当前位置： SCI文献检索 > CANCER期刊下所有文献 > Ethical communication in clinical trials. Issues faced by data managers in obtaining informed consent.

Ethical communication in clinical trials. Issues faced by data managers in obtaining informed consent.

Abstract：

BACKGROUND:Informed consent has been proposed as the optimal method for ensuring the ethical entry of patients into clinical trials. However, it is known that problems with informed consent exist from the perspective of both patients and physicians. This has led to the suggestion that a third party, such as a research nurse or data manager, should be responsible for obtaining informed consent. The objective of this study was to explore the views of data managers concerning the nature, challenges, and rewards of their role and the similarities and differences between their role and that of physicians in obtaining informed consent. METHODS:Four focus groups in three large teaching hospitals were conducted. Twenty-one data managers who were involved in cancer or pain clinical trials participated. The focus groups were audiotaped, transcribed, and subjected to content analysis to identify themes. RESULTS:Data managers identified three primary roles complementary to that of physicians: information provision, quality assurance of the informed consent process, and ongoing support during the trial. Despite expressed concern that medical and drug company interests may lead to subtle coercion of the patient, participants did not support the notion that they may be solely responsible for the consent process. Participants described a range of ethical dilemmas they confronted, including patients asking them for medical details they could not provide and situations in which they felt that informed consent was compromised in some way, for example, dealing with situations in which the patient appeared to be entering the trial for the wrong reasons due to misunderstanding, need, or passivity. Effective functioning of the multidisciplinary team assisted data managers in performing their role. A range of training needs were identified, particularly communication skills training and trial start-up briefing. CONCLUSIONS:The issues raised by these data managers have important implications for the successful conduct of clinical trials, particularly the need for an integrated, multidisciplinary approach at all levels of the informed-consent process.

journal_name

Cancer

journal_title

Cancer

authors

Loh WY,Butow PN,Brown RF,Boyle F

doi

10.1002/cncr.10994

subject

Has Abstract

pub_date

2002-12-01 00:00:00

pages

2414-21

issue

11

eissn

0008-543X

issn

1097-0142

journal_volume

95

pub_type

杂志文章

相关文献

CANCER文献大全
  • A randomized phase 3 trial comparing nimotuzumab plus cisplatin chemoradiotherapy versus cisplatin chemoradiotherapy alone in locally advanced head and neck cancer.

    abstract：BACKGROUND:Because the addition of nimotuzumab to chemoradiation in patients with locally advanced head and neck cancer improved outcomes in a phase 2 study, the authors conducted a phase 3 study to confirm these findings. METHODS:This open-label, investigator-initiated, phase 3, randomized trial was conducted from 20...

    journal_title：Cancer

    pub_type： 杂志文章,随机对照试验

    doi：10.1002/cncr.32179

    authors： Patil VM,Noronha V,Joshi A,Agarwal J,Ghosh-Laskar S,Budrukkar A,Murthy V,Gupta T,Mahimkar M,Juvekar S,Arya S,Mahajan A,Agarwal A,Purandare N,Rangarajan V,Balaji A,Chaudhari SV,Banavali S,Kannan S,Bhattacharjee A,D

    更新日期：2019-09-15 00:00:00

  • Concurrent radiation therapy, 5-fluorouracil, and cisplatin for stage II, III, and IV, node-negative, squamous cell head and neck cancer. Results and surgical implications.

    abstract：METHODS:Between 1983 and 1989, 42 patients with Stage II, III, and IV, node-negative, squamous cell head and neck cancer were treated with concurrent 5-fluorouracil, cisplatin, and radiation therapy. Two courses of chemotherapy with 30 Gy of concurrent radiation therapy were to be followed in all patients by definitive...

    journal_title：Cancer

    pub_type： 临床试验,杂志文章

    doi：10.1002/1097-0142(19921201)70:11<2685::aid-cncr282

    authors： Adelstein DJ,Sharan VM,Damm C,Earle AS,Shah AC,Haria CD,Trey JE,Carter SG,Hines JD

    更新日期：1992-12-01 00:00:00

  • Clear cell sarcoma. A clinicopathologic study of 27 cases.

    abstract：:Clear cell sarcoma is an indolent tumor of uncertain histogenesis. Twenty-seven patients ranging in age from 9 to 57 years (average, 28.5 years) were followed an average of 7.0 years. Females outnumbered males by 2 to 1. Distal extremity locations predominated. At presentation, the tumor was localized in 21 patients, ...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/1097-0142(19831015)52:8<1482::aid-cncr2820

    authors： Eckardt JJ,Pritchard DJ,Soule EH

    更新日期：1983-10-15 00:00:00

  • Barriers and incentives for primary care physicians in cancer prevention and detection.

    abstract：:The American Cancer Society estimates that nearly a million new cases of cancer will occur and that approximately a half million lives will be lost in 1987. These figures may double by the year 2000 primarily because of our aging population, with age being the leading risk factor for cancer. It is believed that the ma...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/1097-0142(19880601)61:11+<2382::aid-cncr28

    authors： Williams PA,Williams M

    更新日期：1988-06-01 00:00:00

  • Prostatic acid phosphatase in strumal carcinoids of the ovary. An immunohistochemical study.

    abstract：BACKGROUND:Strumal carcinoids (SC) are ovarian tumors containing thyroid parenchyma admixed with carcinoid elements. Microscopically, the carcinoid component of SC usually presents a ribbon or trabecular pattern similar to the pattern exhibited by hindgut carcinoids. The authors designed an immunohistochemical study to...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/1097-0142(19930901)72:5<1673::aid-cncr2820

    authors： Sidhu J,Sánchez RL

    更新日期：1993-09-01 00:00:00

  • Focal nodular hyperplasia of the liver: report of six patients. Concepts of surgical management.

    abstract：:The authors add six patients with focal nodular hyperplasia of the liver to the increasing number reported. All had ingested hormones as contraceptives for periods of from one and one-half to seven years. In five patients, the initial manifestation was massive intraabdominal hemorrhage and hypovolemic shock. Five of t...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/1097-0142(197702)39:2<587::aid-cncr2820390

    authors： Catalano PW,Early ME,Topolosky HW,Martin EW Jr,Carey LC

    更新日期：1977-02-01 00:00:00

  • The impact of conventional plus high dose chemotherapy with autologous bone marrow transplantation on hematologic toxicity during subsequent local-regional radiotherapy for breast cancer.

    abstract：BACKGROUND:Forty patients with Stage II-III breast cancer with 10 or more positive axillary nodes were treated with mastectomy followed by four cycles of standard dose CAF (cytoxan, Adriamycin, 5-FU), followed by high dose cytoxan, cisplatin, carmustine (HDCT) with autologous bone marrow transplant support (ABMT), and ...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/1097-0142(19941201)74:11<2964::aid-cncr282

    authors： Marks LB,Rosner GL,Prosnitz LR,Ross M,Vredenburgh JJ,Peters WP

    更新日期：1994-12-01 00:00:00

  • Primary radiotherapy versus radical prostatectomy for high-risk prostate cancer: a decision analysis.

    abstract：BACKGROUND:Two evidence-based therapies exist for the treatment of high-risk prostate cancer (PCA): external-beam radiotherapy (RT) with hormone therapy (H) (RT + H) and radical prostatectomy (S) with adjuvant radiotherapy (S + RT). Each of these strategies is associated with different rates of local control, distant m...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/cncr.26272

    authors： Parikh R,Sher DJ

    更新日期：2012-01-01 00:00:00

  • Immunohistochemical expression of Ets-1 transcription factor and the urokinase-type plasminogen activator is correlated with the malignant and invasive potential in meningiomas.

    abstract：BACKGROUND:The Ets-1 transcription factor has been proposed to play an important role in the invasive process of tumor cells through the induction of urokinase-type plasminogen activator (u-PA). METHODS:Because meningiomas are potentially invasive tumors, irrespective of their malignancy grades, the authors immunohist...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/1097-0142(20001201)89:11<2292::aid-cncr18>

    authors： Kitange G,Tsunoda K,Anda T,Nakamura S,Yasunaga A,Naito S,Shibata S

    更新日期：2000-12-01 00:00:00

  • Carcinocythemia (carcinoma cell leukemia) due to metastatic carcinoma of the breast: report of a case.

    abstract：:A patient with a 17-year course of metastatic lobular carcinoma of the breast is described who developed large numbers of circulating carcinoma cells which were easily detectable in several routine peripheral blood smears shortly before death. This rare complication of carcinoma has been called "carcinocythemia." Carc...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/1097-0142(197712)40:6<3107::aid-cncr282040

    authors： Myerowitz RL,Edwards PA,Sartiano GP

    更新日期：1977-12-01 00:00:00

  • Radiation therapy of malignant melanomas: an evaluation of clinically used fractionation schemes.

    abstract：:To assess the importance of radiation dose fraction size in the treatment of malignant melanomas, the records of 48 patients (83 sites) treated at Tufts-New England Medical Center from 1971 to 1979 have been retrospectively reviewed. During this period, the dose fractionation schemes evolved from standard fraction siz...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/1097-0142(19810315)47:6<1262::aid-cncr2820

    authors： Strauss A,Dritschilo A,Nathanson L,Piro AJ

    更新日期：1981-03-15 00:00:00

  • Medical treatment and long-term survival in a prospective study of 84 patients with endocrine pancreatic tumors.

    abstract：:A prospective study was performed on 84 patients with neuroendocrine pancreatic tumors. Fifty-nine (70%) had malignant tumors and received causal medical treatment. Streptozotocin in combination with 5-fluorouracil or doxorubicin was used as first-line treatment and produced overall objective responses in 20 of 44 (45...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/1097-0142(19900501)65:9<1883::aid-cncr2820

    authors： Eriksson B,Skogseid B,Lundqvist G,Wide L,Wilander E,Oberg K

    更新日期：1990-05-01 00:00:00

  • Detection of human papillomavirus in esophageal squamous cell carcinoma.

    abstract：BACKGROUND:Human papillomavirus (HPV) DNA has been identified in esophageal carcinomas. However, the incidence of HPV varies significantly in different geographic locations. In the current study, neoplasms from two separate geographic regions were analyzed for the presence of HPV DNA: METHODS:One hundred and ten esoph...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/(SICI)1097-0142(19960815)78:4<704::AID-CNC

    authors： Suzuk L,Noffsinger AE,Hui YZ,Fenoglio-Preiser CM

    更新日期：1996-08-15 00:00:00

  • Plasma immunoglobulin levels in patients with breast cancer.

    abstract：:The plasma levels of the immunoglobulins IgA, IgG and IgM have been measured in 55 patients with benign breast disease, 28, 68 and 22 patients with early breast cancer one day before, 10-14 days after and three-six months after mastectomy, respectively, and 35 normal healthy control women. The mean levels of IgA, IgG ...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/1097-0142(197705)39:5<2190::aid-cncr282039

    authors： Wang DY,Goodwin PR,Bulbrook RD,Hayward JL

    更新日期：1977-05-01 00:00:00

  • Patterns of recurrence of rectal cancer after potentially curative surgery.

    abstract：:The results of surgical treatment alone for 142 cases of carcinoma of the rectum and rectosigmoid from the Massachusetts General Hospital were reviewed. The incidence of local failure as any component of failure was found to be strongly dependent on the pathologic stage, and for Dukes' A was 8.0% (3/39); Dukes' B, 31%...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/1097-0142(19831001)52:7<1317::aid-cncr2820

    authors： Rich T,Gunderson LL,Lew R,Galdibini JJ,Cohen AM,Donaldson G

    更新日期：1983-10-01 00:00:00

  • Some observations concerning the demographic and geographic incidence of carcinoma of the lip and buccal cavity.

    abstract：:The geographic and demographic data obtained during the Third National Cancer Survey have provided a perspective on etiologic factors and incidence trends for cancers of low frequency. The incidence of cancer of the lip, oral cavity and skin from this survey was compared to similar studies in 1947 and intra-regional p...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/1097-0142(197707)40:1<343::aid-cncr2820400

    authors： Szpak CA,Stone MJ,Frenkel EP

    更新日期：1977-07-01 00:00:00

  • Gross and histological types of early gastric carcinomas in relation to the acid-secreting area.

    abstract：:The relation of gastric acid-secreting function to the gross and histological types and locations of carcinomas was examined in 53 patients with early gastric carcinomas. Studies were made by the endoscopic Congo red test developed in this clinic. Results indicated a close correlation between the gross and histologica...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/1097-0142(197901)43:1<317::aid-cncr2820430

    authors： Tatsuta M,Okuda S,Taniguchi H,Tamura H

    更新日期：1979-01-01 00:00:00

  • Gemcitabine and platinum combinations in pancreatic cancer.

    abstract：:Progress in the treatment of pancreatic cancer in the past several decades has been very modest. Several new agents with activity against this disease have been identified. Of these, gemcitabine appears to be the most promising when used in combination with other drugs. Gemcitabine and cisplatin combinations have been...

    journal_title：Cancer

    pub_type： 杂志文章,评审

    doi：10.1002/cncr.10757

    authors： Philip PA

    更新日期：2002-08-15 00:00:00

  • The prevalence of patients with colorectal carcinoma under care in the U.S.

    abstract：BACKGROUND:Prevalence usually is defined as the proportion of individuals alive who previously had a diagnosis of the disease, regardless of whether the individuals still are receiving treatment or are cured. The objective of this study was to estimate the proportion of elderly patients with colorectal carcinoma (CRC) ...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/cncr.11631

    authors： Mariotto A,Warren JL,Knopf KB,Feuer EJ

    更新日期：2003-09-15 00:00:00

  • Sequelae of treatment in 109 patients followed for 5 to 15 years after diagnosis of sarcoma of the bladder and prostate. A report from the Intergroup Rhabdomyosarcoma Study Committee.

    abstract：BACKGROUND:As increasing numbers of young patients with cancer survive, interest in the late effects of therapy is rising. METHODS:The sequelae of treatment were reviewed after a minimum of 5 years of observation in 109 surviving patients with sarcoma of the bladder or prostate who were enrolled in the Intergroup Rhab...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/1097-0142(19930401)71:7<2387::aid-cncr2820

    authors： Raney B Jr,Heyn R,Hays DM,Tefft M,Newton WA Jr,Wharam M,Vassilopoulou-Sellin R,Maurer HM

    更新日期：1993-04-01 00:00:00

  • OVX1 as a marker for early stage endometrial carcinoma.

    abstract：BACKGROUND:Endometrial carcinoma is generally diagnosed only after the onset of postmenopausal bleeding. Although most patients with Stage I disease can be cured, the prognosis worsens significantly when the tumor is no longer confined to the uterine corpus. Serum CA 125 is elevated in only 10-20% cases of Stage I and ...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/1097-0142(19940401)73:7<1855::aid-cncr2820

    authors： Xu FJ,Yu YH,Daly L,Anselmino L,Hass GM,Berchuck A,Rodriguez GC,Soper JT,Clarke-Pearson DL,Hollis D

    更新日期：1994-04-01 00:00:00

  • Evaluation and limitations of the lipid-associated sialic acid test for the detection of human cancer.

    abstract：:Previous studies and those of the authors have reported about raised levels of lipid-bound sialic acid (LSA) in sera of patients with various neoplasms. Most authors have used the method of Katopodis and Stock for isolating serum LSA. Because of the discrepancy of the amount of extracted LSA with the content of pure g...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/1097-0142(19891201)64:11<2279::aid-cncr282

    authors： Voigtmann R,Pokorny J,Meinshausen A

    更新日期：1989-12-01 00:00:00

  • A phase 2 trial of lenvatinib (E7080) in advanced, progressive, radioiodine-refractory, differentiated thyroid cancer: A clinical outcomes and biomarker assessment.

    abstract：BACKGROUND:Lenvatinib is an oral, multitargeted tyrosine kinase inhibitor of the vascular endothelial growth factor receptors 1 through 3 (VEGFR1-VEGFR3), fibroblast growth factor receptors 1 through 4 (FGFR1-FGFR4), platelet-derived growth factor receptor α (PDGFRα), ret proto-oncogene (RET), and v-kit Hardy-Zuckerman...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/cncr.29395

    authors： Cabanillas ME,Schlumberger M,Jarzab B,Martins RG,Pacini F,Robinson B,McCaffrey JC,Shah MH,Bodenner DL,Topliss D,Andresen C,O'Brien JP,Ren M,Funahashi Y,Allison R,Elisei R,Newbold K,Licitra LF,Sherman SI,Ball DW

    更新日期：2015-08-15 00:00:00

  • Treatment of the neck in patients with squamous cell carcinoma of the head and neck.

    abstract：:A retrospective study of 702 patients with clinically positive nodes associated with squamous cell carcinoma of the oral cavity, supraglottic larynx, and hypopharynx observed from 1954 to 1968 was done. The policies of treatment for the neck were not standardized during those years. Three hundred eleven patients who s...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/1097-0142(197702)39:2+<868::aid-cncr282039

    authors： Jesse RH,Fletcher GH

    更新日期：1977-02-01 00:00:00

  • Risk of hypothyroidism in older breast cancer patients treated with radiation.

    abstract：BACKGROUND:Hypothyroidism is a potential complication after radiation therapy (RT) when treatment fields include the thyroid. The authors assessed risk of hypothyroidism in breast cancer patients who were receiving RT to a supraclavicular field, which typically includes a portion of thyroid. METHODS:The authors identi...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/cncr.23307

    authors： Smith GL,Smith BD,Giordano SH,Shih YC,Woodward WA,Strom EA,Perkins GH,Tereffe W,Yu TK,Buchholz TA

    更新日期：2008-03-15 00:00:00

  • Parathyroid hormone-related protein is an independent prognostic factor for renal cell carcinoma.

    abstract：BACKGROUND:Parathyroid hormone-related protein (PTHrP) has been shown to be the principal cause of humoral hypercalcemia associated with renal cell carcinoma (RCC). Recent studies have demonstrated that the amino-terminal region of PTHrP has growth factor-like activities, suggesting it may play a role in the developmen...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/(sici)1097-0142(19990915)86:6<1028::aid-cn

    authors： Iwamura M,Wu W,Muramoto M,Ohori M,Egawa S,Uchida T,Baba S

    更新日期：1999-09-15 00:00:00

  • Dose escalation of gemcitabine concomitant with radiation and cisplatin for nonsmall cell lung cancer: a phase 1-2 study.

    abstract：BACKGROUND:The current study was conducted to evaluate the maximum tolerable dose of weekly gemcitabine administered simultaneously with radiation and cisplatin in patients with locally advanced nonsmall cell lung cancer (NSCLC). METHODS:Patients with stage IIIA/B NSCLC received concurrently 63 grays radiation and 20 ...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/cncr.25366

    authors： Momm F,Kaden M,Tannock I,Schumacher M,Hasse J,Henke M

    更新日期：2010-10-15 00:00:00

  • Childhood cancer in relation to parental race and ethnicity: a 5-state pooled analysis.

    abstract：BACKGROUND:Children of different racial/ethnic backgrounds have varying risks of cancer. However, to the authors' knowledge, few studies to date have examined cancer occurrence in children of mixed ancestry. METHODS:This population-based case-control study examined cancer among children aged <15 years using linked can...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/cncr.25099

    authors： Chow EJ,Puumala SE,Mueller BA,Carozza SE,Fox EE,Horel S,Johnson KJ,McLaughlin CC,Reynolds P,Von Behren J,Spector LG

    更新日期：2010-06-15 00:00:00

  • Coexistence of leukemic reticuloendotheliosis and histiocytic lymphoma: a case report.

    abstract：:A 65-year-old woman had pancytopenia, splenomegaly, and an inaspirable bone marrow. Diagnostic evaluation demonstrated that she had both leukemic reticuloendotheliosis (LRE), or hairy cell leukemia, and an additional lympho-reticular neoplasm, most likely a "histiocytic" lymphoma. The diagnosis of LRE was based on the...

    journal_title：Cancer

    pub_type： 杂志文章

    doi：10.1002/1097-0142(197905)43:5<1872::aid-cncr282043

    authors： Adler SS,Shetty J,Golomb HM

    更新日期：1979-05-01 00:00:00

  • Accelerated fractionation for high-grade cerebral astrocytomas. Preliminary treatment results.

    abstract：:A Phase I/II accelerated fractionation study for high-grade cerebral astrocytomas began in October 1987. Forty-two patients, 25 men and 17 women, were entered in the study. Median age was 58.5 years of age (range, 32 to 78 years). Performance status was 0, 1, 2, and 3 on Eastern Cooperative Oncology Group (ECOG) scale...

    journal_title：Cancer

    pub_type： 临床试验,杂志文章

    doi：10.1002/1097-0142(19910501)67:9<2247::aid-cncr2820

    authors： Shenouda G,Souhami L,Freeman CR,Hazel J,Lehnert S,Joseph L

    更新日期：1991-05-01 00:00:00