3. Objectives
Collaborative partnerships can be a vital tool for improving reach, influence
and supplementing resources. Presenters will provide examples of how
successful partnerships have been leveraged to help engage the community
around clinical trials.
My role: Look broadly at the changing relationships, collaborations, and
possibilities for researchers, participants, ethics boards, and the general public
Explore how Internet/Social media/big data have become the norm for all aspects of
research, from recruitment to dissemination of results/data, but also address potentially
negative implications
4. A (Very) Brief History
Early Internet (circa 1960s)
•BBS/Telnet/Usenet—mailing lists,
newsgroups; asynchronous
communications viewed in a
thread
1960s
Growing use in universities,
research institutions
1970s-1980s
AOL!
•Beginning of the social
connectedness
•Support Groups
1990s
Listserves, chat rooms (In
2005, there were more than
400,000 Internet cancer
support groups)
2000s
Circa 2005: Social Media!
FB, Twitter, etc
2005
Circa 2010: Big Data
(2012: Pfizer's REMOTE Trial)
2010
5.
6.
7.
8. Where are the IRBs?
The Information Society
issue on IRBs, ethics,
and these new spaces
1995
Journal of Medical
Internet Research
1998
AAAS Report
1999
AoIR Ethics Guidelines
2001
Three books addressing
the intersections of
research ethics and
Internet research
2002
APA’s Psychological
Research Online
2004
Development of
institutional policies and
guidelines
2005-ongoing
AoIR 2; SACHRP
2012
SACHRP
2014
AoIR 3
2019
9. In research, these sites/tools are used
for:
Recruitment
Engagement
Intervention
Data Collection
Experimentation
Tracking
Documenting
10. And what are the concerns?
Privacy/Security
Consent
Researchers are but one stakeholder in a larger framework (think Cambridge
Analytica)
Secondary subjects
Remote research—separation of researcher-subject
Dissolving public v private sector data flows
Non-consensual access to data
Individuals are known by association or through a composite of data, true or
untrue: your data persona
11. More specifically:
“We are human beings and we will talk; patients are not going to change, so
the researchers must.”
“As use of online networks continues to rise, research sponsors and regulators
must begin studying the implications of social media on the integrity of
current blinded and randomized clinical trials” (Lipset, 2014)
How to get around eligibility criteria
Breaking the blind
Sharing AE information
Encouraging/discouraging AE reporting
Premature efficacy assumptions
Misinformation
12.
13. The (study drug) is causing the [side effect] ….. and it must be removed ….(1)
Stop the (study drug) and get it out of your system; (2) Go to a dermatologist
…(3) Get them to start you on a prednisolone taper starting at 40 mg first day,
then 30mg for 4 days, then 20mg for 4 days and then 15mg for one day….. [if
that is not successful] try 125mg iv of Solu-Medrol. ..don’t let some jive-
talking doctor try and tell you it’s the same thing… I’m the resident expert on
the subject at this point. So yeah, I’m gonna … assert you should stop the
(study drug)! And no I’m not a doctor...”
14. Merck & Co. cautioned that social media reports could result in an AE being
blown out of proportion, citing the example of Sanofi, which had to shut
down its Facebook page when a patient who reacted to cancer drug
Taxotere posted a flood of comments about experiencing hair loss, triggering
major reactions from the larger patient community.
15. Would you consider this?
“In all clinical studies, it is important that the people participating in the
study (doctors, nurses and subjects) do not make any conclusions about what
the results of the study might be, until all the data has been collected and
reviewed. If there are rumors about how many subjects have side effects, or
about whether the drug is working or not working, it may affect the study. If
the data from the study might be affected by early conclusions, it could cause
the study to have to be repeated. .If you participate in this clinical study, you
should feel free to discuss the study with your family and with other people
who are close to you. You should also tell any health care providers who treat
you that you are in the study. However, to help make sure that the data from
the study is as accurate and reliable as possible, please do not discuss
information about the study in public places while the study is in progress.
Public places may be situations like support groups, or may be places like
internet message boards. If you have questions about side effects, please talk
to your study nurse or study doctor.”
In 1981, only 213 computers were hooked to the Internet but by 1994 that number jumped to 2.5 million people. Fast forward to 2015, and Internet users have soared to over 3.2 billion people; by 2018, 4 Billion
First mention of Big Data was in the 1990s
