The CLARA new submission form requires study teams to provide a so-called “lay summary” about their study. Consider the lay summary an opportunity to summarize the study and highlight any important points someone would want to know as they’re reviewing the study. Providing complete information in this section will speed your review and approval.
For example, let’s say you have an investigational drug study. You’re looking to see whether fruit candies alone or fruit candies in combination with chocolate bars work better in treating a rare skin condition called Gitchigumee Itch. It’s industry sponsored and being done under an IND. Here are two examples of how we might see the lay summary question answered:
- This study will compare fruit candies alone to fruit candies in combination with chocolate bars in treating a rare skin condition called Gitchigumee Itch.
- This study is an investigational drug study being done under an IND to study two potential treatments for a rare skin condition called “Gitchigumee Itch.” Subjects will be randomized to one of two treatment regimens — fruit candies alone, or fruit candies in combination with chocolate bars. The test articles are approved for other conditions but not for Gitchigumee Itch. Subjects will attend a total of 15 study visits over three years. They will be given the study drugs to take at home. Subjects will also have the option of allowing their data and samples to be retained for future use. This is an industry-sponsored trial. The protocol describes enrolling subjects age 16 and up. This site will enroll only adults.
Note that option two lets the reviewers immediately know some important facts about the trial. It’s FDA-regulated and involves randomization. It also answers the question of whether our site will participate in the entire protocol or only parts of it. It tells us whether subjects are randomized or if group assignment will be done some other way.
Here are some highlights of what the lay study should summarize:
–The research question(s) you’re trying to answer.
–The process by which you’re going to try to answer the research questions.
–What types of instruments or test articles will be involved. Are they already approved/validated? Do they involve any special procedures for administration?
–How long will the subjects be in the study? Who or what is sponsoring/regulating the study (e.g. FDA, industry sponsor)
–Anything unique to that protocol, e.g. this site will enroll only adults, or will enroll only to arms 3 and 4, or will not participate in the substudy described in the protocol.
Please don’t copy and paste protocol language in response to the “lay summary” query. Protocols are written for scientists. Lay summaries are designed to be understandable to those with no scientific background.