OR WAIT null SECS
© 2023 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
Applied Clinical Trials
Outlining the growing attention and pursuits around social media in adverse event reporting and advancing patient-centric initiatives in clinical trials.
Social media has moved beyond being a fashionable word to one that is drawing renewed attention from the pharma and healthcare industries. The power of these tools and the impact that they can have not only on brand perception and, effectively, on sales, as well as the increasing interest of the regulators in social media is resulting in this shift. In addition, tools and technology and the growth of the data sciences industry have proven to be powerful enablers. As patient centricity becomes the cynosure of attention, the need to capture their views becomes necessary. Social media brings in a pragmatic component to clinical trials, supporting the world of evidence-based medicine (EBM). Patients themselves want to draw more informed decisions and want to be participants in the decision-making process on how their health is going to be managed.
It has been observed in studies that of the more than 74% of Internet users that engage on social media, 80% are looking for health information,1 with 90% of the younger media-savvy 18-to-24 year-olds2 claiming that they relied upon this source, using it twice as often as the more senior population. They shared health-related conversations and patient stories on diverse topics such as how someone coped with a chronic condition, views on diet and exercise, and their choice of physician.2 The most accessed online resources for health-related information included WebMD (56%) and Wikipedia (31%).3 Patients wanted doctors to actively share updates on the disease, new pipeline compounds, their experience with different drugs, etc., on social media and 60% claimed that they trusted what the doctors were posting.4 It becomes all the more important for healthcare professionals (HCPs) to share accurate information and timely updates with the patient community. It was not only patients who were leveraging social media, 60% of HCPs were also actively watching what their counterparts are sharing on health-related issues. Doctors themselves seemed to truly believe that social media is impacting the quality of care. Forty percent of patients also relied upon social media to assess how others were dealing with chronic conditions.2
All of these situations have led to the development of numerous online patient communities such as:
Geo-based social media strategy
There is a whole spectrum of social media services being leveraged by pharma and healthcare, ranging across listening and analytics, marketing, and engagement. Companies are designing geography-based social media strategies based on the audience that they are targeting. Novartis, for example, thus engages with the public for its brand Gilenya® (the once-a-day pill developed to treat multiple sclerosis) through a dedicated handle on Twitter, @GILENYAGoUSOnly. The introduction section of this Twitter handle clearly calls out that it is only for a US audience and also sets forth other guidelines of interaction, such as the response window, how to share personal details, and also the discretion Novartis would practice in responding or not responding to certain tweets.13 Internally, for a pharma company, this means the need for increased harmonization in social media efforts across countries and regions, while staying compliant with local regulations. When it comes to listening, social media tends to be more porous and it no longer matters, for instance, where an adverse event (AE) was reported, as it can find interested audiences anywhere in the world. But engagement is a different world altogether, as it has to be contextualized to the specific user, geography, local regulations, and so on.
More AE traffic?
The most significant challenge faced by pharma was identifying the reporter of AE information on social media sites. The FDA defines an “identifiable reporter” as one who is privately contactable. While Novartis believed that additional demographics were important, AstraZeneca felt that an email ID or even a Facebook contact was enough. However, both companies agreed that AEs collected from organized data collections systems should be considered as “solicited,” whereas the rest should be treated as “spontaneous” reports. Though the European Union (EU) does not mandate the monitoring of social media for AEs, it does require that events that have been observed should be reported. This may change as observations from the WEB-RADR (Recognizing Adverse Drug Reactions) project gain traction in the EU. Launched in September 2014 by the Innovative Medicines Initiative, WEB-RADR, a €2.3 million, three-year public-private project, is responsible for developing a mobile application for reporting adverse drug reactions (ADRs) to regulatory bodies in the EU region. The mobile app would help evaluate the potential of social media data in identifying safety issues.15
It has also been observed that in a study conducted on AE reported for Lipitor® (atorvastatin) and Meridia® (sibutramine) in the FDA Adverse Event Reporting System (FAERS) database and on AskaPatient.com (a patient-support group website), the majority of AE reports on social media came from a younger population and focused on milder AEs on AskaPatient.com, as compared to those reported in FAERS.16
An evolving landscape
Pharma companies need to be mindful of varying regulations on the advertising of branded prescription products, while defining their product promotion strategy. It is very important, therefore, that each company develops its own social media policy guidelines. It has been observed that 23% of pharma organizations do not have policies to address data security and privacy, whereas 31% of healthcare organizations do have healthcare policies in place.2 A review of the top 100 companies listed on the London Stock Exchange demonstrated that the top three social media-savvy pharma companies are Johnson & Johnson, GlaxoSmithKline, and Pfizer, respectively This becomes especially relevant when a company is marketing its products in multiple geographies, with varying local regulations. While this is acceptable in the U.S., advertising of branded prescription products is not accepted by many other countries.
In addition, when tweeting, one needs to be mindful of the FDA draft guidance on Internet/Social Media Platforms with Character Space Limitations - Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices, issued in June 2014.18 This guidance specifically focuses on FDA-regulated medical products, the 140 character space limit associated with tweets, and the need of the pharma industry to present both benefit and risk information during product promotion while tweeting. While this does not apply to company websites, or product pages on social media websites such as Facebook or Twitter, the important take-home from this guidance is that irrespective of the character limitation, if a company is promoting the benefits of its product in a tweet, it also needs to bring to the attention of the consumer, albeit in a concise manner, the potential risks of the drugs as well, or else evaluate other platforms for product promotion.
Twitter, for its part, has been simplifying its rules, which gives pharma marketers some leeway. The site’s 140-character limit has revised to 280, making it easier for benefits and risks to be included together. In a survey conducted by Ogilvy Healthworld with 14 big pharma companies, a 530% increase in the number of tweets in 2014 as compared to 2013 was observed. With access significantly enhanced, the need for regulations in this regard is understandable. Interestingly, the highest increase (300%) was noted in the activity of a key German drugmaker.19
One recent example of the FDA coming down hard on pharma social media practice was with respect to the promotion of Diclegis®, a Duchesnay’s morning sickness drug, via social media posts from Kim Kardashian. The agency pointed out that while the posts highlighted the benefits of Diclegis®, the risks were not highlighted. This resulted in a warning letter being issued by the FDA’s Office of Prescription Drug Promotion (OPDP).20 It was one of 19 letters issued by the FDA, including three warning letters and 16 untitled letters.
Mining the web: who owns the data?
Not only do regulations regarding the posting of promotional information deter the pharma industry, but a large sector still perceives “listening” to be a liability. The key concern is that if companies do go down the social media path, they would need to notify regulators regarding all AEs identified by them on social media sites. The reality is that up to 90% of AEs go unreported and reporting by patients and HCPs is extremely low.21 In efforts to address these gaps, Novartis and other pharma companies have been working on Web-RADR. Over three million posts from Facebook and Twitter (55% excluded as spam) were analyzed. Two percent were termed as “proto-AEs”-information which could represent potential AEs and were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Epidemico is developing algorithms to help detect potential AEs reported online and also eliminate duplicate reports. It is important to use a sophisticated, natural language processing system to eliminate the noise and draw meaningful results. About 12 drugs are being monitored by WebRADR and the data will then be analyzed by the European Medicines Agency (EMA) and the companies in the WebRADR consortium.
The ownership of such data-whether it should be the patient, the company, or regulator-is still being debated.15,22 Patient advocacy group, EURODIS, which is associated with Web-RADR and represents patients with rare diseases, recommends that all data from social media be added to EudraVigilance, the EU’s pharmacovigilance ADR database. This database is freely accessible to patients and researchers to aid signal detection. Currently, in the EU, companies are not obliged to scan social media and report AEs. However, if they do scan and find them, then they are obliged to report them to regulators. Regardless, it is mandatory for companies to monitor and report any side effects of drugs reported on their own sponsored websites.23
Drugmakers may have to reconsider their strategies for tracking AEs spontaneously, as the General Data Protection Regulation (GDPR) is set to go into effect in May. As per GDPR, the collection of any personally identifiable information (PII) by pharma would be regulated, provided the companies declare on their websites and social media properties that they are doing social listening and that the information shared by users may be used for this purpose. It is important to note that ethics-committee requirements vary from country to country and it is crucial that they also be examined so as to ensure compliance.
A good example of an ADR being identified through social media channels was the identification of “Crix belly” syndrome, also known as lipodystrophy syndrome, which results while taking antiretrovirals to treat HIV. It was detected using social media but was not identified during clinical trials, as the study duration was 48 weeks and the side effect manifested after that.15 Patients themselves are screening multiple social media websites to find out more information about ADRs, and are sharing their experiences on sites such as PatientsLikeMe and 23andMe. An FDA-funded study, which analyzed 61,401 tweets, demonstrated that 4,041 (7.2%) could be classified as proto-AEs (posts that resembled AEs), which was three times the amount typically reported to the FDA by patients.24
While the agency has been firm in addressing critical issues such as a balance in reporting benefits and risks of drugs, it also established a research partnership with PatientsLikeMe in June 2015 to help monitor AE reports from patients.25 PatientsLikeMe has also partnered with UCB to create an online epilepsy community to track real-world experiences in dealing with the disease; the platform provides patients with an opportunity to directly report AEs to the FDA.26
Patient recruitment and social media
Today, 11% of clinical trials are leveraging social media for patient recruitment. Biogen Idec (now Biogen), for example, had been screening an average of six patients per week in its clinical studies. That rate reportedly shot up to 800 patients within two weeks of partnering with MyHealthTeam.27 It was also interesting to note that as per a U.S. study on omni-channel recruitment outreach, apart from the benefit of significantly higher accrual speeds, it was found that the per-patient cost by direct mail was $30, versus 86 cents via the social media route.28 In addition, the opportunity cost associated with a delay per day is significant. With 37% of sites failing to meet recruitment criteria and up to 10% not recruiting a single patient during a trial, the use of social media to rapidly and cost effectively scale up patient recruitment becomes key.28
The Mayo Clinic conducted a pilot study to demonstrate that social media can be effectively used to recruit large, demographically diverse patient groups in a cost-efficient manner, which served as a key message to HCPs.29 A study of 1,516 randomly chosen tweets out of 15,346 that contained the phrase “lung cancer” demonstrated that about 18% of the tweets were about clinical trials. Interestingly, only one of the tweets provided a link to a patient recruitment website.30 With over 320 million monthly active users, Twitter could offer significant potential in driving patient recruitment.13
On the Facebook front, as the world progresses gradually toward virtual clinical trials, VERKKO, Sanofi’s successful Phase IV trial for diabetes that evaluated a wireless blood glucose meter in a remote setting, recruited 60 patients, all online through Facebook. Interestingly, the average patient age was 56, with some patients older than 70; patient satisfaction scores were 4.52 out of 5, indicating that social media is not the domain of only the young.31
Patient centricity continues to be an emerging theme in clinical research-and social media has been a key facilitator in this transformation. The dynamic between the two goes a step beyond reporting of AEs or patient recruitment, but also moves into the crowdsourcing of protocols. The first protocol to be crowdsourced with an investigational new drug approval was for Transparency Life Sciences’ antihypertensive lisinopril.32 Crowdsourcing was also used to assess the use of metformin in men with rising prostate-specific antigen after localized treatment for prostate cancer. Inputs were obtained from 43 physicians and 33 patients using Transparency’s Protocol Builder platform. As patients would provide their feedback based on their own real-life experiences, it is expected that accrual rates would be much higher, since the real needs of the patient would be addressed. Protocols for irritable bowel disease, Parkinson’s disease, and MS are also being developed using crowdsourcing.
Where does pharma move from here? The biggest challenge the industry faces today is not that the value of social media is not well recognized or that the risk of AEs is deemed too high-it is how to reap the benefits of social media optimally. Clearly, the answer does not lie in listening alone, as most brands experience a steady state after listening for a while and no new incremental insights are observed. The industry’s plain, vanilla social media services are not the answer; instead, the evolving trend is more toward digital services such as
mobile apps that help track drug adherence, or more complex solutions like Amazon’s Echo, a voice-enabled computer that can recite potentially lifesaving instructions for a user on say, for example, cardiopulmonary resuscitation during an emergency.34
The life sciences industry is also cognizant that today’s informed patients and caregivers are looking for more credible information and better tactics of engagement than the traditional leaflets or, more recently, the occasional tweets. Engagement through online communities, health and fitness devices, and mobile apps is what the industry is looking at today.35 Even traditional social media listening is moving into a new dimension, as pharma companies increasingly explore big data and natural language processing solutions and direct partnerships with forums such as PatientsLikeMe, with the two-pronged objective of (1) driving efficiency in the process and (2) getting real patient viewpoints.
The power of social media to transform healthcare is substantial. While the pharma industry has long suffered from social anxiety, it is increasingly opening up to the use of social media, and both HCPs and patients are becoming more cognizant of the power the communication tool wields. Watchful steps are being taken in this direction. When GSK recently conducted a search across Facebook and Twitter, the company found 21 million mentions of its products, and this data also resulted in the recall of one of its drugs. GSK worked with Epidemico to filter out irrelevant posts and to ensure compliance with FDA-reporting requirements.36
While one may think that the cost implications are considerable and it would perhaps have been best if GSK would not have mined this data, the reality is that ADRs will be identified at some point of time, resulting potentially in more severe consequences for the manufacturer and significantly more harm for the patient population. Social media thus serves as a powerful enabler for responsible pharma companies that take ownership of patient safety, for patients who want to make informed decisions and share experiences, and for HCPs who want to engage with their patients and drive mutually agreeable decisions that are in the best interest of the patient. True patient centricity is not about ignoring commercial value, but about prioritizing the patient. Social media is the game changer in that equation.
Nimita Limaye, PhD, is CEO, Nymro Clinical Consulting Services, email: Nimita.firstname.lastname@example.org; Awani Saraogi is SME, Social Media, Tata Consultancy Services; email: email@example.com
1. 30 Facts and Statistics on Social Media and Healthcare. https://getreferralmd.com/2017/01/30-facts-statistics-on-social-media-and-healthcare/
2. 24 Outstanding Facts and Statistics and Figures on how Social Media has impacted the Healthcare industry. https://getreferralmd.com/2013/09/healthcare-social-media-statistics/
3. Stricker P. Social Media: An Emerging Communication Modality (2014) http://www.naylornetwork.com/cmsatoday/articles/index-v2.asp?aid=296436&issueID=30171
4. Kotenko J. The doctor will see you now: How the Internet and social media are changing healthcare. (2013) https://www.digitaltrends.com/social-media/the-internet-and-healthcare/
5. Castellucci M. Leveraging online platforms to measure how patients feel Modern Healthcare (2017) http://www.modernhealthcare.com/article/20170831/NEWS/170839984
6. Raths D. NQF Turns to Online Communities on Patient-Reported Outcomes. Healthcare Informatics (2017) https://www.healthcare-informatics.com/news-item/nqf-turns-online-communities-patient-reported-outcomes
7. Brunner, G. FDA authorizes 23andMe to market health-related genetic testing. (2015) http://www.extremetech.com/extreme/199602-fda-authorizes-23andme-to-market-health-related-genetic-testing
8. 23andMe. https://ipfs.io/ipfs/QmXoypizjW3WknFiJnKLwHCnL72vedxjQkDDP1mXWo6uco/wiki/23andMe.html
9. Strickland M. Patients Know Best: A Changemaker Health Case Study. (2017) https://medium.com/change-maker/patients-know-best-a-changemaker-health-case-study-2f203b0971ae
10. 5 things to know about Doximity. https://www.doximity.com/about/company
11. Sermo Pages. http://www.sermo.com/sermo-pages
12. MomMD. https://www.mommd.com/
13. Ghinn, D. Pharma gets social: FDA guidance on twitter is irrelevant for global pharma (2013) http://www.pharmaphorum.com/articles/pharma-gets-social-fda-guidance-on-twitter-is-irrelevant-for-global-pharma
14. Mack, J. Solving the Social Media Adverse Event Reporting Problem. Is it just too much ‘noise’ to sift through? (2010) Pharma Marketing News, 9.3, 1- 9. http://www.news.pharma-mkting.com/pmn93-article04.pdf
15. Sukkar, E. Searching social networks to detect adverse reactions. (2015) The Pharmaceutical Journal. http://www.pharmaceutical-journal.com/news-and-analysis/features/searching-social-networks-to-detect-adverse-reactions/20067624.article
16. Duh MS et al. Learning From Social Media For Adverse Event Reporting. (2017) http://www.analysisgroup.com/uploadedfiles/content/insights/publishing/learning_from_social_media.pdf
17. Global Top 10 Pharma Companies on Social Media. (2014) https://www.slideshare.net/simplify360/johnson-johnson-top-pharma-company-in-social-media-gsk-and-pfizer-follow
18. Krackov, D.A., Davar, M.V., Kailasnath, V. and Gitterman, A. FDA’s New Online Media Draft Guidance Documents. (2014) Arnolds and Porter Advisory, 1 – 15. http://www.arnoldporter.com/resources/documents/ADV614FdasNewOnlineMediaDraftGuidanceDocs.pdf
19. Taylor, N.P. Bayer, Boehringer lead rapid rise in pharma’s social media output. (2015). FierceBiotechIT. http://www.fiercebiotechit.com/story/bayer-boehringer-lead-rapid-rise-pharmas-social-media-output/2015-04-27
20. Perrone, M. Kim Kardashian’s social media posts prompt FDA warning. (2014) http://www.azcentral.com/story/money/business/consumer/2015/08/11/fda-warning-kim-kardashian-diclegis/31501143/
21. Papple D. Up to 90 percent of adverse events go unreported, pharma companies search social media to make drugs safer. (2015) Inquistr.https://www.inquisitr.com/1914900/up-to-90-percent-of-adverse-reactions-unreported-pharma-companies-search-social-media-to-make-drugs-safer/
22. Innovative Medicines Initiative WEB-RADR Workshop Report: Mobile Technologies and Social Media as New Tools in Pharmacovigilance (2017) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2017/02/WC500221615.pdf
23. Points to consider about clinical trial data and transparency. (2013) https://globalhealthtrials.tghn.org/site_media/media/medialibrary/2014/02/points_to_consider_final-1.pdf
24. Banks L. Social adverse event reporting – giving a voice to patients. (2015) https://pharmaphorum.com/views-and-analysis/monitoring-social-adverse-event-reporting/
25. Okun, S. Sally Okun explains the new research collaboration with the FDA (2015) http://blog.patientslikeme.com/2015/06/16/sally-okun-explains-the-new-research-collaboration-with-the-fda/
26. Wicks, P., Keinenger, D., Massagli, M.P., et al. Perceived benefits of sharing health data between people with epilepsy on an online platform. Epilepsy and Behavior (2012) 23.1, 16-23.
27. Rosenberg R. Biogen Idec turns to MyHealthTeam in successful test of social networks for enrolling MS clinical trial (2014) https://www.myhealthteams.com/wp-content/uploads/2015/01/cww1827_myHealthTeams.pdf
28. Patient recruitment: is social media the cure for this headache? Clinical Accelerator (2015) https://clinicalaccelerator.com/2015/02/17/patient-recruitment-is-social-media-the-cure-for-this-headache/
29. Donahue M. Patient Recruitment via Social Media: Lessons Learned (2012). http://www.pharmexec.com/patient-recruitment-social-media-lessons-learned
30. Fassbender M Twitter for #Clinical Trials Recruitment? Researchers see the potential. (2016) https://www.outsourcing-pharma.com/Article/2016/03/09/Twitter-for-ClinicalTrials-recruitment-Researchers-see-the-potential
31. Adams B. eClinicalHealth, Sanofi boast of success in their Facebook recruited study. (2016) Fierce Biotech.http://www.fiercebiotech.com/cro/eclinicalhealth-sanofi-boast-success-their-facebook-recruited-study
32. Mansell P. Lisinopril IND is crowdsourcing first, says Transparency Life Sciences (2012) PharmaTimes. http://www.pharmatimes.com/Article/12-12 20/Lisinopril_IND_is_crowdsourcing_first_says_Transparency_Life_Sciences.aspx
33. Carlson RH. Crowdsourcing Clinical Trial Protocol (2014) Oncology Times 36.6, 30-32 http://www.opensourcepharma.net/uploads/3/1/7/8/31787557/crowdsourcing_clinical_trial_protocols_april_2014.pdf
34. A digital revolution in healthcare is speeding up. The Economist. https://www.economist.com/news/business/21717990-telemedicine-predictive-diagnostics-wearable-sensors-and-host-new-apps-will-transform-how
35. Champagne, D., Hung, A. and Leclerc, O. The road to digital success in pharma, (2015) McKinsey&Company. https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/the-road-to-digital-success-in-pharma
36. Taylor, N.P. GSK finds 21M mentions of its drugs in trawl of social media. (2015) FierceBiotechIT. http://www.fiercebiotechit.com/story/gsk-finds-21m-mentions-its-drugs-trawl-social-media/2015-10-11