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Expectations, experiences and preferences of patients and physicians in the informed consent process for clinical trials in oncology



The aim of the present study was to explore (1) informed consent (IC) representations, level of understanding, needs, and factors that influence the willingness of cancer patients to participate in randomized controlled trials (RCTs) (phase I) and (2) representations, experiences, and critical issues of physicians involved in the same process (phase II).


Semi-structured interviews were conducted with 20 cancer patients who had been asked to enroll in a phase II/III RCT (phase I). Two focus groups were conducted with 13 physicians enrolled in the same process (phase II). The content produced was analyzed through a thematic analysis.


The themes that emerged in the first phase I were grouped into six categories: IC representation, randomization, experimentation, meeting with the physician, factors that influence the willingness to participate, and trial participants’ needs. The themes emerged in the phase II were grouped into four: IC representation, critical issues of the IC, relationship, and recruitment of trial participants. Each theme is articulated into sub-themes and deeply discussed.


This study highlights (1) the gap between what is ethically demanded in a RCT consultation and the reality of the situation and (2) the difference in perceptions between patients and physicians with reference to the meaning, objectives, and level of understanding of IC.

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Data availability

All transcripts and qualitative analyzes are available in Italian. It is sufficient to write to the corresponding author to have them.

Code availability

Not applicable.


  1. 1.

    Brehaut JC, Carroll K, Elwyn G, Saginur R, Kimmelman J, Shojania K, Syrowatka A, Nguyen T, Fergusson D (2015) Elements of informed consent and decision quality were poorly correlated in informed consent documents. J Clin Epidemiol 68(12):1472–1480

    Article  Google Scholar 

  2. 2.

    Food and Drug Administration (2014) International duration evaluation of adjuvant therapy informed consent information sheet: guidance for IRBs, clinical investigators, and sponsors. Draft guidance

  3. 3.

    Italian Medical Code of Ethics, available at Accessed August-September 2021

  4. 4.

    Law n. 219, 22 December 2017, available at:

  5. 5.

    Schumacher A, Sikov WM, Quesenberry MI et al (2017) Informed consent in oncology clinical trials: a brown university oncology research group prospective cross sectional pilot study. PLoS One 12(2):e0172957

    Article  Google Scholar 

  6. 6.

    Kim EJ, Kim SH (2015) Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level. Clin Trials 12(3):232–236

    Article  Google Scholar 

  7. 7.

    Atwere P, McIntyre L, Carroll K, Hayes T, Brehaut JC (2018) Informed consent documents used in critical care trials often do not implement recommendations. Crit Care Med 46(2):e111–e117

    Article  Google Scholar 

  8. 8.

    Nathe JM, Krakow EF (2019) The challenges of informed consent in high-stakes, randomized oncology trials: a systematic review. MDM Policy Pract 4(1):2381468319840322

    PubMed  PubMed Central  Google Scholar 

  9. 9.

    Sheridan R, Martin-Kerry J, Hudson J, Parker A, Bower P, Knapp P (2020) Why do patients take part in research? An overview of systematic reviews of psychosocial barriers and facilitators. Trials 21(1):259

    Article  Google Scholar 

  10. 10.

    Nipp RD, Hong K (2019) Paskett ED Overcoming barriers to clinical trial enrollment. Am Soc Clin Oncol Educ Book 39:105–114

    Article  Google Scholar 

  11. 11.

    Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G (2009) Informed consent: how much and what do patients understand? Am J Surg 198:420–435

    Article  Google Scholar 

  12. 12.

    Nusbaum L, Douglas B, Damus K, Paasche-Orlow M, Estrella-Luna N (2017) Communicating risks and benefits in informed consent for research: a qualitative study. Glob Qual Nurs Res 4:1–13

    Google Scholar 

  13. 13.

    Dellson P, Carlsson C, Nilbert M, Jernström H (2019) Patients’ and physicians’ disagreement on patients’ understanding of clinical cancer trial information: a pairwise pilot study of mirroring subjective assessments compared with objective measurements. Trials 20(1):301

    Article  Google Scholar 

  14. 14.

    Joffe S et al (2001) Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 358(9295):1772–1777

    CAS  Article  Google Scholar 

  15. 15.

    Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W (1987) False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep 17:20–24

    CAS  Article  Google Scholar 

  16. 16.

    Sanchini V, Reni M, Calori G, Riva E, Reichlin M (2014) Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient’s informed consent comprehension. J Med Ethics 40(4):269–275

    Article  Google Scholar 

  17. 17.

    Black L et al (2013) Physician recruitment of patients to non-therapeutic oncology clinical trials: ethics revisited. Front Pharmacol 4:25

    Article  Google Scholar 

  18. 18.

    Kinney AY et al (1998) The effect of physician recommendation on enrollment in the breast cancer chemoprevention trial. Prev Med 27(5):713–719

    CAS  Article  Google Scholar 

  19. 19.

    World Medical Association et al (2013) World medical association declaration of helsinki: ethical principles for medical research involving human subjects. Jama 310(20):2191–2194

    Article  Google Scholar 

  20. 20.

    Dekking S, Van Der Graaf R, Van Delden JJM (2014) Strengths and weaknesses of guideline approaches to safeguard voluntary informed consent of patients within a dependent relationship. BMC Med 12(1):1–11

    Article  Google Scholar 

  21. 21.

    Braun V, Clarke V (2006) Using thematic analysis in psychology. Qual Res Psychol 3(2):77–101

    Article  Google Scholar 

  22. 22.

    Miles MB, Huberman AM (1984) Qualitative data analysis: an expanded sourcebook, 2nd edn. Sage Publications, Thousand Oaks, CA

    Google Scholar 

  23. 23.

    Court of the Sick [Tribunale per i diritti del malato], 2015. Accessed August-September 2021

  24. 24.

    Parliamentary Commission of Inquiry into Health Errors Commissione [Parlamentare d’inchiesta sugli errori sanitari], 2013). Accessed August-September 2021

  25. 25.

    Dias AL, Chao JH, Lee D, Wu Y, Kloecker GH (2016) Patient perceptions concerning clinical trials in oncology patients. Contemp Clin Trials Commun 4:179–185

    CAS  Article  Google Scholar 

  26. 26.

    Sulmasy DP et al (2010) The culture of faith and hope: patients’ justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials. Cancer 116(15):3702–3711

    Article  Google Scholar 

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We sincerely thank the Ethics Committee of INT for their valuable suggestions and encouragement to carry out the study. We also thank the anonymous referee for the valuable suggestions provided and Prenay Agarwal for the English revision.

Author information




LG, MG, PC, and CB designed the study and critically revised the paper; SA, DF, and LG wrote the article; SA, LG, and MS performed the analysis; MS, MG, and EB contributed to data collection and critically revised the paper. DF also revised the English. All authors had full access to data and are responsible for the integrity and the accuracy of the data.

Corresponding author

Correspondence to Sara Alfieri.

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Ethics approval

The study was approved by the Ethics Committee of INT with number of acceptance 135/12.

Consent to participate and consent for publication

All participants were given adequate informed consent both verbally and through the specific form authorized by the Ethics Committee.

Conflict of interest

The authors declare no competing interests.

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Gangeri, L., Alfieri, S., Greco, M. et al. Expectations, experiences and preferences of patients and physicians in the informed consent process for clinical trials in oncology. Support Care Cancer (2021).

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  • Ethics
  • Informed consent
  • Oncology
  • Patients’ experiences
  • Physicians’ experiences
  • Randomized controlled trials