Introduction
Andy Vail, RDS NW Associate Director
Introduction Andy Vail, RDS NW Associate Director Programme Part - - PowerPoint PPT Presentation
Introduction Andy Vail, RDS NW Associate Director Programme Part I: Morning session - 10.00 am to 12.30 pm 10.00 am Introduction 10.10 am How the Research Design Service can help you 10.20 am Importance of Patient and Public Involvement
Andy Vail, RDS NW Associate Director
Part I: Morning session - 10.00 am to 12.30 pm
10.00 am Introduction 10.10 am How the Research Design Service can help you 10.20 am Importance of Patient and Public Involvement 10.30 am Introduction to NIHR funding programmes (video) 10.50 am Questions – please use the chat facility 11.10 am Break 11.20 am The Supporting Network – Clinical Research Network (CRN) and Clinical Trials Units (CTU) 11.45 am The i4i funding programme 11.55 am Questions – please use the chat facility 12.10 pm End of morning session – stories from successful applicants (videos)
Part II: Virtual Marketplace - 1.30 pm to 3.30 pm For those who have signed up.
Thomas Allen, RDS NW Adviser
@NIHR_RDSNW
Research Design Service North West
Provides advice on research design to researchers to develop high quality research proposals for national, peer-reviewed funding competitions for applied health or social care research.
Example of funders where we can advise
Funding needs to be national and peer reviewed. Research needs to be in applied health or social care.
Our expertise
See www.rds-nw.nihr.ac.uk/about-us/expertise-a-z for more examples
We can also help with
Social Care events.
Find all our resources at - www.rds-nw.nihr.ac.uk Sign-up for information and news - www.rds-nw.nihr.ac.uk/about-us/rds-nw-mailing-list
Complete an advice request form Case manager will provide advice and/or other advisers will provide advice Depending on your requirements, you will be advised face-to-face via email, video conference or telephone. If eligible you will be allocated a case manager and/or you will be signposted to other sources of help
Depending on your needs we may cover:
“Support from the RDS has been invaluable in guiding us through the complexities of the application process. The blend of structured meetings and one-to-one support was very helpful. The team also had excellent contacts with relevant expertise that could support our proposal.” Consultant Clinical Psychologist
Hear from our clients at www.rds-nw.nihr.ac.uk/our-clients
How to access the service
01524 593209
@
rds.nw@nihr.ac.uk
WWW
www.rds-nw.nihr.ac.uk/request-advice @NIHR_RDSNW
Suzanne Parsons, RDS NW Specialist Public Involvement Adviser
than ‘to’, ‘about’ or ‘for’ them
care services
research priorities, commenting on and developing research materials, co-applicant on bid, undertaking interviews with research participants etc What it’s not:
2025
developed by Chief Scientist Office (Scotland), Health and Care Research Wales, the Public Health Agency (NI) and the NIHR (England) “Our vision is for a population actively involved in and engaged with research to improve health and wellbeing for themselves, their family and communities” (NIHR Going the Extra Mile)
including patient and public members
Applications should demonstrate evidence of:
https://www.rds-nw.nihr.ac.uk/public-involvement/
competitions for applied health or social care research
planned public involvement activity
https://www.rds-nw.nihr.ac.uk/public-involvement/fund/
Can you demonstrate sufficient public involvement in the development of the application? If not, consider applying to public involvement fund What plans are in place for public involvement during the research? Has a budget been included for public involvement during the research? Is your plan English summary understandable?
NIHR funding programmes overview
Broad research area EME HS&DR HTA i4i PGfAR PDG PHR PRP RfPB SR Public health Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Health services and organisation No Yes Yes No Yes Yes No Yes Yes Yes Clinical evaluation and translation Yes No Yes Yes Yes Yes No Yes Yes Yes Technology development No No No Yes No No No Yes No No Social care Yes Yes Yes No Yes Yes Yes Yes Yes Yes Types of evidence EME HS&DR HTA i4i PGfAR PDG PHR PRP RfPB SR Evidence synthesis No Yes Yes No Yes Yes Yes Yes Yes Yes Evidence generation Yes Yes Yes Yes Yes Yes Yes Yes Yes No Programmes
No Yes No No Yes Yes Yes Yes No Yes
Funding calls, amounts and length
EME HS&DR HTA i4i PGfAR PDG PHR PRP RfPB SR Calls and competitions (number of opportunities to apply per year) Researcher-led 3 3 3 3 3 3 3* N/A 3 1* Commissioned 3 3 3 1* N/A N/A 3* 3* N/A N/A Themed Frequency as advertised EME HS&DR HTA i4i PGfAR PDG PHR PRP RfPB SR Funding amounts and periods Funding limit** No limit No limit No limit No limit No limit*** £100k No limit No limit**** £350k £400k## Period of funding No fixed period No fixed period No fixed period Up to 3 years# No fixed period*** 0-18 months No fixed period No fixed period**** Up to 3 years Up to 3 years
* Subject to change. ** Applicants must fully justify all costs. *** Period and level of funding depends on nature of proposed work, in particular whether a fully powered evaluative is included – funding above £2.5 million will be unusual. Programmes terminating in feasibility studies will be unlikely to receive more than £500,000. **** Period and level of funding depends on the requirements of the research specification. # For i4i Connect, the funding limit is £150,000 and the maximum duration is 12 months. For Challenge, the maximum duration is five years. ## Researcher-led period is 9-12 months with funding limit of £5000. Commissioned-led is every 3 years with a funding limit of £400,000.
Funding Streams
Commissioned work stream Designed to meet the needs of decision makers, typically but not exclusively within NHS. Researcher-led work stream Calls for applications on research topics/questions directly proposed by researchers. Theme calls Calls in priority areas e.g. Injuries, accidents and urgent and emergency care – see www.nihr.ac.uk/explore-nihr/funding- programmes/themed-calls.htm
MRC-NIHR Efficacy and Mechanism Evaluation (EME)
This Programme primarily supports clinical trials, and other robustly designed studies that test the efficacy of interventions. The Programme looks to attract studies with novel methodological designs that deliver results more efficiently, reduce the study timeline, and maximise the knowledge gained.
www.nihr.ac.uk/eme
NIHR Health Technology Assessment (HTA)
This programme supports research that is immediately useful to patients, clinical practice, and policy or decision makers.
www.nihr.ac.uk/hta
NIHR Health Services & Delivery Research (HS&DR)
This programme funds research to produce evidence to impact on the quality, accessibility and organisation of health and social care
might improve delivery of services.
www.nihr.ac.uk/hsdr
NIHR Public Health Research (PHR)
The primary aim of the programme is the evaluation of practical
also some preparatory research, and secondary research i.e. evidence synthesis.
www.nihr.ac.uk/phr
NIHR Invention for Innovation (i4i)
The aim of this programme is to de-risk early stage projects that have a strong potential for commercialisation and acceptance for use in the NHS, making them attractive to follow-on funders and investors. i4i funds collaborative research projects that have demonstrated proof-of-principle and have a clear pathway towards adoption and commercialisation.
www.nihr.ac.uk/i4i
NIHR Research for Patient Benefit (RfPB)
This programme supports research that is concerned with the day- to-day practice of health service staff. Research proposals should have a clear trajectory towards benefiting the health or wellbeing of patients and users of the NHS.
www.nihr.ac.uk/rfpb
NIHR Research for Social Care (RfSC)
Research for Patient Benefit is now running a dedicated social care funding call every year, starting September 2019. This is an annual call for social care research proposals.
www.nihr.ac.uk/documents/nihr-research-for-social-care-rfsc-call-specification/21740
NIHR Programme Grants for Applied Research (PGfAR)
The aim of this funding programme is to deliver research findings that will lead to clear and identifiable patient benefits, typically through promotion of health, prevention of ill health, and optimal disease management, including safety and quality.
www.nihr.ac.uk/pgfar
NIHR Programme Development Grants (PDG)
This funding programme is designed to position and equip a research team in submitting a competitive research proposal to PGfAR in the future.
www.nihr.ac.uk/pdg
NIHR Policy Research Programme (PRP)
This programme funds high quality research to deliver robust, relevant, timely, accessible and intelligible evidence to government and arms-length bodies.
www.nihr.ac.uk/prp
NIHR Systematic Reviews (SR)
Systematic reviews identify, evaluate, combine and summarise the findings of all relevant individual studies, to provide decision makers with the best possible information about the effects of tests, treatments and other interventions used in health and social care.
www.nihr.ac.uk/sr
Dace Dimza-Jones Industry Facilitator
(...because Manchester “CAN” and delivers today, “what the world does tomorrow”)
Dayle Roberts Assistant Research Delivery Manager
to innovate, shape and create the best possible healthcare for the current and future generations of Greater Manchester and increase the wealth of population.
Facilitate research delivery within the NHS and non-NHS settings
Non-NHS settings
Schools Care homes Hospices Prisons
Academic studies Commercial studies
15 Local Clinical Research Networks
Green Domain
Delivering research across 30 clinical specialties
Infectious diseases & microbiology Injuries & emergencies Mental Health Metabolic & endocrine disorders Musculoskeletal disorders Neurological disorders Ophthalmology Oral & dental heath Primary Care Public Health Renal Disorders Reproductive health & childbirth Respiratory disorders Stroke Surgery Ageing
Anaesthesia, Perioperative Medicine & Pain Management
Cancer Cardiovascular disease Children Critical Care Dementias & neurodegeneration Dermatology Diabetes Ear, nose & Throat Gastroenterology Genetics Haematology Health Services & delivery research Hepatology
Primarily funded by the Department
receive UK Aid funding to support research for people in low- and middle-income countries. Nation's largest funder of health and care research Provides the people, facilities and technology that enables research to thrive Works in partnership with the NHS, universities, local government, other research funders, patients and the public, delivering and enabling world- class research that transforms people's lives, promotes economic growth and advances science.
Coordinating Centre
Manages the CRN
Department of Health and Social Care.
Time and Target
Deliver NIHR CRN Portfolio studies to recruitment target within the planned recruitment period
Participant Recruitment
Deliver significant levels
in NIHR CRN Portfolio studies
New Commercial Studies
Increase the number of studies delivered for the commercial sector with support from the NIHR Clinical Research Network
Provider Participation
Widen participation in research by enabling the involvement of a range of health and social care providers
Dementia and Neurodegeneration Recruitment
Deliver significant levels of participation in NIHR CRN Portfolio Dementias and Neurodegeneration (DeNDRoN) studies
Participant Experience
Demonstrate to people taking part in health and social care research studies that their contribution is valued
Site Set-up
Reduce intra-study site set-up times for NIHR CRN Portfolio studies
Local Specialties
Improve access to research by increasing recruitment in priority specialties (including difficult to reach groups)
We support delivery of research across
Population of almost 3 million
Commercial 28.49% Academic 71.51%
25.1% Median
Help to increase the opportunities for participants to take part in clinical research Ensure that studies are carried out efficiently ( to time and target)
Support the Government’s Strategy for UK Life Sciences by improving the environment for commercial contract clinical research
11 Clinical Commissioning Groups
More than 500 GP practices and pharmacies
GM LCRN share of English recruitment in FY 2019/20 is 6.9%
10K 20K 30K 40K 50K 60K 70K 80K 90K 100K 10.00K 20.00K 30.00K 40.00K 50.00K 60.00K 70.00K 80.00K 90.00K 100.00K Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar
Recruitment Cumulative Target
Recruitment Cumulative Target
Interventional Observational Both 48 % 44 % 7 %
1st to recruit to Time and Target (Commercial)
PAT-POPS is 3rd highest recruiting study ever
One of the most commercially active networks
High number of
1st 1st 1st
Global
Europien UK
Competitive Global market
Commercial 28.49% Academic 71.51%
25.1% Median
Company approaches PI/Study team directly PI/Study team decides to carry/not to carry out the study Study successfully
4
LCRN send EOI to the suggested PI/Study teams PI/Study team has 5-10 days to respond LCRN returns competed EOIs to NIHR CC
5
EOIs from across England submitted to Sponsor/CRO Sponsor decides which site will be site selected
6 Study successfully
1
Company approaches NIHR CC
2
Site ID Process EOI forms sent to LCRNs
3
LCRN (Speciality lead) identifies potencial PIs/Sites
Expression
Expressions of interest
Realistic recruitment targets Specialty lead
Recommendations Local intelligence Local feasability
Industry Facilitator
3 Business Days 7-9 Business Days 1 Business Day
Spot where the support
Business Development
Our experienced team has strong relationships with researchers and the industry. We are present at every step
conversation to ensure swift study set up and delivery
Industry team
Dedicated IOM alongside with research facilitators ensure that every study is performance managed and recruit to time &
support & assistance to sponsors and CROs
Type something
janet.eastwood@mft.nhs.uk david.pickthall@mft.nhs.uk
Raise the profile of clinical research Promote the importance of clinical research with local service providers and provide communications expertise to staff/partners Work with local clinicians and patents to develop stories (case studies) Deliver local elements of national campaigns i.e. ‘Be Part of Research’ Events represent the network and help to arrange networking events
Help you to promote studies Branding, leaflets, materials, social media – events etc. Celebrate success – global firsts Campaigns and Awareness Weeks
Be n Ha rdwic k Supe rvising T ria ls Ma na g e r L ive rpo o l Clinic a l T ria ls Ce ntre Unive rsity o f L ive rpo o l
T
he NI HR pa ne l inc re a sing ly re q ue st CT U suppo rt e ve n fo r fe a sib ility studie s. CT U c o lla b o ra tio n re a ssure s the pa ne l tha t the de sig n a nd de live ry o f the tria l will b e ro b ust a nd o ptimise a c c rua l.
Spe c ia list units with a spe c ific re mit to de sig n, c o nduc t, a na lyse a nd
pub lish c linic a l tria ls & o the r we ll-de sig ne d studie s
Pro vide spe c ia list sta tistic a l, e pide mio lo g ic a l, me tho do lo g ic a l
a nd c o o rdina tio n e xpe rt a dvic e ne e de d to unde rta ke suc c e ssful c linic a l tria ls
ria l c o -o rdina to rs a re the ma in c o nta c t fo r a tria l a nd ke y to the suc c e ssful tria l de live ry.
T ria l ma na g e me nt
size c a lc ula tio ns, c o mple te inte rim a nd fina l a na lyse s in a c c o rda nc e with the Sta tistic a l Ana lysis Pla n. I nput fo c use s o n the pla nning pha se , mo nito ring da ta q ua lity, inte rim a nd fina l a na lyse s.
Sta tistic s
S pro g ra mme rs de ve lo p b e spo ke a pplic a tio ns fo r ra ndo misa tio n a nd da ta c o lle c tio n syste ms a nd a lso tria l we b site s a nd mo b ile a pplic a tio ns
I nfo rma tio n Syste ms
T he y a re invo lve d in the tria l fro m the pla nning sta g e a nd a re invo lve d in CRF De sig n, Da ta e ntry a nd Da ta Que rying
Da ta Ma na g e me nt
Asse sse d by international
review committee
key competencies & evaluation criteria
CT Us (47 F ull/ 6 pro visio na l)
T SCC Suppo rt funding fo r Re g iste re d CT Us
to se a rc h fo r CT Us
www.ukcrc-ctu.org.uk
Sta tistic s & Me tho do lo g y F
e a sib ility
Budg e t T
ime ly sub missio n to F unde r
Advic e o n e sta b lishme nt a nd c o nstitutio n o f I
DSMC & T SC
L
ia iso n with Spo nso r
T
ria l supplie s
Links to other expertise (e.g. Health Economics) Pre -a pplic a tio n c o ntrib utio n no t c o ste d to g ra nt Po st a wa rd c o ntrib utio n c o sts inc lude d in a wa rd
Pro to c o l de ve lo pme nt Co o rdina te me e ting s o f o ve rsig ht c o mmitte e s L
ia ise with spo nso r
Ma na g e me nt o f tria l supplie s CRF
a nd da ta b a se de ve lo pme nt (E lse vie r MACRO,
T
ria l a ppro va ls – e thic a l, re g ula to ry, institutio na l
E
sta b lish/ ma inta in E sse ntia l Do c ume nts c e ntra lly
Site initia tio n a nd o ng o ing c o mmunic a tio n
Prima ry c o nta c t Sa fe ty mo nito ring / re po rting Pro g re ss re po rts, a me ndme nt no tific a tio n Mo nito r a c c rua l Ong o ing da ta b a se suppo rt, da ta q ue ry re so lutio n I
nte rim sta tistic a l a na lysis a s pe r a na lysis pla n
Org a nise a nd pre pa re re po rts fo r o ve rsig ht
c o mmitte e s
No tific a tio n o f the e nd o f the tria l Arc hiving a rra ng e me nts
As e a rly a s po ssib le CT
I MP (usua lly)
Multi-c e ntre RCT
(CT I MP/ no nCT I MP)
Multi-c e ntre pilo t/ fe a sib ility Me tho do lo g y Hig h risk Pro po se d funde r Co sts fo r CT
U a re inc lude d in g ra nt a pplic a tio ns
Steven Lane – RDS NW Adviser and I4I champion
I4I
medical devices in areas of existing or emerging patient need.
early stage projects that have a strong potential for commercialisation and acceptance for use in the NHS.
adoption and commercialisation.
I4I
device, technology or intervention.
Product Development Award (PDA) Connect Award Challenge Award. Two-stage application process.
PDA
development pathway.
institution or Small to Medium enterprise (SME)
applications per year.
PDA
What is funded:
diagnostic devices.
clinical use.
sectors that could impact in health care.
Challenge awards
care need.
patients.
nearly CE marked technologies and what is required by commissioners and regulators.
Challenge awards
What is funded:
innovations in real-world setting.
case for adoption.
Connect award
development pathway – apply for further funding PDA.
projects at any stage
the translational research and development pathway to follow-on investment.
Thank you
Watch two RDS NW clients speak about their experiences next or later at:
clients-video-shalom-srirangam
clients-videos-professor-simon-rogers