Non-therapeutic Trials Research Articles

Video intervention increases participation of black breast cancer patients in therapeutic trials

There is a striking racial and ethnic disparity in incidence and mortality of cancer yet minorities remain markedly underrepresented in clinical trials. This pilot study set out to determine the impact of a 15-min culturally tailored educational video on three outcomes relating to clinical trials: likely participation, attitudes (assessed based on six barriers), and actual enrollment. Breast cancer patients with Stage I-III, if diagnosed within previous 6 months, or metastatic disease who self-identified as black or African American were invited to participate. The primary outcome measure was the decision to participate in a therapeutic clinical trial after the intervention. Patients’ intention to enroll on a therapeutic clinical trial and the change in attitudes toward clinical trials were measured by the previously developed Attitudes and Intention to Enroll in Therapeutic Clinical Trials (AIET) questionnaire. Of the 200 patients that participated, 39 (19.5%) patients signed consent to participate in a therapeutic clinical trial; 27 (13.5%) patients enrolled, resulting in a 7.5% increase from our baseline comparison of 6% clinical trial enrollment rate in black cancer patients (p < .001). Pre-test versus post-test assessment demonstrated the proportion of patients expressing likelihood to enroll in a therapeutic trial following the intervention increased by 14% (p < .001). Among 31 AIET items, 25 (81%) showed statistically significant and positive change post-intervention. The findings suggest the promising utility of a culturally tailored video intervention for improving black patients’ attitudes regarding clinical trial participation and resultant enrollment. Future efforts should continue to target facilitators of population-specific recruitment, enrollment, and retention in therapeutic and non-therapeutic clinical trials.

Regulatory experience of TOPS: an internet-based system to prevent healthy subjects from over-volunteering for UK clinical trials.

The aim was to review the use of The Over-volunteering Prevention System (TOPS) since the HRA began hosting it in 2013, and the Medicines and Healthcare products Regulatory Agency (MHRA) experience of monitoring its use by UK clinical research units. The HRA searched the TOPS database for the number, type and location of units and the number of entries. The MHRA inspectors reviewed their findings from routine inspections. Twenty-two additional UK units registered to use TOPS during 2013-2016, making a total of 84 units since TOPS was established in 2002. Use of TOPS is now a condition of research ethics committee approval of a phase 1 study and fulfils MHRA accreditation requirements for preventing over-volunteering. The total number of entries by all active units during 2013-2016 was 89,335, of which 84% were UK citizens and 16% non-UK citizens. The total number of entries during 2002-2016 was 249,612. Only 15 of 24,531 subjects (1/1600) and 18 of 18,745 subjects (1/1040) entered in 2015 and 2016, respectively, were deemed potential over-volunteers. The findings continue to support the concept that TOPS not only helps to prevent over-volunteering, but also deters subjects from trying to do so. Regulation of TOPS by the HRA and MHRA has enhanced its effectiveness, benefited all users and helped to improve the safety of volunteers who participate in non-therapeutic trials in the UK. The UK is still the only country with a national database to prevent over-volunteering that has published data on its widespread use and effectiveness.

Development of a consensus operational definition of child assent for research

BackgroundThere is currently no consensus from the relevant stakeholders regarding the operational and construct definitions of child assent for research. As such, the requirements for assent are often construed in different ways, institutionally disparate, and often conflated with those of parental consent. Development of a standardized operational definition of assent would thus be important to ensure that investigators, institutional review boards, and policy makers consider the assent process in the same way. To this end, we describe a Delphi study that provided consensus from a panel of expert stakeholders regarding the definitions of child assent for research.MethodsBased on current guidelines, a preliminary definition of assent was generated and sent out for review to a Delphi panel including pediatric bioethicists and researchers, Institutional Review Board members, parents, and individuals with regulatory/legal expertise. For each subsequent review, the process of summarizing and revising responses was repeated until consensus was achieved. Panelists were also required to rank order elements of assent that they believed were most important in defining the underlying constructs of the assent process (e.g., capacity for assent, disclosure). In providing these rankings, panelists were asked to frame their responses in the contexts of younger (≤ 11 yrs) and adolescents/older children (12-17 yrs) in non-therapeutic and therapeutic trials. Summary rankings of the most important identified elements were then used to generate written construct definitions which were sent out for iterative reviews by the expert panel.ResultsConsensus regarding the operational definition was reached by 14/18 (78%) of the panel members. Seventeen (94%) panelists agreed with the definitions of capacity for assent, elements of disclosure for younger children, and the requirements for meaningful assent, respectively. Fifteen (83%) members agreed with the elements of disclosure for adolescents/older children.ConclusionsIt is hoped that this study will positively inform and effect change in the way investigators, regulators, and IRBs operationalize the assent process, respect children’s developing autonomy, and in concert with parental permission, ensure the protection of children who participate in research.

MP32-06 VARIATIONS IN ACCRUAL AND RACE/ETHNICITY REPORTING IN UROLOGY AND NON-UROLOGY RELATED CANCER TRIALS.

You have accessJournal of UrologyGeneral & Epidemiological Trends & Socioeconomics: Value of Care: Cost and Outcomes Measures II1 Apr 2017MP32-06 VARIATIONS IN ACCRUAL AND RACE/ETHNICITY REPORTING IN UROLOGY AND NON-UROLOGY RELATED CANCER TRIALS. Koushik Paul, Chap Le, and Badrinath Konety Koushik PaulKoushik Paul More articles by this author , Chap LeChap Le More articles by this author , and Badrinath KonetyBadrinath Konety More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.981AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES We sought to compare if accrual difficulties are unique to urologic cancer trials compared to other solid organ tumor trials. We also sought to assess the extent to which race/ethnicity is reported in both urologic and non-urologic cancer trials. METHODS We analyzed online data for all phase III/IV trials from clinicaltrials.gov and the ISRCTN registry for prostate, bladder, kidney, colorectal, breast, and lung cancer. All closed therapeutic and non-therapeutic trials between 2000-2016 were included. For the selected trials, information about accrual sufficiency, age group, allocation, funding, gender, intervention model and type, masking, organ site, primary purpose, race/ethnicity reporting, trial duration, and trial phase were collected. Accrual sufficiency and race/ethnicity reporting by cancer type was determined. Chi squared and logistic regression analyses were used to determine factors associated with accrual sufficiency and minority enrollment. RESULTS 326/658 (49%) clinical trials identified met our selection criteria. Data from 234/326 (71.8%) of the trials were cross-verified using peer-reviewed publications. Accrual sufficiency overall was 62%, with kidney cancer reporting the highest (79%) and bladder cancer trials reporting the lowest (50%) accruals. 57% of the trials reported race and ethnicity in their analysis with lung cancer trials reporting the highest (68%) and bladder cancer trials reporting the lowest (30%). Non-urologic (77%) trials reported higher race/ethnicity reporting than urologic (23%) trials (p<0.01). Factors associated with accrual sufficiency included funding source (p=0.01) and gender (p=0.03). Government funded trials involving women were associated with better accrual. Factor associated with minority enrollment include trial phase (p=0.03). Factors associated with reporting of African-American enrollment include allocation (p=0.03), funding source (p<0.01), and intervention model (p=0.04). Government funded trials, non-randomized trials, and cross over trials were associated with higher levels of reported African American enrollment. CONCLUSIONS Clinical trial accrual is low, raising questions about the statistical validity of results from trials with incomplete accrual. Overall race/ethnicity reporting in trials remains low, specifically in urologic trials. Government funded trials appear to perform better on both these aspects. This makes it difficult to generalize results from large trials to minority populations, especially using data from industry-sponsored trials. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e410 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Koushik Paul More articles by this author Chap Le More articles by this author Badrinath Konety More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Enrolling Minority and Underserved Populations in Cancer Clinical Research.

Research suggests that community involvement is integral to solving public health problems, including involvement in clinical trials-a gold standard. Significant racial/ethnic disparities exist in the accrual of participants for clinical trials. Location and cultural aspects of clinical trials influence recruitment and accrual to clinical trials. It is increasingly necessary to be aware of defining characteristics, such as location and culture of the populations from which research participants are enrolled. Little research has examined the effect of location and cultural competency in adapting clinical trial research for minority and underserved communities on accrual for clinical trials. Utilizing embedded community academic sites, the authors applied cultural competency frameworks to adapt clinical trial research in order to increase minority participation in nontherapeutic cancer clinical trials. This strategy resulted in successful accrual of participants to new clinical research trials, specifically targeting participation from minority and underserved communities in metropolitan Washington, DC. From 2012 to 2014, a total of 559 participants enrolled across six nontherapeutic clinical trials, representing a 62% increase in the enrollment of blacks in clinical research. Embedding cancer prevention programs and research in the community was shown to be yet another important strategy in the arsenal of approaches that can potentially enhance clinical research enrollment and capacity. The analyses showed that the capacity to acquire cultural knowledge about patients-their physical locales, cultural values, and environments in which they live-is essential to recruiting culturally and ethnically diverse population samples.

Survey of users of TOPS, an internet-based system to prevent healthy subjects from over-volunteering for clinical trials

To analyse users' experience of TOPS, an internet-based system that helps UK clinical research units to prevent healthy volunteers from participating in more than one non-therapeutic trial simultaneously, or starting a second trial too soon after the first. We sent to all units that currently use TOPS an anonymous questionnaire comprising 18 questions about the effectiveness and ease of use of the system. Of 35 units that currently use TOPS, 31 (85.7 %) returned questionnaires. Most users find TOPS easy to use, had increased their detection rate of over-volunteering, and had rejected subjects as a result of using TOPS. A GP reply alone is not enough to prevent over-volunteering. Ethics committees, the MHRA and sponsors know about TOPS and support its use. The results confirm that TOPS does prevent healthy subjects from over-volunteering. Consequently, the Health Research Authority has agreed to take over the management of TOPS. Ethics committee approval of a phase 1 trial and MHRA accreditation of the unit will henceforth be conditional on consistent and proper use of TOPS. That should enhance its effectiveness and improve the safety of volunteers in non-therapeutic trials in the UK.

Evaluation of factors that motivate participants to consent for non-therapeutic trials in India

Background and rationaleSeveral factors that motivate individuals to participate in non-therapeutic studies have been identified. This study was conducted as limited data is available regarding these motivations from developing countries.MethodsThis...

Recruiting Terminally Ill Patients into Non-Therapeutic Oncology Studies: views of Health Professionals

BackgroundNon-therapeutic trials in which terminally ill cancer patients are asked to undergo procedures such as biopsies or venipunctures for research purposes, have become increasingly important to learn more about how cancer cells work and to realize the full potential of clinical research. Considering that implementing non-therapeutic studies is not likely to result in direct benefits for the patient, some authors are concerned that involving patients in such research may be exploitive of vulnerable patients and should not occur at all, or should be greatly restricted, while some proponents doubt whether such restrictions are appropriate. Our objective was to explore clinician-researcher attitudes and concerns when recruiting patients who are in advanced stages of cancer into non-therapeutic research.MethodsWe conducted a qualitative exploratory study by carrying out open-ended interviews with health professionals, including physicians, research nurses, and study coordinators. Interviews were audio-recorded and transcribed. Analysis was carried out using grounded theory.ResultsThe analysis of the interviews unveiled three prominent themes: 1) ethical considerations; 2) patient-centered issues; 3) health professional issues. Respondents identified ethical issues surrounding autonomy, respect for persons, beneficence, non-maleficence, discrimination, and confidentiality; bringing to light that patients contribute to science because of a sense of altruism and that they want reassurance before consenting. Several patient-centered and health professional issues are having an impact on the recruitment of patients for non-therapeutic research. Facilitators were most commonly associated with patient-centered issues enhancing communication, whereas barriers in non-therapeutic research were most often professionally based, including the doctor-patient relationship, time constraints, and a lack of education and training in research.ConclusionsThis paper aims to contribute to debates on the overall challenges of recruiting patients to non-therapeutic research. This exploratory study identified general awareness of key ethical issues, as well as key facilitators and barriers to the recruitment of patients to non-therapeutic studies. Due to the important role played by clinicians and clinician-researchers in the recruitment of patients, it is essential to facilitate a greater understanding of the challenges faced; to promote effective communication; and to encourage educational research training programs.

TOPS: an internet-based system to prevent healthy subjects from over-volunteering for clinical trials

Aim Our aim was to set up a system to help UK clinical research units to prevent healthy volunteers from participating in more than one non-therapeutic trial simultaneously, or from starting a second trial too soon after the first.

TOPS: an internet-based system to prevent healthy subjects from over-volunteering for clinical trials

AimOur aim was to set up a system to help UK clinical research units to prevent healthy volunteers from participating in more than one non-therapeutic trial simultaneously, or from starting a second trial too soon after the first.MethodsTOPS (The Over-volunteering Prevention System) is internet-based, simple and quick to use, free to users and a charity run by a Board of Trustees. Users enter only two or three pieces of information: (1) ‘National Insurance number’ (NINO) of UK citizens, or ‘passport number’ and country of origin of non-UK citizens, as their identifier, (2) ‘date of last dose’ of trial medicine or (3) ‘never dosed’. Subjects must consent, but TOPS collects only non-personal data, so it does not require Ethics Committee approval and is not covered by the Data Protection Act.ResultsA total of 55 research units (29 clinical research organisations, 5 pharmaceutical companies, 13 universities and 8 hospitals) throughout the UK have registered to use TOPS, and have entered 124,906 volunteers since we launched it. All commercial and many non-commercial units now use TOPS. In our unit, no subject has to the best of our knowledge participated in two trials simultaneously. TOPS has reduced to <1% the incidence of subjects attempting to volunteer within 3 months of completing another trial elsewhere, and very few have to our knowledge succeeded.ConclusionTOPS is widely used and effective, and helps research units to comply with UK clinical trial regulations.

Geographic Proximity and Racial Disparities in Cancer Clinical Trial Participation

This study assessed the effects of race and place of residence on clinical trial participation by patients seen at a designated NCI comprehensive cancer center. Clinical trial accrual to cancer case ratios were evaluated using a database of residents at the continental United States seen at The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins from 2005 to 2007. Place of residence was categorized into 3 nonoverlapping geographic areas: Baltimore City, non-Baltimore City catchment area, and non-catchment area. Controlling for age, sex, county poverty level, and cancer site, significant race and place of residence differences were seen in therapeutic or nontherapeutic clinical trials participation. White non-Baltimore City catchment area residents, the designated reference group, achieved the highest participation rate. Although the test of interaction (control group compared with all others) was not significant, some race-geographic area group differences were detected. In therapeutic trials, most race-place of residence group levels were statistically lower and different from reference; in nontherapeutic trials, race-specific Baltimore City groups participated at levels similar to reference. Baltimore City residents had lower participation rates only in therapeutic trials, irrespective of race. County poverty level was not significant but was retained as a confounder. Place of residence and race were found to be significant predictors of participation in therapeutic and nontherapeutic clinical trials, although patterns differed somewhat between therapeutic and nontherapeutic trials. Clinical trial accruals are not uniform across age, sex, race, place of residence, cancer site, or trial type, underscoring that cancer centers must better understand their source patients to enhance clinical trial participation.

Abstract A44: Minority enrollment to clinical trials: Experience at the Dan L. Duncan Cancer Center

Abstract Background: The Dan L Duncan Cancer Center (DLDCC) is located in Houston, Texas, and provides care to uninsured and minority patients in several large hospitals including Ben Taub General Hospital, The Michael E. DeBakey VA Medical Center, and Texas Children's Hospital. The catchment area for the DLDCC is Harris County, an urban area with a population of nearly 4 million; approximately 18% of county residents are African American and 39% are Hispanic. While the percentage of African Americans in Harris County is nearly equal in all age groups, Hispanics make up nearly 45% of residents less than 30 years old, but only 10% of residents over 60, those most likely to develop cancer. One-third of the county population has no health insurance. Objective: In 2006 the DLDCC set out to increase overall enrollment to therapeutic clinical trials while maintaining enrollment of patients belonging to racial and ethnic minorities. Methods: A four-pronged strategy was used to maintain and improve accrual of racial and ethnic minority patients to cancer-related clinical trials while increasing overall accrual. First, the DLDCC invested significant resources in establishing research infrastructure in the hospitals including hiring bilingual coordinators and nurses, translating consents into Spanish, and underwriting the cost for conduct of NCI-sponsored trials. Second, the DLDCC partnered with hospitals to make office space available for research personnel, to provide discounted investigational pharmacy services and to obtain access to laboratory and imaging data and pathology samples. Third, the DLDCC introduced programs to make minority residents aware of clinical trials and build relationships and trust in the community including the establishment of a community advisory board, sponsorship of plays by minority playwrights that carry a cancer message, sponsorship of community health events, and creation of clinical trials newsletters and websites. Finally, the DLDCC pioneered and gained IRB approval for a form designed to collect accurate racial and ethnic data from trial participants. Results: Overall enrollment to DLDCC therapeutic clinical trials increased by more than 50% between 2005/2006 and 2009 to an average of 13.4% of new cancer patients enrolled on trial. In 2009, 16.8% of subjects enrolled to therapeutic trials were African American, and 35.4% were Hispanic. Accrual of minority subjects was equivalent in pediatric and adult programs and on therapeutic and nontherapeutic trials. Conclusion: Recruitment of pediatric and adult members of underserved minorities to clinical trials is possible with targeted strategies, dedicated research staff, hospital partnership and community involvement. Citation Information: Cancer Epidemiol Biomarkers Prev 2010;19(10 Suppl):A44.

Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials.

A major challenge for randomized phase III oncology trials is the frequent low rates of patient enrollment, resulting in high rates of premature closure due to insufficient accrual. We conducted a pilot study to determine the extent of trial closure due to poor accrual, feasibility of identifying trial factors associated with sufficient accrual, impact of redesign strategies on trial accrual, and accrual benchmarks designating high failure risk in the clinical trials cooperative group (CTCG) setting. A subset of phase III trials opened by five CTCGs between August 1991 and March 2004 was evaluated. Design elements, experimental agents, redesign strategies, and pretrial accrual assessment supporting accrual predictions were abstracted from CTCG documents. Percent actual/predicted accrual rate averaged per month was calculated. Trials were categorized as having sufficient or insufficient accrual based on reason for trial termination. Analyses included univariate and bivariate summaries to identify potential trial factors associated with accrual sufficiency. Among 40 trials from one CTCG, 21 (52.5%) trials closed due to insufficient accrual. In 82 trials from five CTCGs, therapeutic trials accrued sufficiently more often than nontherapeutic trials (59% vs 27%, p = 0.05). Trials including pretrial accrual assessment more often achieved sufficient accrual than those without (67% vs 47%, p = 0.08). Fewer exclusion criteria, shorter consent forms, other CTCG participation, and trial design simplicity were not associated with achieving sufficient accrual. Trials accruing at a rate much lower than predicted (<35% actual/predicted accrual rate) were consistently closed due to insufficient accrual. This trial subset under-represents certain experimental modalities. Data sources do not allow accounting for all factors potentially related to accrual success. Trial closure due to insufficient accrual is common. Certain trial design factors appear associated with attaining sufficient accrual. Defining accrual benchmarks for early trial termination or redesign is feasible, but better accrual prediction methods are critically needed. Future studies should focus on identifying trial factors that allow more accurate accrual predictions and strategies that can salvage open trials experiencing slow accrual.

Ethical quandaries posing as conflicts of interest

Conflicts of interest are receiving increased attention in medical research, clinical practice and education. Criticism of, and penalties for, conflicts of interest have been insufficiently discussed and have been applied...

Addressing clinical trials: Can the Multidisciplinary Tumor Board improve participation? A study from an academic women's cancer program

Objective The Tumor Board (TB) allows for an interdisciplinary approach to cancer treatment designed to encourage evidence-based treatment. However, its role in facilitating clinical trial participation has not been reported. We aimed to determine whether a prospective TB is an effective strategy for trial recruitment and to identify steps within the TB process that facilitate discussion of trial eligibility and optimize accrual. Methods We conducted a retrospective cross-sectional analysis of women presented to Gynecologic Oncology TB between March and December 2008. Patient demographics, TB recommendations, and post-TB patient discussions were abstracted. These were compared to data derived from the Department of Oncology Research to determine research team awareness of eligible patients and confirm trial enrollment(s). Data analysis was completed with Chi-square test; risk ratios and confidence intervals were calculated as summary measures. Results We reviewed 1213 case presentations involving 916 women. Overall, 358 TB recommendations (30%) identified eligible patients, of which enrollment consisted of 87 (24%) trials (6% therapeutic trials and 18% non-therapeutic trials). Compared to other types of TB recommendations, those involving trials were discussed less frequently at post-TB patient visits (79% vs. 44%). Documentation of trial discussion at the post-TB visit was more likely to result in trial participation, versus solely relying on the research staff to communicate enrollment eligibility with the treating team (RR 2.5, p = 0.006). Conclusions Patients identified by the TB were 2.5-times as likely to enroll in a clinical trial, but trials were mentioned only 44% of the time. Interventions that facilitate trial discussions during post-TB meetings are needed to improve trial participation.

Balancing Disclosure of Diagnosis and Assent for Research in Children With HIV

CHILDREN COMPRISE A LARGE SUBGROUP OF PAtients with human immunodeficiency virus (HIV) infection, and their treatment must be defined by pediatric clinical trials. Children’s participation in research trials requires the fully informed consent of the parent or legal guardian, to whom most of the information is commonly directed. However, for nontherapeutic trials, the Code of Federal Regulations also requires that assent (the “affirmative agreement to participate in research”) be obtained from children at appropriate developmental ages. It also assigns to institutional review boards (IRBs) the duty to “determine that adequate provisions are made for soliciting the assent of the children . . . capable of providing assent.” Truly meaningful assent requires that children’s conditions be appropriately disclosed to them. However, disclosure of diagnosis to children with HIV is a complex issue that, when poorly managed, can cause harm to the child and family. For various reasons, parents may be reluctant to allow disclosure of HIV infection to their child. They often worry that children will not exercise discretion and that the child or family will be stigmatized. Cases of maternally transmitted HIV infection may be complicated by parental guilt and a desire to avoid further harm to the child through premature disclosure. Therefore, 3 important questions arise. Can a child who has reached the age of assent participate in pediatric HIV research without knowing his or her diagnosis of HIV or AIDS? What does “disclosure of diagnosis” mean in the context of pediatric HIV? What should be the response of a clinician or researcher when a parent of a child who has reached the age of assent will not agree to a developmentally appropriate process of disclosure? In this Commentary, we consider these questions and offer a practical stepwise disclosure method. Research Participation Without Knowing the Diagnosis

Research Issues Affecting Preoperative Systemic Therapy for Operable Breast Cancer

Preoperative systemic therapy (PST) in operable breast cancer allows a small increase in breast conservation rates and has significant potential as a research platform. PST offers the ability to discern treatment effect in vivo, and may allow smaller trials targeting specific breast cancer subtypes and making more efficient use of resources. Early observations of a specific outcome of interest in individual patient subgroups may improve the design of larger definitive randomized adjuvant trials using survival as a main outcome. PST offers the potential for therapeutic adjustments midcourse, which assumes the existence of validated intermediate end points and effective alternative therapies. This article reviews critical research issues affecting the design of PST trials, including the appropriate selection of trial end points and markers for long-term outcome, baseline marker expression as a predictor of response, and statistical considerations using novel trial designs. Key issues regarding optimal tumor subtype selection for individual trials, novel approaches using nontherapeutic window trial designs, and ethical and advocacy considerations are also discussed. PST requires an experienced and cohesive multidisciplinary team for it to fulfill its potential in both research and clinical care.

The Swiss Regulatory Framework for Paediatric Health Research

Medical research on minors entails both risks and benefits. Under Swiss law, clinical trials on children, including nontherapeutic drug trials, are permissible. However, ethics committees must systematically verify that all clinical studies have a favorable risk-benefit profile. Additional safeguards are designed to ensure that children are not unnecessarily involved in research and that proper consent is always obtained. Federal Swiss law is undergoing revision to extend these protections beyond clinical trials to a broad array of health research. The Swiss drug agency also seeks to improve the incentives for pharmaceutical firms to develop new paediatric drugs and relevant paediatric drug labels.

An Educational Video to Increase Clinical Trials Enrollment among Lung Cancer Patients

Only 3 to 5% of new adult cancer patients participate in clinical trials nationwide. The lack of knowledge and awareness about clinical trials is a significant barrier to clinical trials participation. A randomized trial was conducted to test the effect of an educational video on positively changing patients' knowledge and attitudes regarding clinical trials and thereby increasing enrollment rates. Lung cancer patients were randomized to viewing either an 18-minute video about clinical trials before first clinic appointment or to standard care. Participants completed a baseline and 2-week postintervention survey to assess their knowledge and attitudes toward trials participation. Fisher's exact test tests, t tests, and regression were used to compare patient characteristics and outcomes between arms. Of 145 subjects randomized, 126 (63/arm) satisfied all inclusion criteria and were included in the analysis. A linear regression showed that the video intervention was significantly associated with patients' self-assessed likelihood to enroll score measured at 2-week follow-up (p = 0.019). Although statistically insignificant, enrollment rates were found to be higher in the intervention arm for therapeutic trials alone (17.5% versus 11.1%) and for therapeutic and nontherapeutic trials combined (25.4% versus 15.9%). The brief educational video seems to be effective in positively changing lung cancer patients' attitudes about participation in clinical trials. Higher enrollment rates were also observed in the intervention group but the differences did not reach statistical significance. These findings suggest a potential impact of the educational video on clinical trial enrollment; however, larger studies are needed to confirm these findings.

Should research ethics triumph over clinical ethics?

Evidence-based medicine (EBM) and its main strategy, randomized clinical trials, have had less impact on medical practice than might be expected. Of the various reasons that make practitioners wary of applying research results, this paper explores some consequences of scientists' and research sponsors' adamant insistence that reliable science can only be achieved if protocols adhere exclusively to the ethics of investigation basically reduced to obtaining informed consent and avoiding risks as far as possible. This means, and has been explicitly contended, that neither patients nor doctors should fall prey to the therapeutic fallacy which leads them to expect that research will also take care of patient-subjects' medical welfare. Doctors would betray their profession if they allowed clinical research to disregard their therapeutic obligations in favour of strict scientific methodology, as is bound to happen when using placebos in spite of existing therapy, disregarding equipoise, disallowing benefit claims, emphasizing the distinction between research ethics and clinical ethics but denying any difference between therapeutic and non-therapeutic trials. That scientists and practitioners should not agree on needs and priorities in the medical context, constitutes an additional factor in the less than optimal reception of EBM by the health care professions.