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The ProtecT Trial and Associated Translational Research – Management of Localised Prostate Cancer -Neal

Summary of the impact

ProtecT (Neal, Cambridge; Donovan, Bristol; Hamdy, Oxford), funded by NIHR in 1999, is the largest randomised controlled trial in localised prostate cancer; and compares a deferred conservative approach (Active Monitoring — developed by the Trial PIs) with surgery and radiotherapy. Avoiding "over-treatment" in low risk cancer is important and Active Monitoring (AM) and Surveillance (AS) have now had a major impact on patients and on national health policy through NICE guidance, which recommends such management approaches. The linked bio-repository was critical to characterising the genetic pre-disposition alleles (SNPs) in prostate cancer, which are now being used to identify high risk populations.

Submitting Institution

University of Cambridge

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Oncology and Carcinogenesis, Public Health and Health Services

Improving the health and wellbeing of cancer survivors

Summary of the impact

Improvements in therapy have increased the 5-year survival rate for a number of cancers, leading to a new focus on promoting the health and wellbeing of cancer survivors. In the UK alone, over 500,000 people have physical or psychological consequences associated with cancer or its treatment.

Research at the University of Surrey has led to the development of self-management interventions for cancer survivors, demonstrating that active patient involvement leads to significant health and wellbeing benefits. These studies have driven national and international practice policy in the management of the consequences of cancer and its treatment.

Submitting Institution

University of Surrey

Unit of Assessment

Allied Health Professions, Dentistry, Nursing and Pharmacy

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Public Health and Health Services

Avoiding harm and evaluating benefit: establishing and implementing an evidence-based policy for prostate cancer screening in the UK

Summary of the impact

Research at the University of Bristol (UoB) led to the Department of Health (DH) decision in 1997 that screening for prostate cancer would not be introduced in the UK until there was evidence that benefits outweighed harms. UoB-led and collaborative research subsequently provided evidence to support informed decision-making in the NHS. A formal review by the DH in 2010 endorsed the policy and confirmed that any change would be based on evidence from the team's randomised trials. This research has ensured UK men have avoided known harms of prostate cancer screening in the context of uncertain benefits, and saved the UK economy £ billions.

Submitting Institution

University of Bristol

Unit of Assessment

Public Health, Health Services and Primary Care

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Oncology and Carcinogenesis, Public Health and Health Services

Development of abiraterone for the treatment of castration-resistant prostate cancer

Summary of the impact

Abiraterone (trade name Zytiga) was designed, synthesised and developed by a multidisciplinary team of academic chemists, biologists and clinicians at The Institute of Cancer Research (ICR). Following ICR-led phase I, II and III clinical trials, which demonstrated prolonged survival and improved quality of life for patients with castration-resistant prostate cancer (following cytotoxic therapy), abiraterone was granted approval by the FDA, EMA and NICE. In 2011-2012, abiraterone worldwide sales reached $2.755 billion. In 2012-13, FDA and EMA approval was extended to use in the treatment of metastatic castration-resistant prostate cancer in men who have not received standard chemotherapy.

Submitting Institution

Institute of Cancer Research

Unit of Assessment

Clinical Medicine

Summary Impact Type

Technological

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Oncology and Carcinogenesis

Meeting the information needs of men with penile cancer

Summary of the impact

Men with penile cancer often feel very isolated as they are reluctant to talk to others about their condition, and as it is so rare, they do not encounter others who have experienced it. Branney and colleagues' work has produced a resource, available through the Health Talk Online website, for men and their families: http://www.healthtalkonline.org/Cancer/Penile_Cancer.

Men with penile cancer are routinely signposted to this resource. An exhibition of the project's findings has helped to raise awareness of the condition in the general public. By increasing patient information support, clinician insight and men's awareness of the condition, this research has improved the quality of life of men with penile cancer.

Submitting Institution

Leeds Metropolitan University

Unit of Assessment

Psychology, Psychiatry and Neuroscience

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Public Health and Health Services

The Prostate Core Mitomic Test: a commercial diagnostic to improve the efficiency of prostate cancer diagnosis

Summary of the impact

A novel test for prostate cancer was developed from research in mitochondrial genetics conducted at Newcastle University. The Prostate Core Mitomic Test was the first of its kind and is now commercially available in North America. It provides molecular evidence to confirm conventional pathology results showing that men identified as being at risk of prostate cancer are, at the time of examination, free of disease. This is an important patient benefit, as conventional pathology has a 30% chance of missing prostate cancer. The Mitomic test obviates the short-term need for a follow-up biopsy, which is an invasive and very uncomfortable procedure. It is also capable of identifying some men at high risk of having prostate cancer that conventional pathology would miss. The test was introduced to the American market in June 2011 and has generated a multi-million dollar investment and turnover.

Submitting Institution

Newcastle University

Unit of Assessment

Biological Sciences

Summary Impact Type

Technological

Research Subject Area(s)

Biological Sciences: Genetics
Medical and Health Sciences: Oncology and Carcinogenesis

A safer and shorter treatment for thyroid cancer

Summary of the impact

The HiLo trial has changed management for patients with well-differentiated thyroid cancer. Patients undergoing radioiodine ablation therapy are now given a low dose of radioactive iodine, which has fewer side effects, compared to the previous (standard) high dose. Also, to prepare patients for ablation they now have recombinant human TSH (thyrotropin alfa), which is associated with a better quality of life before and during ablation. The combination of low dose radioiodine and thyrotropin alfa means that patients can be treated as outpatients rather than inpatients. This is a more convenient treatment package, reducing health service and societal costs.

Submitting Institution

University College London

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Oncology and Carcinogenesis

Case Study 4. Improving chemotherapy, radiotherapy and patient outcomes for colorectal cancer through patient-focused integrated clinical trials

Summary of the impact

Colorectal cancer is a common disease, which frequently causes death or morbidity, either because of failure to control the primary tumour or failure to prevent distant metastases. Leeds researchers have devised new treatment approaches using chemotherapy and radiotherapy and tested them in large randomised controlled trials which have led to major changes in clinical practice in the management of rectal cancer and advanced colorectal cancer (aCRC), driving clinical decision-making and improving outcomes for patients. This includes better-evidenced treatment for elderly patients and patient stratification on the basis of molecular biomarkers.

Submitting Institution

University of Leeds

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Oncology and Carcinogenesis

Re-assessment of Cancer risk in Barrett’s oesophagus.

Summary of the impact

Research within the Northern Ireland Barrett's oesophagus Register demonstrated that cancer risk in this disease was substantially lower than previously thought. It identified clinico-pathological characteristics and potential biomarkers that allow Barrett's patients to be stratified into those with higher and lower cancer risk. This research has influenced recommendations from Gastroenterological Associations in the UK and USA and resulted in altered clinical practice nationally and internationally, in which costly routine endoscopic surveillance is now targeted to Barrett's oesophagus patients with the highest cancer risk.

Submitting Institution

Queen's University Belfast

Unit of Assessment

Public Health, Health Services and Primary Care

Summary Impact Type

Political

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Public Health and Health Services

Refining the role and optimising the delivery of radioiodine in the treatment of thyrotoxicosis and thyroid cancer

Summary of the impact

Thyrotoxicosis (over-activity of the thyroid) affects up to 5% of the UK population and causes excess mortality, especially from vascular diseases, even in its mildest form. Thyroid cancer is the commonest endocrine cancer, its treatment being associated with adverse consequences which need to be minimised. A large programme of thyroid research in Birmingham led by Prof Jayne Franklyn has made major contributions to improving the management of thyrotoxicosis, specifically through optimal use of radioiodine treatment. Her group has developed and delivered a national training scheme to allow endocrinologists (hormone specialists) to give this treatment safely and effectively. Radioiodine is also a crucial part of treatment of thyroid cancer; Franklyn helped deliver a major trial showing that lower doses are as effective as higher doses in most cases but with fewer days in hospital and side effects. This research has changed clinical practice regarding more effective and safe use of radioiodine in thyrotoxicosis and thyroid cancer. It has been incorporated in national and international clinical guidance, patient information sources, and has directly affected clinician training and patient care pathways.

Submitting Institution

University of Birmingham

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Cardiorespiratory Medicine and Haematology, Oncology and Carcinogenesis, Public Health and Health Services

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