Abstract:
:Research misconduct and fraud in clinical research is an increasing problem facing the scientific community. This problem is expected to increase due to discoveries in central statistical monitoring and with the increase in first-time clinical trial investigators in the increasingly global reach of oncology clinical trials. This paper explores the most common forms of fraud in clinical trials in order to develop offensive and defensive strategies to deal with fraud. The offensive strategies are used when fraud is detected during a trial and the defensive strategies are those design strategies that seek to minimize or eliminate the effect of fraud. This leads to a proposed fraud recovery plan (FRP) that would be specified before the start of a clinical trial and would indicate actions to be taken upon detecting fraud of different types. Statistical/regulatory issues related to fraud include: dropping all patients from a site that committed fraud, or just the fraudulent data (perhaps replacing the latter through imputation); the role of intent-to-treat analysis; effect on a planned interim analysis; effect on stratified analyses and model adjustment when fraud is detected in covariates; effect on trial-wide randomization, etc. The details of a typical defensive strategy are also presented. It is concluded that it is best to follow a defensive strategy and to have an FRP in place to follow if fraud is detected during the trial.
journal_name
Int J Clin Oncoljournal_title
International journal of clinical oncologyauthors
Herson Jdoi
10.1007/s10147-015-0876-6subject
Has Abstractpub_date
2016-02-01 00:00:00pages
22-7issue
1eissn
1341-9625issn
1437-7772pii
10.1007/s10147-015-0876-6journal_volume
21pub_type
杂志文章,评审abstract::A 74-year-old female was referred to our hospital for non-muscle invasive bladder tumors initially treated at another hospital. Preoperatively, computed tomography and magnetic resonance imaging demonstrated non-muscle invasive bladder tumors and a vaginal tumor. A second transurethral resection of the bladder tumors,...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-010-0097-y
更新日期:2010-12-01 00:00:00
abstract:BACKGROUND:We evaluated clinical outcomes of region target focal therapy with high-intensity focused ultrasound (HIFU) for the localized prostate cancer (PCa) based on magnetic resonance imaging-based biopsy and systematic prostate biopsy for Asian. METHODS:We prospectively recruited patients with localized PCa, locat...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-020-01723-9
更新日期:2020-10-01 00:00:00
abstract:BACKGROUND:Neoplastic cardiac tamponade (NCT) is a life-threatening complication of cancer. The interval between cancer diagnosis and NCT onset and the prognosis after pericardiocentesis may differ according to cancer type. METHODS AND RESULTS:We performed a retrospective study of 113 patients (54 % male) with NCT who...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-015-0794-7
更新日期:2015-10-01 00:00:00
abstract:BACKGROUND:We conducted a phase I dose escalation study to determine the maximum tolerated dose (MTD), the recommended dose (RD) and the safety profile of amrubicin (AMR) plus paclitaxel (PTX) combination regimen for patients with previously treated non-small cell lung cancer (NSCLC). PATIENTS AND METHODS:PTX was admi...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-015-0883-7
更新日期:2016-04-01 00:00:00
abstract:BACKGROUND:High-risk factors for recurrence of head and neck squamous cell carcinoma after surgical resection include involvement of ≥ 2 regional lymph nodes, extracapsular spread, and microscopic involvement of resected mucosal margins. Adjuvant chemoradiotherapy is thought to improve postoperative locoregional contro...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-013-0532-y
更新日期:2014-02-01 00:00:00
abstract:BACKGROUND:We aimed to determine the appropriateness of adding 18F-fluorodeoxyglucose (FDG)-positronemission tomography (PET) to computed tomography (CT) and other pre-existing diagnostic imaging modalities for detecting subclinical lymph node metastasis of esophageal cancer, by comparing images from these modalities w...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-009-0893-4
更新日期:2009-10-01 00:00:00
abstract:BACKGROUND:Testicular cancer is a rare type of cancer in males. Since the disease is seen in young men and long-term survival is ensured following a high treatment success rate, fertility in testicular cancer patients is much more important. Prior to commencement of cancer treatment, patients are given counselling with...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-019-01534-7
更新日期:2020-03-01 00:00:00
abstract:BACKGROUND:We evaluated the association between subclinical interstitial lung disease (ILD) and fatal radiation pneumonitis (RP) in patients with thoracic tumors treated with thoracic radiotherapy (RT). METHODS:Sixty-two consecutive patients with thoracic tumors treated with thoracic RT were retrospectively analyzed. ...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-014-0679-1
更新日期:2015-02-01 00:00:00
abstract:BACKGROUND:Lip carcinomas are rare oral tumors, and there have been few reports of lip carcinoma in Japan. METHODS:Of 914 patients with oral carcinomas treated between January 1980 and December 1998, 12 (1.3%) had lip carcinoma and 5 (0.5%) had lip mucosal carcinoma. We investigated the clinicopathological features of...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/pl00012093
更新日期:2001-06-01 00:00:00
abstract:BACKGROUND:Previous reports concerning the prevalence of human papillomavirus (HPV) in oral squamous cell carcinoma (OSCC) have observed varied results. The aim of this study was to evaluate the prevalence of HPV in oral premalignant lesions (OPL) and OSCC. For accurate HPV detection in oral lesions, comparative analys...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-011-0236-0
更新日期:2011-12-01 00:00:00
abstract:BACKGROUND:We evaluated the longer-term efficacy and safety of concurrent chemoradiotherapy (CCRT) incorporating high-dose-rate intracavitary brachytherapy (HDR-ICBT) with a lower cumulative radiotherapy (RT) protocol and analyzed prognostic risk factors for survival among patients with FIGO stage III-IVA squamous cell...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-012-0457-x
更新日期:2013-10-01 00:00:00
abstract:BACKGROUND:The optimal treatment for elderly patients with glioblastoma has not been established. METHODS:We retrospectively analyzed the safety and efficacy of hypofractionated radiotherapy (45 Gy/15 fr) combined with temozolomide (TMZ) followed by bevacizumab (BEV) salvage treatment in 18 glioblastoma patients aged ...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-018-1298-z
更新日期:2018-10-01 00:00:00
abstract:BACKGROUND:Hypofractionated proton therapy (HFPT) is expected to become an effective treatment approach for localized prostate cancer (PCa). The purpose of this study was to evaluate differences in acute toxicity among patients with localized PCa treated with either conventional fractionated proton therapy (CFPT) or HF...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-017-1209-8
更新日期:2018-04-01 00:00:00
abstract:BACKGROUND:We aimed to compare the impact of systematic uncertainties in patient setup and prostate motion on three different external-beam radiotherapy protocols for prostate cancer. METHODS:To simulate possible near-maximum systematic errors, the isocenter position was shifted to eight points with +/-1.65 SD of the ...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-007-0724-4
更新日期:2008-02-01 00:00:00
abstract:BACKGROUND:We aimed to find the prognostic factors predicting overall survival (OS) in patients with castration-resistant prostate cancer (CRPC) who had docetaxel (DTX) chemotherapy, and to construct a model predicting the optimum number of cycles of DTX. METHODS:A total of 279 CRPC patients who received DTX (≥50 mg/m...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-013-0638-2
更新日期:2014-10-01 00:00:00
abstract::We report the case of a 68-year-old Japanese man who presented with postrenal azotemia due to bilateral upper ureteral stenosis. The patient's right kidney was nonfunctional; therefore, right nephroureterectomy was performed for the purpose of pathologic diagnosis. Histopathologic examination revealed follicular lymph...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-007-0685-7
更新日期:2007-12-01 00:00:00
abstract:OBJECTIVE:Most Brenner tumors are benign, with only 1% being malignant. In this study we report on 13 cases with malignant Brenner tumor of the ovary and discuss the clinical, demographic and histologic features. METHOD:Thirteen patients with malignant Brenner tumor of the ovary who were treated at Selçuk University G...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-011-0290-7
更新日期:2012-08-01 00:00:00
abstract:BACKGROUND:Obstructive colorectal cancer (CRC) is an emergency situation with high morbidity and mortality, but long-term outcomes of stage II/III obstructive CRC remain unclear. The aim of this study was to evaluate prognostic factors, including colorectal obstruction. METHODS:Data were retrospectively reviewed from ...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-018-1307-2
更新日期:2018-12-01 00:00:00
abstract:BACKGROUND:We performed a retrospective study to clarify the outcome of stage IB2-IIB patients with bulky cervical cancer who underwent neoadjuvant chemotherapy (NAC) followed by radical hysterectomy and adjuvant treatment. METHODS:Sixty-five patients with bulky stage IB2-IIB cervical cancer, treated at Tottori Univer...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-013-0559-0
更新日期:2014-04-01 00:00:00
abstract:BACKGROUND:Although regorafenib or trifluridine/tipiracil (FTD/TPI) has been recognized as a later-line standard treatment in patients with metastatic colorectal cancer (mCRC), not all patients have beneficial outcomes. This study aimed to develop a prognostic scoring system for evaluating the overall survival (OS) ben...
journal_title:International journal of clinical oncology
pub_type: 杂志文章,多中心研究
doi:10.1007/s10147-019-01600-0
更新日期:2020-04-01 00:00:00
abstract:BACKGROUND:Radium-223 is a first-in-class targeted alpha therapy to prolong overall survival (OS) in castration-resistant prostate cancer with bone metastases (mCRPC). The aim of the present analysis was to assess the long-term safety with radium-223 in Japanese patients with mCRPC. METHODS:Patients with symptomatic m...
journal_title:International journal of clinical oncology
pub_type: 杂志文章,多中心研究
doi:10.1007/s10147-018-01389-4
更新日期:2019-05-01 00:00:00
abstract:PURPOSE:Boron neutron capture therapy (BNCT) is among the radiation treatments known to have a selective lethal effect on tumor cells. This study summarizes the tumor responses and the acute and late adverse effects of BNCT in the treatment of patients with both recurrent and newly diagnosed T4 salivary gland carcinoma...
journal_title:International journal of clinical oncology
pub_type: 临床试验,杂志文章
doi:10.1007/s10147-013-0580-3
更新日期:2014-01-01 00:00:00
abstract::We report a rare case of advanced ovarian mucinous adenocarcinoma in a pregnant woman. A 28-year-old pregnant Japanese woman was diagnosed with an ovarian tumor 8 cm in diameter at a local hospital. She was sent to a private hospital at 25 weeks of gestation because of the growing ovarian tumor. Advanced ovarian carci...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-007-0655-0
更新日期:2007-10-01 00:00:00
abstract:BACKGROUND:The influence of resection of the primary lesion on the prognosis of patients with incurable stage IV colorectal cancer is unclear. METHODS:We retrospectively analyzed 158 asymptomatic patients with incurable stage IV colorectal cancer who received systemic chemotherapy in our center from 2002 to 2009, eith...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-014-0662-x
更新日期:2014-12-01 00:00:00
abstract:BACKGROUND:Pulmonary wedge resection is an option for lung cancer patients with limited cardiopulmonary preservation. As the impact of underlying lung status on the prognosis of such patients remains unclear, we assessed this issue. METHODS:A total of 149 borderline surgical candidates with localized lung cancer who h...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-018-1367-3
更新日期:2019-04-01 00:00:00
abstract:BACKGROUND:Zoledronic acid treatment reduces the incidence of skeletal-related events (SREs) in patients with bone metastases from breast, lung, and urologic cancers including prostate and renal cancer. The aim of this study was to evaluate the effect of zoledronic acid on SREs in patients with bone metastases from bla...
journal_title:International journal of clinical oncology
pub_type: 杂志文章,随机对照试验
doi:10.1007/s10147-010-0074-5
更新日期:2010-08-01 00:00:00
abstract:PURPOSE:The purpose of our study was to evaluate the efficacy of a new combination antiemetic therapy consisting of palonosetron, aprepitant, and dexamethasone in gastric cancer patients undergoing chemotherapy with S-1 plus cisplatin. METHODS:This prospective, multi-institutional observational study assessed patient-...
journal_title:International journal of clinical oncology
pub_type: 杂志文章,多中心研究
doi:10.1007/s10147-015-0916-2
更新日期:2016-06-01 00:00:00
abstract::In Japan, the first actual survey of morbidity from cancer was conducted by Dr. Mitsuo Segi in Miyagi Prefecture from 1951 to 1953. Population-based cancer registries were started in 1957 in Hiroshima and 1958 in Nagasaki for the follow-up of survivors of the atomic bombings. Public population-based cancer registries,...
journal_title:International journal of clinical oncology
pub_type: 历史文章,杂志文章
doi:10.1007/s10147-008-0759-1
更新日期:2008-04-01 00:00:00
abstract:BACKGROUND:Merkel cell carcinoma (MCC) is a rare cutaneous malignancy with a high rate of nodal metastasis. Sentinel lymph node biopsy (SLNB) is used in MCC and other cancers to identify regional node micrometastases in patients with clinically negative nodes; however, whether SLN status is associated with recurrence o...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-014-0685-3
更新日期:2015-02-01 00:00:00
abstract:OBJECTIVE:To evaluate the predictive value of preoperative hydronephrosis for pathological outcome and prognosis in patients with upper tract urothelial carcinoma treated with nephroureterectomy. METHODS:167 patients with UTUC treated with nephroureterectomy at our two institutions in Japan between 2002 and 2017 were ...
journal_title:International journal of clinical oncology
pub_type: 杂志文章,多中心研究
doi:10.1007/s10147-019-01535-6
更新日期:2020-03-01 00:00:00