1. Social Media and Clinical Trials
2/22/2011
Social Media and Clinical Trials
Darcy Hille, Merck
Paulette Ceesay, Merck
JSM 2018 Vancouver

2. Background
2/22/2011
Social media is having extensive and evolving impacts on clinical trials, which represent both opportunities and risks.
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3. Positive Impacts and Opportunities
2/22/2011
Patient awareness of trials
Recruitment
Trials in therapeutic areas with historically poor accrual rates, such as oncology, may benefit from social media’s ability to reduce barriers to entry. Example: recently Novartis used a Twitter feed to boost awareness of a phase 2 trial in oncology 
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4. Positive Impacts and Opportunities
2/22/2011
Participation
A phase 2 study of prostate cancer solicited opinions about protocol design from patients online.
Engaged patients may have a better clinical trial experience.
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5. Positive Impacts and Opportunities
2/22/2011
Patients benefit from forums that offer support and education
Yelp posts reviews of facilities that conduct clinical trials
Social media interactions can build engagement and satisfaction among trial participants – patients feel that they have a support network beyond clinical staff
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For individuals interested in participating in phase 1 trials, JALR.org provides links to commercial sites, including details about factors such the quality of the Wi-Fi and food, and the speed of payment, enabling participants to be ‘informed shoppers.’ 

6. PatientsLikeMe And Duke Bring Novel Approach To ALS Trial
2/22/2011
PatientsLikeMe And Duke Bring Novel Approach To ALS Trial
ALS Patients are highly motivated to take part in research, but here are not that many trials for them to participate in
No patient wants to be on placebo
In this study, all of the participants would have to make a baseline visit to the Duke ALS Clinic to be screened
Participants then perform 12 months of online follow-up via PatientsLikeMe. All data would be live for everyone to see. Anyone can go to the trial website and see the data and how the patients feel the treatment is working for them.
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For individuals interested in participating in phase 1 trials, JALR.org provides links to commercial sites, including details about factors such the quality of the Wi-Fi and food, and the speed of payment, enabling participants to be ‘informed shoppers.’ 

7. 2/22/2011
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For individuals interested in participating in phase 1 trials, JALR.org provides links to commercial sites, including details about factors such the quality of the Wi-Fi and food, and the speed of payment, enabling participants to be ‘informed shoppers.’ 

8. ALS Nutrition JSM 2018 Vancouver 2/22/2011
For individuals interested in participating in phase 1 trials, JALR.org provides links to commercial sites, including details about factors such the quality of the Wi-Fi and food, and the speed of payment, enabling participants to be ‘informed shoppers.’ 

9. Negative impacts and risks
2/22/2011
Patients’ ability to interact with each other in patient forums and discuss adverse events may lead to unintended negative consequences.
Actual thread “… And my pills are very bitter and nasty tasting. I’ve also cross referenced my taste experiences with others who I know are getting the (study drug) and we all agree on the flavor…”
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 Patients have posted structured data on efficacy and safety on an investigational drug to public and social websites

10. Negative impacts and risks
2/22/2011
Negative impacts and risks
Social media may be responsible for the spread of misinformation
Patients may try to determine their treatment assignment, possibly compromising the adverse event reporting and even the blind
Potential for inappropriate self-diagnosis and treatment
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 Patients have posted structured data on efficacy and safety on an investigational drug to public and social websites

11. Social Media Policies
2/22/2011
Trial sponsors have been slow to enact social media policies
Social media policies vary widely, with smaller companies being more nimble in their responses
Where they exist, social media policies tend to concentrate on marketed products 
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12. Social Media Policies
2/22/2011
 Both patients and clinical staff may need education and training about the opportunities and risk of using social media during a clinical trial.
Patient confidentiality could suffer
At this point it is not possible to ignore social media or instruct participants to not use social media.
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13. Social Media Policies
2/22/2011
 Current FDA Guidance for industry provides recommendations for the presentation of risk and benefit information for prescription drugs using social media sources
The website is directed at potential trial participants. It explores the impact of social interactions on screening, participation, side effects, and the placebo effect. The main message is “Speak out, but speak smart.”
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14. Strategies
2/22/2011
Harness the positive aspects of social media on clinical trials while minimizing the negative
For discussion: Do Data Monitoring Committees have any responsibility for monitoring social media activity during the life of a clinical trial?
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In future, social media use among clinical trial participants is likely to increase

15. Strategies
2/22/2011
Clinical trial sponsors must work with regulators to define ways to monitor social media use by trial participants
Is there a way to determine if social interactions among participants will affect their interpretation of study results?
Sponsors might develop an informal ‘risk calculator’ to assess the chance of negative impacts from social media in a particular trial.
JSM 2018 Vancouver
In future, social media use among clinical trial participants is likely to increase

16. Author Contact Information
2/22/2011
Darcy Hille
Director, Biostatistics
Merck & Co., Inc.
351 N. Sumneytown Pike
North Wales, PA
USA
Paulette Ceesay
Principal Scientist, Biostatistics
Merck & Co., Inc.
351 N. Sumneytown Pike
North Wales, PA
USA
JSM 2018 Vancouver

17. References
2/22/2011
| 2014 ASCO EDUCATIONAL BOOK e101
Lipset, CH. Engage with research participants about social media. Nature Medicine 20(3), 2014
on/Guidances/UCM pdf
media-but-smaller-drugmakers-rate-highly-too
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