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Summary in Thirty Seconds
Targeted therapy is rapidly transforming oncologic pharmaceutical development and cancer care. However, many patients and healthcare providers (HCPs) are unaware of clinical trials and biomarkers for targeted therapy, which limits the speed and efficiency with which new compounds are tested and introduced.
People with cancer obtain information and raise their awareness about cancer clinical trials from multiple sources. However, there is a disparity in awareness among different racial groups unaccounted for by low education or health literacy levels.
The two most common ways people with cancer learn about clinical trials are the internet (including social media) and HCPs. HCPs, including pathologists, are particularly important in raising awareness of new clinical trials, new molecular targets, and genetic alteration testing.
Two other sources of information regarding targeted cancer clinical trials are pharmaceutical companies and their contracted agencies, and patient advocacy groups and other patient advocates.
Recommendations for improving awareness of cancer clinical trials include integrating cancer clinical trial elements into standard-of-care clinical practice; engaging local grassroots organizations and Patient Advocacy Groups; using community ambassadors/patient navigators; using targeted messages on social media platforms; and conducting biomarker testing programs to help promote simultaneous pre-screening for multiple targeted therapy trials.
Targeted Treatment Gains
Cancer treatment is being reshaped by gains in genomic understanding and technology. In the four years between 2104 and 2018, the percentage of biomarker-targeting oncology drugs approved by the US Food and Drug Administration (FDA), doubled: from 21% to 42%.[1] A review of novel oncology drugs approved in 2022 finds that over half are targeted therapy.[2] As an example, advancements in non-small cell lung cancer demonstrate the progress of targeted therapy. Ten molecularly distinct subtypes of non-small cell lung cancer (representing more than 50% of all affected patients) now have effective targeted therapies with many more currently under study.[3],[4] Notably, osimertinib, which targets EGFR mutations in NSCLC, has shown highly significant overall survival benefits in large, global clinical trials.[5]
The Problem of Low Awareness
However, if people with cancer are unaware of clinical trials for these new targeted treatments, they won’t enroll even if they’re willing to do so. Without trial participants, drugs may not be developed, or they will reach patients far more slowly.[6] Thus, the challenge is getting potential trial participants as well as healthcare providers to increase their clinical trial awareness. And while many targeted oncology compounds are currently under development, healthcare providers (HCPs) are often unaware of them and/or miss the opportunity to discuss clinical research trials with their patients as viable treatment options. A survey of nearly 2,000 cancer patients found that 73% of patients who joined a clinical trial said they did so because of their healthcare provider’s awareness of clinical trials.[7] Thus, awareness of trials, both in patients and HCPs, is critical for enrollment.
Awareness Disparity
A recent study looking at racial differences in awareness of cancer clinical trials found that far more White patients (80%) were aware of cancer clinical trials than Black patients (52%).[8] Such an awareness gap is related to multiple factors (although adjusting for lower education and health literacy levels did not alter the awareness gap), but the disparity is a factor in the problem of minority underrepresentation in clinical trials. Therefore, partnering with HCPs who work with underserved communities is an effective way to pass along information regarding cancer clinical trials while helping a medically neglected patient population gain access to cancer prevention, screening, and treatments.
Awareness Information Sources
Where do people with cancer and their families learn about (become aware of) clinical trials?
1. The Internet
The biggest reason people enroll in clinical trials is that they have searched for information on different treatment options for their condition. The source of this information is most often the internet, including social media.[9]Those who participate in clinical research increasingly cite the “information [they] read, saw, or had heard” about the study as being a major influence on their decision to participate.[10] Importantly, although online searches for clinical trials continue to increase,[11] the resulting information is often on a reading level beyond the literacy capabilities of the average reader, regardless of whether the information is sought from national authorities,[12] a Google search,[13] or the webpages of NCI-designated Cancer Centers in the US.[14] Thus, to raise awareness, internet-based clinical trial information needs to be readily understandable and easily accessible.
2. Healthcare Providers
While people with cancer increasingly rely on their own searching for clinical trial information, 77% of patients who participated in a trial learned about it from their HCPs. Yet only 32% of patients who participated in clinical trials reported that their HCPs took the time to explain the trial clearly.[15] Given that many patients seek information on their own, HCPs can augment raising awareness about clinical trial options. Such awareness begins with providing HCPs with the right information and a platform to discuss clinical trial options that may be appropriate for their patients. Having HCPs promote awareness is particularly invaluable to early/new clinical trials. These are clinical trials for which information is not yet publicly available, not easy to find on the internet, or not yet published in journals. By having a focused conversation about treatment options including clinical trials, a patient can be made aware of, and invited to enroll in a clinical trial.[16]
Importantly, HCPs are critical in pushing for comprehensive genetic testing that can link patients with cancer to targeted clinical trials specific to their genetic profile. A new study revealed that only 7% of people with cancer who meet the criteria for having germline genetic testing received such testing.[17] Other studies have revealed NGS testing rates far below what clinical standards would suggest, especially for cancers such as NSCLC where multiple targets have been identified.[18]
Pathologists are a sometimes-overlooked group of HCPs who can raise targeted cancer clinical trial awareness. Molecular pathologists are the front line in testing for identifying genetic alterations targeted in precision clinical trials. Thus, educating pathologists (at conferences, and/or through webinars and other continuing education) about new genetic targets and clinical trials can help them communicate with and raise awareness in their clinical oncologist colleagues about new precision medicine trials and molecular targets.[19]
3. Pharmaceutical Companies or Their Contracted Agencies
Pharmaceutical companies or their contracted agencies can improve HCP awareness by offering resources, information, and education (e.g., through seminars, webinars, and targeted websites) on a specific clinical trial or biomarker or by sharing their clinical research with KOLs and stakeholders, who in turn pass the information along to their HCP networks.[20] Sponsored webinars and similar educational presentations can be an opportunity to share findings from clinical trials with a network of HCPs (including, importantly, pathologists), which can stimulate enthusiasm and generate awareness of potential new treatments to attract participants.[21]
4. Patient Advocacy Groups and Other Patient Advocates
Molecular-specific advocacy PAGs have created much-needed online communities. While these PAGs first provided support and education to people with molecularly identified cancers, many now also push to fund research for the development of new life-saving medicines and work to raise awareness of the specific biomarker their PAG was developed around.[22] Two important roles for PAGs are helping patients find appropriate clinical trials and raising targeted therapy awareness.[23] Patient navigators and liaisons are another important resource to provide clinical trial information and raise awareness, as well as to help patients meet individual needs, overcome barriers, and address concerns about participation.[24]
Recommendations
Based on these multiple sources of information and the ongoing problems with clinical trial enrollment and poor awareness of not just clinical trials but of ever-emerging biomarkers targeted by these trials, it is important to explore multiple options to improve awareness leading to improved enrollment. Recommendations include the following:
Use targeted messages on social media platforms to raise awareness and stimulate interest in specific cancer clinical trials; such websites can also connect patients, families/caregivers, and others with trial centers' websites.[25]
Employ television, radio, and newspaper outreach to the public, plus use newsletters, brochures, and a presence at tumor boards to reach the clinical audience for many types of cancer clinical trials.[26]
Embed and integrate cancer clinical trial elements into standard-of-care clinical practice, which can raise awareness of cancer clinical trials while reducing clinical trial inefficiencies.[27]
The American Cancer Society Cancer Action Network recommends “broad panel biomarker testing programs to help promote simultaneous pre-screening for multiple targeted therapy trials.”[28] Such biomarker testing is particularly effective if molecular pathologists are aware of new(er) biomarkers, which can be fostered through well-thought-out pharma-sponsored educational programs (e.g., webinars and continuing education).
Pharma companies can also raise awareness by offering resources, information, and education on specific clinical trials or biomarkers or by sharing their clinical research with KOLs and stakeholders, who in turn pass the information along to their HCP networks.[29]
Engage local grassroots organizations and Patient Advocacy Groups that can reach the local community, building both awareness of and trust in clinical trials. [30]
Amongst its recommendations for improving cancer clinical trial participation, the Government Accounting Office (GAO) suggests using community ambassadors/patient navigators to raise awareness of and educate people on clinical trials.[31]
Awareness and consequently improved enrollment in cancer clinical trials can be enhanced by providing patients with clear, easy-to-understand information that enhances their decision-making.[32]
[1] https://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/PM_at_FDA_A_Progress_and_Outlook_Report.pdf [2] New Drug Therapy Approvals 2022 | FDA [3] Nat. Med. 2022; 28:658–665 [4] J Clin Oncol. 2023; 41(16_suppl):6506 [5] J Clin Oncol. 2023; 41(17_suppl):LBA3 [6] Nat. Med. 2022; 28:658–665 [7] The Need for Awareness of Clinical Research | National Institutes of Health (NIH) [8] BMC Cancer. 2022; 22:983 [9] Info, Comm, & Soc. 2023; 26(4):716-729 [10] The Need for Awareness of Clinical Research | National Institutes of Health (NIH) [11] AMIA Ann. Symp. Proc. 2010:597-601 [12] Euro J of Cancer Care. 20189; 27(6):e12937 [13] JMIR Cancer. 2018; 4(1):e10060 [14] AMIA Ann. Symp. Proc. 2003:470-474 [15] The Need for Awareness of Clinical Research | National Institutes of Health (NIH) [16] ibid [17] J Clin. Oncol. 2023; 41(16_Suppl):Abstr10500 [18] J Clin. Oncol. 2022; 40(16_Suppl):Abstr9128 [19] Am J Clin. Path. 2020; 153(2):149-155 [20] Info, Comm, & Soc. 2021; 26(4):716-729 [21] How to generate clinical research awareness - Aptitude Health [22] Nature. 2020; 587:S16-S17 [23] How Patient Advocates Help Cancer Research: An Expert Q&A | Cancer.Net [24] Contemp. Clin Trials Commun. 2018; 12:98-102 [25] JAMA Oncol 2021; 7:1447-1448 [26] J. Oncol. Pract. 2009; 5(4):205-207 [27] J Clin Pathways. 2021;7(8):22 [28] Recommendations - Overcoming Barriers to Patient Enrollment in Therapeutic Clinical Trials for Cancer (fightcancer.org) [29] Info, Comm, & Soc. 2021; 26(4):716-729 [30] Clin. Researcher. 2021; 35:9:28-32 [31] US Gov. Accountability Off. Dec. 2022. Cancer Clinical Trials [32] J Cancer Educ.2013; 28:458-465