It's Time for a Medical Information Response Revolution
As a seasoned medical writer and medical affairs professional, I’ve recognized a glaring inefficiency in the way we handle medical information standard response letters. It’s astonishing how much time and resources are consumed in this process, and it is time we said, “enough.” It’s time for a medical information response revolution.
The Current State of Medical Information Responses
Traditionally, the development of medical information standard response letters involves countless hours spent on:
- Exhaustive Literature Search: countless hours are spent searching every keyword, every congress abstract, every study type in hopes of finding that one outlier that’s gonna provide a perfect answer to the question.
- Summarizing: Dedicating several hours to summarize each study with an excruciating level of detail.
- Reviews, Edits, and Approvals: The endless cycle of review and revision before final approval.
- Localization: Adapting the content for every major and niche market across the globe.
- Continuous Updates: Regular updates every time a letter is “expired” or a bit of new information comes out, each necessitating a repeat of the steps above.
The Medical Information Standard Response Revolution
The primary objective of medical information standard response letters is to convey actionable information that healthcare professionals (HCPs) can easily comprehend and apply in practice. This mission is impeded when an overabundance of information overwhelms the reader.
Step 1: Efficient Literature Search for New Letters
Conduct a focused literature search, relying on the most obvious search terms first. Limit results to published randomized controlled trials (RCTs). If this fails to return quality data, then you can change up the search terms or reduce the level of evidence (eg, observational studies, congress abstracts, etc).
Pro Tip: Don’t forget to double check the pulse of the field with a quick Google search as described in this post.
Now it is time to select the content for the letter.
- First rely on existing materials and align data with the overarching medical plan.
- Choose up to three key articles of similar design to summarize. Ok, a maximum of five articles if absolutely necessary. If you need any more than that, you likely need to break the response up to answer more specific questions.
- Be wary of the law of diminishing returns. Adding excessive information increases the time needed for writing, reviewing, and approving the letter, while reducing its practical utility for HCPs.
- Refer to other articles as “additional data”, including only references as described below.
Step 2: Create an Outline
- Develop a bulleted list of headings. List out key endpoints to present from your three articles as sub-bullets.
- This outline will be used to expedite the review process by providing the medical director with a snapshot of the content to review instead of a written draft.
Step 3: Concise Summaries
- Summarize the selected studies using the simple format discussed in a previous post.
- Ensure the content is universally applicable and refrain from including local/regional data (eg, prescribing information or country specific regulatory data). Use sources like a core data sheet as data on file, company press releases, or US/EU regulatory filings available online.
- Add a sentence at the end about the availability of additional information and its general nature, with citations to the additional articles.
Pro Tip: In the reference section, hyperlink to all articles. This is kinda difficult with programs like Endnote, but you can set it up to include the full hyperlink at the end. Then if you put your cursor at the end of the link and click the spacebar, it will hyperlink it in the document. Do this right before you upload your final draft for activation, since each time you regenerate the bibliography it will rest the links.
Step 4: Streamlining the Review Process
The review typically includes a data check, a medical director review, a proofreading step, and an occasional review from ancillary departments at the direction of the medical director. Here is how to streamline this.
- Medical Director Review: Encourage medical directors to review only the outline. Trust me, they don’t need to see the final letter. Their job is to make sure what we are saying aligns with the overall company medical strategy and is consistent across medical affairs. Set a strict review timeframe of one business day to maintain momentum. The outline is not going to be a big document to review. Don’t let this step eat up your timeline and delay your ability to get actionable information into the hands of HCPs.
- Ancillary Review: This is where the medical director can recommend other groups review the content. Again, try an get a review of the outline, not the letter. Some groups, like legal/regulatory, are going to insist on seeing the final version of the letter. However, an initial sign-off of the outline is still helpful. Again they get one business day to review an outline.
- Medical Information/Peer Review: This should be one review to check the information against the references and proofread the document. Proofreading is done to make sure the letter aligns to the department style guide, is well written, and error free. Because these letters will not be overly large (3-5 references), these do not get a long review timeline. One day per reference is plenty.
Step 5: Final Approval
Upon obtaining necessary approvals, the letter should be made available for global use. This will eliminate or reduce the time spend localizing documents. If there are specific localization or translation needs, you can create “one-off” localizations and exclude those markets from using the global document.
Step 6: Forgoing Expiration Dates
Instead of setting expiration dates, conduct an annual literature search to update the letters as required. Since we are going to actively monitor the literature, expiration dates are unnecessary. An annual lit search will catch any data that may have fallen through the cracks.
Pro Tip: An annual literature search doesn’t have to be overly complex or formal, just search your keywords, limited to the last year. You are looking for articles that add something to the letter. If a new article doesn’t add anything, just add it to your reference list on the last sentence as described above.
Step 7: Efficient Letter Updates
In case of emerging data, update the existing outline and proceed through the streamlined review process above. When adding articles to your response, don’t forget to remove the lower quality data, adding the citation to your reference list in the last sentence.
Pro Tip: The outline can be sent for medical director approval before the article is published. Then the day it is published, or you are certain you have a final draft, you can summarize the article and send for medical information/peer review as described previously. Now all that is left to do is mark it “approved” when the data are published.
Change Begins with Us
It’s evident that the traditional way of handling medical information standard responses is ripe for revolution. By adopting a leaner, more focused approach, we can cut down on unnecessary information and provide HCPs with the crux of what they need. This not only saves time and resources but also adds value to the pharmaceutical industry by promoting an agile and efficient sharing of medical information.
CoreMed Communications, LLC, specializes in agile precision and boutique craftsmanship for standard response letters. Our commitment to expediency, quality, and bespoke service sets us apart in medical affairs communications. We understand the importance of having timely standard responses available to your medical information call center to meet HCP demand for actionable information. Whether you represent pharmaceutical companies, biotechnology firms, or provide contract support as a medical communication agency, CoreMed Communications, LLC is here for you.
Engage with CoreMed Communications, LLC
Are you ready to be part of the medical information response revolution? Join hands with CoreMed Communications, LLC and elevate your medical affairs communications. Our expert insights and services in crafting standard response letters, addressing medical information unsolicited requests, and developing frequently asked question documents, set us apart as industry leaders.
Reach out to CoreMed Communications, LLC for a consultation and learn how our specialized services can make a difference in your medical information department or call center.