Currents in Contemporary Ethics

2004 ◽  
Vol 32 (2) ◽  
pp. 365-368 ◽  
Author(s):  
Timothy Caulfield ◽  
Trudo Lemmens ◽  
Douglas Kinsella ◽  
Michael McDonald
Keyword(s):  
Clinical Trials ◽  
Conflicts Of Interest ◽  
New Products ◽  
Prescribing Patterns ◽  
Consent Process ◽  
Regulatory Agencies ◽  
Inclusion Criteria ◽  
Community Based ◽  
Funded Research ◽  
Drug Regulatory Agencies

An increasing number of community physicians are involved in clinical research.Indeed, 60 of industry-funded research is now spent on community based trials. This surge in community based clinical trials has increased the number of clinical trials applications submitted to the drug regulatory agencies by pharmaceutical sponsors. Many have argued that the commercial interests connected to the conduct and outcome of these trials also increases the potential for conflicts of interest for participating physicians. The context in which these trials take place increases the potential for a host of practices that infringe on ethical, legal and clinical obligations of physicians For example, financial recruitment incentives may lead to violations of the inclusion criteria and the consent process. It may result in inappropriate recruitment of patient participants and a blurring of the ethically significant distinctions between treatment and research. In some cases, it may be hard to distinguish research from the marketing of new products and attempts to influencing prescribing patterns.

Azacitidine Is Effective in Patients with Myelodysplastic Syndrome Managed in Community-Based Practice: Preliminary Data From the Spanish Azacitidine Compassionate Use Registry.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4836-4836
Author(s):  
Regina Garcia ◽  
Dunia de Miguel ◽  
Alicia Bailen ◽  
Jose Ramon Gonzalez ◽  
Rafael Andreu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Preliminary Data ◽  
Conflicts Of Interest ◽  
Performance Status ◽  
Injection Site Reaction ◽  
Complete Response ◽  
International Prognostic Scoring System ◽  
Compassionate Use ◽  
Community Based ◽  
Ecog Performance Status

Abstract Abstract 4836 Background Azacitidine (AZA), a hypomethylating agent recently approved in Europe for the treatment of MDS, prolongs the median survival time in patients enrolled in clinical trials (Fenaux et al 2009). Decisions regarding treatment are based on performance status, age, patient preference and concomitant illnesses. NCCN-recommended treatment approaches vary according to International Prognostic Scoring System (IPSS) classification. AZA was available in Spain under compassionate use before its regulatory approval in May 2009. Material and Methods We present the preliminary analysis of the clinical results of the data from a longitudinal, multicenter Spanish patient registry, which retrospectively collected data from community-based hematology clinics on the disease course and management of patients with MDS treated with AZA in a compassionate use setting, in whom the dosing schedule administered was documented. AZA dosing was applied to the patients in different regimens in 28-day cycles. As of August 1, 2009, data from 147 patients with MDS diagnosed according to WHO criteria had been collected. Results Median age was 71 years and 66% were men. Most of the patients had primary MDS (129 patients; 88%). The most prevalent ECOG performance status was 0-1 (125 patients; 85%). An IPSS risk classification of low/intermediate-1 was documented in 80 patients (55%). An initial AZA dose of 75 mg/m2 was used in 124 patients (84%). Most of the patients (57%) received a 7-day regimen (either with or without a weekend rest). A 5-day regimen was used in 50 patients (31%). AZA was administered mostly subcutaneously (122 patients, 84%). The mean number of cycles administered was 6 (range 2-29). The overall treatment response was 60% (International Working Group 2006 criteria): 18% complete response, 16% complete bone marrow response, 7% partial response, 23% hematological response. Stable disease was documented in an additional 17% of the patients, who did not achieve a response. AZA was generally well tolerated. Grade 3/4 adverse events documented in these patients, regardless of their relationship to the active treatment, were neutropenia (42%), thrombocytopenia (31%), anemia (22%), febrile neutropenia (10%), rash (1%), vomiting or nausea (1%), septic shock (1%), injection site reaction (1%), and constitutional symptoms (1%) Conclusion These preliminary data do not differ from those previously obtained from clinical trials (Silverman et al 2006, Fenaux et al 2009). These results demonstrate that in a community-based setting, patients with MDS respond to AZA treatment. In line with previous clinical trials, we expect this could point to a better prognosis for MDS patients in Spain, with prolonged survival and a better quality of life. Disclosures No relevant conflicts of interest to declare.

Azacitidine Is Effective in Patients with Intermediate-2 / High IPSS Risk Myelodysplastic Syndrome Managed in Community Based Practice: Preliminary Data From the Spanish Azacitidine Compassionate Use Registry.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4835-4835
Author(s):  
Regina Garcia ◽  
José Ramón González ◽  
Alicia Bailen ◽  
Jose F Falantes ◽  
Joaquin Sanchez ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Myelodysplastic Syndrome ◽  
Preliminary Data ◽  
Conflicts Of Interest ◽  
Performance Status ◽  
Complete Response ◽  
Compassionate Use ◽  
Community Based ◽  
Ecog Performance Status ◽  
Female Ratio

Abstract Abstract 4835 Background Myelodysplastic syndrome (MDS) is comprised of a group of heterogeneous hematological disorders. Although the decision regarding treatment of a patient with MDS is based on performance status, age, patient preference and concomitant illnesses, NCCN-recommended treatment approaches vary according to IPSS risk score. Azacitidine (AZA) is a hypomethylating agent recently approved in Europe for the treatment of MDS. AZA was available in Spain under compassionate use before its regulatory approval and marketing authorization from the Spanish Medicines Agency in May 2009. Material and Methods We present the preliminary analysis of the clinical data from a longitudinal, multicenter Spanish patient registry. Data on the disease course and management of patients with MDS treated with AZA under compassionate use conditions were retrospectively collected from community-based hematology clinics. As of August 1, 2009, 65 patients with intermediate-2 / high IPSS-risk MDS diagnosed according to WHO criteria had been included. Results At baseline the median age was 69 years, the male/female ratio was 60/40, and the majority of patients had primary MDS (56 patients; 88%) and an ECOG performance status of 0-1 (43 patients; 67%). The most frequent initial dose of AZA applied was 75 mg/m2 (53 patients, 83%), and the most common dosing schedules were as follows: days 1-7 (82%), and days 1-5 and 8-9 (5%) in a 28-day cycle. AZA was administered mostly subcutaneously (56 patients, 89%). The mean number of cycles administered was 6 (range 2-29). The overall treatment response was 59% (International Working Group 2006 criteria): 16% complete response, 13% complete bone marrow response, 13% partial response and 18% hematological response. In addition, 23% achieved stable disease. AZA was generally well tolerated. The grade 3/4 adverse events documented in these patients, regardless of their relationship to active treatment, were neutropenia (37%), thrombocytopenia (26%), anemia (17%), febrile neutropenia (8%), rash (2%), vomiting or nausea (2%), and constitutional symptoms (2%). Conclusion These preliminary data do not differ from those previously obtained from clinical trials (Silverman et al 2006, Fenaux et al 2009). Our results demonstrate that in a community-based setting, patients with intermediate-2 / high-risk MDS respond to treatment with AZA. In line with previous clinical trials, we expect this could point to a better prognosis for MDS patients in Spain, with prolonged survival and a better quality of life. Disclosures No relevant conflicts of interest to declare.

Clinical Trial Enrolment In the Adolescent and Young Adult (AYA) Population with Hematologic Malignancies: A South Carolina (SC) Community Practice Perspective

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 2577-2577
Author(s):  
Jill Sullivan ◽  
Jamie Jackson ◽  
Griffen Kristie ◽  
John Eberly ◽  
Jennifer Davis ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
South Carolina ◽  
Pediatric Patients ◽  
Conflicts Of Interest ◽  
Cancer Center ◽  
Similar Distribution ◽  
Community Based ◽  
Acute Leukemias ◽  
Leukemias And Lymphomas

Abstract Abstract 2577 Background: Leukemias and lymphomas comprise 25% of all cancers in AYA patients age 15–39 years. Survival benefit from treatment advances has been less for AYA patients compared to the pediatric patients (<15 years of age). One reason for this disparity in survival is the relative lack of clinical trial accrual in AYA population. Previous population-based analysis of cooperative group participation between 1992 and 1997 found 71% of children under age 15 participated in clinical trials versus 24% of 15–19 year olds and less than 2% of 20–29 year olds (Liu et al., 2003). The majority of reports on this “AYA Gap” have been from large academic institutions or pooled national databases. We report our 5 year experience of clinical trial enrolment of AYA leukemias and lymphomas (L&L) from a SC community-based practice. Methods: We retrospectively analyzed the data on all patients, age 0–39 years, with newly diagnosed acute leukemias(ALL, AML) and lymphomas (Hodgkin {HL} and non-hodgkin lymphoma{NHL}) between 2005 and 2009 through the Greenville Memorial Hospital (GMH) and BI-LO Charities Children's Cancer Center (BCCCC) registries in Greenville SC. AYA was defined ages 15–39, with the pediatric ages <15 as the control. Demographic comparisons were made with available state-wide and SEER registry data. Clinical trial availability was abstracted from practice clinical research offices and NCI database using www.clinicaltrials.gov. Results: Among 684 total oncology patients 0–39 years of age, 528 were AYA. Median age was 33 for the total AYA population but 26 for the 76 patients with L&L (ALL = 14, AML = 7, HL = 27, NHL = 28); there was no difference between the pediatric and AYA populations in regards to other demographic characteristics (race, gender, insurance, or vital status). Leukemia and lymphoma patients age 15–39 represented a similar distribution (4.7% and 10.4% of total diagnosis, respectively) in comparison to statewide and SEER data. Leukemia accounted for 80% of pediatric diagnoses while lymphoma comprised the bulk (72%) of AYA diagnoses; this is similar to data observed nationally. Statewide clinical trials were available to 72% of pediatric patients and 60% of AYA patients; local clinical trial availability was higher in the pediatric population than the AYA population (94% versus 69%). Sixty-two percent of pediatric patients were actually enrolled on a clinical trial in comparison to only 17% of AYA patients. Only 21% of AYA were treated at a pediatric facility, as compared to 98% of pediatric patients. Clinical trial enrollment of AYA patients treated at a pediatric facility was 75% versus 3% of patients treated at an adult facility. For the 97% of AYA patients treated at an adult facility but not enrolled on a clinical trial, 55% of patients had a trial available to them locally (34%) or statewide (21%). When considering lymphoma alone, as the most prominent AYA diagnosis, the majority of HL (89%) and NHL (82%) patients were not enrolled on clinical trials; of those patients not enrolled on a clinical trial, only 30% and 22% of HL and NHL, respectively, had a clinical trial available to them locally. Conclusion: In a community-based adult and pediatric oncology practice, there is a significant discrepancy in the number of L&L patients enrolled on a clinical trial when comparing pediatric and AYA cohorts. AYA L&L patients fail to be enrolled on clinical trials due to lack of clinical trial availability as compared to the pediatric L&L population. Disclosures: No relevant conflicts of interest to declare.

scholarly journals On the design of early-phase Alzheimer’s disease clinical trials with cerebrospinal fluid tau outcomes

2021 ◽  
pp. 174077452110344
Author(s):  
Michelle M Nuño ◽  
Joshua D Grill ◽  
Daniel L Gillen ◽  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Cerebrospinal Fluid ◽  
Phosphorylated Tau ◽  
Inclusion Criteria ◽  
Eligibility Criteria ◽  
Total Tau ◽  
Prodromal Alzheimer’S Disease ◽  
Study Power

Background/Aims: The focus of Alzheimer’s disease studies has shifted to earlier disease stages, including mild cognitive impairment. Biomarker inclusion criteria are often incorporated into mild cognitive impairment clinical trials to identify individuals with “prodromal Alzheimer’s disease” to ensure appropriate drug targets and enrich for participants likely to develop Alzheimer’s disease dementia. The use of these eligibility criteria may affect study power. Methods: We investigated outcome variability and study power in the setting of proof-of-concept prodromal Alzheimer’s disease trials that incorporate cerebrospinal fluid levels of total tau (t-tau) and phosphorylated (p-tau) as primary outcomes and how differing biomarker inclusion criteria affect power. We used data from the Alzheimer’s Disease Neuroimaging Initiative to model trial scenarios and to estimate the variance and within-subject correlation of total and phosphorylated tau. These estimates were then used to investigate the differences in study power for trials considering these two surrogate outcomes. Results: Patient characteristics were similar for all eligibility criteria. The lowest outcome variance and highest within-subject correlation were obtained when phosphorylated tau was used as an eligibility criterion, compared to amyloid beta or total tau, regardless of whether total tau or phosphorylated tau were used as primary outcomes. Power increased when eligibility criteria were broadened to allow for enrollment of subjects with either low amyloid beta or high phosphorylated tau. Conclusion: Specific biomarker inclusion criteria may impact statistical power in trials using total tau or phosphorylated tau as the primary outcome. In concert with other important considerations such as treatment target and population of clinical interest, these results may have implications to the integrity and efficiency of prodromal Alzheimer’s disease trial designs.

Community-Based Interventions to Reduce Child Maltreatment

2021 ◽  
pp. 104973152098696
Author(s):  
Camilla Kin-Ming Lo ◽  
Yuet Wing Cho
Keyword(s):  
Child Maltreatment ◽  
Hybrid Approach ◽  
Inclusion Criteria ◽  
Community Members ◽  
Protective Services ◽  
Community Based Interventions ◽  
Community Based ◽  
Community Institutions ◽  
Core Components ◽  
Further Development

Purpose: This review seeks to summarize selected literature on existing findings on the impacts of community-based interventions on the actual reduction of child maltreatment and to identify the core components of the interventions. Methods: This study systematically searched electronic databases, including PsycInfo, Medline, and Web of Science. The findings of the selected studies were summarized using narrative synthesis. Results: A total of four studies met the inclusion criteria of this study. The studies showed declines in child maltreatment incidences reported by child protective services and hospitals during the study periods. Four major components and approaches were identified among the selected interventions, including (1) the involvement of community members, (2) partnerships with community institutions, (3) multidisciplinary collaboration, and (4) responsiveness to the needs of the communities involved. Conclusions: The results of this review support the need for further development of community-based interventions using a hybrid approach.

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

2011 ◽  
Vol 27 (1) ◽  
pp. 67-74 ◽  
Author(s):  
Margo Michaels ◽  
Elisa S. Weiss ◽  
John A. Guidry ◽  
Natasha Blakeney ◽  
Liz Swords ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Clinical Trials ◽  
Community Based

Common late complications of longitudinal forefoot amputations in neuropathic foot treatment

2021 ◽  
Vol 30 (6) ◽  
pp. 498-503
Author(s):  
Rodrigo Sousa Macedo ◽  
Lucas Sousa Macedo ◽  
Marcos Hideyo Sakaki ◽  
Rafael Barban Sposeto ◽  
Rafael Trevisan Ortiz ◽  
...  
Keyword(s):  
Conflicts Of Interest ◽  
Reoperation Rate ◽  
Late Complications ◽  
Inclusion Criteria ◽  
Patients With Diabetes ◽  
Partial Amputation ◽  
Neuropathic Foot ◽  
Foot Clinic ◽  
Ray Amputation

Objective: To describe and quantify the complications arising in consecutive neuropathic patients undergoing partial longitudinal amputations of the foot. Method: A retrospective study was conducted with data collected from the medical records of patients monitored at the Insensitive Foot Clinic of the Foot and Ankle Group of our institution who underwent partial amputation of foot rays from 2000 to 2016. Results: A total of 28 patients met the inclusion criteria, with a total of 31 amputated/partially amputated feet. Of these, 18 (58.1%) feet were amputated/partially amputated due to diabetes, seven (22.6%) due to leprosy, two (6.5%) due to alcoholic neuropathy, two (6.5%) secondary to traumatic peripheral nerve injury, and two (6.5%) due to other causes. Fifth ray amputation was the most frequent type (n=12). The cause of amputation was the presence of an infected ulcer in 93.6% of the samples. At a mean follow-up time of 60 months, 13 (41.9%) feet required new amputations—five (38.5%) transtibial, five (38.5%) transmetatarsal, two (15.4%) of the toes, and one (7.7%) at Chopart's joint. Patients with diabetes had a 50.0% reamputation rate. Patients who initially underwent amputation of the fifth ray had a 58.3% reamputation rate. Conclusion: Partial longitudinal amputation of the foot in neuropathic patients exhibited a high reoperation rate, especially in patients with diabetes or in patients with initial amputation of the peripheral rays. Declaration of interest: The authors have no conflicts of interest.

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