Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive “push” of information to patients to a “pull” of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape.
Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating and for engaging multiple groups involved in cancer clinical research.
POOR ACCRUAL TO CLINICAL TRIALS
The clinical trial accrual for adult patients with cancer is only 2% to 7%.1 Clinical trials are a type of research to determine what works and what does not work—usually with patients in a specific disease such as cancer. Without a rigorous and systematic method to determine the efficacy (how well something works in a group) and effectiveness (how well something works in a “real world” community population) we can be deluded about medicine. Many examples were described by Dr. Prasad et al in “A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices.”2 The drugs we have available today are based on laboratory research and clinical trial participation with patients.
Dr. Sandra Swain, MD, FASCO, the 2012–2013 president of the American Society of Clinical Oncology (ASCO) noted “Only the 3% of patients who participate in clinical trials are able to contribute to advances in treatment.”3 Or put another way, it is a “… stunning fact that 97% of today's cancer care does nothing to advance our collective knowledge of the disease…”4 A review of a large Community Clinical Oncology Program (CCOP) Research Base showed that only about one third of accruals were to early phase drug trials. So only approximately 1% (1/3 of 3%) of patients may be participants in evaluating new drug therapies (personal communication from 2010 review). Tomasz Beer, MD has noted “Without clinical trials, cancer treatment would always remain the same.”5
Dilts et al looked at “Steps and Time to Process Clinical Trials at the Cancer Therapy Evaluation Program” from 2000 to 2007.6 They noted: “at least 296 distinct processes are required for phase III trial activation: at least 239 working steps, 52 major decision points, 20 processing loops, and 11 stopping points.” And concluded: “Because of their complexity, the overall development time for phase III clinical trials is lengthy, process laden, and highly variable. To streamline the process, a solution must be sought that includes all parties involved in developing trials.” In 2010 Dilts et al reiterated the complexity of opening studies as well as noted the high zero accruals (38.8%) in cooperative group studies with more than 50% of trials accruing fewer than 5 patients and 49% of phase III trials never get to 25% of accrual goals.7
Patients can even be discouraged about cancer clinical trials by physicians. Virani et al found that approximately 60% were discouraged by their oncologist and 50% by family physician to participate in clinical trials.8 Zaren et al have shown that early phase clinical trials are possible in the community setting with adequate infrastructure and collaboration.9 Dr. Somkin and others looked at the “Effect of Medical Oncologists' Attitudes on Accrual to Clinical Trials in a Community Setting” and found that even in a system with an active clinical trials program the “…broad concept of awareness had the greatest correlation with enrollment and mediated the effect on enrollment of other values and beliefs, such as welcoming a patient's initiation of a trial discussion and valuing the support of research nurses and coordinators.”10
There are awareness and educational barriers for physicians as well as patients. The National Cancer Institute (NCI) HINTS (Health Information Trends Survey, hints.cancer.gov) found that 34% of Americans have not heard of a clinical trial. Recently a description of the “Use of the National Cancer Institute Community Cancer Centers Program (NCCCP) Screening and Accrual Log to Address Cancer Clinical Trial Accrual” showed that major barriers for patients included no desire to participate in trials (43%) and preference for standard of care (39%). Major reasons for physicians declining to offer trials to patients were preference for standard of care (53%) and concerns about tolerability (29%).11 This study did not address patient or physician understanding of the individual studies. Educating patients may not improve accrual, but trying to disrupt the status quo and providing increased interactive education is something to consider.
SOCIAL MEDIA TO OVERCOME BARRIERS
Social media utility in oncology has been well described elsewhere. The e-patient that is “empowered, engaged, equipped, and enabled”12 can be engaged using social media for education, including for clinical trials.13 Dizon et al discussed “Practical Guidance: The Use of Social Media in Oncology Practice” which is useful for practitioners.14 However, the social norms of the use of social media are changing, so guidelines will need to change over time. The idea of using social media for physician and patient engagement goes back a little farther than most realize. In a 2009 article “Twitter for ‘Tweatment’” Dan Von Hoff, MD presciently stated: “Wouldn't it be special if we have a drug that has activity, to be able to tell people right away that ‘we do not know if it would work for you but we have seen patients’ tumors respond'. Then at least they have a chance to be put on to a clinical trial.”15
At the American Society of Hematology (ASH) 2012 Annual Meeting Matthias Weiss, MD et al in the NCI Myeloma Steering Committee Accrual Working Group presented “Significant Barriers to Accrual to NCI Sponsored Multiple Myeloma—Clinical Trials: A Step Toward Improving Accrual to Clinical Trials.”16 They thought that identification of barriers for a less common cancer such as myeloma may have application other cancers and may also lead to improvements in trial accrual. At ASCO 2013 they identified strategies to overcome those barriers.17 One of those strategies included to: “… educate patients and providers about the significance of a new CT [clinical trial] using social media…” With the instigation of a patient with myeloma and the help of a patient advocate we formed a Twitter chat discussion about myeloma using the hashtag (#mmsm) to educate the public and physicians about clinical trials. I described this in the blog post “Online Patient Communities for the E-Patient: ‘Betwixt and Between’ a New Patient and an Expert”18 We are now in an era where the patients are collaborators and there is a continuum of need from paternalism to complete autonomy.
TWITTER HASHTAGS—CREATING STRUCTURE
As Twitter use has increased in oncology, grassroots efforts created hashtags to “flag” or “tag” discussions that could be searched for content. Examples include Tweet chat hashtags #mmsm as noted above as well as more popular ones such as #bcsm for breast cancer and #lcsm for lung cancer. Meeting hashtags such as #ASH13 and #ASCO14 also help track and follow discussions at major scientific meetings. A list of ASCO social media tags is at: www.asco.org/about-asco/social-media.
To get a handle on organizing all of the information from health related tweets, Matthew Katz, MD (@subatomicdoc) a radiation oncologist and an External Advisor for the Mayo Clinic Center for Social Media published a series of blog posts on the topic of hashtags in cancer including: “Hashtag Folksonomy for Cancer Communities on Twitter”,19 “Health Tag Ontology Project: Adding Meaning to Social Media?”,20 and “Health Hashtags: Successes and Challenges in Organizing Oncology Online”.21 An updated and evolving list of oncology hashtags is here: Cancer tag Ontologysymplur.com/health care-hashtags/ontology/cancer/. The role of physicians was highlighted in the blog “Why Doctors Should Participate in Twitter Chats”22 with the quote from Farris Timimi, MD, the Medical Director for the Mayo Clinic Center for Social Media: “This is a conversation, and that is what we are trained to do… This is where our patients are these days and this is where we need to reach them. We can engage learners, patients and peers, and we are not limited by geography or time.” Newer hashtags such as #CardioOnc may help us recognize and track cross disciplinary topics including potential collaborators for clinical trials.
ONLINE PATIENT COMMUNITIES
Patients have used peer-to-peer communication before the Internet and before social media. Patient mentoring programs are present in many advocacy and support groups. Online patient communities are a form of networked social media that can provide support for patients and caregivers, education, links to resources, and even research ideas. A forum for patients with Spontaneous Coronary Artery Dissection (SCAD) resulted in the group suggesting a research project to a Mayo Clinic cardiologist, who listened and engaged with that rare patient population.23 This patient-researcher collaboration could work in cancer as well. Online patient communities may be as general as Facebook or specialized such as PatientsLikeMe and Smart Patients.
A few share clinical trial links—for example, https://www.smartpatients.com/trials and www.mpatient.org/faqs-clinical-trials/or even physician finders for specific diseases—for example, www.mpatient.org/business-directory/.
Similarly there are physician online communities that care be potentially useful to share updates in medicine and clinical trial information. A few professional physician related networks include: Doximity, HealthTap, LinkedIn, ResearchGate, and Sermo.
SOCIAL MEDIA FOR CLINICAL TRIAL RECRUITMENT
The Internet is one of the first sources people use after a cancer diagnosis. Patients, family, and other physicians are using social media. Social media is an obvious avenue to help educate and share information about clinical trials without “spamming” those that are not interested. This is more efficient than mass mailing. Social media links should follow institutional rules, but can link to publicly available “static” websites such as ClinicalTrials.Gov or other resources including individual institutions or cooperative groups. Providing any additional (i.e., nonpublic) information may require institutional review board (IRB) approval.
O'Connor et al recently published “Can I get a retweet please? Health research recruitment and the Twittersphere” as a mechanism to recruit participants and conduct online health service research.24 The conclusions were: “Twitter is a cost-effective means of recruitment, enabling engagement ith potentially difficult-to-reach populations, providing participants with transparency, anonymity and a more accessible method by which to participate in health research.” Some considerations for utilizing social media for clinical trials are noted in Table 1. Social media encompasses more than the examples for Facebook, Twitter, and blogging, but the concepts translate to other venues. The themes are around control of content and professionalism. This sounds easy but can be more difficult during “real time” communications with multiple inputs and over a mix of platforms. A recurrent risk and mandate is to not violate Health Insurance Portability and Accountability Act (HIPAA, www.hhs.gov/ocr/privacy/hipaa/administrative/combined/index.html) rules and to obey any institutional other pertinent guidelines.
Social Media and Clinical Trials: Considerations
SOCIAL MEDIA FOR EDUCATING ABOUT CLINICAL TRIALS—COOPERATIVE GROUPS, U.S. FOOD AND DRUG ADMINISTRATION (FDA), AND NCI
Cooperative groups, the FDA, and the NCI are using Twitter feeds and hashtags to educate and inform varied constituencies. These groups realize the utility of using social media to reach various populations. Examples include the National Cancer Institute (@theNCI), the Food and Drug Administration (@US_FDA), Alliance (@Alliance_org), ECOG-ACRIN (@EAOnc, #EAOnc), SWOG (@SWOG, #SWOGOnc) and others. A few examples of tweets sharing clinical trial information:
ECOG-ACRIN = Eastern Cooperative Oncology Group (ECOG) & American College of Radiology Imaging Network (ACRIN) http://ow.ly/leLum #EAOnc
ECOG-ACRIN Active Cancer #clinicaltrials: http://ow.ly/quted #EAOnc
Active #Myeloma Trials—ECOG-ACRIN Ecog-acrin.org/trials/myeloma #EAOnc #mmsm
PHARMA AND FDA GUIDANCE ON SOCIAL MEDIA
Biotech and pharmaceutical companies have been slow to engage on social media fearing regulatory punishments, bad public relations, or the unknown. Laura Strong, PhD, a biotech president and chief operating office, wrote about “Social Media & Cancer Drugs: Conversation, not Promotion”25 and noted that:
“While most pharmaceutical companies have a social media presence…they can be difficult to find and often have the feel of one-way communication, typically centered on company news and press releases. I estimate that a minority of company Web pages provided a summary of social media sites.”
The FDA draft social media guidance that was released on January 2014 may help clarify use of social media by the pharmaceutical industry.26 This document relates to “interactive promotional media” such as blogs, microblogs (i.e., Twitter), social networking sites, online communities, live podcasts, which pharma uses to promote its drugs. The “DRAFT GUIDANCE” (capitals in document) notes that “This guidance document is being distributed for comment purposes only.” Notably this is hardly definitive. Further “It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.” The main points are below:
A firm is responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm. EG— company website, Facebook page, or Twitter feed.
Under certain circumstances, a firm is responsible for promotion on third-party sites (e.g., promotional content given to a third party).
A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm's product (e.g., a medical science liaison (MSL) or paid speaker or blogger).
For static promotional materials (e.g., sites that do not allow real-time communications/feeds) there are no changes to existing regulations. For “interactive” sites the draft guidelines suggest that pharma has a reporting obligation for sites in which they have complete or any partial control of content even on third-party sites.
These preliminary guidelines are relevant not only for promotional material but also for off-label marketing. Potentially, it may set parameters for the use of social media in discussing clinical trials, though currently that issue is not explicitly addressed in this draft. Currently, it is unclear whether a person is an “agent” if he or she has received research funding or consultant fees not related to social media and subsequently discusses that company/product on social media.
Many cooperative group, institutional, or industry clinical trials are developed by individual principle investigators (PI) with influence from a group (disease specific committees, etc). In a sense this is utilizing a crowdsourcing on a micro scale, where the “micro” is the experts and not the general public. Crowdsourcing is obtaining something (money, ideas, resources) from a large (or micro = small) group of people. This may be generalized to prior activities, but is often applied to obtaining from online networked communities.
David Lee Scher, MD noted that crowdsourced clinical studies may be a new paradigm in health care?”27 However, this disruptive paradigm shift hasn't been widely realized in clinical trials. Dr. Katz also looked at “Three Ways to Improve Clinical Trials through Crowdsourcing.”28 This is worth reading in full including the many comments. A few obstacles considered were academic culture and regulatory barriers. To which Dr. Katz asked “What if regulators were partners in the process rather than being seen in an adversarial role?” This is not dissimilar than patient focus groups or patient advocates on disease committees. It is just moving the process online, making it more open, and potentially more transparent. The cooperative group Alliance for Clinical Trials in Oncology notes that “…it welcomes concept submissions from the general public.” So, the paradigm may already be shifting, even if not optimized yet.
Baron (from Roche) and Rosenblatt (from Merck) commented on “Access to Patient-Level Trial Data” recently in the New England Journal of Medicine.29 The “crowd” wants its data. This will be an interesting and important area to follow over time.
Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from the 2009 Von Hoff idea of tossing information into the Twittersphere about potential clinical trial options to a more organized and patient centric and patient engaged forum with the potential to crowdsource to improve clinical trial accrual and design. This is evolving and will change over time with a number of potential obstacles.
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