Macmillan Cancer Support and the University of Birmingham urge researchers to use newly developed international guidelines so that all key data is published and patients are fully informed about how cancer drugs affect quality of life.

Important feedback about quality of life from up to 49,000 cancer patients who took part in UK-led clinical trials from 2000-2014 remains unpublished, according to a new study led by researchers at the University of Birmingham and funded by Macmillan Cancer Support.

The findings, published today in the Journal of the National Cancer Institute, analysed clinical trials which collected ‘Patient-Reported Outcome’ (PRO) data: feedback from patients about how the trial treatment affected their overall health and quality of life. This trial data provides a crucial insight into what a patient’s life may be like if they opt to take the treatment.

The study found that while most trials consistently published data around survival or cancer progression, more than one in three (38%) failed to publish the PRO data they had collected, meaning that this important information was not available for other patients to help them make decisions about treatment.

New cancer treatments can help prolong people’s lives or even offer the chance of a cure, but they can also have serious side-effects and long-term impacts on people’s health. Macmillan Cancer Support and the University of Birmingham call upon researchers to use new international guidelines, called SPIRIT-PRO2, developed by a team led by the University, to help ensure vital patient-reported data is available from all trials to assist life-changing treatment discussions between cancer patients and their clinicians.

Dr Rosie Loftus, Chief Medical Officer at Macmillan Cancer Support, said:  “Embarking on a new cancer treatment can be a daunting leap into the unknown, and patients must be given all available information about possible side effects to help them make an informed decision.

"Cancer treatment can have a massive impact on someone’s quality of life, and it is really important that people are able to consider this alongside the likelihood of increased survival thanks to a particular drug.

“Cancer researchers must adopt a more consistently transparent approach to publishing quality of life data, otherwise some people with cancer will continue to make decisions about their treatment without the full picture.”

The National Cancer Research Institute (NCRI), a UK-wide partnership of cancer research funders, has agreed that more consistency is needed and is leading the way on sharing best practice.

Joint-Chief Investigator for the study Dr Derek Kyte, of the University of Birmingham’s Institute of Applied Health Research and the NIHR Birmingham Biomedical Research Centre, said: “Whilst the majority of trials routinely publish survival and progression data, our research has shown that researchers need to work far harder to make sure important quality of life data are made available to patients and their clinicians.

“We recognise trialists need help to do this, which is why Macmillan, the NCRI and the University of Birmingham are working together to share best-practise international guidelines known as SPIRIT-PRO and to provide bespoke training.

“We are also calling for Journals, funders and policy-makers to help make it easier for researchers to make patient-reported trial data available in the public domain, but to hold those to account where information is collected from patients, but not shared.”

Mr Richard Stephens, Chair of the National Cancer Research Institute (NCRI) Consumer Forum, and a cancer patient who has participated in clinical trials and contributed PRO data, said: "I welcome this timely piece of research. In 2015, the Cancer Strategy for England called for Patient Experience to become as important a priority as clinical outcomes.

“That must apply to research for the future as much as to the current care delivered in our NHS.

“This study looks at cancer research studies up to 2015, and so it establishes a useful benchmark from which we can move forwards. I hope we see not only more research making better use of Patient Reported Outcomes and Experiences, but more research designed and delivered with the active involvement of patients and of carers too.”

Dr Iain Frame, National Cancer Research Institute (NCRI) CEO, said: “Clinical research is a vital step in putting new ideas to the test and finding better ways to treat cancer and improve lives.

"High-quality data on a patient's quality of life and responses to new treatments are an important part of clinical research because without them we don't get the bigger picture around how a new treatment or approach can affect a patient.

“The NCRI works with many researchers and patient advocates to improve the quality of cancer research. Through our Clinical Study Groups, we will continue to share expertise and best practice to help ensure that patient feedback is collected routinely and is done so to the highest standards so it can be used to drive improvements in cancer treatment.”

The next phase of the study will involve interviewing researchers who the study team found were effectively collecting and reporting patient reported outcome data, so that best practice can be shared among the wider research community.

For further information, please contact:

  1. Ruth Moore, Media & PR Officer, Macmillan Cancer Support, 0207 840 4852 (out of hours 07801 307068)
  2. To request interviews with Dr Derek Kyte or for more information please call Emma McKinney, Press Office, University of Birmingham, at +44 (0)121 414 6681 or contact the Press Office out of hours on +44 (0)7789 921165.
  • The new international guidelines are known as the SPIRIT-PRO protocol checklist and has been developed by a team led by researchers from the University of Birmingham, working with the National Cancer Research Institute and a range of international partners. The checklist is available from the Journal of the American Medical Association.
  • About Macmillan Cancer Support: We’re here to help everyone with cancer live life as fully as they can, providing physical, financial and emotional support. So whatever cancer throws your way, we’re right there with you. For information, support or just someone to talk to, call 0808 808 00 00. To give, fundraise or volunteer call 0300 1000 200.
  • About the University of Birmingham: The University of Birmingham is ranked amongst the world’s top 100 institutions. Its work brings people from across the world to Birmingham, including researchers, teachers and more than 6,500 international students from over 150 countries.
  • About the Centre for Patient-Reported Outcomes Research (CPROR): CPROR aims to optimize the use of PROs in clinical trials and routine care, to improve service delivery, enhance patient care and outcomes and ensure that the patient perspective is at the heart of health research and NHS decision-making.  CPROR hosts a free PRO training resource for patients, clinicians and researchers.
  • About the NCRI: The National Cancer Research Institute (NCRI) is a UK-wide partnership of cancer research funders, established in 2001.  NCRI works to coordinate research related to cancer, to improve the quality and relevance of research and to accelerate translation of research into clinical practice for the benefit of patients.
  • NCRI Partners are: Biotechnology and Biological Sciences Research Council (BBSRC); Bloodwise; Brain Tumour Research; Breast Cancer Now; Cancer Research UK; Children with Cancer UK; Department of Health and Social Care; Economic and Social Research Council (ESRC); Macmillan Cancer Support; Marie Curie; Medical Research Council (MRC); Northern Ireland Health and Social Care Public Health Agency (Research & Development Department); Pancreatic Cancer Research Fund; Prostate Cancer UK; Scottish Government Health Directorates (Chief Scientist Office); Tenovus Cancer Care; The Wellcome Trust and Welsh Assembly Government (Health and Care Research Wales).
  • About The National Institute for Health Research (NIHR): The National Institute for Health Research (NIHR) is the nation's largest funder of health and care research. The NIHR:
  1. Funds, supports and delivers high quality research that benefits the NHS, public health and social care
  2. Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
  3. Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
  4. Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
  5. Partners with other public funders, charities and industry to maximise the value of research to patients and the economy
  • The NIHR was established in 2006 to improve the health and wealth of the nation through research, and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR commissions applied health research to benefit the poorest people in low- and middle-income countries, using Official Development Assistance funding.