“The Promise of Community-Based Advocacy and Education Efforts for Increasing Cancer Clinical Trials Accrual”

Abstract

Only 3% of cancer patients participate in cancer clinical trials (CCTs). A number of barriers to participation, particularly for minority groups, can be addressed through community-focused education and advocacy efforts. Working with community partnerships, a pilot program sought to change knowledge, attitudes, and role behaviors among community leaders, primary care providers (PCPs), and clinical researchers about CCTs, to increase patient awareness of and participation in CCTs. A mixed method evaluation utilized quantitative analysis of surveys administered to participants during the program period (2006-2008) and qualitative data from interviews with key participants. Programmatic efforts were effective in increasing knowledge and training community leaders and PCPs to disseminate messages about clinical trials, and ultimately increasing patient inquiries about local trials. Training improved cultural competency skills among clinical researchers to recruit and retain CCT participants. Partnerships fostered new processes and structures to facilitate CCT participation in their communities. Clinical trials education and advocacy efforts through community partnerships have an important role in enhancing clinical trial access and in increasing clinical trial participation. Oncologists' involvement in and leadership of such partnerships are critical to promoting CCT accrual, particularly for minority groups.

Ethics Standards (HRPP) and Public Partnership (PARTAKE) to Address Clinical Research Concerns in India: Moving Toward Ethical, Responsible, Culturally Sensitive, and Community-Engaging Clinical Research

“…A wide and representative sample of participants in clinical research is essential to ensure adequate generalization of the findings to the population at large [57,70]. Informed persons and research participants could assist in enforcement of research standards (ethical and methodological) and increase the quality of data generated.…”

“…This makes research more costly and less powerful in detecting meaningful therapeutic effects, and it delays the arrival of new treatments to those who need them [57,65,[71][72][73].…”

“…Withholding important contributions that the public may provide as an active partner in the clinical research process (communicating therapeutic preferences; enhancing study design; helping with data collection; enforcing standards; and helping with research funding, lobbying, and public policy [53,54,56,57] A government-commissioned committee confirmed the deaths were not related to the vaccine [41] CDSCO report Government report finds deficiency in enforcement of regulation [40] Activist protests, Supreme Court intervention, regulatory overhaul, hold on clinical trial approvals [18, 19,30] "Collusion" of regulators with industry sponsors is decried in the media; it is inferred by the identification of copycat letters sent by physician experts to the regulators in support of pharmaceutical clinical trial applications…”

Engaging Referring Physicians in the Clinical Trial Process

“…1,2,5 A study conducted by the Education Network to Advance Cancer Clinical Trials found that PCPs who attended an education program about clinical trials had a statistically significant increase in knowledge about the training content and an increase in "positive attitudes about the role of a PCP for CCT referrals." 5 The training focused on discussions PCPs could have with patients and their families about clinical trials and the role of clinical trials as an element of quality care. 5 When holding meetings at the office of a referring physician, it is important to involve nurses and other ancillary staff at the practice.…”

“…5 The training focused on discussions PCPs could have with patients and their families about clinical trials and the role of clinical trials as an element of quality care. 5 When holding meetings at the office of a referring physician, it is important to involve nurses and other ancillary staff at the practice. These individuals can be very influential and often serve as "research champions."…”