Dear Clinical Trial Participant,

Feedback from participants and patient organizations support the concept that individuals like yourself, who participate in clinical trials, wish to understand the outcomes of their studies. Additionally, the European Medicines Agency has issued the EU Clinical Trial regulation (No 536/2014) requiringorganizations that conduct clinical trialsto make available to you, a plain language summary that describe the outcome of the study. As a result, you will have the option to receive this plain language summary about the clinical trial you are participating in.

The plain language summary will be available 1 year after the last participant who entered the study completes their final visit. (Note to Sponsors: For studies conducted in children, revise this statement as plain language summary may be available 6 months after the last child has completed their final study visit.) You should know that depending upon when you joined the study that the timeline to receive it could be greater than 1 year from your final visit as the recruitment period of a study can span across months or years. Your study doctor should be able to let you know more about what participant number you are in the study (one of the first, middle or last participants to join the study).

This document is to help answer some of the questions you may have about the plain language summary:

  • What is a plain language summary- what is included and what is not?
  • How can I receive a copy?
  • Can I share the summary with friends, family or members of my medical team?
  • Is it necessary for me to receive a copy of the plain language summary?
  • Is there a cost associated with receiving a plain language summary?
  • What to do if I have questions after you have read the plain language summary?
  • Where can I get more information about plain language summaries, the regulation and clinical research?

What is a plain language summary?

Plain language summaries describe the results your study in a language in non-scientific terms (similar to the language used in your informed consent form). The plain language summaries will not contain your own personal data or information about your treatment assignment in the study. It will be a general overview of the overall learnings of the clinical study. The plain language summaries, will be at the very minimum, posted to the public EU Clinical Trials portal in all official languages recognized by the European member states. The summaries may also be provided to you directly either in an electronic or paper format in your primary language.

How will I receive a copy?

The options to receive your plain language summary should be known at the time you finish the study. The manner in which plain language summaries are shared with study participants, will be based on circumstances such as whether most of the study participantscan easily access the internet, concerns that mailing a paper copy to a home address might interfere with the participant’s privacy and the number of countries and sites involved.

Can I share the summary with friends, family or members of my medical team?

Yes. If you wish to share the plain language summary with friends, family members or any member of your personal medical team, you are able to do so. The information is not considered confidential.

Is it necessary for me to receive a copy of the plain language summary?

You are not required to receive a copy of the plain language summary. You can choose not to receive a copy. If your study doctor will be providing it, you can inform them of your decision and they can make a note of your wishes. If the plain language summary is available on a website, you are not required to register to receive it. Choosing not to receive it will have no impact on your future medical treatment or ability to participate in other clinical research activities.

Is there a cost associated with receiving a plain language summary?

There is no cost to receive the plain language summary.

What to do if I have questions after I have read the plain language summary

You may have questions about what the information means in general or to you specifically. After reading the plain language summary if you have questions about the content or what it means for your future medical treatment options, you should speak with your study doctor or members of your personal medical team. Information about the study results will likely be known the best by your study doctor. There will be no cost to you to have these questions answered.

Where can I get more information about plain language summaries and clinical research?

The EU Clinical Trial regulation No 536/2014 can be found in EU Clinical Trial website and publicly available reference sites on the internet. Additionally, the local Institutional Review Board / Research Ethics Committee listed in your consent form can provide you with details about your rights as a clinical study participant. To learn more about clinical research, you can refer to patient organization associated with your personal condition and/or the website of the company conducting the study.