Written by: Gerald L. Klein, MD; Roger E. Morgan, MD; Michael Fath, PhD; Larry Florin, MBA
Product Development
The FDA has just issued a new guidance document June 2024: Diabetic Foot Infections: Developing Drugs for Treatment.[1] This guidance provides important trial design such as emphasizing the importance of including subjects with diverse foot ulcer depths and area of involvement. The guidance considers surgical debridement after 48 hours as a criterion for treatment failure.
The importance of using a placebo in Phase I clinical trials is particularly crucial when testing medication on patients with disorders known to exhibit a significant nocebo and placebo effect. The nocebo effect results from the negative anticipations, beliefs, expectations, or previous experiences that study participants have toward the medication that they will be administered.[2] This effect in clinical trials may not always be recognized but may distort the results, leading to increased withdrawal of participants, and complicate interpretation of the data.[3]
When is an AE resolved so that it no longer has to be followed by the Principal Investigator (PI)?[4] This is usually straight forward such as when an infection that was treated with an antibiotic resolves. However, in certain chronic conditions this decision point may be difficult to ascertain. Some protocols state that when the condition returns to baseline the event is resolved. Not all conditions will return to baseline. Other studies state that if it is a chronic condition that has stabilized, it should be considered resolved. However, if it has not stabilized and/or requires long-term treatment, such as an aggressive cancer (and the protocol does not cover this), we suggest that it be listed as resolving and only followed until the study ends. For SAEs, the protocol should include specific language that outlines the duration of follow-up required after a patient has discontinued participation in the study.
Medical Affairs
It may be difficult to present evidence demonstrating the effectiveness of one pharmaceutical product over another marketed therapy. Meta analysis has been frequently used for such proof, but these have multiple drawbacks and may not be readily accepted by healthcare providers. The use of real world data and clinical studies may help solve this problem.[5]
The more rapid adapatation to the use of plain langauge can go a long way in getting your message out to the public and even to some health care providers. Just because pharmaceutical diagnostics and therapeutics may be complicated, it does not mean that your language has to be written in more difficult to understand jargon.[6] An improved communication methodology can significantly enhance the value and impact of your messaging.
Although there has been a significant increase in the use of omnichannel digital marketing in medical affairs, direct person-to-person contact should not be overlooked. A medical liaison who has established respect, trust, and likeability will magnify the effectiveness of a personal digital campaign sent from that same individual.[7]