Mené sur 200 patients atteints d'un carcinome hépatocellulaire, cet essai évalue, dans le cadre des critères de Milan et du point de vue du taux de survie sans récidive et du taux de survie globale à 1, 3 et 5 ans, l'efficacité d'une hépatectomie partielle par rapport à un traitement séquentiel comportant une chimio-embolisation transartérielle et une ablation percutanée par radiofréquence

Randomized clinical trial of chemoembolization plus radiofrequency ablation versus partial hepatectomy for hepatocellular carcinoma within the Milan criteria

Liu, H. ; Wang, Z. G. ; Fu, S. Y. ; Li, A. J. ; Pan, Z. Y. ; Zhou, W. P. ; Lau, W. Y. ; Wu, M. C.

Background : This study aimed to compare sequential treatment by transcatheter arterial chemoembolization (TACE) and percutaneous radiofrequency ablation (RFA) with partial hepatectomy for hepatocellular carcinoma (HCC) within the Milan criteria. Methods : In a randomized clinical trial, patients with HCC within the Milan criteria were included and randomized 1 : 1 to the partial hepatectomy group or the TACE + RFA group. The primary outcome was overall survival and the secondary outcome was [...]

A partir d'une revue systématique de la littérature publiée entre 1976 et 2015 (99 articles), cette étude analyse les indications de la radiothérapie dans le traitement de divers types de mélanome, puis présente des recommandations

Role of radiation therapy in melanomas: systematic review and best practice in 2015

Fort, Magali ; Guet, Saada ; Husheng, Shan ; Calitchi, Elie ; Belkacémi, Yazid

Radiotherapy has been used for skin cancers since early after the discovery of x-rays. The introduction of sophisticated surgery techniques and information of the general population on potential late radiation-induced toxicity and carcinogenesis have led to limiting indications in the dermatologist community. However, radiotherapy has undergone considerable developments, essentially including technological advances, to sculpt radiation delivery, with demonstration of the benefit either alone or [...]

Menée à partir de données portant sur 2 230 patients atteints d'un cancer du côlon traité entre 2008 et 2013, cette étude évalue, du point de vue du taux de mortalité à 90 jours et des complications, l'intérêt d'une exérèse mésocolique complète par rapport à une intervention chirurgicale standard

Short-term outcomes after complete mesocolic excision compared with ‘conventional’ colonic cancer surgery

Bertelsen, C. A. ; Neuenschwander, A. U. ; Jansen, J. E. ; Kirkegaard-Klitbo, A. ; Tenma, J. R. ; Wilhelmsen, M. ; Rasmussen, L. A. ; Jepsen, L. V. ; Kristensen, B. ; Gögenur, I. ; on the behalf of the Copenhagen Complete Mesocolic Excision Study, Group ; the Danish Colorectal Cancer, Group

Background : Complete mesocolic excision (CME) seems to be associated with improved oncological outcomes compared with ‘conventional’ surgery, but there is a potential for higher morbidity. Methods : Data for patients after elective resection at the four centres in the Capital Region of Denmark (June 2008 to December 2013) were retrieved from the Danish Colorectal Cancer Group database and medical charts. Approval from a Danish ethics committee was not required (retrospective study). Results : [...]

Menée à partir de données portant sur 246 patients atteints d'une lésion de haut grade (dysplasie sévère ou carcinome in situ) ou d'un carcinome épidermoïde de la cavité buccale (taille inférieure à 4 cm) et traités entre 2004 et 2009 (âge moyen : 60 ans), cette étude évalue, par rapport à une intervention chirurgicale classique et du point de vue du taux de récidive locale à 3 ans, l'efficacité d'une résection guidée par fluorescence

Fluorescence visualization–guided surgery for early-stage oral cancer

Poh, C. F. ; Anderson, D. W. ; Durham, J. ; et al.,

Importance : The prevalence of genetically altered cells in oral cancers has a negative influence on the locoregional recurrence rate and lowers survival. Fluorescence visualization (FV) can identify clinically occult, high-risk oral lesions by allowing health care professionals and surgeons to visualize and map occult disease. This process may improve overall survival by decreasing rates of locoregional recurrence. Objective : To assess the efficacy of FV-guided surgery in reducing [...]

A partir d'échantillons tumoraux prélevés sur des patients traités par le pembrolizumab, cette étude met en évidence, à l'intérieur des tumeurs, une augmentation des lymphocytes T à mémoire en réponse au traitement

PD-1 blockade expands intratumoral T memory cells

Ribas, Antoni ; Shin, Daniel Sanghoon ; Zaretsky, Jesse ; Frederiksen, Juliet ; Cornish, Andrew ; Avramis, Earl ; Seja, Elizabeth ; Kivork, Christine ; Siebert, Janet ; Kaplan-Lefko, Paula ; Wang, Xiaoyan ; Chmielowski, Bartosz ; Glaspy, John A. ; Tumeh, Paul C. ; Chodon, Thinle ; Pe'er, Dana ; Comin-Anduix, Begona

Tumor responses to PD-1 blockade therapy are mediated by T cells, which we characterized in 102 tumor biopsies obtained from 53 patients treated with pembrolizumab, an antibody to PD-1. Biopsies were dissociated and single cell infiltrates were analyzed by multicolor flow cytometry using two computational approaches to resolve the leukocyte phenotypes at the single cell level. There was a statistically significant increase in the frequency of T cells in patients who responded to therapy. The [...]

Menée à l'aide de modèles murins, cette étude suggère l'intérêt d'anticorps monoclonaux bloquant CD96, en combinaison avec des anticorps anti-CTLA-4 ou anti-PD1, pour réduire la taille des métastases

Suppression of metastases using a new lymphocyte checkpoint target for cancer immunotherapy

Blake, Stephen J. ; Stannard, Kimberley ; Liu, Jing ; Allen, Stacey ; Yong, Michelle C. R. ; Mittal, Deepak ; Roman Aguilera, Amelia ; Miles, John J. ; Lutzky, Viviana P. ; Ferrari de Andrade, Lucas ; Martinet, Ludovic ; Colonna, Marco ; Takeda, Kazuyoshi ; Kühnel, Florian ; Gurlevik, Engin ; Bernhardt, Gunter ; Teng, Michele W. L. ; Smyth, Mark J.

CD96 has recently been shown as a negative regulator of mouse NK cell activity, with Cd96-/- mice displaying hyper-responsive NK cells upon immune challenge. In this study we have demonstrated that blocking CD96 with a monoclonal antibody inhibited experimental metastases in three different tumor models. The anti-metastatic activity of anti-CD96 was dependent on NK cells, CD226 (DNAM-1) and IFN-γ, but independent of activating Fc receptors. Anti-CD96 was more effective in combination with [...]

Menée sur des lignées cellulaires de leucémie de type B et à l'aide de xénogreffes, cette étude évalue la faisabilité et l'efficacité d'un interrupteur moléculaire intégré à une immunothérapie CAR-T pour contrôler ses effets indésirables

Switch-mediated activation and retargeting of CAR-T cells for B-cell malignancies

Rodgers, David T. ; Mazagova, Magdalena ; Hampton, Eric N. ; Cao, Yu ; Ramadoss, Nitya S. ; Hardy, Ian R. ; Schulman, Andrew ; Du, Juanjuan ; Wang, Feng ; Singer, Oded ; Ma, Jennifer ; Nunez, Vanessa ; Shen, Jiayin ; Woods, Ashley K. ; Wright, Timothy M. ; Schultz, Peter G. ; Kim, Chan Hyuk ; Young, Travis S.

Chimeric antigen receptor T (CAR-T) cell therapy has produced impressive results in clinical trials for B-cell malignancies. However, safety concerns related to the inability to control CAR-T cells once infused into the patient remain a significant challenge. Here we report the engineering of recombinant antibody-based bifunctional switches that consist of a tumor antigen-specific Fab molecule engrafted with a peptide neo-epitope, which is bound exclusively by a peptide-specific switchable [...]

Menée in vitro, cette étude met en évidence des mécanismes suggérant l'intérêt d'une stratégie ciblant le micro-ARN miR-522 pour le traitement des patients atteints d'un cancer du poumon non à petites cellules

Downregulation of miR-522 suppresses proliferation and metastasis of non-small cell lung cancer cells by directly targeting DENN/MADD domain containing 2D

Zhang, Tianze ; Hu, Yingying ; Ju, Jin ; Hou, Liangyu ; Li, Zhange ; Xiao, Dan ; Li, Yongchao ; Yao, Jianyu ; Wang, Chao ; Zhang, Yong ; Zhang, Linyou

Non-small cell lung cancer (NSCLC), one of the most common causes of cancer-related death, is a worldwide public health problem. MicroRNAs (miRNAs) have recently been identified as a novel class of regulators of carcinogenesis and tumor progression, including miRNAs associated with NSCLC. This study aimed to explore the role of miR-522 in NSCLC and the mechanisms underlying this role. We report here that miR-522 expression was significantly increased in both human NSCLC tissues and cell lines. [...]

Menée sur des lignées cellulaires de cancer de la prostate ayant développé une résistance à l'enzalutamide, cette étude suggère l'intérêt thérapeutique d'une stratégie combinant un inhibiteur de BET et un antagoniste du récepteur des androgènes

BET Bromodomain Inhibitors Enhance Efficacy and Disrupt Resistance to AR Antagonists in the Treatment of Prostate Cancer

Asangani, Irfan A. ; Wilder-Romans, Kari ; Dommeti, Vijaya L. ; Krishnamurthy, Pranathi M. ; Apel, Ingrid J. ; Escara-Wilke, June ; Plymate, Stephen R. ; Navone, Nora M. ; Wang, Shaomeng ; Feng, Felix Y. ; Chinnaiyan, Arul M.

Next generation anti-androgen therapies such as enzalutamide and abiraterone have had a profound impact on the management of metastatic castration-resistant prostate cancer (mCRPC). However, mCRPC patients invariably develop resistance to these agents. Here, a series of clonal cell lines were developed from enzalutamide-resistant prostate tumor xenografts to study the molecular mechanism of resistance and test their oncogenic potential under various treatment conditions. Androgen receptor (AR) [...]

Menée sur des lignées cellulaires et à l'aide de xénogreffes de cancer du sein, cette étude suggère l'intérêt de combiner un inhibiteur de c-Met et un inhibiteur de PARP1 pour le traitement de patientes dont les tumeurs surexpriment c-Met

Blocking c-Met-mediated PARP1 phosphorylation enhances anti-tumor effects of PARP inhibitors

Du, Yi ; Yamaguchi, Hirohito ; Wei, Yongkun ; Hsu, Jennifer L. ; Wang, Hung-Ling ; Hsu, Yi-Hsin ; Lin, Wan-chi ; Yu, Wen-Hsuan ; Leonard, Paul G. ; Lee Iv, Gilbert R. ; Chen, Mei-Kuang ; Nakai, Katsuya ; Hsu, Ming-Chuan ; Chen, Chun-Te ; Sun, Ye ; Wu, Yun ; Chang, Wei-Chao ; Huang, Wen-Chien ; Liu, Chien-Liang ; Chang, Yuan-Ching ; Chen, Chung-Hsuan ; Park, Morag ; Jones, Philip ; Hortobagyi, Gabriel N. ; Hung, Mien-Chie

Poly (ADP-ribose) polymerase (PARP) inhibitors have emerged as promising therapeutics for many diseases, including cancer, in clinical trials. One PARP inhibitor, olaparib (Lynparza, AstraZeneca), was recently approved by the FDA to treat ovarian cancer with mutations in BRCA genes. BRCA1 and BRCA2 have essential roles in repairing DNA double-strand breaks, and a deficiency of BRCA proteins sensitizes cancer cells to PARP inhibition. Here we show that the receptor tyrosine kinase c-Met [...]

Cet article passe en revue les travaux récents sur la prise en charge d'une thrombocytopénie induite par une chimiothérapie chez des patients pédiatriques atteints d'un cancer

Chemotherapy induced thrombocytopenia in pediatric oncology

Tamamyan, Gevorg ; Danelyan, Samvel ; Lambert, Michele P.

Thrombocytopenia has long been recognized as a significant problem of cancer therapy, but there is still lack of consensus about the optimal approach to prophylaxis and/or treatment of this important complication. In pediatric oncology, since there are very few studies dedicated to this problem, the knowledge gap is even larger and no final conclusions or pediatric evidence based guidelines are available. Those guidelines that are available consist mostly of experts' personal opinions and data [...]

Mené sur 120 patients atteints d'une tumeur solide, cet essai de phase I évalue la dose maximale tolérée et l'activité antitumorale de l'apitolisib, un inhibiteur dual des kinases PI3K et mTOR

Phase I Study of Apitolisib (GDC-0980), Dual Phosphatidylinositol-3-Kinase and Mammalian Target of Rapamycin Kinase Inhibitor, in Patients with Advanced Solid Tumors

Dolly, Saoirse ; Wagner, Andrew J ; Bendell, Johanna C ; Kindler, Hedy L. ; Krug, Lee M. ; Seiwert, Tanguy Y. ; Zauderer, Marjorie G. ; Lolkema, Martijn ; Apt, Doris ; Yeh, Ru-Fang ; Fredrickson, Jill ; Spoerke, Jill M ; Koeppen, Hartmut ; Ware, Joseph A ; Lauchle, Jennifer O ; Burris, Howard A. ; de Bono, Johann S.

Purpose: This first-in-human phase I trial assessed the safety, tolerability, and preliminary anti-tumor activity of apitolisib (GDC-0980), a dual inhibitor of class I phosphatidylinositol-3- (PI3K) and mammalian target of rapamycin (mTOR) kinases. Experimental Design: Once-daily (QD) oral apitolisib was administered to patients with solid tumors for days 1-21 or 1-28 of 28-day cycles. Pharmacokinetic and pharmacodynamic parameters were assessed. Results: Overall, 120 patients were treated at [...]

Menée sur 825 patients pédiatriques atteints d'une leucémie myéloïde aiguë, cette étude évalue l'association entre le niveau d'expression de CD33 et la réponse thérapeutique au gemtuzumab ozogamicine

CD33 Expression and Its Association With Gemtuzumab Ozogamicin Response: Results From the Randomized Phase III Children’s Oncology Group Trial AAML0531

Pollard, Jessica A. ; Loken, Michael ; Gerbing, Robert B. ; Raimondi, Susana C. ; Hirsch, Betsy A. ; Aplenc, Richard ; Bernstein, Irwin D. ; Gamis, Alan S. ; Alonzo, Todd A. ; Meshinchi, Soheil

Purpose : CD33 is variably expressed on acute myeloid leukemia (AML) blasts and is targeted by gemtuzumab ozogamicin (GO). GO has shown benefit in both adult and pediatric AML trials, yet limited data exist about whether GO response correlates with CD33 expression level. Patients and Methods : CD33 expression levels were prospectively quantified by multidimensional flow cytometry in 825 patients enrolled in Children’s Oncology Group AAML0531 and correlated with response to GO. Results : [...]

Mené sur 757 patients atteints d'un cancer de la prostate résistant à la castration et présentant des métastases osseuses, cet essai évalue l'efficacité, du point de vue de la survie sans progression et de la survie globale, d'un traitement à base de docétaxel, d'acide zolédronique et de strontium-89, seuls ou en combinaison

Clinical outcomes and survival following treatment of metastatic castrate-refractory prostate cancer with docetaxel alone or with strontium-89, zoledronic acid, or both: The TRAPEZE randomized clinical trial

James, N. D. ; Pirrie, S. J. ; Pope, A. M. ; et al.,

Importance  Bony metastatic castrate-refractory prostate cancer (CRPC) has a poor prognosis and high morbidity. Zoledronic acid (ZA) is commonly combined with docetaxel in practice but lacks evidence that combining is effective, and strontium-89 (Sr89) is generally used palliatively in patients unfit for chemotherapy. Phase 2 analysis of the TRAPEZE trial confirmed combining the agents was safe and feasible, and the objectives of phase 3 include assessment of the treatments on survival. [...]

A partir d'une revue systématique de la littérature sur des essais de phase II ou III (3 094 patients au total), cette méta-analyse évalue l'efficacité, du point de vue de la survie sans progression, de la survie globale et du taux de réponse globale, du sorafénib dans le traitement des patients atteints d'un carcinome métastatique à cellules rénales

Is there still a role for sorafenib in metastatic renal cell carcinoma? A systematic review and meta-analysis of the effectiveness of sorafenib over other targeted agents

Iacovelli, Roberto ; Verri, Elena ; Rocca, Maria Cossu ; Aurilio, Gaetano ; Cullurà, Daniela ; Santoni, Matteo ; De Cobelli, Ottavio ; Nolé, Franco

Background :The treatment of metastatic renal cell carcinoma (mRCC) has largely improved over the last decade, due to the availability of several targeted agents (TAs). Sorafenib was the first TA to report a benefit in terms of this disease, and it has largely been used as a comparator in randomized trials. We tested its activity compared to other TAs by performing a systematic review and meta-analysis. Methods : MEDLINE/PubMed, the Cochrane library, and the ASCO university websites were [...]

Mené sur 31 patientes atteintes d'un cancer métastatique du sein ER+ HER2- après la ménopause, cet essai de phase I évalue la dose maximale tolérée et l'activité antitumorale d'un composé appelé MK-2206, un inhibiteur d'AKT, en combinaison avec une hormonothérapie

A Phase I Study of the AKT Inhibitor MK-2206 in Combination with Hormonal Therapy in Postmenopausal Women with Estrogen Receptor Positive Metastatic Breast Cancer

Ma, Cynthia X ; Sanchez, Cesar ; Gao, Feng ; Crowder, Robert ; Naughton, Michael ; Pluard, Timothy ; Creekmore, Allison ; Guo, Zhanfang ; Hoog, Jeremy ; Lockhart, A. Craig ; Doyle, Austin ; Erlichman, Charles ; Ellis, Matthew J.

Purpose: Phosphatidylinositol-3-kinase (PI3K)/AKT pathway activation is an important endocrine resistance mechanism in estrogen receptor positive (ER+) breast cancer. After promising preclinical modeling of MK-2206, an allosteric pan-AKT inhibitor, with either estrogen-deprivation or fulvestrant, we conducted a Phase 1 trial in patients with metastatic ER+HER2- breast cancer to determine the recommended phase II treatment dose (RPTD) of MK-2206 when combined with either anastrozole, [...]

A partir de données portant sur 1 869 patients atteints d'un glioblastome et inclus dans 4 essais randomisés, cette étude évalue l'efficacité, du point de vue de la survie sans progression et de la survie globale, de l'ajout d'un anti-épileptique (acide valproïque ou lévétiracétam) à une chimioradiothérapie à base de témolozomide

Does Valproic Acid or Levetiracetam Improve Survival in Glioblastoma? A Pooled Analysis of Prospective Clinical Trials in Newly Diagnosed Glioblastoma

Happold, Caroline ; Gorlia, Thierry ; Chinot, Olivier ; Gilbert, Mark R. ; Nabors, L. Burt ; Wick, Wolfgang ; Pugh, Stephanie L. ; Hegi, Monika ; Cloughesy, Timothy ; Roth, Patrick ; Reardon, David A. ; Perry, James R. ; Mehta, Minesh P. ; Stupp, Roger ; Weller, Michael

Purpose : Symptomatic epilepsy is a common complication of glioblastoma and requires pharmacotherapy. Several uncontrolled retrospective case series and a post hoc analysis of the registration trial for temozolomide indicated an association between valproic acid (VPA) use and improved survival outcomes in patients with newly diagnosed glioblastoma. Patients and Methods : To confirm the hypothesis suggested above, a combined analysis of survival association of antiepileptic drug use at the start [...]

Menée à partir de données portant sur 219 patients traités par résection pour des métastases hépatiques d'origine colorectale et une ou plusieurs lésions extra-hépatiques synchrones (âge médian : 59 ans), cette étude évalue la survie globale à 3, 5 et 10 ans des patients, puis identifie les facteurs pronostiques associés

Colorectal Cancer Liver Metastases and Concurrent Extrahepatic Disease Treated With Resection

Leung, Universe ; Gonen, Mithat ; Allen, Peter J. ; Kingham, T. Peter ; DeMatteo, Ronald P. ; Jarnagin, William R. ; D’Angelica, Michael I.

Objective : The aim of the study was to evaluate outcomes after resection of colorectal liver metastases (CRLM) and concurrent extrahepatic disease (EHD), and to define prognostic factors. Background : There is increasing evidence to support resection of liver metastases and concurrent EHD in selected patients. Long-term survival data are lacking, and prognostic factors are not well defined. Methods : Retrospective review of 219 patients was undertaken between January 1992 and December 2012, [...]

Mené sur 181 patients atteints d'un carcinome de l'œsophage ou de la jonction gastro-œsophagienne, cet essai multicentrique évalue, du point de vue de la réponse complète histologique, l'intérêt d'ajouter une radiothérapie à une chimiothérapie néoadjuvante par sels de platine et 5-fluorouracile dans le cadre d'un traitement chirurgical avec lymphadénectomie

A Randomised Clinical Trial of Neoadjuvant Chemotherapy vs. Neoadjuvant Chemoradiotherapy for Cancer of the Oesophagus or Gastro-Oesophageal Junction

Klevebro, F. ; Alexandersson von Döbeln, G. ; Wang, N. ; Johnsen, G. ; Jacobsen, A-B. ; Friesland, S. ; Hatlevoll, I. ; Glenjen, N. I. ; Lind, P. ; Tsai, J. A. ; Lundell, L. ; Nilsson, M.

Background : Neoadjuvant therapy improves long-term survival after oesophagectomy treating oesophageal cancer, but the evidence to date is insufficient to determine which of the two main neoadjuvant therapy types, chemotherapy (nCT) or chemoradiotherapy (nCRT), is more beneficial. We aimed to compare the effects of nCT with those of nCRT. Patients and methods : This multicenter trial, which was conducted in Sweden and Norway, recruited 181 patients with carcinoma of the oesophagus or the [...]

Menée à partir de données portant sur 1 574 patients atteints d'un cancer du poumon à petites cellules de stade pT1-2N0M0 traité entre 2003 et 2011, cette étude évalue, du point de vue du taux de survie à 5 ans, l'intérêt d'une chimiothérapie et/ou d'une radiothérapie après une intervention chirurgicale

Role of Adjuvant Therapy in a Population-Based Cohort of Patients With Early-Stage Small-Cell Lung Cancer

Yang, Chi-Fu Jeffrey ; Chan, Derek Y. ; Speicher, Paul J. ; Gulack, Brian C. ; Wang, Xiaofei ; Hartwig, Matthew G. ; Onaitis, Mark W. ; Tong, Betty C. ; D’Amico, Thomas A. ; Berry, Mark F. ; Harpole, David H.

Purpose : Data on optimal adjuvant therapy after complete resection of small-cell lung cancer (SCLC) are limited, and in particular, there have been no studies evaluating the role of adjuvant chemotherapy, with or without prophylactic cranial irradiation, relative to no adjuvant therapy for stage T1-2N0M0 SCLC. This National Cancer Data Base analysis was performed to determine the potential benefits of adjuvant chemotherapy with and without prophylactic cranial irradiation in patients who [...]

A partir d'une revue systématique de la littérature publiée entre 1990 et 2014 (41 articles), cette étude évalue, du point de vue de la survie, l'efficacité de différentes stratégies thérapeutiques (traitements épargnant la vessie, cystectomie radicale, curage ganglionnaire étendu, chimiothérapie adjuvante) chez les patients atteints d'un cancer invasif de la vessie

Treatment of muscle-invasive bladder cancer: A systematic review

Chou, Roger ; Selph, Shelley S. ; Buckley, David I. ; Gustafson, Katie S. ; Griffin, Jessica C. ; Grusing, Sara E. ; Gore, John L.

There is uncertainty regarding the use of bladder-sparing alternatives to standard radical cystectomy, optimal lymph node dissection techniques, and optimal chemotherapeutic regimens. This study was conducted to systematically review the benefits and harms of bladder-sparing therapies, lymph node dissection, and systemic chemotherapy for patients with clinically localized muscle-invasive bladder cancer. Systematic literature searches of MEDLINE (from 1990 through October 2014), the Cochrane [...]

Cet article présente les recommandations d'un groupe international d'éditeurs de revues médicales pour faciliter la transparence en matière de données d'essais cliniques

Sharing Clinical Trial Data — A Proposal from the International Committee of Medical Journal Editors

Taichman, Darren B. ; Backus, Joyce ; Baethge, Christopher ; Bauchner, Howard ; de Leeuw, Peter W. ; Drazen, Jeffrey M. ; Fletcher, John ; Frizelle, Frank A. ; Groves, Trish ; Haileamlak, Abraham ; James, Astrid ; Laine, Christine ; Peiperl, Larry ; Pinborg, Anja ; Sahni, Peush ; Wu, Sinan

The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk. In a growing consensus, many funders around the world — foundations, government agencies, and industry — now mandate data sharing. Here we outline the ICMJE’s proposed requirements to help meet this obligation. We encourage feedback on the proposed requirements. Anyone [...]

Signé par des auteurs de la Food and Drug Administration (FDA), cet article met en évidence un défaut d'informations dans la majorité des rapports soumis par les industriels pour signaliser des événements indésirables sérieux et inattendus liés à des médicaments en cours d'examen par la FDA

The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative

Jarow, Jonathan P. ; Casak, Sandra ; Chuk, Meredith ; Ehrlich, Lori A. ; Khozin, Sean

Sponsors of human drug and biological products subject to an investigational new drug application (IND) are required to distribute expedited safety reports of serious and unexpected suspected adverse reactions to participating investigators and FDA to assure the protection of human subjects participating in clinical trials. On September 29, 2010, FDA issued a final rule amending its regulations governing expedited IND safety reporting requirements that revised the definitions used for reporting [...]