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

Background 2/22/2011 Social media is having extensive and evolving impacts on clinical trials, which represent both opportunities and risks. JSM 2018 Vancouver

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  JSM 2018 Vancouver

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. JSM 2018 Vancouver

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   JSM 2018 Vancouver 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.’ 

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. JSM 2018 Vancouver 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.’ 

2/22/2011 JSM 2018 Vancouver 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.’ 

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.’ 

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…” JSM 2017  Patients have posted structured data on efficacy and safety on an investigational drug to public and social websites

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 JSM 2018 Vancouver  Patients have posted structured data on efficacy and safety on an investigational drug to public and social websites

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    JSM 2018 Vancouver

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.   JSM 2018 Vancouver

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 https://www.ciscrp.org/primer/index.php 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.”   JSM 2018 Vancouver

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?   JSM 2018 Vancouver In future, social media use among clinical trial participants is likely to increase

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

Author Contact Information 2/22/2011 Darcy Hille Director, Biostatistics Merck & Co., Inc. 351 N. Sumneytown Pike North Wales, PA 19454 USA 267-305-7265 darcy_hille@merck.com Paulette Ceesay Principal Scientist, Biostatistics Merck & Co., Inc. 351 N. Sumneytown Pike North Wales, PA 19454 USA 267-305-7544 paulette_ceesay@merck.com JSM 2018 Vancouver

References 2/22/2011 http://www.quintiles.com/blog/social-media-the-evolving-impact-on-clinical-trials http://asco.org/edbook | 2014 ASCO EDUCATIONAL BOOK e101 https://www.ciscrp.org/primer/index.php https://www.patientslikeme.com/ Lipset, CH. Engage with research participants about social media. Nature Medicine 20(3), 2014 https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati on/Guidances/UCM401087.pdf http://www.fiercepharma.com/sales-and-marketing/j-j-glaxo-are-tops-social- media-but-smaller-drugmakers-rate-highly-too JSM 2018 Vancouver