Impact of organ function based standard exclusion criteria in diffuse large b-cell lymphoma (DLBCL) patients: Who gets left behind?

e14100 Background: Only 3-5% of adult cancer patients in the US enroll in clinical trials. Patients with organ dysfunction are often excluded from clinical trials, regardless of specific drug metabolism or relative function of the organ. The ASCO and the US FDA recommend modernizing criteria related to baseline organ function and comorbidities. In hematological malignancies, often the disease itself is the reason for organ function derangement. In order to better inform clinical trial eligibility and improve participation in the future, we evaluated the impact of baseline organ function on the potential eligibility for clinical trial enrollment for real world patients with newly diagnosed DLBCL. Methods: Consecutive, newly diagnosed lymphoma patients were offered enrollment from 2002-2015 into the Molecular Epidemiology Resource (MER) of the University of Iowa/Mayo Clinic Lymphoma Specialized Program of Research Excellence. This analysis is based on 1270 DLBCL patients receiving immunochemotherapy. Baseline organ function parameters were identified from the exclusion criteria for hemoglobin, absolute neutrophil count (ANC), platelet count, creatinine, and bilirubin reported in recent frontline trials in DLBCL (Table). Abstracted clinical labs from the MER were used to determine the percent of patients that would be excluded based on the criteria. Results: We determined that 11-23% of MER DLBCL patients receiving standard of care frontline therapy would have been excluded in the various trials utilizing baseline organ function alone (Table). Hemoglobin and renal function had the greatest impact on exclusion. Conclusions: Current national and international (phase II and III) trials are excluding up to 23% of patients from clinical trial participation based on organ function alone in DLBCL. These data will be useful in future clinical trial development to meet ASCO recommendations to increase trial accrual, while balancing the drug toxicities and patient safety. An online tool was developed based on these results to aid future trial development. [Table: see text]

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Patient Income Level and Cancer Clinical Trial Participation

Journal of Clinical Oncology ◽

10.1200/jco.2012.45.4553 ◽

2013 ◽

Vol 31 (5) ◽

pp. 536-542 ◽

Cited By ~ 114

Author(s):

Joseph M. Unger ◽

Dawn L. Hershman ◽

Kathy S. Albain ◽

Carol M. Moinpour ◽

Judith A. Petersen ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Universal Access ◽

Participation Rate ◽

Treatment Decision ◽

Trial Participation ◽

Lower Income ◽

Clinical Trial Participation ◽

Clinical Trial Results ◽

The Impact

Purpose Studies have shown an association between socioeconomic status (SES) and quality of oncology care, but less is known about the impact of patient SES on clinical trial participation. Patients and Methods We assessed clinical trial participation patterns according to important SES (income, education) and demographic factors in a large sample of patients surveyed via an Internet-based treatment decision tool. Logistic regression, conditioning on type of cancer, was used. Attitudes toward clinical trials were assessed using prespecified items about treatment, treatment tolerability, convenience, and cost. Results From 2007 to 2011, 5,499 patients were successfully surveyed. Forty percent discussed clinical trials with their physician, 45% of discussions led to physician offers of clinical trial participation, and 51% of offers led to clinical trial participation. The overall clinical trial participation rate was 9%. In univariate models, older patients (P = .002) and patients with lower income (P = .001) and education (P = .02) were less likely to participate in clinical trials. In a multivariable model, income remained a statistically significant predictor of clinical trial participation (odds ratio, 0.73; 95% CI, 0.57 to 0.94; P = .01). Even in patients age ≥ 65 years, who have universal access to Medicare, lower income predicted lower trial participation. Cost concerns were much more evident among lower-income patients (P < .001). Conclusion Lower-income patients were less likely to participate in clinical trials, even when considering age group. A better understanding of why income is a barrier may help identify ways to make clinical trials better available to all patients and would increase the generalizability of clinical trial results across all income levels.

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Survival After Failure of Initial Therapy for Newly-Diagnosed or Relapsed/Refractory AML At An Academic Center: Subsequent Clinical Trial Vs. Not

Blood ◽

10.1182/blood.v118.21.1497.1497 ◽

2011 ◽

Vol 118 (21) ◽

pp. 1497-1497

Author(s):

Ravinder K Sandhu ◽

Jack M. Lionberger ◽

Megan Othus ◽

John M. Pagel ◽

Kathleen ShannonDorcy ◽

...

Keyword(s):

Clinical Trial ◽

Salvage Therapy ◽

Survival Benefit ◽

Trial Participation ◽

Therapeutic Trial ◽

Trial Group ◽

Newly Diagnosed ◽

Data Set ◽

Cell Counts ◽

The Impact

Abstract Abstract 1497 Background: Many adult patients do not enter complete remission (CR) after therapy for acute myeloid leukemia (AML) and the physician must often give advice regarding continued anti-AML therapy in a clinical trial. Even with novel therapeutics and approaches, numerous publications suggest a probability of CR <20% in these patients. Considering the time investment, the possibility of toxicity, and the impact on quality of life, the “non trial” (i.e. supportive or palliative care) approach becomes a potentially attractive alternative for some patients. These factors are especially critical when the patient lives a considerable distance from the treating center. To better inform this decision-making process, we compared survival in two groups of patients who had each received therapy at the Seattle Cancer Care Alliance (outpatient) or University of Washington (inpatient) (SCCA/UW) without obtaining a CR. One group included those who subsequently elected to enroll in a clinical trial and did not achieve a remission (Trial group), and the other group included patients who subsequently decided to receive no further specific anti-leukemic therapy at the SCCA/UW (the Non-trial group). Methods: Patients were identified by database query, and when necessary confirmed by direct review of paper and electronic medical records. Our data set included patients arriving to the SCCA/UW between January 2008 and March of 2011. Patients selected for this study were those whose most recent therapy was given at SCCA/UW and was unsuccessful (no CR). The date this outcome was determined is called the “resistance date” (RD). We dated survival from RD in the Non-trial group and from the date on which the salvage treatment was started in the patients receiving therapy. As best we can tell, none of the Non-Trial patients received subsequent salvage outside the SCCA/UW (i.e., after returning home). Multivariate analysis was used to assess the effect on survival time of (a) Trial participation (yes or no), (b) age, (c) performance status (PS 0–1 vs. 2–4) at resistance date, (d) cytogenetics (unfavorable vs. favorable/intermediate), and (e) status at initial SCCA/UW visit (newly-diagnosed vs. secondary vs. relapsed vs. refractory). Results: 134 patients had their initial SCCA/UW therapy without obtaining CR. Sixty-four of these subsequently received unsuccessful salvage therapy at the SCCA/UW (the Trial group) and 70 did not (Non-trial group). Distribution of age (median 59), cytogenetic risk (60% unfavorable), and PS of 2 or higher (35%) was similar in both groups. Independent predictors of shorter survival were: PS 2–4 (HR 1.70, p=0.02), “unfavorable” cytogenetics (HR 1.77, p = 0.01), relapsed at initial SCCA visit compared to newly-diagnosed (HR 1.93, p = 0.03), and presence in the non-trial group (HR 3.20, p <.001). The unadjusted survival comparison is shown below and indicates an approximate 10 month median survival benefit for patients receiving salvage at SCCA (HR 2.68, p<.001). Conclusions: There is a survival benefit associated with receiving salvage therapy (Trial group) for adult AML at the SCCA/UW (and presumably similar centers) despite failure to achieve CR with this salvage therapy. This degree of benefit in a new therapeutic trial would likely lead to FDA approval. The seeming advantage may reflect a non-quantifiable bias leading to selection of “better” patients for trials, a closer follow-up of patients placed on trials, or a true survival benefit despite lack of CR. The latter might reflect a regimen's ability to lower malignant proliferation and/or improve functional cell counts. Despite the confounding, and recognizing that a randomized trial to address this issue is unlikely, it seems reasonable for a patient to attempt to participate in clinical trials of new AML salvage therapies, recognizing however, that factors other than survival may affect a given patient's decision. Disclosures: No relevant conflicts of interest to declare.

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Understanding Factors That Determine Clinical Trial Enrollment for African American Patients with Lymphoma

Blood ◽

10.1182/blood-2021-152433 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 4965-4965

Author(s):

Gygeria Manuel ◽

Amy Ayers ◽

Jonathan Berman ◽

Shannon Blee ◽

Claire Sibold ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

African American ◽

African Americans ◽

Cell Lymphoma ◽

B Cell Lymphoma ◽

Trial Participation ◽

Clinical Trial Participation ◽

Large B Cell Lymphoma ◽

Emory University

Abstract Background: Although the incidence of non-Hodgkin lymphoma (NHL) is lower in minority populations, there is a difference in presentation, survivorship and participation in clinical trials (Becnel et al., 2017). African American patients with diffuse large B-cell lymphoma (DLBCL) present with more aggressive features including higher lactate dehydrogenase, increased frequency of B-symptoms, and higher rate of HIV co-infection, while also presenting at a younger age than other patients. (Tiu et al., 2020). Given the association of race with lymphoma presentation and outcomes, minority participation in clinical trials is of vital importance when developing novel therapies. There have been efforts to increase participation of African Americans in cancer clinical trials including patient navigation outreach which resulted in improvement of 9% to 16% of patients approached (Fouad et al., 2016). However, a recent study illustrated that for DLBCL, acute myeloid leukemia, and acute lymphoblastic leukemia, individuals of African descent represented 1.5%, 2.3%, and 6.7% of clinical trial participants, respectively (Gopishetty et al., 2020). We are conducting the current study to identify factors that influence decisions regarding clinical trial participation in African American patients with NHL. Methods: We are identifying African American patients with diffuse large B cell lymphoma and follicular lymphoma who enrolled in a therapeutic clinical trial at Emory University between 2010-2020. We will utilize the electronic medical record to identify patient characteristics such as distance from medical facility, insurance status, type of insurance, comorbidities, education status, type of diagnosis, and race of diagnosing physician. This data will compare African American patients who participated in clinical trials to those who did not participate as part of their initial treatment, specifically comparing baseline characteristics of interest between the groups. Furthermore, the data mention above will be compared between African American and white patients. We are also conducting interviews with a selected group of African American patients that have opted to participate in therapeutic clinical trials to gain a thorough understanding of the barriers and benefits they endured during their experience. The interview questions are based on prior knowledge of clinical trials, distance to facility, religious/ spiritual belief, trust of the physician, additional expenses, and time corresponded to treatment. Patients are asked to rate the importance each factor in their decision to participate and elaborate on points most specific to them. In addition, the interview allows for discussion of possible factors that challenged their participation in clinical trials which may allow for insight on low participation levels nationally. Furthermore, we are going to target patients who enrolled on clinical trials and will subsequently identify patients who did not participate in studies to identify differences in perception of treatment and clinical investigation. This project is partnered with Accounting for the High Enrollment of African Americans in Winship Cancer Institute's Clinical Trials, at Emory University. Conclusions:This study is currently enrolling patients and will answer key questions related to clinical trial participation in African American patients with lymphoma. We aim for the data collected from this study to assist in creating lymphoma clinical trials that better cater to the unique needs and considerations of African Americans. Disclosures Cohen: Genentech, Takeda, BMS/Celgene, BioInvent, LAM, Astra Zeneca, Novartis, Loxo/Lilly: Research Funding; Janssen, Adaptive, Aptitude Health, BeiGene, Cellectar, Adicet, Loxo/Lilly, AStra ZenecaKite/Gilead: Consultancy.

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Increasing participation in breast cancer research: (INSPIRE-BrC).

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.26_suppl.53 ◽

2014 ◽

Vol 32 (26_suppl) ◽

pp. 53-53

Author(s):

Brandi Robinson ◽

Sandra M. Swain

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Clinical Trials ◽

Primary Outcome Measure ◽

Test Method ◽

Trial Participation ◽

Lower Survival Rate ◽

Black Patients ◽

Clinical Trial Enrollment ◽

The Impact

53 Background: Increasing black patients’ participation in cancer clinical trials is particularly important because of the population’s lower survival rate. Accrual to clinical trials remains low among the general population (1 to 3%), with recruitment of blacks the lowest of all groups at 0.5 to 1.5%. Clinical trials are key to developing new methods to prevent, detect, and treat cancer. INSPIRE-BrC aims to increase trial participation rates among black patients with breast cancer and examine the relationship between the intervention and attitudes/beliefs on the decision to participate. Methods: A sample size of 123 black patients with breast cancer at five MedStar sites will view a 15 minute, culturally tailored video about clinical trials, which targets six cultural and attitudinal barriers to participation. A pre-test/post-test method is used to determine the impact of the video on three variables — likely participation in therapeutic clinical trials; attitudes toward therapeutic clinical trials (assessed based on the 6 barriers); and actual trial enrollment. Expected Findings: We hypothesize that the intervention will increase clinical trial enrollment compared to our 2012 clinical trial enrollment baseline rate of 6% (22/384) for black patients with breast cancer in five MedStar hospitals. The primary outcome measure is the proportion of black patients with breast cancer who agree to participate in a therapeutic clinical trial among those who sign consent to INSPIRE-BrC. Study findings have the potential to increase patient recruitment as a promising tool for rapid dissemination of a theory-driven, evidence-based model to enhance clinical trial accrual among black patients with cancer. [Table: see text]

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Impact of clinical trial enrollment on episode costs in the Oncology Care Model (OCM).

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.6513 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 6513-6513

Author(s):

Garrett Young ◽

Larry Edward Bilbrey ◽

Edward Arrowsmith ◽

L. Johnetta Blakely ◽

Davey B. Daniel ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Routine Care ◽

Cost Of Care ◽

Trial Participation ◽

Clinical Trial Participation ◽

Total Cost ◽

Comparator Group ◽

Hospice Use ◽

The Impact

6513 Background: Clinical trials are critical for improving outcomes for patients with cancer. However, there is some concern from health insurers that clinical trial participation can increase total cost of care for cancer patients. We investigated the impact of clinical trial participation on total costs paid by Medicare during the OCM program in a large community-based practice. Methods: Tennessee Oncology (TO) is a community oncology practice comprising over 90 oncologists across 30 sites of care. We linked TO trial data and electronic medical record data with OCM data for episodes of care from 2016-2018. To assess the impact of trial participation on total cost relative to routine care, we created matched comparator groups for each OCM episode based on cancer type, metastatic status, number of comorbidities, performance status, and age. Patients with breast cancer receiving hormone therapy only were excluded. Absolute and percent cost differences between groups were calculated for episodes that had a comparator group size of five or greater. Differences in total cost for trial episodes were compared to non-trial episodes, and significance was assessed using the Mann–Whitney U test. We also studied the impact of trial participation on receipt of active treatment in the last 14 days of life (TxEOL), hospice use, and hospitalizations. Results: During the study period, 8,026 completed OCM episodes met study criteria. Patients were enrolled in a clinical trial for 459 of these episodes. On average, episodes during which patients were on trial cost $5,973 less than matched non-trial episodes (Table), independent of early versus late-phase trial. Most savings resulted from decreased drug costs. There were no differences in rates of TxEOL (15% vs. 14% p=1.0), rates of hospitalizations (31% vs. 30% p=0.54), or hospice use (52% vs. 62% p=0.08) between trial and non-trial episodes. Median difference from comparator group average cost was significantly lower for clinical trial episodes (-18% vs. -6%, p<0.01). Conclusions: In the community setting, total costs paid by Medicare for patients participating in clinical trials during OCM episodes were lower than costs for similar patients receiving routine care. Clinical trial participation did not adversely impact end-of-life care or likelihood of hospitalization. These findings suggest that patient participation in clinical trials does not increase total cost of care nor enhance financial risk to payers.[Table: see text]

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Transforming Clinical Trial Eligibility Criteria to Reflect Practical Clinical Application

American Society of Clinical Oncology Educational Book ◽

10.1200/edbk_155880 ◽

2016 ◽

pp. 83-90 ◽

Cited By ~ 4

Author(s):

Edward S. Kim ◽

Jennifer Atlas ◽

Gwynn Ison ◽

Jennifer L. Ersek

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Diagnostic Testing ◽

Standard Of Care ◽

Trial Participation ◽

Eligibility Criteria ◽

Number Of Patients ◽

Oncology Clinical Trials ◽

Clinical Trial Accrual ◽

Clinical Trial Results

Historically, oncology clinical trials have focused on comparing a new drug’s efficacy to the standard of care. However, as our understanding of molecular pathways in oncology has evolved, so has our ability to predict how patients will respond to a particular drug, and thus comparison with a standard therapy has become less important. Biomarkers and corresponding diagnostic testing are becoming more and more important to drug development but also limit the type of patient who may benefit from the therapy. Newer clinical trial designs have been developed to assess clinically meaningful endpoints in biomarker-enriched populations, and the number of modern, molecularly driven clinical trials are steadily increasing. At the same time, barriers to clinical trial enrollment have also grown. Many barriers contribute to nonenrollment in clinical trials, including patient, physician, institution, protocol, and regulatory barriers. At the protocol level, eligibility criteria have become a large roadblock to clinical trial accrual. Over time, eligibility criteria have become more and more restrictive. To accrue an adequate number of patients to molecularly driven trials, we should consider eligibility criteria carefully and attempt to reduce restrictive criteria. Reducing restrictive eligibility criteria will allow more patients to be eligible for clinical trial participation, will likely increase the speed of drug approvals, and will result in clinical trial results that more accurately reflect treatment of the population in the clinical setting.

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119 A Descriptive Epidemiological Study of Clinical Trials, Comparing Trials Targeted At Older People to Adults of All Ages

Age and Ageing ◽

10.1093/ageing/afab030.80 ◽

2021 ◽

Vol 50 (Supplement_1) ◽

pp. i12-i42

Author(s):

J P Renton ◽

D McAllister

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Adverse Events ◽

Older People ◽

Exclusion Criterion ◽

Trial Participation ◽

Exclusion Criteria ◽

Eligibility Criteria ◽

Serious Adverse Events ◽

Icd 10

Abstract Introduction Fewer clinical trials are carried out in older people. It is unclear how representative and applicable clinical trials carried out exclusively in older people are. We compared clinical trials recruiting older people exclusively “older trials” to those recruiting adults of all ages “all age trials”, using anti-hypertensives acting on the renin-angiotensin aldosterone system (RAAS drugs) as an exemplar. Method We searched the US clinical trials register 1, to identify all trials carried out exclusively in those aged over 60. From these we selected trials of RAAS drugs. These were matched in a 2:1 ratio to trials carried out in adults of all ages. Data regarding baseline characteristics, adverse events and eligibility criteria were collected from clinical trial reports and clinicaltrials.gov. Estimated associations were calculated for age, sex and adverse events. Eligibility criteria were described and ICD- 10 coded, as appropriate. Results 71 clinical trials were carried out exclusively in older people.13 related to RAAS drugs. Participants in “Older trials” had higher mean age (73.1 and 55.9 respectively), mean difference 16.17 (CI 15.31–17.02). Older trials had fewer male participants. Participants in older trials had lower mean body mass index (BMI). A higher rate of participants in older trials experienced serious adverse events. (2.07, CI 1.55–2.75.) Few older trials had upper age limits (23.1% V 27% all age trials). All trials had exclusion criteria in multiple ICD blocks. Concurrent medications were a more common exclusion criterion in older trials (61.5% v 40.9%). Conclusions Clinical trials carried out exclusively in older people are representative in terms of age, serious adverse events and eligibility. Although there are multiple exclusion criteria for clinical trial participation in both groups, this is not prohibitive. This supports carrying out more trials exclusively in older people. References 1. NIH, US national library of medicine.ClinicalTrials.gov Available at https://clinicaltrials.gov/

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Determinants of Clinical Trial Participation and Impact on Survival Outcomes Among Patients with Newly Diagnosed Multiple Myeloma

Blood ◽

10.1182/blood-2019-131776 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 5833-5833

Author(s):

Gabriella C Malave ◽

Prashant Kapoor ◽

Angela Dispenzieri ◽

Morie A. Gertz ◽

Martha Q. Lacy ◽

...

Keyword(s):

Clinical Trial ◽

Overall Survival ◽

Clinical Trials ◽

Board Of Directors ◽

Research Funding ◽

Trial Participation ◽

Newly Diagnosed ◽

Clinical Trial Participation ◽

Advisory Committees ◽

Baseline Characteristics

Background: The overall participation of cancer patients in interventional clinical trials in the United States remains very low, with ~5% of patients being enrolled in clinical trials nationwide. The outcomes of patients with MM have improved significantly over the past decade, but available data suggest that the participation rates for patients with MM is comparable to other cancers. The drivers of participation and the potential impact of clinical trial participation have not been systematically studied in MM. Patients and Methods: We identified 228 patients who were enrolled into clinical trials for initial therapy of newly diagnosed MM between 2004 and 2018, and 4 controls for each of these patients. Controls were patients with NDMM, who were diagnosed closest in time to the index patients and did not participate in an interventional treatment trial. Various baseline characteristics as well as overall survival were compared between the two groups. Results: The baseline characteristics of the two groups are as shown in the Table. Patients who entered clinical trials were more likely to be female, resided closer to the clinic, and were more likely to have a prior history of MGUS. They were more likely to have higher ISS Stage, and a higher serum LDH, but there was no difference in the FISH risk status. Other indices of disease burden such as lower hemoglobin and platelets, higher serum creatinine were all seen more often in the control group, but may have been influenced by the trial entry criteria. Looking at the outcomes, the overall survival was longer among those enrolled into clinical trials compared to those who did not [median 103 (95% CI; 86, 136) vs. 63 (95% CI; 53, 69) months, p<0.001 (Figure). Conclusions: The current study provides important clues regarding demographic determinants of trial participation and disease biology related features that reflect likelihood of trial participation. Overall survival was significantly longer among the trial participants, which likely represent a mix of reasons including baseline status of patients, intensity of monitoring and efficacy of novel treatment approaches. Table Disclosures Kapoor: Janssen: Research Funding; Celgene: Honoraria; Cellectar: Consultancy; Sanofi: Consultancy, Research Funding; Amgen: Research Funding; Glaxo Smith Kline: Research Funding; Takeda: Honoraria, Research Funding. Dispenzieri:Alnylam: Research Funding; Janssen: Consultancy; Pfizer: Research Funding; Takeda: Research Funding; Celgene: Research Funding; Akcea: Consultancy; Intellia: Consultancy. Gertz:Ionis: Honoraria; Alnylam: Honoraria; Prothena: Honoraria; Celgene: Honoraria; Janssen: Honoraria; Spectrum: Honoraria, Research Funding. Lacy:Celgene: Research Funding. Dingli:Karyopharm: Research Funding; Rigel: Consultancy; alexion: Consultancy; Janssen: Consultancy; Millenium: Consultancy. Leung:Omeros: Research Funding; Aduro: Membership on an entity's Board of Directors or advisory committees; Takeda: Research Funding; Prothena: Membership on an entity's Board of Directors or advisory committees. Russell:Imanis: Equity Ownership. Kumar:Takeda: Research Funding; Janssen: Consultancy, Research Funding; Celgene: Consultancy, Research Funding.

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The general data protection regulation, the clinical trial regulation and some complex interplay in paediatric clinical trials

European Journal of Pediatrics ◽

10.1007/s00431-021-03933-3 ◽

2021 ◽

Author(s):

H. W. Dalrymple

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Data Privacy ◽

Trial Participation ◽

General Data Protection Regulation ◽

Trial Conduct ◽

Trial Protocols ◽

Trial Subject ◽

A Minor ◽

The Impact

AbstractAlthough a number of authors have commented upon the impact of the GDPR on clinical trial conduct, few have examined the specific setting of paediatric trials. Whilst the general principles are the same as those for adults, some additional considerations arise. The ages of consent relating to data privacy and clinical trial participation are different in a number of countries, but the distinction is often not recognised in non-drug trials. Accidental pregnancies in clinical trials always raise complexities, but these are amplified when the trial subject is a minor, and the processes described in clinical trial protocols rarely take account of GDPR requirements. This paper describes approaches which can be taken to ensure the rights of children are respected.Conclusion: The conduct of paediatric clinical trials within GDPR requirements is quite possible provided authors think carefully when drafting protocols. What is Known:•GDPR is applicable to clinical trials, including paediatric trials.•A number of challenges at the interface between the GDPR and CTR have been described. What is New:•The application of the GDPR to certain specific situations in paediatric trials does not appear to have been explored.•Three such situations are described and solutions offered.

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Adult participation in oncology clinical trials by indication, race, and age.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e17586 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e17586-e17586

Author(s):

Austin James Combest ◽

Dirk J. Reitsma ◽

Angelena Moseley ◽

Savanna D. Steele ◽

Marie-Edith Anne Bonneterre

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Ethnic Diversity ◽

Age Groups ◽

Standard Of Care ◽

The United States ◽

Phase Iii ◽

Trial Participation ◽

Clinical Trial Participation ◽

Nccn Guidelines

e17586 Background: According to the National Cancer Institute (NCI), approximately 3 percent of adult cancer patients participate in clinical trials despite the NCCN guidelines frequently recommending clinical trials as standard of care in many circumstances (Mooney, 2010). In a large analysis of NCI Cancer Therapy Evaluation Program (CTEP) trials, 40 percent of trials failed to achieve minimum enrollment, including 3 of 5 phase III trials (Cheng, 2010). Additionally, concerns about unequal access to clinical trials led Congress to enact the National Institutes of Health (NIH) Revitalization Act 20 years ago (June 10, 1993). Using data from Ipsos’ Tandem Oncology Monitor, a robust, nationwide system that collects actual prescriptions and clinical trial participation by indication from 500 oncologists and hematologists from the United States, we evaluated current participation and ethnic diversity in clinical trials. Methods: We assessed adult clinical trial participation from October 2011 to September 2012. Age, ethnicity and practice type were also collected to identify descriptive trends. Results: With regards to indication, clinical trial participation ranged from 1 percent (prostate, renal cell and head and neck) to 12 percent (thyroid) averaging between 2 and 3 percent. We observed a decline in first-line metastatic melanoma participation between pre- and post- vemurafenib/ipilimumab approval (9%-pre versus 2%-post). Patient diversity results are included in the Table. Conclusions: Despite efforts to increase oncology clinical trial participation, we have observed overall low clinical trial participation. Additionally, we observed better trial participation in the youngest age groups and minor differences between ethnic categories. Continued focus on increasing trial participation and patient diversity is still needed. [Table: see text]

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