Communicating Clinical Study Outcomes
Important Note: All publications of studies funded by the NIH must be deposited in the PubMed Central repository upon acceptance by a publisher and receive a designated identification number. Some journals submit publications to the database automatically, others do not. Investigators can ensure that their publication(s) receive(s) a PMCID number by contacting: email@example.com. A copy of the final, accepted peer-reviewed manuscript is required to initiate the deposit process. The NIH website contains information regarding its public access policies located here: http://publicaccess.nih.gov/policy.htm.
Registering your study on ClinicalTrials.gov
Applicable trials are to register and update the study posting on ClinicalTrials.gov to improve transparency with the public and to show others the type of research that is being done to prevent duplication of effort. This NIH website provides further insight on the requirements by law under the Food and Drug Administration Amendments Act (FDAAA) of 2007, including an interactive flowchart. Information regarding the obligation to register Clinical Trials as a condition of consideration for publication from the International Committee of Medical Journal Editors (ICMJE) can be found on their website.
More information, including the definition of applicable trials can be found on the University of Michigan Regulatory Affairs website. University of Michigan study teams should contact Diane Wilson, the Regulatory Affairs Compliance Specialist at 734.764.0634 or firstname.lastname@example.org with questions, or for more information.
Assess whether your findings have “news value”
A media relations specialist from the Public Relations and Marketing Communications department will work with you to assess whether your findings are likely to generate interest among the general public. If so, a press release will be prepared with your input and approval.
Contact PRMC at least two weeks in advance of the date of your clinical trials results are published or the date of your presentation. Manuscripts or abstracts may be shared with media relations professionals in advance. Information will be distributed publicly following the embargo guidelines set forth by the journal or meeting organizers.
PRMC controls what is published on the UMHS newsroom and social media outlets. However, publication of stories by the external media is dependent on the editors and reporters receiving the press release. Their coverage will vary widely based on the topic and findings, its appeal to a broad audience, the timing of a press release and other local, national or world news that may take precedence.
Examples of previous research press releases can be found on the UMHS newsroom.
For more information about and resources from the UMHS media relations program, go to www.med.umich.edu/prmc/services/pmr/mediac.html.
Why is it important to publicize your research findings?
There are good reasons why it is important to publicize U-M research, including the simple fact that your results reach a broader audience and this can increase the impact of your research. Additionally, we are able to provide the general public with key health information and tell them what we are doing with tax dollars supporting medical research. Publicizing research also gives positive recognition to the U-M Health System and your funding source for supporting your research.
What is a press release?
Press releases (also called news releases) are generally 1-2 page summaries of your research, written specifically for a lay audience. A press release is designed to interest news reporters in pursuing coverage of the research presented, so it should be written similarly to a newspaper story. The most pertinent finding is featured in the headline and first paragraph. Information about funding source and any patent or licensing disclosures is included, as is a full list of study authors. One to two lead or senior researchers are typically quoted.
How are they distributed?
Press releases are distributed as follows:
- Emailed by PRMC to as many as 1,500 reporters across the country, including print, radio, TV and online outlets. Reporters with an interest in covering health, medical and science news are targeted.
- Distributed through three press release services that health reporters subscribe to:
- Posted to the UMHS newsroom. Press releases may also be posted to center and department websites, when appropriate.
- Emailed to communicators within the University of Michigan, including internal U-M and UMHS publications such as the University Record, Health System Headlines and Medicine at Michigan.
- Posted to UMHS Facebook and Twitter accounts, as well as any relevant center or department social media pages.
Prepare to talk to reporters about your study
Following distribution of a press release, reporters may contact the Public Relations office to request interviews with the study authors. Study authors are encouraged to respond expediently to these requests, which are normally funneled through your media relations representative. The media relations representative will work with you in advance to prepare you for the interview experience. Additional media training may be available on request.
Reporters may want to speak to a study participant
In some cases, reporters may wish to speak to a study participant about his or her experience. Participants will not be asked or expected to answer technical questions about the research, but rather will be asked to speak to their experience on the study – their personal motivation to participate, their relevant health information, what they personally did as part of the study and any side effects, inconvenience or benefit they personally received. This information is generally presented as one person’s experience and is put in the greater context of overall study findings.
You will be asked to assist the media relations representative in identifying a patient/study participant who may be willing to speak to media. This may include making initial contact with the volunteer to determine interest. You may share patient information with the media relations representative, who is protected under HIPAA. The media relations representative will contact the patient to provide more details and to ensure patient signs a HIPAA release form.
Please note that participants in current studies may not be interviewed. After the study has been completed, they may be made available to the media – if they are willing. Contact IRBMED or PRMC if you need further guidance.
Gather videos or photos that can be used with the press release
Depending on the study findings, the timing and resources available, the media relations representative may also work with you to create a video or photos to accompany the press release. Video will be posted along with the press release as well as to the UMHS YouTube page. Videos may vary from a simple 1-2 question recording of the study author, to a fully produced and narrated story including interviews with the study author and a participant. Decisions about video will be made by the media relations representative based on a number of factors.
If you publish results of your clinical trial in a peer-reviewed journal or present the results at a professional society meeting, contact the Public Relations office at 734-764-2220.