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Cancer Patients Struggle with Key Aspects of Clinical Trial Methodology

10 Sep 2017
Communication Skills;  Patient Education and Advocacy

LUGANO-MADRID – Clinical trials are fundamental to the development of new treatments for cancer, yet the annual accrual to cancer clinical trials worldwide is low, estimated at three to five percent. A nationwide study in Ireland (1), the preliminary results of which are to be presented at the ESMO 2017 Congress in Madrid, shows that although most oncology patients consider it important to have clinical trials available, many struggle with the central concepts that underpin trial methodology.

“As a medical oncologist, I have experienced situations where patients have declined clinical trial options because of misconceptions about them,” said study author Dr. Catherine Kelly from Mater Misericordiae University Hospital in Dublin, Ireland. “To improve participation in clinical trials, we need to understand the factors influencing patients’ decisions about taking part.”

In the course of the study, 1090 adult patients with a diagnosed malignancy and being treated at one of 14 participating oncology centres across Ireland filled out anonymised questionnaires in which they were asked to evaluate statements about clinical trials and research.

“Consistent with previous studies, the concepts of chance and randomisation posed difficulties to a significant proportion of patients. Over half of previous medical trial participants and 73 percent of those who had never been on a cancer clinical trial did not understand that in a randomised trial, the treatment given was decided by chance,” Kelly reported.

“We also found that most patients did not understand clinical equipoise: the fact that no one knows which treatment is best. Surprisingly, this was more marked in previous clinical trial participants, 60 percent of whom believed that their doctor would know which study arm was best,” she said.

“To provide informed consent when participating in a trial, patients need to understand these key concepts – and doctors explaining them well is essential to alleviating any fears that might prevent patients from participating. For example, many didn’t realise that clinical trials are not just an option for when standard treatment has failed,” she observed.

“Doctors have a responsibility to properly inform their patients in this regard, because they are the ones patients trust the most,” Kelly said. “As we analyse the data further, we will be able to offer physicians a more detailed picture of the questions patients need answered and the factors that influence their decision-making according to age group, cancer type, educational background and other demographics.”

Dr. Bettina Ryll, Chair of the ESMO Patient Advocates Working Group (PAWG) (2), commented: “The question of whether patients understand clinical trial methodology is a very valid one, and what makes this study so interesting is that more than a quarter of the patients questioned had actually been on clinical trials before,” she said.

“However, I was surprised at the median age of the cohort: 60 years. It would be interesting to compare the data collected here with younger patient groups, who access information in a very different way,” Ryll observed. “I would also expect to see differences across tumour groups: among breast cancer patients, for instance, who make up almost a third of the study cohort and for most of whom there is a well-established standard of care, clinical trials are likely to be of less interest than among lung cancer patients, for whom the standard treatment is less effective.”

Ryll further cautioned: “When we talk about understanding, it is important to consider that patients and physicians approach clinical trials from different perspectives: For example, the concept of randomisation is one that many patients question from a moral standpoint. Equipoise, by contrast, may be a laudable moral concept, but it is difficult to uphold if the results of earlier trials are already known: finding out whether a treatment is, say, 51 percent better or only 49 percent, may matter to an Health Technology Assessment (HTA) assessor – but not to a patient. This undermines the conclusion that patients simply do not understand equipoise.”

Trial design is a complex issue – one of many that cancer patients can face in the course of their treatment. Complementing the educational role of doctors, ESMO’s Patient Advocates also play a crucial part in making sure that patients are well-informed and giving them the opportunity to take part in research that can truly benefit them.


  1. Abstract 1465P_PR ‘Do oncology patients understand clinical trials? A nationwide study by Cancer Trials Ireland’ will be presented by Catherine Kelly during the Poster Display Session on Sunday, 10 September, 13:15 to 14:15 (CEST) in Hall 8.
  2. ESMO Patient Advocates Working Group http://www.esmo.org/Patients/Patient-Advocates-Working-Group
  3. Workshop: ‘Cancer Patient Advocacy Networks Driving Research’ http://www.esmo.org/Conferences/Workshops-Courses/ESMO-Workshop-Cancer-Patient-Advocacy-Networks-Driving-Research
  4. ESMO 2017 Patient Advocacy Track http://www.esmo.org/Patients/Patient-Advocacy-Track

This press release contains information provided by the authors of the highlighted abstracts and reflects the content of those abstracts. It does not necessarily reflect the views or opinions of ESMO who cannot be held responsible for the accuracy of the data. Commentators quoted in the press release are required to comply with the ESMO Declaration of Interests policy and the ESMO Code of Conduct.

About the European Society for Medical Oncology (ESMO)

ESMO is the leading professional organisation for medical oncology. With 16,000 members representing oncology professionals from over 130 countries worldwide, ESMO is the society of reference for oncology education and information. We are committed to supporting our members to develop and advance in a fast-evolving professional environment.

Abstract 1465P_PR

Do Oncology Patients Understand Clinical Trials? A Nationwide Study By Cancer Trials Ireland

C.M. Kelly (1), R. Feighery (2), J. McCaffrey (3), M. Higgins (3), M. Smith (3), S. O'Reilly (4), C. Murphy (5), A. Horgan (6), J. Walshe (7), R. McDermott (8), D. O'Donnell (9), P.G. Morris (10), M. Keane (11), M. Martin (12), K. Duffy (13), A. Mihai (14), J. Armstrong (15), E. Mulroe (2), V. Murphy (2), C. Kelly (3)

(1) Medical Oncology, Mater Misericordiae University Hospital University College Dublin, Dublin/IRELAND, (2) Translational Research, Cancer Trials Ireland, Dublin/IRELAND, (3) Medical Oncology, Mater Misericordiae University Hospital, University College Dublin (UCD) & Cancer Trials Ireland, Dublin/IRELAND, (4) Medical Oncology, Cork University Hospital, Cork/IRELAND, (5) Medical Oncology, Bon Secours Hospital & Cancer Trials Ireland, Cork/IRELAND, (6) Medical Oncology, University Hospital Waterford, Waterford/IRELAND, (7) Medical Oncology, St Vincents University Hospital & Cancer Trials Ireland, Dublin/IRELAND, (8) Genito-urinary Oncology, Tallaght & St. Vincent’s University Hospital and Cancer Trials Ireland, Dublin/IRELAND, (9) Department Of Medical Oncology, St James's Hospital, Dublin/IRELAND, (10) Medical Oncology, Beaumont Hospital & RCSI, Dublin/IRELAND, (11) Medical Oncology, University College Hospital Galway & Cancer Trials Ireland, Galway/IRELAND, (12) Medical Oncology, Sligo General Hospital & Cancer Trials Ireland, Sligo/IRELAND, (13) Medical Oncology, Letterkenny General Hospital & Cancer Trials Ireland, Letterkenny/IRELAND, (14) Radiation Oncology, Beacon Hospital & Cancer Trials Ireland, Dublin/IRELAND, (15) Radiation Oncology, St. Lukes Hospital & Cancer Trials Ireland, Dublin/IRELAND

Background: Clinical trials are critical to improve cancer outcomes. We conducted a nationwide survey to assess oncology patients (pts) understanding of some fundamental concepts in clinical trial methodology.

Methods: Patients with a diagnosis of malignancy, ≥18 years, able to provide informed consent and complete a questionnaire independently were eligible. Questionnaires were administered to pts attending 14 cancer centres across Ireland. Collection began 22nd April 2016 and ended Nov 23rd 2016.

Results: The median age of the 1,090 pts completing the survey was 60 years (IQR 50-69), comprising 386 (35.6%) men and 697 (64.4%) women. 303 pts (27.8%) stated they had previously participated in a cancer clinical trial. Most were diagnosed between 2014-2016 (694, 66%). Breast (31.4%), colorectal (15.6%), haematological (12.6%), genitourinary (11.6%) and lung (6.8%) were the most commonly reported cancer types. Almost all pts (n=1048, 98.3%) considered it important to have clinical trials available in Ireland. Most pts (n=841, 82.3%) reported understanding the term medical/cancer clinical trials. Pts were given statements about clinical trials and asked to indicate whether they were ‘True’ or ‘False’ or to mark as ‘Don’t know’ if they were unsure. When asked ‘In a randomised trial the treatment you get is decided by chance’ 334 (33.5%) pts answered ‘True’, 425 (41.4%) answered ‘False’ and 257 (25%) answered ‘Don’t know’. When asked ‘Clinical trials are only used when standard treatments have not worked’ 226 (22%) pts answered ‘True’ and 273 (26.6%) answered ‘Don’t know’. When asked ‘My doctor would know which treatment in a clinical trial was better’ 581 (56.5%) pts answered ‘True’, and 238 (23.2%) answered ‘Don’t know’. When asked ‘My doctor would make sure I get (got) the better treatment in a clinical trial’ 633 (60.9%) answered ‘True’. Of the 303 pts who had taken part in a cancer clinical trial 185 (63.6%) answered ‘True’.

Conclusions: Although oncology pts consider it important to have clinical trials available to them, many do not understand key concepts such as randomisation, chance and equipoise. The data collected from this study will be used to address this and develop customised interventions to improve understanding and informed trial participation.

Keywords: Decisions, National survey, Understanding, clinical trials

Funding: Funding provided to Cancer Trials Ireland by Amgen, Abbvie, Bayor and Inveva

Disclosure:vC.M. Kelly: Funding was provided by the following companies; Bayer, Amgen, Abbvie, Inveva to Cancer Trials Ireland (formerly ICORG) our National Clinical Trials group. The research conducted was totally independent of these funders.

All other authors have declared no conflicts of interest.

Last update: 10 Sep 2017

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