Clinical trial resources

This section of the website contains some useful resources, which are designed to help you understand the clinical trial process. These resources also provide you with further information about clinical research to help you make a decision about taking part in a clinical trial. On this page you will find links to videos, articles and slide presentations, which provide information in addition or complimentary to that contained within our website.

Please note, that we cannot be held responsible for the contents of any pages referenced by an external link.

What are clinical trials and what can I expect if I enrol?

Prof. Alan Burnett from Cardiff University describes the different phases of clinical trials and how they work. This video was recorded at the American Society of Hematology (ASH) Annual Meeting 2015, in Orlando, Florida, and was commissioned by the Patient Empowerment Foundation. Click on the screen below or click here to see the video (duration 2 min).

European Patients’ Acadamy (EUPATI)

eupati_logo_trans_poThe European Patients’ Academy (EUPATI) is a pan-European Innovative Medicines Initiative project of 33 organisations, led by the European Patients’ Forum, with partners from patient organisations (the European Genetic Alliance, the European AIDS Treatment Group, and EURORDIS), universities and not-for-profit organisations, along with a number of European pharmaceutical companies.

EUPATI focuses on education and training to increase the capacity and capability of patients to understand and contribute to medicines research and development, and also improve the availability of objective, reliable, patient-friendly information for the public.

Their Patient Expert Training Course was launched in October 2014 in English, and their web-based educational toolbox, hosting educational material, was launched in January 2016. The toolbox contains an A to Z of how medicines are developed, including the basics of medicines research, clinical development and trials, health technology assessments, personalised medicine and regulatory affairs. The articles are written in patient-friendly language and provide a comprehensive resource for those wanting to know more about the development of new medicines.

Access the EUPATI toolbox here

Ever wondered how and why we do clinical research?

clinical trialFind out the answers to this and much more in the National Institute for Health Research (NIHR) free online course, available to anyone wanting to understand more about clinical research.

 

Entitled ‘Improving Healthcare through Clinical Research’, the course will run for 6 weeks from 6 June 2016. It is a flexible approach to learning; you can choose how and when to engage. You’ll have online course moderators guiding you along the way, and interactive materials available throughout your learning journey.

Hear what past participants have to say

Sign up now

What is meta-analysis?

Meta-analysis is a statistical technique for combining the results (data) from multiple independent studies to provide an estimate of treatment effect, giving due weight to the individual studies included. Meta-analysis improves estimates of the size of the effect of a particular drug, and/or resolves uncertainty when reports disagree.

Decisions about the use of a new treatment cannot be based on the results of a single study, because results typically vary from one study to the next. Meta-analysis standardises the data across a number of studies.

Meta-analysis is used by pharmaceutical companies to gain approval for new drugs with regulatory agencies sometimes requiring a meta-analysis as part of the approval process. Clinicians and researchers use meta-analysis to determine which treatments work, and which ones work best.

Read more about meta-analysis in medical research – only for those of us with a mathematical mind!

What is Patient and Public Involvement?

The following short films on Patient and Public Involvement (PPI) in clinical research were made at the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL). They aim to answer common questions about PPI and share some experiences of patients and the public.

What is patient and public involvement explores how patients and the public can work together with doctors and researchers on clinical research. In this short film, three patient representatives talk about their experience of being involved in clinical trials.

The practicalities of patient and public involvement in clinical research looks at the practicalities of being involved in clinical research: the time needed, and what payment and expenses you can expect to receive.

Why do patients get involved in clinical research from the perspective of three patient representatives, and what motivates them to stay involved.

How do patients make a difference to research explores three examples of how input from patients and the public can enhance research.

Research Involvement and Engagement

patients-includedResearch Involvement and Engagement is an interdisciplinary, health and social care journal focussing on the engagement of patients and the public in research, at all stages. The journal is co-produced by all key stakeholders, including patients, academics, policy makers and service users.

The editors welcome articles from anyone involved with research and supporting, encouraging, or delivering the patient/public voice in research.

The journal publishes online articles about patient and public involvement in the research process, including decision-making, strategy development and clinical trials.

Read Research Involvement and Engagement here.

PET CT scans in clinical research

 

The NCRI PET Research Network has produced a video to give patients an idea of what is involved when you have a PET CT scan. PET stands for ‘Positron Emission Tomography’ and CT stands for ‘Computerised Tomography’.

The video also explains the science behind a PET CT scan, and the ways PET CT scans might be used in cancer clinical trials. This information is aimed at adults, as the process for PET CT scans in children is different, and covers the general principles of having a scan: It does not replace individualised information that you receive from your doctor or nurse.

Click on the screen above or click here to see the NCRI PET scan video

Taking part in clinical trials – how patients can make a difference

A short information film about clinical trials where patients share their experience of taking part. Click on the screen above or click here to see the video.

Presented by patient and carer representative, Simon Rodwell, the film covers three key areas:
• What clinical trials are
• What is involved for the people taking part in trials
• How people can find out if there is a suitable trial near them

“The knowledge gained in clinical trials will help people in future, allowing researchers to compare drugs and techniques and see which treatment is the most effective for a given type of cancer.” Simon Rodwell.

Human Tissue Authority

htaThe Human Tissue Authority (HTA) is the regulator for human tissue and organs. The HTA was set up in 2005 following events in the 1990s that revealed a culture in hospitals of removing and retaining human organs and tissue without consent. The legislation that established the HTA not only addressed this issue, but also updated and brought together other laws that relate to human tissue and organs.

The HTA was created by Parliament as an executive agency of the Department of Health, and are overseen by an authority of lay and professional members appointed by the Government.

The HTA regulate organisations that remove, store and use human tissue for research, medical treatment, post-mortem examination, education and training, and display in public. We also give approval for organ and bone marrow donations from living people.

Visit the HTA website for more information.

MRC Patient and Public Involvement Group

mrc-ctuThe Medical Research Council (MRC) Clinical Trials Unit (CTU) is based at University College London. The MRC CTU Patient and Public Involvement (PPI) Group is responsible for developing, promoting and supporting the active involvement of patients and the public in all clinical studies that are being led by MRC CTU. Members of the Group provide practical help to staff working on individual studies and promote research around issues relating to PPI within CTU trials. The group is made up of CTU staff and patients who are actively involved in the work of the MRC CTU.

The MRC website also contains information about PPI and general information about taking part in clinical trials.

 

Visit the MRC CTU PPI website here for further information

INVOLVE

INVOLVE is a national advisory group funded by the National Institute for Health Research (NIHR) that brings together NHS patients, carers, service users and researchers to make sure research is focused on the issues that really matter.

There are a range of opportunities for getting involved in research. Involving members of the public in research is important to help ensure that the research is relevant, reliable and usable for people.

There is a regular NIHR patients and the public newsletter, which you can access if you sign up to the NIHR mailing list.

Click on the screen above or click here to find out more.

NIHR Consumer Liaison Group

nihr-clgThe National Institute for Health Research (NIHR) Consumer Liaison Group (CLG) operates to improve the quality, relevance and benefit of cancer research for patients and their families through the active involvement of patients, carers and the public.

The Group brings together people with personal experiences of cancer, including patients, carers and relatives with an active interest in research. It also works with representatives from cancer support organisations, researchers, charities, research funders and other health and research professionals.

The CLG provides feedback and advice to the NIHR Clinical Research Network for Cancer and the National Cancer Research Institute through membership of its Clinical Studies Groups; as well as to wider organisations on issues of importance to patients, carers and the public.

By working with other groups and organisations the CLG also helps to raise public awareness of the importance of clinical research and of cancer research in particular. The CLG is supported by the NIHR Clinical Research Network for Cancer and the NCRI and meets three times each year.

Read more about the work of the CLG here


Patient on trial – what trial participation is really like

A melanoma patient describes her personal experience with trial participation and what randomisation to an inferior comparator is like: a must-watch for anyone concerned about patient participation in clinical trials and any trial designer.

This is a very frank account of a stage 4 melanoma patient’s experience of clinical trials. However, please remember when watching this film that the standard treatments for kidney cancer are not the same as those for melanoma, and chemotherapy is not used for the treatment of kidney cancer.

Click on the screen above or click here to see the video.

Is it worth doing?

In recent years, there has been considerable interest in finding out what difference patient and public involvement makes to research projects. The evidence published so far has been criticised for being weak and anecdotal. Some people argue we need robust evidence of impact from scientific studies of involvement.

This review considers examples of where impact has been measured using statistical methods. The article concludes that the statistical evidence is weak, if the studies do not consider the context in which involvement takes place and the way that it is done. Studies designed to take this into account give us more confidence that the involvement did make a difference to that particular project. They do not tell us whether the same impact will occur in the same way in other projects and, therefore, have limited value.

Researchers gain an understanding of involvement through their direct experience of working with patients and the public. This is ‘knowledge in context’ or ‘insight’ gained in the same way that patients gain expertise through their direct experience of a health condition. This means that detailed accounts of involvement from researchers already provide valuable learning to others, in the same way that patients’ insights help shape research.

However, the impact of involvement will always be somewhat unpredictable, because at the start of any project researchers ‘don’t know what they don’t know’—they do not know precisely what problems they might anticipate, until the patients/public tell them.

Read the full article here

Safety of medicinal products in the EU

european-commissionThe European Commission have produced a slide presentation covering all aspects of the development of medicinal products from clinical trials through to the use by a patient.

 

prescription_drugs

The presentation describes how medicines are authorised and monitored in the European Union. It is interactive, and simple to use and understand.

Click here to follow the life of a pill from clinical trials to use by a patient.

Lilly Trials

lily-trialsLilly Trials is a selection of resources that help to make clinical research ‘more connected, engaging, and accessible than ever before.’

Lilly Trials is managed by Eli Lilly and Company (a pharmaceutical company) and is part of an initiative to involve patients in the development of new medicines through ‘open and honest conversations with patients, caregivers, researchers and innovators.’

This is an American website, which focuses on the American clinical research environment. However, there is a lot of useful information about clinical trials in the form of blogs and articles that might be of interest to you.

Take a look at Lilly Trials here.

Patient Research Ambassador Initiative (PRAI)

A Patient Research Ambassador is someone who promotes health research from a patient point of view. They could be a patient, service user, carer, or lay person who is enthusiastic about health research and willing to communicate that to other patients and the public, as well as healthcare professionals.

To enable the NHS to embed a patient-centred research culture, they need to engage both patients and NHS research staff in better ways. PRAs are patients, carers and lay people who have experienced research, and can often be the best research ambassadors in their local NHS care organisation. The can help ensure that the people using local NHS care have the best opportunities and choices about taking part in research studies.

Read more about the Patient Research Ambassador role here.

Click on the screen below or click here to see a video about the role of a PRA.

NIHR Clinical Research Network

RCML logo - finalIn 2006, the Department of Health set up the National Institute for Health Research (NIHR) within the NHS, and the Clinical Research Network is part of this wider organisation.  At the centre of the work of the NIHR is a portfolio of high-quality clinical studies that benefit from the infrastructure provided by the Clinical Research Network.

The NIHR Clinical Research Network:

  • Funds research posts in the NHS, and provides training, so that researchers have access to experienced “front-line” staff, who can carry out activities such as obtaining patient consent, carrying out extra tests, and collecting clinical data.
  • Provides funding to meet the costs of using facilities, such as scanners and X-rays that are needed in the course of the study, so that research activity adds value to patient care.
  • Provides practical help in identifying and recruiting patients onto CRN studies, so that researchers can be confident of completing the study on time, and on target.

 

Click here to find out how patients, carers and the public can aid research, and click here to read inspirational stories about how research changed the life of some people. Click here to discover you local Clinical Research Network.

NCRI Clinical Studies Groups

NCRIThe National Cancer Research Institute (NCRI) Clinical Studies Groups (CSGs) have been in existence for more than ten years, and are a central part of the UK’s cancer research infrastructure. There are 19 CSGs that bring together clinicians, scientists, statisticians, patients and lay representatives to coordinate development of a strategic portfolio of trials within their field. All CSGs interact with clinical research networks, funders and researchers to develop studies aimed at improving outcomes for patients.

Click here to read more about the work of the NCRI Clinical Studies Groups.

The Bladder and Renal Cancer CSG runs clinical trials for kidney cancer. Click here to see the portfolio of studies in the Bladder and Renal Cancer CSG.

Independent Cancer Patients’ Voice

Independent Cancer Patients’ Voice (ICPV) is a patient advocate group, independent of established UK cancer charities, and aware of the value of medical research to both public health and to the national economy. Their aim is to improve existing treatments for every cancer patient, and develop new treatments by bringing the patients’ voice into clinical research by; (1) educating, supporting and mentoring patients so that they can have an equal voice with clinicians and researchers and (2) bringing the patients’ voice to clinicians and researchers by being patient advocates in clinical research. Both Rose Woodward and Julia Black are members of the ICPV.

Read more about the work of the ICPV here.

Are patients being told about opportunities to take part in research?

The recent Cancer Patient Experience Survey (CPES) shows that a little over a quarter of all patient (27%) had a discussion with their doctor about taking part in research. This article from Cancer Research UK questions why this is, and looks at the variability between Hospital Trusts with respect to whether cancer patients are being told about the clinical trial opportunities available to them.

Click on the video below or click here to see a kidney cancer patient’s experience of clinical research:

Read the full article on the Cancer Research UK website here.

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