. 2019 May; 2(5):e193684.
doi: 10.1001/jamanetworkopen.2019.3684.

Association of Industry and Academic Sponsorship With Negative Phase 3 Oncology Trials and Reported Outcomes on Participant Survival: A Pooled Analysis

Alfredo Addeo 1 Glen J Weiss 2 Bishal Gyawali 3 
  • PMID: 31074821
  •     71 References
  •     2 citations


Importance: Only 3.4% of cancer drugs evaluated in phase 1 trials are approved by the US Food and Drug Administration, with most failing in phase 3 trials.

Objective: To investigate whether an association exists between the sponsorship and conduct of a negative phase 3 randomized clinical trial (RCT) investigating a cancer drug that lacked supporting phase 2 trial evidence for that drug, and to evaluate the association with overall survival among patients randomized to the experimental arm of such phase 3 trials.

Data Sources: Articles in the Lancet, Lancet Oncology, JAMA, JAMA Oncology, and Journal of Clinical Oncology published between January 2016 and June 2018 were searched.

Study Selection: Phase 3 RCTs of cancer drugs that failed to improve the primary end point were selected and any prior phase 2 trial of the same drug that supported the phase 3 trial was selected without any date or journal restrictions.

Data Extraction And Synthesis: Percentages of negative phase 3 RCTs of cancer drugs that lacked any phase 2 evidence, had a negative phase 2 trial, or had a positive phase 2 study were extracted. Associations were assessed using the Fisher exact test. Pooled hazard ratios and 95% CIs for the overall survival of patients enrolled in these negative phase 3 RCTs were estimated using a random-effects model.

Main Outcomes And Measures: Negative phase 3 RCTs with a lack of a phase 2 trial or the presence of a negative phase 2 trial and overall survival of enrolled patients in the phase 3 RCTs.

Results: In this meta-epidemiological study, 67 negative phase 3 RCTs on cancer drugs, which included 64 600 patients, met the criteria of being sponsored by industry or academic groups, of which 42 RCTs (63%) were industry sponsored and the remaining 25 RCTs (37%) were academic. A phase 2 trial was not available for 28 of these trials (42%). Of 29 trials (43%) with a phase 2 trial available, 8 trials (28%) failed to meet their primary end points and 5 of those were industry sponsored. There was no association with overall survival for patients participating in these negative phase 3 RCTs (pooled hazard ratio, 0.99; 95% CI, 0.96-1.02). When the pooled analysis was limited to the 27 RCTs with a hazard ratio above 1.00, the overall pooled hazard ratio for overall survival was 1.11 (95% CI, 1.06-1.16). No association between having a negative or undefined phase 2 trial and trial sponsorship was found using the Fisher exact test.

Conclusions And Relevance: More than 40% of the negative phase 3 RCTs in oncology published in these 5 journals were conducted without a supporting phase 2 trial and were sponsored by both academia and industry. Running such trials not only may risk loss of resources owing to a failed trial but also may be associated with decreased patient survival. Further research and regulations in this area appear warranted.

Adjuvant capecitabine plus bevacizumab versus capecitabine alone in patients with colorectal cancer (QUASAR 2): an open-label, randomised phase 3 trial.
Rachel S Kerr, Sharon Love, +12 authors, David J Kerr.
Lancet Oncol, 2016 Sep 24; 17(11). PMID: 27660192
PICASSO III: A Phase III, Placebo-Controlled Study of Doxorubicin With or Without Palifosfamide in Patients With Metastatic Soft Tissue Sarcoma.
Christopher W Ryan, Ofer Merimsky, +18 authors, Patrick Schöffski.
J Clin Oncol, 2016 Sep 14; 34(32). PMID: 27621408
Phase III Randomized Study of 4 Weeks of High-Dose Interferon-α-2b in Stage T2bNO, T3a-bNO, T4a-bNO, and T1-4N1a-2a (microscopic) Melanoma: A Trial of the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group (E1697).
Sanjiv S Agarwala, Sandra J Lee, +18 authors, John M Kirkwood.
J Clin Oncol, 2017 Jan 31; 35(8). PMID: 28135150    Free PMC article.
Efficacy of the MAGE-A3 cancer immunotherapeutic as adjuvant therapy in patients with resected MAGE-A3-positive non-small-cell lung cancer (MAGRIT): a randomised, double-blind, placebo-controlled, phase 3 trial.
Johan F Vansteenkiste, Byoung Chul Cho, +27 authors, Nasser Altorki.
Lancet Oncol, 2016 May 02; 17(6). PMID: 27132212
Highly Cited.
Phase III Trial of Ipilimumab Combined With Paclitaxel and Carboplatin in Advanced Squamous Non-Small-Cell Lung Cancer.
Ramaswamy Govindan, Aleksandra Szczesna, +19 authors, Martin Reck.
J Clin Oncol, 2017 Aug 31; 35(30). PMID: 28854067
Highly Cited.
Guidelines for reporting meta-epidemiological methodology research.
Mohammad Hassan Murad, Zhen Wang.
Evid Based Med, 2017 Jul 14; 22(4). PMID: 28701372    Free PMC article.
Randomized, Double-Blind, Phase III Trial of Enzastaurin Versus Placebo in Patients Achieving Remission After First-Line Therapy for High-Risk Diffuse Large B-Cell Lymphoma.
Michael Crump, Sirpa Leppä, +22 authors, Thomas Habermann.
J Clin Oncol, 2016 May 25; 34(21). PMID: 27217449
Lapatinib in Combination With Capecitabine Plus Oxaliplatin in Human Epidermal Growth Factor Receptor 2-Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Adenocarcinoma: TRIO-013/LOGiC--A Randomized Phase III Trial.
J Randolph Hecht, Yung-Jue Bang, +21 authors, Dennis Slamon.
J Clin Oncol, 2015 Dec 03; 34(5). PMID: 26628478
Highly Cited.
Histotype-tailored neoadjuvant chemotherapy versus standard chemotherapy in patients with high-risk soft-tissue sarcomas (ISG-STS 1001): an international, open-label, randomised, controlled, phase 3, multicentre trial.
Alessandro Gronchi, Stefano Ferrari, +24 authors, Paolo Giovanni Casali.
Lancet Oncol, 2017 May 14; 18(6). PMID: 28499583
Highly Cited.
Effect of First-Line Chemotherapy Combined With Cetuximab or Bevacizumab on Overall Survival in Patients With KRAS Wild-Type Advanced or Metastatic Colorectal Cancer: A Randomized Clinical Trial.
Alan P Venook, Donna Niedzwiecki, +20 authors, Charles Blanke.
JAMA, 2017 Jun 21; 317(23). PMID: 28632865    Free PMC article.
Highly Cited.
Low-value approvals and high prices might incentivize ineffective drug development.
Vinay Prasad, Christopher McCabe, Sham Mailankody.
Nat Rev Clin Oncol, 2018 May 16; 15(7). PMID: 29760505
Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial.
Thomas Powles, Ignacio Durán, +21 authors, Alain Ravaud.
Lancet, 2017 Dec 23; 391(10122). PMID: 29268948
Highly Cited.
Ibrutinib combined with bendamustine and rituximab compared with placebo, bendamustine, and rituximab for previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (HELIOS): a randomised, double-blind, phase 3 study.
Asher Chanan-Khan, Paula Cramer, +27 authors, HELIOS investigators.
Lancet Oncol, 2015 Dec 15; 17(2). PMID: 26655421
Highly Cited.
Italian, Multicenter, Phase III, Randomized Study of Cisplatin Plus Etoposide With or Without Bevacizumab as First-Line Treatment in Extensive-Disease Small-Cell Lung Cancer: The GOIRC-AIFA FARM6PMFJM Trial.
Marcello Tiseo, Luca Boni, +16 authors, Andrea Ardizzoni.
J Clin Oncol, 2017 Jan 31; 35(12). PMID: 28135143
Highly Cited.
NGR-hTNF in combination with best investigator choice in previously treated malignant pleural mesothelioma (NGR015): a randomised, double-blind, placebo-controlled phase 3 trial.
Vanesa Gregorc, Rabab M Gaafar, +15 authors, Mary O'Brien.
Lancet Oncol, 2018 May 14; 19(6). PMID: 29753703
Efficacy and safety of selective internal radiotherapy with yttrium-90 resin microspheres compared with sorafenib in locally advanced and inoperable hepatocellular carcinoma (SARAH): an open-label randomised controlled phase 3 trial.
Valérie Vilgrain, Helena Pereira, +35 authors, SARAH Trial Group.
Lancet Oncol, 2017 Nov 07; 18(12). PMID: 29107679
Highly Cited.
Extended adjuvant aromatase inhibition after sequential endocrine therapy (DATA): a randomised, phase 3 trial.
Vivianne C G Tjan-Heijnen, Irene E G van Hellemond, +14 authors, Dutch Breast Cancer Research Group (BOOG) for the DATA Investigators.
Lancet Oncol, 2017 Oct 17; 18(11). PMID: 29031778
Results From the Phase III Randomized Trial of Onartuzumab Plus Erlotinib Versus Erlotinib in Previously Treated Stage IIIB or IV Non-Small-Cell Lung Cancer: METLung.
David R Spigel, Martin J Edelman, +8 authors, Tony Mok.
J Clin Oncol, 2016 Dec 13; 35(4). PMID: 27937096
Highly Cited.
Gefitinib Plus Chemotherapy Versus Chemotherapy in Epidermal Growth Factor Receptor Mutation-Positive Non-Small-Cell Lung Cancer Resistant to First-Line Gefitinib (IMPRESS): Overall Survival and Biomarker Analyses.
Tony S K Mok, Sang-We Kim, +13 authors, Jean-Charles Soria.
J Clin Oncol, 2017 Oct 03; 35(36). PMID: 28968167
Adjuvant Weekly Girentuximab Following Nephrectomy for High-Risk Renal Cell Carcinoma: The ARISER Randomized Clinical Trial.
Karim Chamie, Nicholas M Donin, +15 authors, Arie S Belldegrun.
JAMA Oncol, 2016 Oct 28; 3(7). PMID: 27787547    Free PMC article.
Double-Blind, Placebo-Controlled, Randomized Phase III Trial Evaluating Pertuzumab Combined With Chemotherapy for Low Tumor Human Epidermal Growth Factor Receptor 3 mRNA-Expressing Platinum-Resistant Ovarian Cancer (PENELOPE).
Christian Kurzeder, Isabel Bover, +20 authors, Antonio Gonzalez-Martin.
J Clin Oncol, 2016 Jun 09; 34(21). PMID: 27269942
Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial.
Sibylle Loibl, Joyce O'Shaughnessy, +16 authors, Charles E Geyer.
Lancet Oncol, 2018 Mar 05; 19(4). PMID: 29501363
Highly Cited.
Effect of the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation Therapy for Patients With Esophageal Cancer: The NRG Oncology RTOG 0436 Phase 3 Randomized Clinical Trial.
Mohan Suntharalingam, Kathryn Winter, +16 authors, Christopher H Crane.
JAMA Oncol, 2017 Jul 09; 3(11). PMID: 28687830    Free PMC article.
Highly Cited.
Rigosertib versus best supportive care for patients with high-risk myelodysplastic syndromes after failure of hypomethylating drugs (ONTIME): a randomised, controlled, phase 3 trial.
Guillermo Garcia-Manero, Pierre Fenaux, +19 authors, ONTIME study investigators.
Lancet Oncol, 2016 Mar 13; 17(4). PMID: 26968357
Zoledronate in combination with chemotherapy and surgery to treat osteosarcoma (OS2006): a randomised, multicentre, open-label, phase 3 trial.
Sophie Piperno-Neumann, Marie-Cécile Le Deley, +23 authors, French Sarcoma Group (GSF-GETO).
Lancet Oncol, 2016 Jun 22; 17(8). PMID: 27324280
Negative phase 3 randomized controlled trials: Why cancer drugs fail the last barrier?
Bishal Gyawali, Alfredo Addeo.
Int J Cancer, 2018 May 11; 143(8). PMID: 29744864
Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): final results of an international, open-label, multicentre, randomised, phase 3 trial.
Stephanie M de Boer, Melanie E Powell, +28 authors, PORTEC study group.
Lancet Oncol, 2018 Feb 17; 19(3). PMID: 29449189    Free PMC article.
Highly Cited.
A Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess Efficacy and Safety of Weekly Farletuzumab in Combination With Carboplatin and Taxane in Patients With Ovarian Cancer in First Platinum-Sensitive Relapse.
Ignace Vergote, Deborah Armstrong, +12 authors, Thomas J Herzog.
J Clin Oncol, 2016 Mar 24; 34(19). PMID: 27001568
Postoperative Concurrent Chemoradiotherapy Versus Postoperative Radiotherapy in High-Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck: The Randomized Phase III TROG 05.01 Trial.
Sandro Virgilio Porceddu, Mathias Bressel, +16 authors, Danny Rischin.
J Clin Oncol, 2018 Mar 15; 36(13). PMID: 29537906
Phase III Intergroup Trial of Adjuvant Androgen Deprivation With or Without Mitoxantrone Plus Prednisone in Patients With High-Risk Prostate Cancer After Radical Prostatectomy: SWOG S9921.
Maha Hussain, Catherine M Tangen, +12 authors, L Michael Glode.
J Clin Oncol, 2018 Apr 07; 36(15). PMID: 29624463    Free PMC article.
Effect of Standard Radiotherapy With Cisplatin vs Accelerated Radiotherapy With Panitumumab in Locoregionally Advanced Squamous Cell Head and Neck Carcinoma: A Randomized Clinical Trial.
Lillian L Siu, John N Waldron, +18 authors, Wendy R Parulekar.
JAMA Oncol, 2016 Dec 09; 3(2). PMID: 27930762
Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial.
Sabino De Placido, Ciro Gallo, +28 authors, GIM Investigators.
Lancet Oncol, 2018 Feb 28; 19(4). PMID: 29482983
Carboplatin and Etoposide With or Without Palifosfamide in Untreated Extensive-Stage Small-Cell Lung Cancer: A Multicenter, Adaptive, Randomized Phase III Study (MATISSE).
Shadia I Jalal, Philip Lavin, +2 authors, Lawrence Einhorn.
J Clin Oncol, 2017 Jun 13; 35(23). PMID: 28605291
Overall Survival in Patients With Advanced Melanoma Who Received Nivolumab Versus Investigator's Choice Chemotherapy in CheckMate 037: A Randomized, Controlled, Open-Label Phase III Trial.
James Larkin, David Minor, +20 authors, Jeffrey Weber.
J Clin Oncol, 2017 Jul 04; 36(4). PMID: 28671856    Free PMC article.
Highly Cited.
Phase III Study of Cabozantinib in Previously Treated Metastatic Castration-Resistant Prostate Cancer: COMET-1.
Matthew Smith, Johann De Bono, +23 authors, Karim Fizazi.
J Clin Oncol, 2016 Jul 13; 34(25). PMID: 27400947
Highly Cited.
Selumetinib Plus Docetaxel Compared With Docetaxel Alone and Progression-Free Survival in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer: The SELECT-1 Randomized Clinical Trial.
Pasi A Jänne, Michel M van den Heuvel, +17 authors, Johan Vansteenkiste.
JAMA, 2017 May 12; 317(18). PMID: 28492898    Free PMC article.
Highly Cited.
IMA901, a multipeptide cancer vaccine, plus sunitinib versus sunitinib alone, as first-line therapy for advanced or metastatic renal cell carcinoma (IMPRINT): a multicentre, open-label, randomised, controlled, phase 3 trial.
Brian I Rini, Arnulf Stenzl, +19 authors, Tim Eisen.
Lancet Oncol, 2016 Oct 11; 17(11). PMID: 27720136
Highly Cited.
Chemotherapy versus chemoradiotherapy after surgery and preoperative chemotherapy for resectable gastric cancer (CRITICS): an international, open-label, randomised phase 3 trial.
Annemieke Cats, Edwin P M Jansen, +16 authors, CRITICS investigators.
Lancet Oncol, 2018 Apr 14; 19(5). PMID: 29650363
Highly Cited.
Doxorubicin plus evofosfamide versus doxorubicin alone in locally advanced, unresectable or metastatic soft-tissue sarcoma (TH CR-406/SARC021): an international, multicentre, open-label, randomised phase 3 trial.
William D Tap, Zsuzsanna Papai, +25 authors, Patrick Schöffski.
Lancet Oncol, 2017 Jun 28; 18(8). PMID: 28651927    Free PMC article.
Highly Cited.
Immunotherapy Combinations in Multiple Myeloma - Known Unknowns.
Nicole J Gormley, Richard Pazdur.
N Engl J Med, 2018 Nov 08; 379(19). PMID: 30403935
Adjuvant Lapatinib and Trastuzumab for Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Results From the Randomized Phase III Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Trial.
Martine Piccart-Gebhart, Eileen Holmes, +32 authors, Edith A Perez.
J Clin Oncol, 2015 Nov 26; 34(10). PMID: 26598744    Free PMC article.
Highly Cited.
Adjuvant Erlotinib Versus Placebo in Patients With Stage IB-IIIA Non-Small-Cell Lung Cancer (RADIANT): A Randomized, Double-Blind, Phase III Trial.
Karen Kelly, Nasser K Altorki, +13 authors, Frances A Shepherd.
J Clin Oncol, 2015 Sep 02; 33(34). PMID: 26324372
Highly Cited.
Adjuvant vemurafenib in resected, BRAFV600 mutation-positive melanoma (BRIM8): a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial.
Michele Maio, Karl Lewis, +13 authors, BRIM8 Investigators.
Lancet Oncol, 2018 Feb 27; 19(4). PMID: 29477665
Highly Cited.
Rilotumumab plus epirubicin, cisplatin, and capecitabine as first-line therapy in advanced MET-positive gastric or gastro-oesophageal junction cancer (RILOMET-1): a randomised, double-blind, placebo-controlled, phase 3 trial.
Daniel V T Catenacci, Niall C Tebbutt, +18 authors, David Cunningham.
Lancet Oncol, 2017 Sep 30; 18(11). PMID: 28958504    Free PMC article.
Highly Cited.
Selumetinib in Combination With Dacarbazine in Patients With Metastatic Uveal Melanoma: A Phase III, Multicenter, Randomized Trial (SUMIT).
Richard D Carvajal, Sophie Piperno-Neumann, +24 authors, Paul Nathan.
J Clin Oncol, 2018 Mar 13; 36(12). PMID: 29528792
Highly Cited.
Ponatinib versus imatinib for newly diagnosed chronic myeloid leukaemia: an international, randomised, open-label, phase 3 trial.
Jeffrey H Lipton, Charles Chuah, +24 authors, EPIC investigators.
Lancet Oncol, 2016 Apr 17; 17(5). PMID: 27083332
Highly Cited.
Comparing Neoadjuvant Nab-paclitaxel vs Paclitaxel Both Followed by Anthracycline Regimens in Women With ERBB2/HER2-Negative Breast Cancer-The Evaluating Treatment With Neoadjuvant Abraxane (ETNA) Trial: A Randomized Phase 3 Clinical Trial.
Luca Gianni, Mauro Mansutti, +18 authors, Ignacio Tusquets.
JAMA Oncol, 2018 Jan 13; 4(3). PMID: 29327055    Free PMC article.
Randomized, Double-Blind, Phase III Trial of Ipilimumab Versus Placebo in Asymptomatic or Minimally Symptomatic Patients With Metastatic Chemotherapy-Naive Castration-Resistant Prostate Cancer.
Tomasz M Beer, Eugene D Kwon, +20 authors, Winald Gerritsen.
J Clin Oncol, 2016 Dec 31; 35(1). PMID: 28034081
Highly Cited.
Cetuximab plus carboplatin and paclitaxel with or without bevacizumab versus carboplatin and paclitaxel with or without bevacizumab in advanced NSCLC (SWOG S0819): a randomised, phase 3 study.
Roy S Herbst, Mary W Redman, +15 authors, David R Gandara.
Lancet Oncol, 2017 Nov 25; 19(1). PMID: 29169877    Free PMC article.
Phase III Prospective Randomized Comparison Trial of Depot Octreotide Plus Interferon Alfa-2b Versus Depot Octreotide Plus Bevacizumab in Patients With Advanced Carcinoid Tumors: SWOG S0518.
James C Yao, Katherine A Guthrie, +11 authors, Howard S Hochster.
J Clin Oncol, 2017 Apr 07; 35(15). PMID: 28384065    Free PMC article.
Effect of Fluorouracil, Leucovorin, and Oxaliplatin With or Without Onartuzumab in HER2-Negative, MET-Positive Gastroesophageal Adenocarcinoma: The METGastric Randomized Clinical Trial.
Manish A Shah, Yung-Jue Bang, +9 authors, David Cunningham.
JAMA Oncol, 2016 Dec 06; 3(5). PMID: 27918764    Free PMC article.
Highly Cited.
Adjuvant chemotherapy with or without bevacizumab in patients with resected non-small-cell lung cancer (E1505): an open-label, multicentre, randomised, phase 3 trial.
Heather A Wakelee, Suzanne E Dahlberg, +21 authors, ECOG-ACRIN.
Lancet Oncol, 2017 Nov 14; 18(12). PMID: 29129443    Free PMC article.
Phase III Randomized, Placebo-Controlled, Double-Blind Trial of Celecoxib in Addition to Standard Chemotherapy for Advanced Non-Small-Cell Lung Cancer With Cyclooxygenase-2 Overexpression: CALGB 30801 (Alliance).
Martin J Edelman, Xiaofei Wang, +16 authors, Alliance for Clinical Trials in Oncology.
J Clin Oncol, 2017 May 11; 35(19). PMID: 28489511    Free PMC article.
Custirsen (OGX-011) combined with cabazitaxel and prednisone versus cabazitaxel and prednisone alone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel (AFFINITY): a randomised, open-label, international, phase 3 trial.
Tomasz M Beer, Sebastien J Hotte, +11 authors, Karim Fizazi.
Lancet Oncol, 2017 Oct 17; 18(11). PMID: 29033099
Neoadjuvant cisplatin and fluorouracil versus epirubicin, cisplatin, and capecitabine followed by resection in patients with oesophageal adenocarcinoma (UK MRC OE05): an open-label, randomised phase 3 trial.
Derek Alderson, David Cunningham, +14 authors, Ruth E Langley.
Lancet Oncol, 2017 Aug 09; 18(9). PMID: 28784312    Free PMC article.
Highly Cited.
Cabazitaxel Versus Docetaxel As First-Line Therapy for Patients With Metastatic Castration-Resistant Prostate Cancer: A Randomized Phase III Trial-FIRSTANA.
Stéphane Oudard, Karim Fizazi, +13 authors, Oliver Sartor.
J Clin Oncol, 2017 Jul 29; 35(28). PMID: 28753384
Highly Cited.
Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer.
Martin Reck, Alexander Luft, +17 authors, David Spigel.
J Clin Oncol, 2016 Jul 28; 34(31). PMID: 27458307
Highly Cited.
Custirsen in combination with docetaxel and prednisone for patients with metastatic castration-resistant prostate cancer (SYNERGY trial): a phase 3, multicentre, open-label, randomised trial.
Kim N Chi, Celestia S Higano, +13 authors, Johann S de Bono.
Lancet Oncol, 2017 Mar 12; 18(4). PMID: 28283282
Comparative Efficacy and Safety of Adjuvant Letrozole Versus Anastrozole in Postmenopausal Patients With Hormone Receptor-Positive, Node-Positive Early Breast Cancer: Final Results of the Randomized Phase III Femara Versus Anastrozole Clinical Evaluation (FACE) Trial.
Ian Smith, Denise Yardley, +14 authors, Joyce O'Shaughnessy.
J Clin Oncol, 2017 Jan 24; 35(10). PMID: 28113032
First-line chemoimmunotherapy with bendamustine and rituximab versus fludarabine, cyclophosphamide, and rituximab in patients with advanced chronic lymphocytic leukaemia (CLL10): an international, open-label, randomised, phase 3, non-inferiority trial.
Barbara Eichhorst, Anna-Maria Fink, +25 authors, German CLL Study Group (GCLLSG).
Lancet Oncol, 2016 May 25; 17(7). PMID: 27216274
Highly Cited.
Rindopepimut with temozolomide for patients with newly diagnosed, EGFRvIII-expressing glioblastoma (ACT IV): a randomised, double-blind, international phase 3 trial.
Michael Weller, Nicholas Butowski, +23 authors, ACT IV trial investigators.
Lancet Oncol, 2017 Aug 29; 18(10). PMID: 28844499
Highly Cited.
Olaparib in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy (GOLD): a double-blind, randomised, placebo-controlled, phase 3 trial.
Yung-Jue Bang, Rui-Hua Xu, +13 authors, Narikazu Boku.
Lancet Oncol, 2017 Nov 07; 18(12). PMID: 29103871
Highly Cited.
Prospective Randomized Comparison of Idarubicin and High-Dose Daunorubicin in Induction Chemotherapy for Newly Diagnosed Acute Myeloid Leukemia.
Je-Hwan Lee, Hawk Kim, +18 authors, Cooperative Study Group A for Hematology.
J Clin Oncol, 2017 Jun 21; 35(24). PMID: 28632487
Phase III, Double-Blind, Randomized Trial That Compared Maintenance Lapatinib Versus Placebo After First-Line Chemotherapy in Patients With Human Epidermal Growth Factor Receptor 1/2-Positive Metastatic Bladder Cancer.
Thomas Powles, Robert A Huddart, +16 authors, Simon Chowdhury.
J Clin Oncol, 2016 Dec 31; 35(1). PMID: 28034079
Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma: The ORCHARRD Study.
Gustaaf W van Imhoff, Andrew McMillan, +15 authors, Anton Hagenbeek.
J Clin Oncol, 2016 Dec 29; 35(5). PMID: 28029326
Accelerated versus standard epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil or capecitabine as adjuvant therapy for breast cancer in the randomised UK TACT2 trial (CRUK/05/19): a multicentre, phase 3, open-label, randomised, controlled trial.
David Cameron, James P Morden, +22 authors, TACT2 Investigators.
Lancet Oncol, 2017 Jun 11; 18(7). PMID: 28600210    Free PMC article.
Once-a-Week Versus Once-Every-3-Weeks Cisplatin Chemoradiation for Locally Advanced Head and Neck Cancer: A Phase III Randomized Noninferiority Trial.
Vanita Noronha, Amit Joshi, +25 authors, Kumar Prabhash.
J Clin Oncol, 2017 Dec 09; 36(11). PMID: 29220295
Estimation of clinical trial success rates and related parameters.
Chi Heem Wong, Kien Wei Siah, Andrew W Lo.
Biostatistics, 2018 Feb 03; 20(2). PMID: 29394327    Free PMC article.
Highly Cited.
CONKO-005: Adjuvant Chemotherapy With Gemcitabine Plus Erlotinib Versus Gemcitabine Alone in Patients After R0 Resection of Pancreatic Cancer: A Multicenter Randomized Phase III Trial.
Marianne Sinn, Marcus Bahra, +18 authors, Hanno Riess.
J Clin Oncol, 2017 Aug 18; 35(29). PMID: 28817370
Highly Cited.
Adjuvant Cyclophosphamide and Docetaxel With or Without Epirubicin for Early TOP2A-Normal Breast Cancer: DBCG 07-READ, an Open-Label, Phase III, Randomized Trial.
Bent Ejlertsen, Malgorzata K Tuxen, +16 authors, Henning T Mouridsen.
J Clin Oncol, 2017 Jul 01; 35(23). PMID: 28661759
Tivantinib for second-line treatment of MET-high, advanced hepatocellular carcinoma (METIV-HCC): a final analysis of a phase 3, randomised, placebo-controlled study.
Lorenza Rimassa, Eric Assenat, +27 authors, Jordi Bruix.
Lancet Oncol, 2018 Apr 08; 19(5). PMID: 29625879
Highly Cited.
Do oncology researchers adhere to reproducible and transparent principles? A cross-sectional survey of published oncology literature.
Corbin Walters, Zachery J Harter, +5 authors, Matt Vassar.
BMJ Open, 2020 Jan 02; 9(12). PMID: 31892667    Free PMC article.
Inefficiencies in phase II to phase III transition impeding successful drug development in glioblastoma.
Adithya Balasubramanian, Ashray Gunjur, +4 authors, Hui Kong Gan.
Neurooncol Adv, 2021 Feb 06; 3(1). PMID: 33543145    Free PMC article.