This week, May 1st – 7th, marks the third annual Clinical Trials Awareness Week, hosted by The Coalition for Clinical Trials Awareness (CCTA). The Coalition for Clinical Trials Awareness is a nonprofit group comprised of health care providers, patient advocates, medical researchers and industry and government stakeholders working together for one common goal - to increase public awareness about the importance of clinical trials participation. Established by the CCTA in 2015, Clinical Trial Awareness Week is observed annually the first week of May, encouraging patient advocacy organizations, medical societies, and other health organizations to rally together to raise public awareness about the importance of clinical trials and the benefits of participation.
Public Awareness = Increased Participation = Access to New Products and Therapies
Access to new medical devices and drug therapies depends on successful clinical trials that can meet enrollment requirements to support safety and effectiveness claims and gain FDA approval. Sounds simple right? Wrong. Low or slow enrollment and difficulty retaining subjects are common challenges in clinical research. Identifying the right patient for the right research study is a difficult task that both drug and device trials often encounter. Likewise, once enrolled, subject retention for the duration of the study can become equally problematic since subjects are free to withdraw consent at any time and may chose to withdraw from a study for any number of reasons, including insurance changes or transportation difficulties.
Low participation in clinical trials has become increasingly detrimental to drug and device study completion. As a result, approvals can be delayed and incur higher medication costs, ultimately impeding patient access to potential life-saving treatments. Recent studies show that less than 10% of Americans participate in research studies. Additionally, surveys conducted by the Tufts Center for the Study of Drug Development found that 11% of research sites fail to enroll a single patient and 37% do not meet their enrollment goals. An article published in the Journal of Clinical Oncology discusses results from a survey indicating that 40% of surveyed adults do not understand clinical trials and less than 10% report knowing “a lot”. Commonly cited concerns by patients included the effectiveness or side effects, uncertainty of research organizations, receiving of a placebo vs treatment, the delay of treatment approval and availability, additional costs or insurance issues, and the time commitment to participate. Interestingly, the greatest reservation that patients conveyed about clinical trials (which also supports the need for awareness) is the perception that clinical trial participants are “treated like guinea pigs.” However, 32% of surveyed adults had a more favorable perception and voiced willingness to participate in a clinical trial after being exposed to information and being educated about these concerns.
Many patients hold a negative opinion of clinical trials and decline to participate due to their lack of knowledge concerning value and benefit. If patients are provided detailed information about clinical trials such as the purposes of the study, anticipated tests and treatments, the benefits and risks, possible side effects, other treatments available, and what services or treatments are paid for by the study, they may feel more comfortable considering participation.
These studies and survey results emphasize that the barriers to clinical trial participation can be overcome by increasing public awareness of clinical trials. Improving patient awareness of the potential personal health benefits and the societal benefits of clinical trials is vital to increasing participation, resulting in more efficient clinical studies and faster access to new, approved treatments.
How Can the Federal Government Increase Clinical Trial Awareness?
The CCTA feels that this challenge can be addressed by means of a federally sponsored public awareness campaign – much like the U.S. Department of Health and Human Services’ campaign to increase organ donor registries. Public-private partnerships and the use of diverse media - such as radio spots, public advertisements and service announcements, billboards and social media - would improve awareness and advance the message of clinical trial participation by emphasizing the larger societal benefits of participating in a clinical trial.
Will this solve the numerous participation barriers facing clinical research? Likely not entirely, as low participation is only one of many challenges to approving new products or treatments. However, a federally-sponsored public awareness campaign – specifically focused on utilization of diverse media – would allow citizens to be educated about clinical trials, heighten awareness, and encourage higher levels of participation.
This week, CCTA intends to focus on fostering dialogue among stakeholders, specifically Congress, about the importance of clinical trial awareness for patients. Several events offer opportunities to participate in Clinical Trial Awareness Week:
Twitter Chat: Can Digital Medial Save Clinical Trials?
Date: Tuesday May 2nd
Time: 1:00 PM EST
CCTA, partnered with Empowered Patient Chats, will facilitate an online forum focusing on the role of digital media in raising the public’s awareness about the benefits of clinical trials.
Review the twitter chat by using #CTAW2017. For additional details see the Empowered Patient Chat blog.
Webinar Hosted by Worldwide Clinical Trials: Eavesdropping on 4 Experts: Differentiated & Quality Clinical Trial Services on Time & Within Budget
Date: Wednesday, May 3rd
Time: 11:00 AM EST
A panel of worldwide experts discusses perceptions relating to what they believe the major influencers are in defining a successful clinical trial from start to finish, as well as where they see the CRO industry heading. Reserve your spot to participate HERE.
LIVE Webinar Hosted by Clinical Trial Myth Busters:
Are Clinical Trials a Last Resort Treatment Option?
Date: Tuesday May 2nd
Time: 3:00 PM EST
Are clinical trials only for patients who run out of treatment options? Watch online and ask our expert panel questions as they debunk common myths around clinical trial participation. Tune in to hear the patient perspective and expert advice for making decisions about clinical trials.
Register and join the live webinar HERE.
For more details, visit CCTAwareness.org.
Beyond Clinical Trials Awareness Week
Clinical Trials Awareness Week allows for a spotlight to be shined on clinical trials and the impact they have on delivering safe medical devices and treatments to patients worldwide. This week’s events encourage the health care and research communities to come together in promoting and increasing public awareness of clinical trials. It also serves as a means to get government involved and to advocate for a federally funded awareness campaign.
Currently, according to Clinicaltrials.gov, the number of clinical studies that are registered for 2017 in the U.S. has surpassed the totally number registered in 2016. However, low participation and lack of awareness will cause many of these clinical trials to be delayed. Key actions that we can do as researchers to increase patient awareness:
• Inform patients. Utilize the internet and social media resources to reach patients and aid in recruitment, so long as these methods are approved by the reviewing IRB. Provide information about clinical trials, addressing the common misconceptions, while providing details on current studies.
• Promote the benefits of clinical trial participation. Again, this can be accomplished through initiatives above, but also through education of health care professionals. Physicians need to understand how to educate patients about clinical trials and the huge role they play in healthcare and medical advancements.
• Cultivate collaboration. Working together as a community towards one common goal. Increasing healthcare provider awareness about current clinical trials results in greater patient awareness. Creation of a federally sponsored public awareness campaign can also increase awareness.
As a research community we need to join together to improve participation and our efforts need to extend beyond #CTAW2017.
What are ways that we can help to increase public awareness? Do you support the need for a federally sponsored awareness campaign? How will you be participating in #CTAW2017?