Drug Evaluation

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  Subject Areas on Research

  • 13-cis-retinoic acid and interferon alpha-2a: effective combination therapy for advanced squamous cell carcinoma of the skin. 
  • 3-Deazaguanine: report of a phase I trial and drug-related cardiac toxicity. 
  • 4-Fluorobenzylamine and phenylalanine methyl ester conjugates of 2-nitroimidazole: evaluation as hypoxic cell radiosensitizers. 
  • 4-Hydroperoxycyclophosphamide purging of breast cancer from the mononuclear cell fraction of bone marrow in patients receiving high-dose chemotherapy and autologous marrow support: a phase I trial. 
  • 5-Fluorouracil in childhood solid tumors. 
  • 7 questions to ask when evaluating a noninferiority trial. 
  • A method for assessing drug therapy appropriateness. 
  • A multicenter trial of oral zidovudine in children with advanced human immunodeficiency virus disease. The Protocol 043 Study Group. 
  • A new syndrome: ascites, hyperbilirubinemia, and hypoalbuminemia after biochemical modulation of fluorouracil with N-phosphonacetyl-L-aspartate (PALA). 
  • A phase I clinical, plasma, and cellular pharmacology study of gemcitabine. 
  • A phase I trial of recombinant human interleukin-1 beta alone and in combination with myelosuppressive doses of 5-fluorouracil in patients with gastrointestinal cancer. 
  • A phase II study of piritrexim in patients with advanced squamous head and neck cancer. 
  • A phase II trial of recombinant human interferon-gamma and recombinant tumor necrosis factor in patients with advanced gastrointestinal malignancies: results of a trial terminated by excessive toxicity. 
  • A phase II trial of streptozotocin and adriamycin in advanced APUD tumors. 
  • Access to patient-level data from GlaxoSmithKline clinical trials. 
  • Acetylation phenotype, platelet monoamine oxidase inhibition, and the effectiveness of phenelzine in depression. 
  • Adjunctive lamotrigine for partial seizures in patients aged 1 to 24 months. 
  • Adriamycin in the treatment of childhood solid tumors. A Southwest Oncology Group study. 
  • Advanced pancreatic cancer: a phase I-II trial of cisplatin, high-dose cytarabine, and caffeine. 
  • An adapted F-test for homogeneity of variability in follow-on biological products. 
  • An adjusted two one-sided t-test for the assessment of bioequivalence with multiple doses. 
  • An overview of the pharmaceutical industry. 
  • Antidepressant drug therapy in psychotic depression. 
  • Application of the parallel line assay to assessment of biosimilar products based on binary endpoints. 
  • Are uncontrolled clinical studies ever justified? 
  • Atovaquone for the treatment of toxoplasma retinochoroiditis in immunocompetent patients. 
  • Bupropion XL in adults with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled study. 
  • Busulfan, cyclophosphamide and fractionated total body irradiation as a preparatory regimen for marrow transplantation in patients with advanced hematological malignancies: a phase I study. 
  • Candesartan in heart failure--assessment of reduction in mortality and morbidity (CHARM): rationale and design. Charm-Programme Investigators. 
  • Carboplatin and vinblastine in advanced non-small-cell lung cancer: a phase II study. 
  • Cefazolin in the treatment of bacterial pneumonia. 
  • Chemotherapy in the management of intraocular lymphoma. 
  • Clinical and pharmacologic effects of high dose single agent busulfan with autologous bone marrow support in the treatment of solid tumors. 
  • Clinical responses to ORG 9426 during isoflurane anesthesia. 
  • Clinical trials with human tumor necrosis factor: in vivo and in vitro effects on human mononuclear phagocyte function. 
  • Clomiphene citrate in the management of male infertility. 
  • Clonidine and chlorthalidone (combipres) in hypertension. 
  • Colony-stimulating factors: clinical applications. 
  • Combination chemotherapy and adriamycin in patients with advanced breast cancer. A Southwest Oncology Group study. 
  • Combination chemotherapy in histiocytosis X. 
  • Combination chemotherapy with cytosine arabinoside (Ara-C) and cis-diamminedichloroplatinum (CDDP) for squamous cancers of the upper aerodigestive tract. 
  • Comments on the FDA draft guidance on biosimilar products. 
  • Comparative study of systemic interferon alfa-nl and isotretinoin in the treatment of resistant condylomata acuminata. 
  • Comparison of prostaglandin F2alpha and hypertonic saline for induction of midtrimester abortion. 
  • Comparison of red cell transfusion and polyethylene glycol-modified adenosine deaminase therapy in an adenosine deaminase-deficient child: measurement of erythrocyte deoxyadenosine triphosphate as a useful tool. 
  • Continuous infusion 5-fluorouracil, etoposide and cis-diamminedichloroplatinum in patients with metastatic carcinoma of unknown primary origin. 
  • Cost of innovation in the pharmaceutical industry. 
  • Cost-benefit and efficacy of aprotinin compared with epsilon-aminocaproic acid in patients having repeated cardiac operations: a randomized, blinded clinical trial. 
  • Criteria supporting the study of drugs in the newborn. 
  • Current challenges in the evaluation of cardiac safety during drug development: translational medicine meets the Critical Path Initiative. 
  • DTIC, CCNU, bleomycin and vincristine (BOLD) in metastatic melanoma. 
  • Design of the blockade of the glycoprotein IIb/IIIa receptor to avoid vascular occlusion (BRAVO) trial. 
  • Does heart failure etiology, New York Heart Association class, or ejection fraction affect the ability of clopidogrel to inhibit heightened platelet activity? 
  • Effect of abciximab on angiographic complications during percutaneous coronary stenting in the Evaluation of Platelet IIb/IIIa Inhibition in Stenting Trial (EPISTENT). 
  • Effect of gamma interferon on the hypothalamic-pituitary-adrenal system. 
  • Effect of recombinant human granulocyte-macrophage colony-stimulating factor on hematopoietic reconstitution after high-dose chemotherapy and autologous bone marrow transplantation. 
  • Effective salvage therapy for refractory disseminated breast cancer with 5-fluorouracil and high-dose continuous infusion folinic acid. 
  • Effects of gamma-interferon on the endocrine system: results from a phase I study. 
  • Effects of pentoxifylline administration on blood viscosity and leukocyte cytoskeletal function in patients with intermittent claudication. 
  • Efficacy of vincristine and cyclophosphamide in the therapy of recurrent medulloblastoma. 
  • Efficiency of the CATIE and BACS neuropsychological batteries in assessing cognitive effects of antipsychotic treatments in schizophrenia. 
  • Electrophysiologic effects of disopyramide phosphate on sinus node function in patients with sinus node dysfunction. 
  • Eliciting stated preferences for health-technology adoption criteria using paired comparisons and recommendation judgments. 
  • Enalapril and hydroxyurea therapy for children with sickle nephropathy. 
  • Enhancing the technology of clinical trials and the trials model to evaluate newly developed, targeted antidepressants. 
  • Etoposide in prostatic cancer: experimental studies and phase II trial in patients with bidimensionally measurable disease. 
  • Evaluation of a delivery system providing long-term release of cyclosporine. 
  • Evaluation of continuous-infusion alpha-difluoromethylornithine therapy for colorectal carcinoma. 
  • Evaluation of daunorubicin (NSC-82151) and methotrexate (NSC-740) in combination as a remission maintenance regimen in the treatment of acute leukemia. 
  • Evaluation of dose and schedule of L-asparaginase in multidrug therapy of childhood leukemia. 
  • Evaluation of dose requirements for prolonged bivalirudin administration in patients with renal insufficiency and suspected heparin-induced thrombocytopenia. 
  • Evaluation of new anticancer agents against human pancreatic carcinomas in nude mice. 
  • Evaluation of temazepam and diphenhydramine as hypnotics in a nursing-home population. 
  • Evaluation of the clinical pharmacology of nilvadipine in patients with mild to moderate essential hypertension. 
  • Extending principles learned in model systems to clinical trials design. 
  • Failure of angiotensin II to reduce plasma renin activity in hypertensive pregnant women. 
  • Fatal esorubicin-induced cardiomyopathy: report of a case and review of the literature. 
  • Fluocinolone acetonide sustained drug delivery device to treat severe uveitis. 
  • Fotemustine (S 10036) in the intra-arterial treatment of liver metastasis from malignant melanoma. A phase II Study. 
  • From thrombolytic megatrials to clinical policy-making: facing the facts. 
  • Gabapentin in the treatment of mental illness: the echo chamber of the case series. 
  • Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force report. 
  • Hemodynamic effects of the antiarrhythmic drug pirmenol. 
  • Hexamethylmelamine and prednisone in the treatment of refractory multiple myeloma. 
  • High-dose amsacrine (AMSA) therapy of relapsed and refractory adult acute nonlymphocytic leukemia. A phase II study. 
  • High-dose combination alkylating agents with bone marrow support as initial treatment for metastatic breast cancer. 
  • High-dose cyclophosphamide and etoposide for patients with refractory acute myeloid leukemia: a case series. 
  • Hormone release and abortifacient effectiveness of a newly developed silastic device containing 15-ME-PGF2alpha methyl ester in concentrations of 0.5% and 1.0%. 
  • How proxies make decisions about research for patients with Alzheimer's disease. 
  • Ifosfamide and mesna: marginally active in patients with advanced carcinoma of the pancreas. 
  • Immunopharmacologic purging of breast cancer from bone marrow for autologous bone marrow transplantation. 
  • Immunotherapy for malignant melanoma with a tumor cell vaccine. 
  • Impact of variability on the choice of biosimilarity limits in assessing follow-on biologics. 
  • Implications of pharmacogenomics for drug development and clinical practice. 
  • Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team. 
  • Inhibition of platelet monoamine oxidase in depressed subjects treated with phenelzine. 
  • Intensive etoposide and carboplatin chemotherapy for advanced non-small-cell lung cancer. A phase II trial of the Cancer and Leukemia Group B. 
  • Interferon-alpha with zidovudine: safety, tolerance, and clinical and virologic effects in patients with Kaposi sarcoma associated with the acquired immunodeficiency syndrome (AIDS). 
  • Intrapleural cisplatin and mitomycin for malignant mesothelioma following pleurectomy: pharmacokinetic studies. 
  • Investigational nanomedicines in 2016: a review of nanotherapeutics currently undergoing clinical trials. 
  • Label-free measurement of microbicidal gel thickness using low-coherence interferometry. 
  • Long-term electrocardiographic safety monitoring in clinical drug development: A report from the Cardiac Safety Research Consortium. 
  • Lovastatin and coadministered antihypertensive/cardiovascular agents. 
  • Lymphoscintigraphy in malignant melanoma: 99mTc antimony sulfur colloid. 
  • Maytansine in refractory childhood acute lymphocytic leukemia: a Pediatric Oncology Group study. 
  • Metformin in the treatment of non-alcoholic steatohepatitis: a pilot open label trial. 
  • Modulation of O6-alkylguanine-DNA alkyltransferase-mediated carmustine resistance using streptozotocin: a phase I trial. 
  • Multiple drug chemotherapy regimen for patients with hormonally-unresponsive carcinoma of the prostate: a preliminary report. 
  • Neoadjuvant chemotherapy and radiotherapy followed by surgery in stage IIIA non-small-cell carcinoma of the lung: report of a Cancer and Leukemia Group B phase II study. 
  • On non-inferiority margin and statistical tests in active control trials. 
  • On the estimation of the binomial probability in multistage clinical trials. 
  • Oral hydration rotavirus diarrhoea: a double blind comparison of sucrose with glucose electrolyte solution. 
  • Outcomes of Maintenance Therapy with Bortezomib after Autologous Stem Cell Transplantation for Patients with Multiple Myeloma. 
  • Outlier detection in bioavailability/bioequivalence studies. 
  • Pharmacokinetic and tolerance evaluation of actisomide, a new antiarrhythmic agent, in healthy volunteers. 
  • Pharmacovigilance and safety aspects of sevoflurane. 
  • Phase I and II studies of the combination of recombinant human interferon-gamma and 5-fluorouracil in patients with advanced colorectal carcinoma. 
  • Phase I and clinical pharmacology study of trimetrexate administered weekly for three weeks. 
  • Phase I clinical trial of cisplatin given i.v. with 5-fluorouracil and high-dose folinic acid. 
  • Phase I evaluation of diaziquone in childhood cancer. A Pediatric Oncology Group study. 
  • Phase I evaluation of doxorubicin and whole-body hyperthermia in dogs with lymphoma. 
  • Phase I studies of recombinant interferon-gamma. 
  • Phase I study of BCNU and intravenous 6-mercaptopurine in patients with anaplastic gliomas. 
  • Phase I study of Datelliptium chloride, hydrochloride given by 24-h continuous intravenous infusion. 
  • Phase I study of pharmacological and immunological effects of human lymphoblastoid interferon given to patients with cancer. 
  • Phase I trial of 1-(2'-deoxy-2'-fluoro-1-beta-D-arabinofuranosyl)-5-methyluracil (FMAU) terminated by severe neurologic toxicity. 
  • Phase I trial of interleukin-2 plus gamma-interferon. 
  • Phase I trial of semustine plus weekly fluorouracil and high-dose leucovorin calcium in patients with advanced colorectal cancer. 
  • Phase I-II trial of mitoxantrone in acute leukemia: an interim report. 
  • Phase II diaziquone-based chemotherapy trials in patients with anaplastic supratentorial astrocytic neoplasms. 
  • Phase II evaluation of aclarubicin in advanced breast cancer: a Southeastern Cancer Study Group trial. 
  • Phase II evaluation of aclarubicin in lung cancer: a Southeastern Cancer Study Group Trial. 
  • Phase II evaluation of aclarubicin in refractory multiple myeloma: a Southeastern Cancer Study Group Trial. 
  • Phase II evaluation of chlorozotocin in refractory multiple myeloma. 
  • Phase II evaluation of cisplatin, bleomycin, and vindesine in advanced squamous cell carcinoma of the esophagus: a Southeastern Cancer Study Group Trial. 
  • Phase II evaluation of etoposide in refractory multiple myeloma: a Southeastern Cancer Study Group Trial. 
  • Phase II evaluation of high-dose intravenous cisplatin for treatment of adult malignant gliomas recurrent after chloroethylnitrosourea failure. 
  • Phase II study demonstrating failure of both a five-drug continuous-therapy regimen and a two-drug pulse-therapy regimen in the treatment of metastatic neuroblastoma: Southwest Oncology Group Study 822. 
  • Phase II study of 4'-deoxydoxorubicin (esorubicin) in advanced or metastatic adenocarcinoma of the stomach. 
  • Phase II study of adriamycin with sequential methotrexate and 5-fluorouracil (AMF) in gastric carcinoma. 
  • Phase II study of amonafide in advanced pancreatic adenocarcinoma. 
  • Phase II study of etoposide for carcinoma of the bladder: the Southeastern Cancer Study Group experience. 
  • Phase II study of etoposide for carcinoma of the prostate. 
  • Phase II study of fludarabine phosphate in patients with advanced colorectal carcinoma. 
  • Phase II study of intravenous 6-thioguanine in patients with advanced carcinoma of the pancreas. 
  • Phase II study of intravenous 6-thioguanine in patients with advanced gastric carcinoma. 
  • Phase II study of intravenous idarubicin in unfavorable non-Hodgkin's lymphoma. 
  • Phase II study of two-weekly temozolomide in patients with high-grade gliomas. 
  • Phase II testing of melphalan in children with newly diagnosed rhabdomyosarcoma: a model for anticancer drug development. 
  • Phase II treatment of medulloblastoma and pineoblastoma with melphalan: clinical therapy based on experimental models of human medulloblastoma. 
  • Phase II trial of diaziquone in anthracycline-resistant adult soft tissue and bone sarcoma patients: a Southeastern Cancer Study Group Trial. 
  • Phase II trial of fazarabine in advanced colorectal carcinoma. 
  • Phase II trial of lymphoblastoid interferon in metastatic colon carcinoma. 
  • Phase II trial of recombinant human granulocyte-macrophage colony-stimulating factor in patients undergoing allogeneic bone marrow transplantation from unrelated donors. 
  • Physicians' preferences for active-controlled versus placebo-controlled trials of new antihypertensive drugs. 
  • Positive relationship of clinical and serologic responses to vaccinia melanoma oncolysate. 
  • Prospective trial of pulse oral versus intravenous calcitriol treatment of hyperparathyroidism in ESRD. 
  • Randomized controlled trial of intraputamenal glial cell line-derived neurotrophic factor infusion in Parkinson disease. 
  • Randomized study of cyclophosphamide, doxorubicin, and vincristine versus etoposide and cisplatin versus alternation of these two regimens in extensive small-cell lung cancer: a phase III trial of the Southeastern Cancer Study Group. 
  • Randomized, double-blind trial of cefonicid and nafcillin in the treatment of skin and skin structure infections. 
  • Rapid infusion of Sandoglobulin in patients with primary humoral immunodeficiency. 
  • Recombinant human granulocyte colony-stimulating factor therapy for patients with neutropenia and/or neutrophil dysfunction secondary to glycogen storage disease type 1b. 
  • Recombinant leukocyte A interferon for the treatment of serious viral infections after marrow transplant: a phase I study. 
  • Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics. 
  • Rubidazone in the treatment of recurrent acute leukemia in children. A Pediatric Oncology Group Study. 
  • Safety and efficacy of abciximab combined with dalteparin in treatment of acute coronary syndromes. 
  • Safety and tolerance of intermittent intravenous and oral zidovudine therapy in human immunodeficiency virus-infected pediatric patients. Pediatric Zidovudine Phase I Study Group. 
  • Saturation of 2',2'-difluorodeoxycytidine 5'-triphosphate accumulation by mononuclear cells during a phase I trial of gemcitabine. 
  • Scientific considerations for assessing biosimilar products. 
  • Sea urchin embryonic development provides a model for evaluating therapies against beta-amyloid toxicity. 
  • Statistical assessment of biosimilarity based on relative distance between follow-on biologics. 
  • Statistical methods in translational medicine. 
  • Substituted 1,3-Dihydro-2H-pyrrolo-[2,3-b]pyridin-2-ones as Potential Antiinflammatory Agents 
  • Successful chemoprophylaxis for Pneumocystis carinii pneumonitis. 
  • Synergistic effects of multiple natural products in pancreatic cancer cells. 
  • The Duke AFM Program. Intensive induction chemotherapy for metastatic breast cancer. 
  • The Stanford experience with high-dose etoposide cytoreductive regimens and autologous bone marrow transplantation in Hodgkin's disease and non-Hodgkin's lymphoma: preliminary data. 
  • The abortifacient effects of a newly developed vaginal silastic device impregnated with an 0.5% concentration of 15(S)-15-methyl-prostaglandin F2alpha methyl ester in the first trimester. 
  • The effect of a 10 cm2, 0.5% 15-ME-PGF2alpha methyl ester intravaginal silastic device on abortion and plasma prostaglandin concentration. 
  • The effect of danazol in the treatment of chronic cystic mastitis. 
  • The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics. 
  • The face of future hepatitis C antiviral drug development: recent biological and virologic advances and their translation to drug development and clinical practice. 
  • The first clinical study of BW-234U in schizophrenia. 
  • The imperative of overcoming barriers to the conduct of large, simple trials. 
  • The price of innovation: new estimates of drug development costs. 
  • The relations of major platelet receptor expression during myocardial infarction. Monitoring efficacy of GPIIb/IIIa inhibitors by measuring P-selectin? 
  • The safety and immunogenicity of a human immunodeficiency virus type 1 (HIV-1) recombinant gp160 candidate vaccine in humans. NIAID AIDS Vaccine Clinical Trials Network. 
  • The use of D-penicillamine in cystinuria: efficacy and untoward reactions. 
  • Tocainide kinetics in congestive heart failure. 
  • Topical application of WR-2721 to prevent radiation-induced proctosigmoiditis. A phase I/II trial. 
  • Transdermal nicotine reduces cigarette craving and nicotine preference. 
  • Treatment of children symptomatic with human immunodeficiency virus infection. 
  • Treatment of children with progressive or recurrent brain tumors with carboplatin or iproplatin: a Pediatric Oncology Group randomized phase II study. 
  • Treatment of metastatic malignant melanoma with trimetrexate: a phase II study. 
  • Trial Characteristics That Affect Parental Consent in Neonatal Drug Trials. 
  • Troponin measurements during drug development--considerations for monitoring and management of potential cardiotoxicity: an educational collaboration among the Cardiac Safety Research Consortium, the Duke Clinical Research Institute, and the US Food and Drug Administration. 
  • Two-stage sampling in pharmaceutical applications. 
  • Using inverse probability-weighted estimators in comparative effectiveness analyses with observational databases. 
  • Vaccine development for HIV infection. 
  • Which antibiotics lead to higher clinical cure rates in adults with acute maxillary sinusitis? 
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  Keywords of People

  • O'Connor, Christopher Michael, Adjunct Professor in the Department of Medicine, Medicine, Clinical Pharmacology
  • Sullivan, Daniel Carl, Professor Emeritus of Radiology, Radiology