline.
This can be an issue when you are drafting centralized materials or advertisements designed to support multiple sites in a research study. How do you standardize your copy so that it can be approved by all regulatory bodies? Following are a few hints on how to avoid IRB issues that can stall production of key recruitment materials.
1) Write any copy like it is being reviewed by the most conservative local IRB
The most important consideration when designing materials that will be reviewed by multiple IRBs is to ensure you do not take too many risks with your writing. Edgy copy might be inspiring to the reader, but could wind up passing through a central IRB while being scrutinized by a local one. While not a universal truth, it is usually the local IRB that will push back aggressively on any language that might be too speculative or promissory.
This is truly the worst-case scenario, because as we often find, academic centers traditionally are activated after dedicated clinical trial sites during study start-up. In that case you may have already had your materials approved by a central IRB and produced (which, in the case of a TV ad can be a significant investment), only to find that a local IRB has a problem with some of the wording. It is much better to write your copy to the most conservative review you can think of so that this is never an issue.
Ultimately, here are a few general tenets to adhere to when drafting copy for patient recruitment ads or materials:
- Do not use the word free when describing anything associated with the study
- Avoid phrases that speculate at all about the potential benefit or efficacy of a study medication
- Be mindful of key words in your copy that could be scrutinized, and limit their use (including clinical trial, study drug, etc.)
- Use limited reference to compensation for participation, including the amount of money someone could be reimbursed for travel (as this may vary by site)
2) Make your materials format as flexible as possible
It pays to have materials that can be easily reformatted to accommodate variable content, should you run into a situation where IRB standards conflict. This is not always easy, especially when it comes to broadcast ads. A good rule of thumb here is to always avoid live action commercials where you have actors with speaking parts. I know that very few clinical recruitment campaigns employ such a sophisticated level of ad, but the cost of reshooting a live action ad would most certainly be prohibitive for a sponsor. Even when using lower cost mediums (print ads, flyers, etc.), it is smart to make sure your creative files can be easily edited by a third-party designer, should you need to have something reformatted on the fly.
3) Communicate with your IRB if there are discrepancies
IRBs can sometimes seem like intractable, soulless bodies that rule with heavy-handed authority. However, if you find an IRB is mandating an edit that contradicts something another body has approved, it might be worthwhile to reach out to the reviewer and discuss the recommendation. Showing an IRB that another IRB has approved copy they are not comfortable with can sometimes result in a change in the ruling.
I recently ran across a situation where two different reviewers at the same IRB had different opinions about the same phrase used in a study flyer. One reviewer approved it, while a few months later, a different reviewer recommended a change. So, even within the same IRB, sometimes you can find variable standards. Ultimately, it never hurts to inquire about a specific decision, especially if not questioning it would result in having to reproduce materials at a significant cost to a sponsor.
Variable decisions by IRBs are something that everyone runs into at some point or another. Poor planning for unexpected deviations in approvals are an easy way to incur unexpected costs in for a study. Make sure you plan accordingly so that any surprise IRB issues don’t derail your recruitment budget or timeline.
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