Advertisement

Generating a Hypothesis for an Oncology Study

  • Beatriz Teixeira Costa
  • Isadora Santos Ferreira
  • Felipe Fregni
Chapter

Abstract

Choosing a relevant and useful research question is fundamental for successfully conducting clinical research. Frequently, the formulation of an interesting, feasible, and innovative question is a challenge to investigators, regardless of their scope of action. Finding the balance of having internal validity (which is essential), while at the same time maintaining external validity and taking into account the risks involved, are some of the main requirements when planning a research study. Some useful tools that may guide researchers throughout this process are the FINER (Feasible, Interesting, Novel, Ethical, and Relevant) criteria and the PICOT (Population of interest, Intervention, by describing the Comparison group, Outcome of interest, and the Time required to assess the outcome) format. By using these tools, investigators are able to develop an adequate research question and, as a consequence, formulate hypotheses that have a scientific impact. In oncology, owing to the complex mechanisms of cancer, the difficulty lies in finding a research question that is simultaneously feasible and interesting. This chapter discusses the thinking processes required to define a research question in the field of oncology, the framework on which to build the question, its potential risks, and the main aspects of strong hypotheses in this field.

Keywords

Research question Research hypothesis Clinical trial Clinical research Oncology 

References

  1. 1.
    Hulley S, Cummings S, Browner W, et al. Designing clinical research. 3rd ed. Philadelphia, PA: Lippincott Williams and Wilkins; 2007.Google Scholar
  2. 2.
    Halvorsen A, Kristensen G, Embleton A, Adusei C, Barretina-Ginesta M, Beale P, Helland Å. Evaluation of prognostic and predictive significance of circulating micro RNAs in ovarian cancer patients. Dis Markers. 2017;2017:3098542.CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Wang Y, Kong X, Guo Y, Wang R, Ma W. Continuous dose-intense temozolomide and cisplatin in recurrent glioblastoma patients. Pany S, ed. Medicine. 2017;96(10):e6261.  https://doi.org/10.1097/MD.0000000000006261. CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Middleton G, et al. Vandetanib plus gemcitabine versus placebo plus gemcitabine in locally advanced or metastatic pancreatic carcinoma (ViP): a prospective, randomised, double-blind, multicentre phase 2 trial. Lancet Oncol. 2017;18(4):486–99.  https://doi.org/10.1016/S1470-2045(17)30084-0.CrossRefPubMedGoogle Scholar
  5. 5.
    Shipley WU, et al. Radiation with or without antiandrogen therapy in recurrent prostate cancer. N Engl J Med. 2017;376(5):417–28.  https://doi.org/10.1056/NEJMoa1607529.CrossRefPubMedPubMedCentralGoogle Scholar
  6. 6.
    Guan Y, Liu S, Wang H-Y, et al. Long-term outcomes of a phase II randomized controlled trial comparing intensity-modulated radiotherapy with or without weekly cisplatin for the treatment of locally recurrent nasopharyngeal carcinoma. Chin J Cancer. 2016;35:20.  https://doi.org/10.1186/s40880-016-0081-7. CrossRefPubMedPubMedCentralGoogle Scholar
  7. 7.
    Riechelmann RP, Alex A, Cruz L, Bariani GM, Hoff PM. Non-inferiority cancer clinical trials: scope and purposes underlying their design. Ann Oncol. 2013;24(7):1942–7.  https://doi.org/10.1093/annonc/mdt073.CrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • Beatriz Teixeira Costa
    • 1
  • Isadora Santos Ferreira
    • 1
  • Felipe Fregni
    • 2
  1. 1.Laboratory of Neuromodulation, Center of Clinical Research Learning, Spaulding Rehabilitation HospitalHarvard Medical SchoolBostonUSA
  2. 2.Department of Physical Medicine and Rehabilitation, Laboratory of Neuromodulation, Center of Clinical Research Learning, Spaulding Rehabilitation HospitalHarvard Medical SchoolBostonUSA

Personalised recommendations