Challenges and potential solutions to meeting accrual goals in a Phase II chemoprevention trial for prostate cancer
Nagi B. KumarTheresa CrockerTiffany SmithJulio M. Pow‐SangPhilippe E. SpiessKathleen M. EganGwendolyn P. QuinnMichael J. SchellSaı̈d M. SebtiAslam KaziChuang TianRaoul SalupMohamed HelalGregory P. ZagajaEdouard J. TrabulsiJerry McLartyTajammul FaziliChristopher R. WilliamsFred SchreiberJoel W. SlatonJ. Kyle Anderson
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Oral health care services are often sparse and inconsistent in India therefore it is often difficult for poor people to get access to the oral health care services. The approach by dental institutions with the help of community outreach programs is a step ahead in overcoming this situation.The study was conducted to evaluate the number of patients, disease pattern and the services provided in the outreach programmes and also effectiveness of patient referral.A retrospective study was conducted and the data were obtained from records of outreach programs conducted, in last 2 years by Pacific Dental College and Hospital. The data were analysed using descriptive statistics for the computation of percentages Chi-square test was applied to know the association of effectiveness of referral with age and gender. Confidence level and level of significance was fixed at 95% and 5% respectively.A total of 22982 individuals in the age group of 4-80 years attended the outreach program. Dental caries (42.3%), periodontal diseases (63.2-69.0%) and dental fluorosis (33.7-35.0%) were commonly observed diseases. Effectiveness of referral was significantly high among the middle age adults and females (P<0.05). The effectiveness of referral was highly improved in 2013 after establishment of certain guidelines and strategies.The approaches by dental institutions with the help of community outreach programs can spread awareness and disseminate treatment and thereby enhancing access to care and eliminating access to care within the rural communities.
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African Americans may have greater risk of AD and are underrepresented in dementia research. Factors influencing minority participation in AD research are not fully understood. Less is known about barriers to participation in more invasive biomarker studies. To define barriers and facilitators to AD biomarker research participation among African Americans. Investigators conducted 11 focus groups with 70 African American participants. Participants responded to questions about barriers and facilitators for participation in AD research including imaging and lumbar puncture (LP) for collection of cerebrospinal fluid. The transcripts were independently reviewed by 2 investigators who identified themes to code transcripts. Data were organized by codes and analyzed. Mean age of the focus group participants was 46 (range 21–86y); they were predominately female (61%). Concerns and attitudes were consistent across education, socioeconomic status, and gender. The importance of medical research and the merits of and barriers to participation were endorsed consistently across levels of education, occupation, or income. The fundamental reason for African Americans’ lack of research participation is mistrust of the healthcare system. Negative perceptions of healthcare providers and health care infrastructure persist due to historical events, institutional racism, and healthcare disparities. The factors underlying mistrust color perceptions of clinicians and investigators. Other barriers included fear of adverse effects, insufficient dissemination of information of the rationale for research in the African American community, and inconvenience involved in participation. Factors preventing participation in biomarker studies include fear of the unknown and of adverse effects of medications or procedures, including a percieved high risk of paralysis and long term health problems associated with LP. Adverse outcomes from prior studies with African Americans are widely disseminated and passed down through generations. Altruism and relevance of research projects to the individual, their family members, or the African American community promote research participation. Important and pervasive barriers mitigate African American research participation. Increased participation in biomarker studies by African Americans will require development of trust, as supported by improved communication and a lasting interactive presence in the community by Alzheimer investigators and staff.
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Most practicing oncologists are committed to the concept of prospective clinical trials but, because of multiple logistic and perceptual deterrents, actually enter only a small portion of their patients into such studies. Physician concerns include discomfort with placebo or "no treatment" randomizations, the burden of cumbersome monitoring of protocol patients, and fear of displeasing referring physicians. Patients have difficulty accepting the uncertainty of randomized trials, particularly those with a placebo arm. They resent the inconvenience and expense of extra visits and studies associated with protocol participation. Informed consent documents are often complex and their intent misconstrued by patients. Rigorous eligibility requirements, although necessary for accurate analysis, reduce accrual. Multiplicity of protocols, with the resulting necessity to prioritize, rapid closure of Phase II studies for common tumors, and negative public attitudes reinforced by the media are significant deterrents to clinical trial participation. Increasing accrual is a daunting challenge to the physician. Simplification of burdensome data collection, consent forms, and institutional review board procedures will reduce reluctance to participate. Most important, physicians must be educators, emphasizing the advantages of clinical trials to their patients and their families, their colleagues, and the public.
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100 Background: Accrual of Black participants to cancer clinical trials remains a major challenge across the country. Here, we report the outcomes of a five-year initiative of community outreach and engagement to improve enrollment of adult Black participants to clinical trials at the Abramson Cancer Center (ACC) at the University of Pennsylvania. Methods: Primary metrics were the percentage of Black patients among all cancer cases in our catchment area, the percentage of adult Black patients cared for at the ACC, and the percentage of adult Black participants enrolled on the three types of NCI-defined clinical trials. Results: In 2014, at baseline, Black residents comprised 19% of the population and 16.5% of cancer cases in our catchment area surrounding Philadelphia, but only 11.1% of ACC patients were Black. The percentages of Black participants accrued onto treatment, non-therapeutic interventional, and non-interventional trials were 12.2%, 8.3%, and 13.0%, respectively. We then established a center-wide program with community guidance to address these gaps. Key elements of the program included: 1) culturally tailored marketing strategies for cancer clinical trials; 2) plans for each protocol to facilitate Black participant enrollment; 3) new partnerships with faith-based organizations serving Black communities to conduct educational events about clinical trials; 4) pilot programs with Lyft and Ride Health to address transportation barriers; 5) patient education by nurse navigators regarding cancer and clinical trials; and 6) an improved informed consent process. These efforts reached more than 10,000 individuals in venues including churches, neighborhoods, community parks and centers, and health centers with formats ranging from educational forums to wellness fairs. Reassessing metrics in 2018, we found that the percentage of Black patients seen at ACC had increased to 16.2%, matching the percentage of Black cancer patients among all cancer cases in our catchment area (16.5%). Total cancer clinical trial accrual had increased from 9,308 participants in 2014 to 13,170 in 2018 (41.5% increase). The percentages of Black participants accrued onto treatment, non-therapeutic interventional, and non-interventional trials were 23.9%, 33.1%, and 22.5%, respectively – a 1.7- to 4.0-fold increase in five years and higher than the percentage of Black patients seen at the ACC. Conclusions: Our multifaceted, community-based engagement initiative to encourage clinical trial enrollment was associated with improved accrual of Black participants to cancer clinical trials. These findings also suggest that gaps in access to cancer centers are a key factor driving access to clinical trials. Medicaid expansion occurred concurrently in all states in our catchment area and its impact on accrual merits further research.
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Whereas much information exists in general oncology regarding the barriers to clinical trial referral, those specific to neuro-oncology are not yet well known. Trial barriers lead to lower patient accrual, which can lead to less-efficient clinical trials and slower improvement of the standard of care, which may negatively effect patient outcomes. Thus, the aim of this study was to determine the clinical trial referral barriers that are specific to neuro-oncology to improve trial accrual rates.An electronic survey was completed by 426 Society for Neuro-Oncology members, of whom 372 are included in this report. Descriptive statistics, including frequencies, means, and proportions, were used to characterize our survey sample.Only 22% of participants reported that their center tracks referrals to clinical trials inside as well as outside their own institution, with an estimate of less than 30% of patients referred. The most commonly reported provider-referral barrier was finding ongoing trials in the patient's geographic area. Providers also perceived that while considering participation in a trial their patients may not qualify for any trials, and if they do, may be unable to travel to the study site for follow-up. Additionally, practice location and provider and institution type all influenced referral patterns.Efforts should be made to broaden trial availability and eligibility criteria, improve trial referral tracking, and ensure patients and their caregivers understand the goals and importance of clinical trials to reduce barriers and improve trial participation.
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