early termination of clinical trials

Summary

Summary: Earlier than planned termination of clinical trials.

Top Publications

  1. Armand P, Sainvil M, Kim H, Rhodes J, Cutler C, Ho V, et al. Pre-transplantation iron chelation in patients with MDS or acute leukemia and iron overload undergoing myeloablative allo-SCT. Bone Marrow Transplant. 2013;48:146-7 pubmed publisher
  2. Guasch Ferré M, Salas Salvado J, Ros E, Estruch R, Corella D, Fito M, et al. The PREDIMED trial, Mediterranean diet and health outcomes: How strong is the evidence?. Nutr Metab Cardiovasc Dis. 2017;27:624-632 pubmed publisher
  3. West H, Jozwiak M, Dodd J. Methods of term labour induction for women with a previous caesarean section. Cochrane Database Syst Rev. 2017;6:CD009792 pubmed publisher
    ..Studies could compare methods believed to provide effective induction of labour with low risk of serious harm, and report the outcomes listed in this review. ..
  4. Lenzer J. Why we can't trust clinical guidelines. BMJ. 2013;346:f3830 pubmed publisher
  5. van den Bogert C, Souverein P, Brekelmans C, Janssen S, Koëter G, Leufkens H, et al. Recruitment failure and futility were the most common reasons for discontinuation of clinical drug trials. Results of a nationwide inception cohort study in the Netherlands. J Clin Epidemiol. 2017;88:140-147 pubmed publisher
    ..The target sample size of trials should be feasible, and interim analyses should be adequately described in trial protocols. ..
  6. Arrowsmith J, Miller P. Trial watch: phase II and phase III attrition rates 2011-2012. Nat Rev Drug Discov. 2013;12:569 pubmed publisher
  7. Delahanty L. The look AHEAD study: implications for clinical practice go beyond the headlines. J Acad Nutr Diet. 2014;114:537-42 pubmed publisher
  8. Loibl S, de la Peña L, Nekljudova V, Zardavas D, Michiels S, Denkert C, et al. Neoadjuvant buparlisib plus trastuzumab and paclitaxel for women with HER2+ primary breast cancer: A randomised, double-blind, placebo-controlled phase II trial (NeoPHOEBE). Eur J Cancer. 2017;85:133-145 pubmed publisher
    ..nct01816594. ..
  9. Pignata S, Scambia G, Bologna A, Signoriello S, Vergote I, Wagner U, et al. Randomized Controlled Trial Testing the Efficacy of Platinum-Free Interval Prolongation in Advanced Ovarian Cancer: The MITO-8, MaNGO, BGOG-Ov1, AGO-Ovar2.16, ENGOT-Ov1, GCIG Study. J Clin Oncol. 2017;35:3347-3353 pubmed publisher
    ..Conclusion MITO-8 supports the recommendation that PBC not be delayed in favor of an NPBC in patients with partially platinum-sensitive OC. PBC should be used as a control arm in future trials of new drugs in this setting. ..

More Information

Publications23

  1. Kristeleit R, Davidenko I, Shirinkin V, El Khouly F, Bondarenko I, Goodheart M, et al. A randomised, open-label, phase 2 study of the IDO1 inhibitor epacadostat (INCB024360) versus tamoxifen as therapy for biochemically recurrent (CA-125 relapse)-only epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer. Gynecol Oncol. 2017;146:484-490 pubmed publisher
    ..Epacadostat was generally well tolerated. ..
  2. Garber K. RIKEN suspends first clinical trial involving induced pluripotent stem cells. Nat Biotechnol. 2015;33:890-1 pubmed publisher
  3. Huddart R, Hall E, Lewis R, Birtle A. Life and death of spare (selective bladder preservation against radical excision): reflections on why the spare trial closed. BJU Int. 2010;106:753-5 pubmed publisher
  4. Loder E, Godlee F, Barbour V, Winker M. Restoring the integrity of the clinical trial evidence base. BMJ. 2013;346:f3601 pubmed publisher
  5. Doshi P, Dickersin K, Healy D, Vedula S, Jefferson T. Restoring invisible and abandoned trials: a call for people to publish the findings. BMJ. 2013;346:f2865 pubmed publisher
  6. Karim S, Kashuba A, Werner L, Karim Q. Drug concentrations after topical and oral antiretroviral pre-exposure prophylaxis: implications for HIV prevention in women. Lancet. 2011;378:279-81 pubmed publisher
  7. Smyth R. Lessons to be learnt from unsuccessful clinical trials. Thorax. 2011;66:459-60 pubmed publisher
  8. Bambakidis N, Cockroft K, Connolly E, Amin Hanjani S, Morcos J, Meyers P, et al. Preliminary results of the ARUBA study. Neurosurgery. 2013;73:E379-81 pubmed publisher
  9. Deng D, Zhang P, Guo Y, Lim T. A randomised double-blind, placebo-controlled trial of allogeneic umbilical cord-derived mesenchymal stem cell for lupus nephritis. Ann Rheum Dis. 2017;76:1436-1439 pubmed publisher
    ..hUC-MSC has no apparent additional effect over and above standard immunosuppression. NCT01539902; Results. ..
  10. Leandro G. How to interpret a randomized controlled study stopped early. Intensive Care Med. 2013;39:1642-3 pubmed
  11. KROP I, Kim S, Martín A, LoRusso P, Ferrero J, Badovinac Črnjević T, et al. Trastuzumab emtansine versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer (TH3RESA): final overall survival results from a randomised open-label phase 3 trial. Lancet Oncol. 2017;18:743-754 pubmed publisher
    ..F Hoffman-La Roche/Genentech. ..
  12. Chan J, Deng W, Higgins R, Tewari K, Bonebrake A, Hicks M, et al. A phase II evaluation of brivanib in the treatment of persistent or recurrent carcinoma of the cervix: An NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol. 2017;146:554-559 pubmed publisher
    ..Based on early results of this phase II trial, brivanib was well tolerated and demonstrated sufficient activity after first stage but trial was stopped due to lack of drug availability. ..
  13. Woodward W, Fang P, Arriaga L, Gao H, Cohen E, Reuben J, et al. A Phase 2 Study of Preoperative Capecitabine and Concomitant Radiation in Women With Advanced Breast Cancer. Int J Radiat Oncol Biol Phys. 2017;99:777-783 pubmed publisher
    ..However, patients with TN breast cancer had poor outcomes even when response was achieved. Further study in non-TN patients may be warranted. ..
  14. Cummings J. What can be inferred from the interruption of the semagacestat trial for treatment of Alzheimer's disease?. Biol Psychiatry. 2010;68:876-8 pubmed publisher