RES Committee London - City & East Annual Report 01 April ... · Lewins Mead Bristol BS1 2NT Telephone: 01173421386 Email: [email protected]. RES Committee

Research Ethics Service

RES Committee London - City & East

Annual Report

01 April 2014 - 31 March 2015

RES Committee London - City & East Annual Report Page 2

Part 1 – Committee Membership and Training

Name of REC: RES Committee London - City & East

Type of REC: REC recognised to review CTIMPs in patients - type iii

Type of Flag: IRB registered /Phase I in patients/Paediatric

Chair: Dr John Keen

Vice-Chair: Ms Alison Eden

Alternate Vice-Chair: Dr Ayse Baxter

REC Manager: Mr Rajat Khullar

REC Assistant: Mr Wai Yeung

Committee Address: Bristol Research Ethics Committee Centre Whitefriars Level 3, Block B Lewins Mead Bristol BS1 2NT

Telephone: 01173421386

Email: [email protected]


Chair’s overview of the past year:

City & East London REC underwent some modernisation in 2014-15, with changes in personnel and a new Chair and Vice-Chair, and process changes at meetings to facilitate the full participation of all members. The Committee is democratic and efficient and there is camaraderie amongst committee members. Feedback already received from researchers has been positive. Our inaugural self-organised ethics training day was a great success. The committee continues to benefit from excellent managerial support from Raj and Wai. Well done and thank you to everyone who has participated and supported me in this notable year.

Dr John W Keen Chair, London - City & East REC


RES Committee London - City & East Membership

Name Profession Expert or

Lay

Dates

Appointed Left

Dr Louise Abrams Pharmacology (Vice Chair)

Expert 01/09/2004 21/12/2014

Dr Chandan Alam Experimental Pathology Expert 01/06/2005

Dr Marie E Bardsley Director Lay 01/10/2009

Ms Clare Barron Solicitor – in-house legal department

Lay Plus 27/02/2014

Ms Jane Batchelor Centre Administrator, Advanced Cardiovascular Imaging

Lay Plus 01/12/2011

Mr James Batchelor Director of Clinical Informatics Research Unit

Lay 01/07/2014

Dr Ayse Baxter Pharmaceutical Physician Expert 01/07/2007

Dr Luis Beltran Consultant Histopathologist

Expert 01/05/2014

Mr Frank Cross Consultant General and Vascular Surgeon

Expert 13/11/2008

Ms Alison Eden Manager Patient Recruitment

Lay Plus 07/01/2015

Dr Miran Epstein Senior Lecturer Medical Ethics

Expert 01/05/2004 01/05/2014

Ms Janelle Hill Non-medical lay member Lay Plus 01/08/2004 31/07/2014

Mrs Lisa Johnson CRO Lay Plus 01/05/2014

Professor Atholl Johnston Professor of Clinical Pharmacology

Expert 01/05/2004 31/12/2014

Dr John Keen GP Expert 01/11/2014

Professor Malcolm Law Epidemiologist Expert 01/04/2004 30/11/2014

Mr John Lynch Lay Member Lay 01/10/2007

Mr Roger Maran Barrister Lay Plus 06/10/2011

Dr Dylan Morrissey Senior Clinical Lecturer in Sports and Exercise Medicine

Expert 01/05/2014

Dr Eleni Palazidou Consultant Psychiatrist & Honorary Senior Lecturer

Expert 01/01/2005

Professor Kim Piper Consultant Histopathologist/Professor of Oral Pathology

Expert 01/03/2008

Mr Roy Sinclair Pharmacist Lay 01/11/2014

Ms Brigid Tucker Head of Policy & Communications, General Osteopathic Council

Lay Plus 01/08/2004

Professor Arthur T. Tucker Lead Clinical Scientist & Reader, (REC Chair)

Expert 01/07/2004 31/10/2014

Professor David Wingate Gastroenterologist Expert 01/05/2004 01/05/2014

Dr Ariel Zosmer Honorary Senior Clinical Lecturer

Expert 01/06/2014


RES Committee London - City & East: Deputy Members

RES Committee London - City & East: Co-opted Members

Name Profession Status Meeting date attended

Ms Clare Barron Solicitor – in-house legal department

Lay Plus 01/05/2014, 05/06/2014, 04/09/2014, 02/10/2014,

06/11/2014

Mr James Batchelor Director of Clinical Informatics Research Unit

Lay 04/09/2014, 04/12/2014

Dr Luis Beltran Consultant Histopathologist

Expert 04/12/2014, 06/11/2014, 04/09/2014, 03/07/2014, 01/05/2014, 05/06/2014

Ms Lisa Johnson Project management of Phase 1 and 2 clinical trials

Lay Plus 02/10/2014, 06/11/2014, 04/12/2014, 03/07/2014, 04/09/2014, 08/01/2015, 01/05/2014, 05/06/2014

Mr D Morrissey Senior Clinical Lecturer in Sports and Exercise Medicine

None 05/06/2014, 08/01/2015, 03/07/2014, 05/02/2015, 06/11/2014, 02/10/2014

Dr Ariel Zosmer Honorary Senior Clinical Lecturer

Expert 03/04/2014,

Name Profession Status Meeting date attended


RES Committee London - City & East: Members’ Declarations of Interest:

Name Declaration of Interest Date

Dr Louise Abrams None 06/11/2014

Dr Chandan Alam Director - Transdermal Delivery Solutions Corp. , Florida, US Director, Medical - Cells United, Oslo, Norway

04/12/2014

Dr Marie E Bardsley Data Manager Data Sharing Initiative Royal London Hospital Whitechapel Commission on Publishing Ethics (COPE) Member of Labour Party

10/04/2014

Ms Clare Barron None 28/04/2014

Mr James Batchelor None 24/07/2014

Ms Jane Batchelor Centre Administrator, Advanced Cardiovascular Imaging, William Harvey Research Institute, QMUL

04/12/2014

Dr Ayse Baxter Shares in AstraZeneca Shares in Glaxo Smithkline 31/03/2015

Dr Luis Beltran No declarations of interest 01/05/2014

Mr Frank Cross No declarations of interest 05/02/2015

Mrs Lisa Johnson Regional Study Manager – Allergan Shares in AstraZeneca

17/06/2014

Dr John Keen Member of NREAP (HRA Advisory Panel) 07/11/2014

Mr John Lynch None 04/12/2014

Mr Roger Maran Shares in GlaxoSmithKline as part of a professionally managed share portfolio

04/12/2014

Dr Dylan Morrissey No declarations of interest 01/10/2014

Mr Roy Sinclair No declarations of interest 01/11/2014

Ms Brigid Tucker Currently employed by a UK statutory healthcare regulator (General Osteopathic Council) and represent the regulator on the UK National Council for Osteopathic Research (NCOR). As a healthcare regulator, we periodically commission research that informs policy development. This forms part of my remit.

04/09/2014

Dr Ariel Zosmer None 11/03/2015

Professor Arthur T Tucker Seahorse Scientific Services Ltd. Seahorse Laboratories Ltd. Edixomed Ltd. Sky Medical Technology Ltd. & FirstKind Ltd. Principal Clinical Scientist, Barts Health NHS Trust Reader, William Harvey Research Institute, QMUL Algaecytes Ltd. Barchester Group Ltd. Cardiocity Ltd. FimpacTT AG. Gabriel Scientific Ltd MAC Ltd. Tarilian Laser Technology Ltd. TransDermal Solutions Corporation.

03/04/2014

Professor David Wingate Member of Whitechapel Society for the Advancement of research in Gastroenterology Trustee of Harold Hyam Wingate Foundation

03/04/2014

Professor Atholl Johnston Positions - Various Pharma Companies Consultant, Director - Esprit Other ownership/ involvement- ASI Ltd. , Seahorse Scientific Services Ltd. Queen

01/05/2015


Mary University of London

Dr Miran Epstein None 03/04/2015

Ms Alison Eden 100% owner of Alison Brand - sometimes writes patient information/interviews sites, advises on recruitment/retention strategy. Employee of ICON. Contract Research Organisation.

02/02/2014 04/06/2015

Dr Eleni Palazidou Reviews research applications for NIHR

27/02/2014 13/04/2015

Ms Janelle Hill None 10/12/2014

Professor Kim Piper None 27/02/2014

Professor Malcolm Law None 03/04/2015


Meetings for Full Ethical Review 01 April 2014 - 31 March 2015:

Proportionate Review Sub-Committee Meetings held during 01 April 2014 - 31 March 2015:

Sub-Committee Meetings held during 01 April 2014 - 31 March 2015:

Month Date Number of Members Present

at Meeting

April 03/04/2014 12

May 01/05/2014 14

June 05/06/2014 14

July 03/07/2014 16

September 04/09/2014 14

October 02/10/2014 15

November 06/11/2014 16

December 04/12/2014 12

January 08/01/2015 10

February 05/02/2015 13

March 05/03/2015 13

11 full committee meetings were held during the reporting period.


at Meeting

April 24/04/2014 3

May 29/05/2014 4

June 26/06/2014 5

July 24/07/2014 4

September 25/09/2014 5

October 24/10/2014 6

November 26/11/2014 5

December 15/12/2014 4

January 22/01/2015 4

February 19/02/2015 3

March 19/03/2015 3

11 proportionate review sub-committee meetings were held during the reporting period.


at Meeting

April 14/04/2014 4

May 05/05/2014 3

May 16/05/2014 4

June 04/06/2014 3

June 23/06/2014 2

July 16/07/2014 4

August 08/08/2014 2

August 18/08/2014 4

September 23/09/2014 2


Details of inquorate meeting held:01 April 2014 - 31 March 2015

October 13/10/2014 3

October 31/10/2014 3

November 12/11/2014 2

November 20/11/2014 4

December 05/12/2014 3

December 12/12/2014 2

December 18/12/2014 2

January 13/01/2015 2

January 23/01/2015 3

January 30/01/2015 3

February 12/02/2015 3

February 23/02/2015 2

March 06/03/2015 3

March 16/03/2015 3

March 27/03/2015 3

24 sub-committee meetings were held during the reporting period.

0


Attendance of Members at full committee meetings:01 April 2014 - 31 March 2015

Attendance of Members at proportionate review sub-committee meetings: 01 April 2014 -

31 March 2015

Name Number of

Meetings

Attended

Dr Louise Abrams 8

Dr Chandan Alam 9

Dr Marie E Bardsley 9

Ms Clare Barron 7

Mr James Batchelor 2

Ms Jane Batchelor 8

Dr Ayse Baxter 8

Dr Luis Beltran 8

Mr Frank Cross 7

Ms Alison Eden 3

Dr Miran Epstein 1

Ms Janelle Hill 4

Ms Lisa Johnson 8

Professor Atholl Johnston 7

Dr John Keen 5

Professor Malcolm Law 5

Mr John Lynch 7

Mr Roger Maran 9

Dr Dylan Morrissey 7

Dr Eleni Palazidou 4

Professor Kim Piper 1

Mr Roy Sinclair 4

Professor Arthur T. Tucker 6

Ms Brigid Tucker 7

Dr Ariel Zosmer 3

Name Number of

Meetings

Attended

Dr Louise Abrams 1

Ms Jane Batchelor 5

Mr James Batchelor 2

Dr Ayse Baxter 2

Ms Alison Eden 1

Ms Janelle Hill 1


Dr John Keen 4

Mr John Lynch 1

Mr Roger Maran 6


Professor Kim Piper 8

Mr Roy Sinclair 1


Attendance of Members at sub-committee meetings: 01 April 2014 - 31 March 2015


Ms Brigid Tucker 2

Dr Ariel Zosmer 4

Name Number of

Meetings

Attended

Dr Louise Abrams 6

Ms Clare Barron 1

Dr Ayse Baxter 9

Mr Frank Cross 1

Ms Alison Eden 1

Ms Janelle Hill 1

Mrs Lisa Johnson 2


Dr John Keen 13

Mr Roger Maran 5


Mr Roy Sinclair 12


Ms Brigid Tucker 2


Training 01 April 2014 - 31 March 2015

Name of Member Date Event(s) attended

Dr Louise Abrams 11/03/2015 London Training Event

Dr Chandan Alam 05/09/2014 Joint Oxford REC Training

Dr Chandan Alam 11/03/2015 London - City & East REC Training Day

Dr Marie E Bardsley 05/09/2014 Joint Oxford REC Training

Dr Marie E Bardsley 11/03/2015 London - City & East REC Training Day

Ms Clare Barron 20/05/2014 New Members Induction

Ms Clare Barron 11/03/2015 London - City & East REC Training Day

Dr Ayse Baxter 11/03/2015 London - City & East REC Training Day

Dr Luis Beltran 11/03/2015 London - City & East REC Training Day

Mr Frank Cross 26/11/2014 The 2014 Vascular Society Annual Meeting

Ms Alison Eden 05/09/2014 Oxford A training day

Ms Janelle Hill 11/03/2015 London - South East training day

Mrs Lisa Johnson 05/09/2014 Joint Oxford Training

Dr John Keen 11/03/2015 London - City & East REC Training Day

Mr John Lynch 11/03/2015 London - City & East REC Training Day

Mr Roger Maran 11/03/2015 London - City & East REC Training Day

Dr Dylan Morrissey 06/11/2014 Self Study (Reading) - Ben Goldacre - Bad Science

Dr Eleni Palazidou 11/03/2015 London Training Event

Mr Roy Sinclair 11/03/2015 London - City & East REC Training Day

Ms Brigid Tucker 11/03/2015 London Training Event

Dr Ariel Zosmer 11/03/2015 London - City & East REC Training Day

Ms Jane Batchelor 06/11/2014 Self-Study – NRES MCA and HTA Course


PART 2: REC WORKLOAD AND ACTIVITY DURING THE REPORTING PERIOD

Table 1: Applications assigned to a full committee meeting held within the reporting

period:

Table 2: Breakdown of full applications and other activity during reporting period

Table 3: Decisions given at meetings held within the reporting period

Applications for full ethical review – Study Type Number %

Clinical Trial of Investigational Medicinal Product 30 44.12

Phase 1 0 0.00

Gene Therapy 0 0.00

Research Tissue Bank (including renewals) 2 2.94

Research Database (including renewals) 0 0.00

Others 36 52.94

Total Applications Reviewed 68 100

Number of applications made invalid by the REC Manager 0

Number of applications withdrawn prior to the meeting 1

Number of student applications reviewed 12

Number of paediatric applications reviewed 10

Number of device applications reviewed 3

Number of prisoner applications reviewed 0

Number of applications involving adults unable consent reviewed 0

Number of applications reviewed that are funded by the US DHHS 3

Number of qualitative applications reviewed 3

Decisions taken at meetings following review of

applications

Number %

Favourable Opinion with Standard Conditions 1 1.47

Favourable Opinion with Additional Conditions 9 13.24

Unfavourable Opinion 5 7.35

Provisional Opinion 51 75.00

Provisional Opinion Pending Consultation with Referee 2 2.94

Total 68 100

Number of studies sent back to full committee meeting for final opinion

0


Table 4: Summary of current status of applications reviewed during the reporting period

Status of applications at date of generation of report Number %

Further Information Favourable Opinion with Standard Conditions

43 63.24

Further Information Favourable Opinion with Additional Conditions

8 11.76

Further Information Unfavourable Opinion 0 0.00





Provisional Opinion Pending Consultation with Referee 0 0.00

Further Information response not complete 0 0.00

No decision entered on system 0 0.00

Number of studies withdrawn after the meeting 1 1.47

Total 68 100


Table 5: Applications assigned to a proportionate review sub-committee within the

reporting period

Table 7: Decisions given at proportionate review sub-committee meetings held within the

reporting period

Table 6: Breakdown of PRS applications and other activity during reporting period:

Number of applications made invalid by the REC Manager 0

Number of studies withdrawn prior to the meeting 2

Number of student applications reviewed 15

Number of paediatric applications reviewed 3

Number of device applications reviewed 1

Number of qualitative applications reviewed 6

Total Applications Reviewed 35

Decisions taken at proportionate review sub-

committee meetings

Number %



No Opinion transfer to full committee for review 2 5.71



Total 35 100


Table 8: Other Management Information for the reporting period:

Average number of applications reviewed per full meeting 6.18

Number of applications for full ethical review 67

Number of applications for full ethical review over 60 days 0

Number of applications over 60 days as a % of total 0.00%

Number of applications for full ethical review over 40 days 8

Number of applications over 40 days as a % of total 11.76%

Number of days taken to final decision – average (mean) 35

Number of proportionate review applications for ethical

review

33

Number of proportionate review applications for ethical

review over 14 days

1

Number of proportionate review applications over 14 days as

a % of total

3.03%

Number of SSAs (non-Phase 1) reviewed 22

Number of applications for SSA review over 25 days 0

Number of applications for SSA review over 25 days as % of

all non- Phase 1 SSAs

0.00%

Number of SSAs (Phase 1) reviewed 0

Number of applications for SSA review over 14 days 0

Number of applications for SSA review over 14 days as % of

all Phase 1 SSAs

0.00%

Number of substantial amendments reviewed 146

Number of substantial amendments over 35 days 1

Number of substantial amendments over 35 days as a % of

total substantial amendments

0.68%

Number of substantial amendments over 28 days 24

Number of substantial amendments over 28 days as a % of

total substantial amendments

16.44%

Number of modified amendments reviewed 2

Number of modified amendments over 14 days 0

Number of modified amendments over 14 days as a % of

total modified amendments

0.00%

Number of minor amendments received 22

Number of substantial amendments received for information 0

Number of substantial amendments received for new

sites/PIs

32

Number of annual progress reports received 15

Number of safety reports received 22

Number of Serious Adverse Events received 0

Number of final reports received 5

RES Committee London - City & East Research Ethics Committee Annual Report Page 17

Table 9.1: Breakdown of current status of all full applications reviewed within the reporting period


REC Reference Title Number of Days on Clock

14/LO/0465 PATRIOT 35

14/LO/0485 Asthma Viral Challenge study 38

14/LO/0506 Investigating immunogenicity to biopharmaceutics version 2 54

14/LO/0629 Tooth loss in periodontitis patients 37

14/LO/0641 1335P1514: S-222611 in combination with anticancer treatments 55

14/LO/0667 MK-5172/MK-8742 in Subjects with HCV/HIV Co-Infection 33

14/LO/0668 Automated brain morphometry for dementia diagnosis (BrainMeasure) 37

14/LO/0680 MEDI4736 in NSCLC (D4191C00003, ATLANTIC Study) 34

14/LO/0706 Dual phase gel on erosion damaged enamel 37

14/LO/0750 CIRCULER, Version 1.0 31

14/LO/0826 A case-control evaluation of the NHS Bowel Cancer Screening Programme 38

14/LO/0852 Brain in Hand – how does it help keep the day on track? 35

14/LO/1139 A Phase 2 Study to Evaluate AMG 334 in Chronic Migraine Prevention 35

14/LO/1182 Iloprost in patients with Eisenmenger Syndrome 39

14/LO/1184 Masitinib/Placebo + Gemcitabine + FOLFIRI.3 in Pancreatic Cancer V1 36

14/LO/1185 Testing a new stepwise strategy for the management of renal anaemia 35

14/LO/1189 Pfizer B3281006-Ph 3 PF-05280586 vs Rituximab in low tumour burden FL 50

14/LO/1193 Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia 25

14/LO/1432 Function Following Laser for Anal Neoplasia (FLAN) 34

14/LO/1514 An Open Label Study of CORâ€”003 on the treatment of Cushing's syndrome 41

14/LO/1519 FACTS 39

14/LO/1578 DMID 11-0069 Valgan Toddler, Version 2.0 Dated 30 May 2014 29

14/LO/1736 Stress Echocardiography vs Exercise ECG in women with chest pain 39

14/LO/1737 U31287-A-U106 37

14/LO/1740 VIRTUE 39

14/LO/1742 prospective multicenter Zimmer TM Ardis post market surveillance study 19

14/LO/1744 Lipid-riche Plaque study, version 1.10 39

14/LO/1786 CapaCiTY Study 1- Chronic Constipation Treatment Pathway 34

14/LO/1870 Genetic Analysis of Adult intraocular tumors 28

14/LO/1882 (duplicate) UCLID 39

14/LO/1923 T2347(Latanoprost/Timolol) vs XalacomÂ® in glaucoma/ocular hypertension 27

14/LO/1939 Octreotide as prophylaxis for lapatinib-capecitabine related diarrhoea 48


14/LO/2036 WP29158-MPDL3280A & Erlotinib in advanced Non-Small Cell Lung Cancer 34

14/LO/2101 GWEP1330 - A Study of GWP42006 in people with focal seizures 29

14/LO/2125 Simeprevir and Daclastasvir in Hep-C Advanced Liver Disease - COMMIT 35

14/LO/2137 (INSIGHT 006: FLU-IVIG) 31

14/LO/2195 ARB v1.0 24

15/LO/0023 Cardamon trial 36

15/LO/0024 Abbreviated Mentalization Based Therapy in Borderline Crises(AMBIC) 40

15/LO/0205 Auditory Verbal Hallucinations in Bipolar Disorder 22

15/LO/0210 CR-AIR-007 47

15/LO/0363 The role of LLT1 in immune evasion and hepatocellular carcinoma 34

15/LO/0386 Changing Heads, Changing Faces (Version 1) 38



14/LO/0855 673-201 Study of BMN 673 in patients with Germline BRCA mutation 40

14/LO/1178 Assessment of Multiple Sclerosis in Routine Clinical Practice v1 35

14/LO/1443 Pyrenees 49

15/LO/0005 TASMA: Targets of Bronchial Thermoplasty in Severe Asthma 38

15/LO/0159 SelPac Version 1 39

15/LO/0302 First-in-Human Study of TAK-659 in Advanced Solid Tumor and Lymphoma 34

15/LO/0380 SUNSHIELD 40

15/LO/0381 Immuni-D 40

Further Information Unfavourable Opinion


Favourable Opinion with Standard Conditions


14/LO/1351 Chronic neuropathic lower limb pain and use of spinal cord stimulator. 28

Favourable Opinion with Additional Conditions



14/LO/0527 GO28754 Anti-PDL1 in locally advanced or metastatic NSCLC 28

14/LO/0836 The experiences of families following hemispheric surgery 28

14/LO/2009 Assessment of validity of PEDI-CAT for children with cerebral palsy 19

14/LO/2149 Distress Thermometer for adult patients with diverse sex development 24

15/LO/0006 Open-Label Extension to the Odanacatib Fracture Trial (PN018) 58

15/LO/0007 MK-5172 + MK-8742 in HCV-infected subjects with hepatic insufficiency (CP-B) 29

15/LO/0022 Experiences of Adults with Grandiose Beliefs 32

15/LO/0182 TIGER-3 28

15/LO/0202 A case study of a pre-school child who gained too much weight-Version1 28

Unfavourable Opinion


14/LO/0493 Brain in Hand - evaluation 29

14/LO/0498 Bright Spots:Local Authorities delivering positive care experiences v2 30

14/LO/0563 Study of MMXÂ® Mesalamine/Mesalazine in Paediatric Ulcerative Colitis 28

14/LO/1383 UCLID 28

14/LO/2134 Do all HEART scores beat the same? 23

Provisional Opinion


15/LO/0355 Immune signatures associated with rapid beta cell loss in T1D n/a

Provisional Opinion Pending Consultation with Referee


Further information response not complete


Withdrawn after the meeting


14/LO/1844 Bright Spots:Local Authorities delivering positive care experiences v2 34


Table 9.2: Breakdown of current status of all PRS applications reviewed within the reporting period



14/LO/1044 Epidemiology and management of premenstrual symptoms in the community 13

14/LO/1183 Smart-device apps as memory aids 6

14/LO/1188 Adherence to Eccentric Exercise for Achilles Tendon Pain: v1 10

14/LO/1359 Visualizing Uncertainty Among Laypersons and Experts (VISUALizE ) 12

14/LO/1772 The prostate cancer patient experience from biopsy to treatment. 14

14/LO/1775 PIPPIN study - models of PPI in LTC services 1

14/LO/1953 Exploring late-effects issues after radiotherapy for breast cancer 13

14/LO/1960 Intervention development for cluster randomised trial in CPRD (eCRT2) 14

15/LO/0193 Efficacy of First Aid Treatment of Acute Apical Abscess (AAA) 9

15/LO/0366 Isoflurane anaesthesia during cardiopulmonary bypass 14

15/LO/0367 Improving auditory outcomes 13

15/LO/0544 Tocilizumab effects on adipokines in Rheumatoid Arthritis 11



15/LO/0187 Acoustic analysis of nasal airflow in normal and abnormal subjects(V2) 14

15/LO/0189 TAC Registry (Study Name: CHORUS) 15

Further Information Unfavourable Opinion


Favourable Opinion with Standard Conditions


14/LO/1777 Development of novel treatments for cancer based on T-cell receptors 10

14/LO/1957 Version 9:Nasolabial soft tissue changes with upper jaw surgery 13


14/LO/2167 Adalimumab (HUMIRAÂ®) use in patients with Ulcerative Colitis 9

14/LO/2184 Impact of Physical activity and Vitamin D on osteoarthritic knee pain 9

14/LO/2286 Particle sizing of masticated tree nuts - cashews and walnuts (v1.0) 3

14/LO/2290 Neurophysiology of fatigue in people with multiple sclerosis 10

15/LO/0204 Nutrition impact symptoms score as a malnutrition screening tool 8

15/LO/0541 Pragmatic versus electrocardiographic-guided loop recorder position 4

15/LO/0545 CARAT - RTSY03 9

Favourable Opinion with Additional Conditions


14/LO/0743 Air Pollution in Lung Transplantation 10

14/LO/0745 Influence of varying tooth shape on perceived smile aesthetics 10

14/LO/1037 Evaluation of the Effect of the OBJ Technology on Fluoride Uptake V3.0 8

14/LO/1350 GARFIELD-VTE 4

14/LO/1352 Placental autoimmunity and fetal loss. 8

14/LO/2185 Analysis of natural killer cell status in Alemtuzumab MS patients 8

14/LO/2274 The effects of MI training on physiotherapists' behaviour and beliefs 7

Unfavourable Opinion


14/LO/1778 The effect of exposure to mercury on disease activity in SLE 13

Provisional Opinion


15/LO/0359 Using Ultrasound to assess tonsil size in children n/a

15/LO/0542 HRQoL, Ethnicity & PCOS n/a

Further information response not complete


Withdrawn after the meeting




Table 10.1: Breakdown of current status of all substantial amendments reviewed within the reporting period

Favourable opinion

Amendment REC

Reference

Title Version Date Number of Days on

Clock

04/Q0603/1/AM44 ASPECT Amendment number115_EndOf

Study

01/05/2014 30

04/Q0603/1/AM48 ASPECT Substantial Amendment

January 2015

20/01/2015 13

06/Q1603/7/AM12 Chemoprevention of Premalignant Intestinal Neoplasia 8 03/02/2015 6

07/H0703/160/AM62 Study of MK822 in osteoporotic fracture prevention AM62 Substantial Amendment 58

09/04/2014 24

07/H0703/160/AM63 Study of MK822 in osteoporotic fracture prevention AM63 Substantial Amendment 60

10/07/2014 18

07/H0703/160/AM64 Study of MK822 in osteoporotic fracture prevention 62 09/10/2014 25

07/Q0603/8/AM14 Phase III, placebo-controlled study in subjects with multiple myeloma

AM14 Substantial Amendment

27/03/2014 28

09/H0703/101/AM11 INSIGHT H1N1v Outpatient Study (FLU 002) Substantial Amendment 8

dated

24/06/2014 12

09/H0703/72/AM03 Hypoglycaemia and brain injury VN1 2 09/06/2014 12

09/H0703/72/AM04 Hypoglycaemia and brain injury VN1 3 03/03/2015 9

10/H0703/107/AM17 A3921061 Long Term Safety & Tolerability of 2 oral doses of CP-690,550

13 Oct 2014 13/10/2014 29

10/H0703/107/AM18 A3921061 Long Term Safety & Tolerability of 2 oral doses of CP-690,550

23/02/2015 23/02/2015 14

10/H0703/14/AM02 Reflux studies on patients with voice disorders 02 15/07/2014 14

10/H0703/30/AM04 Association of Genetic Variation and Neurobiological Change with BPSD

4 17/12/2014 22

10/H0703/45/AM05 CAR-PET 5 12/01/2015 5

10/H0703/56/AM14 Phase Ib/II Eribulin Mesylate Bladder Cancer 12/05/2014 12/05/2014 12

10/H0703/62/AM03 QST and lumbar radiculopathy AM03 Substantial Amendment

23/04/2014 16

10/H0703/79/AM03 CABANA Trial - Version 3.3 -03-March-2010 AM 03 Substantial 31/07/2014 18


Amendment 03

10/H0704/43/AM02 Myocardial inflammation and signaling in atrial fibrillation. Am02 Substantial Amendment 2 d

12/09/2014 32

10/H0704/43/AM03 Myocardial inflammation and signaling in atrial fibrillation. 3 23/03/2015 23

11/H0703/10/AM05 An Exploratory Clinical and Genetic Study of Cone Disorders Substantial Amendment 4

13/01/2015 19

11/LO/0326/AM02 FIT for Follow-up Study AM02 Substantial Amendment

01/04/2014 28

11/LO/0948/AM03 Comparison of DES in Patients with Diabetes Mellitus 2 02/05/2014 10

11/LO/1226/AM11 Study of DE-109 Intravitreal Injections in patients with Uveitis V1

Substantial Amendment 5:

31.05

09/05/2014 27

11/LO/1559/AM21 SPIKE v4 20 02/10/2014 30

11/LO/1595/AM05 FGFR Substantial Amendment 5:

26/06/2014 15

11/LO/1740/AM13 A4001095 Maraviroc comparator study in antiretroviral naive HIV pts

Substantial Amendment dated

8

08/04/2014 34

12/LO/0315/AM07 Phase 2 Study of Anti-CCR4 MBA KW-0761 in subjects with PTCL

CTA Amendment 5, March 2014

07/04/2014 29

12/LO/0482/AM03 Peruse: Global safety study with pertuzumab in Her2+ advanced BC

AM03 06/08/2014 34

12/LO/0593/AM05 Daratumumab with lenalidomide and dexamethasone in multiple myeloma

AM05 Protocol Amendment 5 date

17/03/2014 32

12/LO/0593/AM06 Daratumumab with lenalidomide and dexamethasone in multiple myeloma


30/01/2015 26

12/LO/0794/AM05 CHR258 in HCC Substantial Amendment 3 - 29

J

20/02/2015 13

12/LO/0944/AM04 Neonatal discharge package to increase parental confidence Substantial Amendment dated

14

14/05/2014 17

12/LO/0949/AM09 C16010: Phase 3 study of MLN9708 in Multiple Myeloma 9 20/06/2014 52

12/LO/0949/AM10 C16010: Phase 3 study of MLN9708 in Multiple Myeloma AM10 Substantial Amendment - P

07/08/2014 4

12/LO/1159/AM04 Randomised Control Trial of Aquamantys vs Electrocautery in Substantial 15/07/2014 27


TKR Amendment 3 dated

12/LO/1159/AM05 Randomised Control Trial of Aquamantys vs Electrocautery in TKR

3 Final 29/08/2014 12

12/LO/1168/AM13 R2W: Randomised phase 2 trial in Waldenstrom macroglobulinaemia


26/09/2014 12

12/LO/1492/AM05 Life Study Substantial Amendment 4

21/03/2014 28

12/LO/1492/AM06 Life Study Substantial Amendment 5.0

date

04/04/2014 21

12/LO/1492/AM07 Life Study 6.0 01/12/2014 23

12/LO/1492/AM08 Life Study 7.0, dated 23rd February 2015

23/02/2015 10

12/LO/1653/AM02 NEPTUNE 2 15/07/2014 21

12/LO/1717/AM07 ZEBRA Substantial Amendment 05

dated

04/06/2014 18


13/06/2014 27


dated

28/11/2014 14

13/LO/0009/AM03 HRV16 challenge study to examine JNJ-43260295 in healthy subjects

AM03 Substantial Amendment 2 d

25/04/2014 26

13/LO/0033/AM15 GO28509 PEGGY - Phase 2 study of GDC-0941 in metastatic breast cancer

13, IB7 July 2014 10/10/2014 26

13/LO/0150/AM04 The regorafenib in patients with hepatocellular carcinoma. Substantial Amendment dated

11

11/12/2014 12

13/LO/0315/AM03 BAMI 4.0 31/10/2014 22

13/LO/0393/AM02 INSIGHT: Investigation into biomarkers to predict preterm birth SA2: 14/04/14 29/04/2014 28

13/LO/0393/AM03 INSIGHT: Investigation into biomarkers to predict preterm birth 3 29/09/2014 27

13/LO/0549/AM04 FG-4592 in the Treatment of Anemia in Chronic Kidney Disease Patients

4 13/06/2014 27

13/LO/0549/AM06 FG-4592 in the Treatment of Anemia in Chronic Kidney 6 19/12/2014 22


Disease Patients

13/LO/0555/AM03 Brain in Pain IV (FM,NCCP) 3 14/03/2014 22

13/LO/0555/AM04 Brain in Pain IV (FM,NCCP) AM04 Substantial Amendment 04

19/09/2014 27

13/LO/0582/AM05 Abiraterone with Different Steroid Regimens in Prostate Cancer

4 20/11/2014 26

13/LO/0582/AM06 Abiraterone with Different Steroid Regimens in Prostate Cancer

5 06/03/2015 25

13/LO/0727/AM02 LDK378 in children with malignancies that have ALK alteration 3 14/08/2014 25

13/LO/0817/AM05 Validation of a scale of GPs’ reassurance during LBP consultations

AM05 Substantial Amendment 5 d

25/04/2014 26

13/LO/0908/AM07 Enzalutamide in Triple Negative Breast Cancer AM07 Substantial Amendment

29/05/2014 24

13/LO/0908/AM08 Enzalutamide in Triple Negative Breast Cancer Substantial Amendment dated

26

26/01/2015 28

13/LO/0926/AM03 Phase 1 study to evaluate safety and efficacy of BMN 190 AM03 Substantial Amendment Cha

11/07/2014 27

13/LO/0926/AM04 Phase 1 study to evaluate safety and efficacy of BMN 190 Amendment 4 15/12/2014

15/12/2014 1

13/LO/0926/AM05 Phase 1 study to evaluate safety and efficacy of BMN 190 Amendment 5 dated 27 Jan 2015

27/01/2015 28

13/LO/1167/AM02 Setting survivorship in context: Life after cancer treatment AM02 Substantial Amendment 02

04/06/2014 23

13/LO/1207/AM01 Stereotactic radiotherapy for wet AMD (STAR) 1 07/11/2014 10

13/LO/1245/AM05 156-12-203: Phase I Tolvaptan in subjects with SIADH (Hormone)

3 02/01/2015 8

13/LO/1284/AM01 ROX CONTROL HTN REGISTRY: Protocol RH-03 Version 1.0, June 19, 2013

AM01 Substantial Amendment 01

11/04/2014 8


Amendment 2 dated 05 Sep 2014

05/09/2014 29


3 06/11/2014 11

13/LO/1399/AM03 Brain in Pain III (CFS) Substantial Amendment 3

19/09/2014 27

13/LO/1401/AM02 FORECAST - Focal Recurrent Assessment and Salvage AM02 Substantial 07/11/2014 31


Treatment Amendment

13/LO/1401/AM03 FORECAST - Focal Recurrent Assessment and Salvage Treatment

3 14/01/2015 27

13/LO/1401/AM04 FORECAST - Focal Recurrent Assessment and Salvage Treatment

Version 4 24/02/2015

11/03/2015 20

13/LO/1437/AM01 Phase I/II study of [124I]mIBG PET/CT in neuroblastoma. AM01 Substantial Amendment 01

08/07/2014 16

13/LO/1437/AM02 Phase I/II study of [124I]mIBG PET/CT in neuroblastoma. AM02 Substantial Amendment

29/01/2015 10

13/LO/1437/AM03 Phase I/II study of [124I]mIBG PET/CT in neuroblastoma. 20/03/2015 11

13/LO/1505/AM01 ICORG 11-10/TH v THL AM01 Substantial Amendment

12/01/2015 12

13/LO/1531/AM02 Medicines management in primary care 2, 24th October 20

14

27/10/2014 5

13/LO/1557/AM01 Circulating Tumour Cells in Somatuline Autogel treated NET patients

Substantial Amendment 1.0:

06.

06/05/2014 9

13/LO/1557/AM02 Circulating Tumour Cells in Somatuline Autogel treated NET patients

2.0 29/01/2015 28

13/LO/1685/AM02 A study of the mechanisms that give rise to vascular disease V2, 2nd Sept 2014 11/09/2014 32

13/LO/1720/AM02 Enzalutamide in Combination with Exemestane in Advanced Breast Cancer

2 29/05/2014 24

13/LO/1720/AM03 Enzalutamide in Combination with Exemestane in Advanced Breast Cancer

3 26/01/2015 28

13/LO/1734/AM01 Experiences of Hearing Voices Network groups, recovery & group process


30/05/2014 13

13/LO/1760/AM01 BAMI Platelet Sub-study AM01 Substantial Amendment 01

23/05/2014 31

13/LO/1885/AM01 Patient Evaluation of the NHS Health Check Programme AM01 Substantial Amendment 01

10/09/2014 16

13/LO/1943/AM01 PDOPPS 1 04/11/2014 3

13/LO/1943/AM02 PDOPPS 2 15

14/LO/0021/AM01 CE Mark Home Self-Test finger blood Total WBC, HGB, GRN, + Temperature


23/01/2015 18

14/LO/0122/AM02 Safety, tolerability & pharmacokinetics of regorafenib in Am1 final 08/08/2014 35


paediatrics

14/LO/0122/AM04 Safety, tolerability & pharmacokinetics of regorafenib in paediatrics

Updated dosing diary, 15906,

13/11/2014 9

14/LO/0122/AM05 Safety, tolerability & pharmacokinetics of regorafenib in paediatrics

4 03/12/2014 14

14/LO/0132/AM01 Robotic Surgery After Focal Ablation Therapy (RAFT) Am01 Substantial Amendment 01

18/11/2014 24

14/LO/0141/AM02 iMAP2 1 15/08/2014 28

14/LO/0141/AM03 iMAP2 2 12/02/2015 10

14/LO/0141/AM04 iMAP2 3 09/12/2014 4

14/LO/0165/AM01 Sickle Cell Analgesia Protocol Evaluation (SCAPE) 1 19/03/2015 27

14/LO/0235/AM02 Investigating women's views on the management of a breech pregnancy V1

2 23/06/2014 32

14/LO/0317/AM01 NeoAdapt 1 AM01 Substantial Amendment 01

29/05/2014 17

14/LO/0318/AM01 NeoAdapt 2 AM01 Substantial Amendment 01

29/05/2014 17

14/LO/0319/AM01 NeoAdapt 3 Am01 Substantial Amendment 01

29/05/2014 17

14/LO/0418/AM01 CEDAR AM01 Substantial Amendment 01

23/05/2014 24

14/LO/0465/AM01 PATRIOT AM01 Substantial Amendment 01

25/09/2014 28

14/LO/0485/AM04 Asthma Viral Challenge study 2 13/08/2014 30

14/LO/0506/AM01 Investigating immunogenicity to biopharmaceutics version 2 RevisedÂ VersionÂ

3,Â 27/03/2015

31/03/2015 21

14/LO/0527/AM04 GO28754 Anti-PDL1 in locally advanced or metastatic NSCLC 1 15/08/2014 25

14/LO/0527/AM05 GO28754 Anti-PDL1 in locally advanced or metastatic NSCLC 2 05/11/2014 12

14/LO/0527/AM06 GO28754 Anti-PDL1 in locally advanced or metastatic NSCLC Substantial Amendment dated

22

22/01/2015 25

14/LO/0527/AM07 GO28754 Anti-PDL1 in locally advanced or metastatic NSCLC Substantial Amendment #4

12/02/2015 8

14/LO/0641/AM01 1335P1514: S-222611 in combination with anticancer treatments

1 10/09/2014 33


14/LO/0641/AM02 1335P1514: S-222611 in combination with anticancer treatments

UK EC SA#3 Protocol v5.0

20/03/2015 24

14/LO/0667/AM01 MK-5172/MK-8742 in Subjects with HCV/HIV Co-Infection Substantial Amendment 1

dated

30/06/2014 11

14/LO/0667/AM02 MK-5172/MK-8742 in Subjects with HCV/HIV Co-Infection Am02 Substantial Amendment 02

29/09/2014 27

14/LO/0668/AM01 Automated brain morphometry for dementia diagnosis (BrainMeasure)

1 04/02/2015 0

14/LO/0680/AM02 MEDI4736 in NSCLC (D4191C00003, ATLANTIC Study) 2 11/09/2014 29



14/LO/0750/AM01 CIRCULER, Version 1.0 1 28/07/2014 30

14/LO/1139/AM01 A Phase 2 Study to Evaluate AMG 334 in Chronic Migraine Prevention

Substantial Amendment 01

10/12/2014 13

14/LO/1182/AM01 Iloprost in patients with Eisenmenger Syndrome 1 17/09/2014 26

14/LO/1182/AM02 Iloprost in patients with Eisenmenger Syndrome 2 09/01/2015 22

14/LO/1184/AM01 Masitinib/Placebo + Gemcitabine + FOLFIRI.3 in Pancreatic Cancer V1

AM01 27/10/2014 19

14/LO/1184/AM04 Masitinib/Placebo + Gemcitabine + FOLFIRI.3 in Pancreatic Cancer V1


26/01/2015 23

14/LO/1185/AM01 Testing a new stepwise strategy for the management of renal anaemia

1 01/10/2014 28

14/LO/1193/AM01 Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia

1 14/11/2014 34


AM02 Substantial Amendment IB

21/01/2015 5


Substantial Amendment

25/02/2015 15

14/LO/1443/AM02 Pyrenees Substantial Amendment

21/01/2015 14

14/LO/1514/AM01 An Open Label Study of CORâ€”003 on the treatment of Cushing's syndrome


03/02/2015 11

14/LO/1737/AM01 U31287-A-U106 13/01/2015 20

14/LO/1939/AM01 Octreotide as prophylaxis for lapatinib-capecitabine related diarrhoea


03/02/2015 12


Table 10.2: Breakdown of current status of all modified amendments reviewed within the reporting period

14/LO/2167/AM01 Adalimumab (HUMIRAÂ®) use in patients with Ulcerative Colitis


22/01/2015 17

14/LO/2184/AM01 Impact of Physical activity and Vitamin D on osteoarthritic knee pain


03/02/2015 13

15/LO/0006/AM01 Open-Label Extension to the Odanacatib Fracture Trial (PN018)

SA01 05/02/2015 9

15/LO/0023/AM02 Cardamon trial 1 26/03/2015 26

15/LO/0182/AM02 TIGER-3 2.1 17/03/2015 14

MSA RETRO 11 1 SB/AM07

rotocol to identify suitable volunteers for inclusion Retroscreen Pane

18 30/06/2014 10

MSA RETRO 11 1 SB/AM08

rotocol to identify suitable volunteers for inclusion Retroscreen Pane

19 04/08/2014 28

Unfavourable opinion

Amendment REC

Reference


Clock

07/Q0603/29/AM09 ACIT II: Version 1.3 8.0 (06/11/2014) 09/02/2015 34

10/H0704/78/AM04 The Relationship between gut microbiota and diseases (version1)

4 15/01/2015 33

11/LO/0241/AM07 Parkinson’s Progression Markers Initiative 7 16/06/2014 22

12/LO/0794/AM04 CHR258 in HCC 4 25/09/2014 28

13/LO/1801/AM01 The Men’s Safer Sex (MenSS) Trial: a website to increase condom use


23/05/2014 34

14/LO/0235/AM01 Investigating women's views on the management of a breech pregnancy V1

AM01: Amendment 1

07/04/2014 29

Favourable opinion timeline

Amendment REC Title Version Date Number of Days on


Reference Clock

11/LO/0241/AM07/1 Parkinson’s Progression Markers Initiative Modified Amendment

22/07/2014 8

13/LO/1801/AM01/1 The Men’s Safer Sex (MenSS) Trial: a website to increase condom use

Modified Amendment to

AM01 Sub

21/08/2014 7

Unfavourable opinion timeline

Amendment REC

Reference


Clock


Table 11: Items exceeding timelines

Full applications for ethical review over 60 day timeline


Proportionate review applications for ethical review over 14 day timeline


15/LO/0189 TAC Registry (Study Name: CHORUS) 15

SSAs (non Phase 1) over 25 day timeline


SSAs (Phase 1) over 14 day timeline


Substantial Amendments over 35 day timeline

Amendment REC

Reference


Clock

12/LO/0949/AM09 C16010: Phase 3 study of MLN9708 in Multiple Myeloma 9 20/06/2014 52

Modified Amendments over 14 day timeline

Amendment REC

Reference


Clock

Documents

RES Committee London - City & East Annual Report 01 April ... · Lewins Mead Bristol BS1 2NT Telephone: 01173421386 Email: [email protected]. RES Committee