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We are recruiting: Nottingham University Hospitals Research and Innovation Quality Assurance/GCP Auditor

Do you wish to make a difference to research in the NHS? An opportunity has arisen for a Quality Assurance/GCP Auditor to join the Research and Innovation Department at Nottingham University Hospitals (NUH) NHS Trust.
NUH has identified excellence in research … Continue reading

Vacancy: NUH R&I Quality Assurance / GCP Manager, extended to 16th September

NUH R&I seeks to appoint a QA/GCP Manager to assure the quality of clinical research undertaken within Nottingham University Hospitals NHS Trust in accordance with legislative and best practice requirements. This is a key role in the co-ordination of working practices, policy implementation and preparation for external audits and MHRA inspection. Continue reading

A Randomized multicenter phase III trial comparing enzalutamide vs. a combination of Ra223 and enzalutamide in asymptomatic or mildly symptomatic castration resistant prostate cancer patients metastatic to bone.

Summary:
This trial involves patients with advanced prostate cancer. This trial will compare a group on hormone tablets alone with a group on combination of hormone tablets and a radioactive substance. This trial is supported by the European Organisation for Research and Treatment of Cancer (EORTC).

Doctors often treat advanced prostate cancer with a hormone therapy injection or on rare occasions by removal of both testicles. Both these treatments usually stop working after 13 to 22 months. This trial will
recruit these men whose prostate cancer is no longer responding to hormone injections or removal of testicles. Prostate cancer often spreads to bones and more than 90% of men with advanced prostate cancer have secondary cancer in their bones at this stage. Cancer that has spread to the bones can cause significant pain. The secondary cancer in bone significantly affects the men’s ability to enjoy life.

Radium 223 is a new type of radioactive injection. Radium 223 specifically targets cancer cells in the bones. Radium 223 spares lot of normal body tissues and lose its radioactivity very quickly. Radium 223 is safe to use and is already approved for use in advanced prostate cancer in UK and Europe. Enzalutamide is also a newly licensed hormone therapy tablet that is proven to work in patients after the first hormone injection has failed to work.

This trials aims to find out
>> if men having Enzalutamide tablets in combination with Radium 223 injection have longer duration of cancer control in bones compared to men having Enzalutamide tablets alone;
>> if men having the combination treatment live longer, have less bone complications, better pain control and have a better quality of life.
The trial also aims to collect the safety information in men having Radium 223 injections in combination with Enzalutamide tablets and in men having Enzalutamide tablets alone.

Inclusion criteria:
♦Histologically confirmed diagnosis of prostate adenocarcinoma
♦ Asymptomatic or mildly symptomatic (defined as no opioids and Brief Pain Inventory score, i.e. short form question #3 worst pain must be 25 g/L
♦ Normal cardiac function according to local standard by 12-lead ECG (complete, standardized 12-lead recording).
♦ Able to swallow the study drug and comply with study requirements
♦ Prior or concomitant therapy.
-Prior docetaxel is permitted under the following conditions: started within 2 months of ADT initiation, given for a maximum of 6 cycles and progression after 6 months of the last dose of docetaxel.
-Previous treatment with bicalutamide, flutamide, prednisone, or dexamethasone is allowed if it was stopped at least 4 weeks prior to randomization.
♦ Patients taking bisphosphonates or denosumab are eligible if they have received a stable dose for 4-weeks or more prior to randomization. (These treatments may then be continued on study).
♦ Drugs known to lower the seizure threshold or prolong QT interval are not permitted.
♦ Participants who have partners of childbearing potential must use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 3 months after last dose of enzalutamide and 6 months after the last dose of Ra223. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
♦ Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
♦ Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
♦ For participation in translational research, specific consent must be given.

Exclusion criteria:
♦ Known central nervous system metastases or leptomeningeal tumor spread.
♦ Significant cardiovascular disease including:
-Myocardial infarction within 6 months prior to screening.
-Uncontrolled angina within 3 months prior to screening.
-Congestive heart failure New York Heart Association (NYHA) class III or IV, or patients with history of congestive heart failure NYHA class III or IV in the past, unless a screening echocardiogram or multigated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is ≥ 45%
-History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation,torsades de pointes).
-History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place.
-Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 millimeters of mercury (mm Hg) or diastolic blood pressure > 105 mm Hg at screening.
-Hypotension as indicated by systolic blood pressure Principal Investigator for this trial: Dr Santhanam Sundar

Research Ethics Committee Reference: 16/EM/0017

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

A Randomized multicenter phase III trial comparing enzalutamide vs. a combination of Ra223 and enzalutamide in asymptomatic or mildly symptomatic castration resistant prostate cancer patients metastatic to bone.

Summary:
This trial involves patients with advanced prostate cancer. This trial will compare a group on hormone tablets alone with a group on combination of hormone tablets and a radioactive substance. This trial is supported by the European Organisation for Research and Treatment of Cancer (EORTC).

Doctors often treat advanced prostate cancer with a hormone therapy injection or on rare occasions by removal of both testicles. Both these treatments usually stop working after 13 to 22 months. This trial will
recruit these men whose prostate cancer is no longer responding to hormone injections or removal of testicles. Prostate cancer often spreads to bones and more than 90% of men with advanced prostate cancer have secondary cancer in their bones at this stage. Cancer that has spread to the bones can cause significant pain. The secondary cancer in bone significantly affects the men’s ability to enjoy life.

Radium 223 is a new type of radioactive injection. Radium 223 specifically targets cancer cells in the bones. Radium 223 spares lot of normal body tissues and lose its radioactivity very quickly. Radium 223 is safe to use and is already approved for use in advanced prostate cancer in UK and Europe. Enzalutamide is also a newly licensed hormone therapy tablet that is proven to work in patients after the first hormone injection has failed to work.

This trials aims to find out
>> if men having Enzalutamide tablets in combination with Radium 223 injection have longer duration of cancer control in bones compared to men having Enzalutamide tablets alone;
>> if men having the combination treatment live longer, have less bone complications, better pain control and have a better quality of life.
The trial also aims to collect the safety information in men having Radium 223 injections in combination with Enzalutamide tablets and in men having Enzalutamide tablets alone.

Inclusion criteria:
♦Histologically confirmed diagnosis of prostate adenocarcinoma
♦ Asymptomatic or mildly symptomatic (defined as no opioids and Brief Pain Inventory score, i.e. short form question #3 worst pain must be 25 g/L
♦ Normal cardiac function according to local standard by 12-lead ECG (complete, standardized 12-lead recording).
♦ Able to swallow the study drug and comply with study requirements
♦ Prior or concomitant therapy.
-Prior docetaxel is permitted under the following conditions: started within 2 months of ADT initiation, given for a maximum of 6 cycles and progression after 6 months of the last dose of docetaxel.
-Previous treatment with bicalutamide, flutamide, prednisone, or dexamethasone is allowed if it was stopped at least 4 weeks prior to randomization.
♦ Patients taking bisphosphonates or denosumab are eligible if they have received a stable dose for 4-weeks or more prior to randomization. (These treatments may then be continued on study).
♦ Drugs known to lower the seizure threshold or prolong QT interval are not permitted.
♦ Participants who have partners of childbearing potential must use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 3 months after last dose of enzalutamide and 6 months after the last dose of Ra223. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
♦ Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
♦ Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
♦ For participation in translational research, specific consent must be given.

Exclusion criteria:
♦ Known central nervous system metastases or leptomeningeal tumor spread.
♦ Significant cardiovascular disease including:
-Myocardial infarction within 6 months prior to screening.
-Uncontrolled angina within 3 months prior to screening.
-Congestive heart failure New York Heart Association (NYHA) class III or IV, or patients with history of congestive heart failure NYHA class III or IV in the past, unless a screening echocardiogram or multigated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is ≥ 45%
-History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation,torsades de pointes).
-History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place.
-Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 millimeters of mercury (mm Hg) or diastolic blood pressure > 105 mm Hg at screening.
-Hypotension as indicated by systolic blood pressure Principal Investigator for this trial: Dr Santhanam Sundar

Research Ethics Committee Reference: 16/EM/0017

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

Regulatory and Operational Changes to Clinical Research in the EU

A new EU Clinical Trial Regulations, the prospect of new EU medical device legislation, and changes to the European and national clinical trial authorisation processes will transform the regulatory environment in industry and the public sector. These are welcomed changes … Continue reading

R&I Contact Details

Contact information for the Research and Innovation team is detailed below.
Our postal address is:
Research & Innovation
Nottingham University Hospitals NHS Trust
Nottingham Integrated Clinical Research Centre
C Floor, South Block
Queen’s Medical Centre Campus
Derby Road Nottingham NG7 2UH
For general enquiries please email … Continue reading

Standards, Procedures and Guidance

Our current standard operating procedures, regulatory standards, guidance documents, templates and forms are regularly updated please ensure that you are using the most current version.
If you need further assistance then please contact our QA/GCP Auditor Melanie Boulter.

Vacancy: Senior Research Manager (Regulatory Compliance & Award Management)

NUH Research & Innovation has a vacancy for a Senior Research Manager to lead on Regulatory Compliance & Award management.

Forthcoming MHRA inspection at Nottingham University Hospitals NHS Trust

The MHRA GCP Inspectorate is due to inspect NUH. The Trust was notified in February 2013 that an inspection is due to take place but as yet, the date and agenda of the inspection has not been confirmed. Continue reading

New Clinical Trials Toolkit uses tube map concept to guide researchers

NIHR has launched a new Clinical Trials Toolkit which is based on the design of a tube map. The clickable diagram differentiates between legal and good practice requirements, providing essential information at the ‘stations’ along the route

HEAT (Helicobacter Eradication Aspirin Trial): Can eradication prevent ulcer bleeding?

In 2007 there were 12,864 hospital admissions in England for gastric duodenal or peptic ulcer haemorrhage. HEAT is a large scale outcomes study designed to see whether a one week course of H. pylori eradication reduces hospitalisation for ulcer bleeding in patients using aspirin. With funding from the NIHR HTA Programme, it is being led by the University of Nottingham, with recruiting centres across the UK. Continue reading

Nottingham Penthrox acute pain control trial opens the door to research in A&E

Support provided by the Comprehensive Clinical Research Network recently helped NUH overcome the challenges of A&E and become the top recruiting site in an acute pain study. NUH demonstrates how to successfully conduct a clinical trial in a difficult Emergency Department environment. Continue reading

Nottingham University Hospitals R&I Research Manager vacancy, applications close 17th February

Do you wish to make a difference to research in the NHS? An opportunity has arisen for a Research Manager to join the Research & Innovation Department at Nottingham University Hospitals (NUH) NHS Trust. As Research Manager you will be a key member of the NUH R&I department and will play an important role in supporting the implementation of the Trust’s Research Strategy. Continue reading

Training

Introduction to Good Clinical Practice (GCP) Training Course
NIHR deliver regular GCP training.
For further information on GCP Training please visit the NIHR Website.
HRA Training
NUH R&I are currently delivering training on the HRA approval process and the changes to the research process. … Continue reading

R&I Team Profiles

Dr Steve Ryder
Director of Research
Since June 1994 Dr Ryder has been a consultant Physician in Hepatology and Gastroenterology at the Nottingham Digestive Diseases Centre and Biomedical Research Unit. His major clinical and research interest is hepatitis C infection.
Dr Ryder … Continue reading

Entries Open for Clinical Research Site of the Year 2011

The PharmaTimes has opened a new competition, the Clinical Research Site of the Year, which is jointly sponsored by the NIHR and the ABPI. A new category of the Clinical Researcher of the Year competition, it has been introduced in recognition of the importance to the UK’s global competitiveness that a clinical research site can make. Continue reading

Regulatory Standards

Below is a selection of links related to regulatory standards which are relevant to Healthcare research in the UK. If you cannot find what you are looking for then please contact us on 0115 9709049.

General

Research Governance Framework, 2nd ed

Legislation & … Continue reading

Life Sciences Industry

Commercial research is important to NUH as the driving force for the adoption and diffusion of innovation.

It is through this process that new treatments, devices or laboratory tests are studied and brought forward for use by patients and staff.
Nottingham … Continue reading

NUH R&D completes MHRA inspection successfully

The MHRA has completed a four day routine GCP inspection of systems and processes. This took place in the last week of February and we were notified at the close of the audit that there were no critical findings. A … Continue reading

NUH routine MHRA inspection in February

NUH will soon undergo a routine GCP systems inspection by the MHRA (Medicines and Healthcare Products Regulatory Agency). This will take place during the last week of February and is coordinated by the R&D
department. The investigators who will be … Continue reading

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