Name of Lead PI: / Clinical Trial Grant
Amount Applying for: / Application Form 2013

Clinical Trial Grant (CTG)2013

Application Form

Co-Development Scheme (Co-D)

Investigator-Initiated Trials - Early Phase Scheme(IIT-E) Investigator-Initiated Trials - Late Phase Scheme (IIT-L)

CLOSING DATE FOR CO-D SCHEME:None

CLOSING DATE FOR IIT-E & IIT-L SCHEMES:30April 2013 (Tuesday), 5pm

The submission must comprise the endorsed original hardcopy application and its soft copy (in Word & PDF format in a CD). Applications must be submitted to NMRC, MOH, through the Research Office of the Lead Principal Investigator’s (PI’s) Host Institution, to this address:

(Attn: Sharon Ling / Jennifer Lee)

Clinical Trial Grant (CTG)

National Medical Research Council

11 Biopolis Way

#09-10/11 Helios

Singapore 138667

For further enquiries, you may contact Dr Sharon Ling at or Ms Jennifer Lee at .

NMRC Clinical Trial Grant(CTG) Application Form Checklist

Please ensure that you have completed and included all the items indicated in this checklist below, before submitting your Clinical Trial Grant Application Form.

1. Lead PI isadvised to familiarize themselves with the following documents before applying:

( )NMRC Research Grant T&Cs & Finance T&Cs (available from )

( )Budgeting Requirements – Please refer to the annex of the NMRC Policy Document on Financial Regulations

2. Your Application Form should consist of the following:

( )Category of Research Proposal

( )CTG Scheme

( )Title of Research

( )Name of Lead PI and Host Institution

( )Applicants

( )Funding Request

( )Period of Support Requested

( )Key Words

( )Field of Research

( )Ethical Considerations and Containment

( )ScientificAbstract and Lay Abstract

( )Details of Research Proposal Limited to 15 pages (Sections 13.1 to 13.9); Attach References (Section 13.6 asAnnex1).

( )Biographical Sketch of Lead PI, Co-Is and Collaborators, and declare all vested interestsLimited to 3 pages for the Lead PI, 2 pages each for Co-Is and Collaborators

( )Budget for Research Team (Breakdown & Justifications for Manpower, Equipment and Other Operating Expenses (OOE))

( )Industrial Parties’ Contributions

( )Milestones/ Timeline

( )Expected Outcomes

( )Other support – Attach scientific abstracts of all grants listed in Section 19, KPIs of currently held NMRC grants and document detailing areas of overlap where applicable (Annex C)

( )Peer Review – Inappropriate Reviewers (Conflict of Interest) and Suggested Names of Reviewers

( )Undertaking by Lead Principal Investigator (PI)

( )Undertaking by Head of Department (HOD) & Host Institution

Annexes (if applicable)

( ) Annex A –For Section 10, a copy of the ethics approval

( )Annex B – For Section 13.3.3, attached past reviewers’ comments, reviewers’ report, rebuttal,comments and response to panel (where applicable)

( )Annex C – For Section 19,attach scientific abstracts of all grants listed, KPIs of currently held NMRC grants and document detailing areas of overlap (where applicable)

3. Submission:

( )Softcopyapplication form:

For Co-D Scheme, save as file name as

“CTG_COD_2013_Lead PI Name_Institution Name”;

For IIT-E Scheme, save as file name as

“CTG_IITE_Jan2013_Lead PI Name_Institution Name”;

For IIT-L Scheme, save as file name as

“CTG_IITL_Jan2013_Lead PI Name_Institution Name”

( )Hardcopy application form, with all required signatures and endorsed by corresponding Host Institution's Research Director must be submitted through the lead PI’s Office of Research or equivalent.

Important: Every section/field must be completed. Please indicate “N.A.” if any section/field is not applicable. Incomplete applications will be rejected.

Application for Clinical Trial Grant (CTG)

All information is treated in confidence. The information is furnished to the National Medical Research Council (NMRC) with the understanding that it shall be used or disclosed for evaluation, reference and reporting purposes. If your application is not successful, this form will be destroyed after the retention period deemed as appropriate by the Council.

  1. Category of Research Proposal

Please indicate the relevant information if your proposal is a renewal or resubmission.

New Submission

Renewal (Grant number)

Resubmission

(Application ID & No. of resubmissions inclusive of current application)

  1. Category of CTG Scheme

Please indicate the CTG Scheme that you are applying for.

Co-Development (Co-D)

Investigator-Initiated Trials – Early Phase (IIT-E)

Investigator-Initiated Trials – Late Phase (IIT-L)

  1. Title of Research(Limit to 300 characters)
  1. Name of Lead Principal Investigator[1] & Host Institution[2]

Name of lead PI,NUHS
  1. Applicants

Please note that the definitions of a Lead Principal Investigator (Lead PI), Co-Investigator (Co-I) and Collaborator,as indicated in the footnote. Co-Investigators need to hold at least an adjunct position in a local public institution. Researchers from overseas institutions or private companies can only participate as collaborators.

Applicant / Role / Position / Department / Institution
Lead Principal Investigator
(Lead PI)
E.g. / Co-Investigator
(Co-I)[3]
E.g. / Collaborator[4]
E.g. / Industry Collaborator[5]

(*Please add more rows if required)

  1. FundingRequest

Please indicate the CTG Scheme that you are applying for and the amount of funds requested.

Co-Development Scheme:Funding is capped at SGD 5M, inclusive of 20% indirect costs

Investigator-Initiated Trials – Early Phase Scheme:Funding is capped at SGD 5M, inclusive of 20% indirect costs

Investigator-Initiated Trials – Late Phase Scheme:Funding is capped at SGD 2M, inclusive of 20% indirect costs

Total Amount of Fund Applying for:SGD

  1. Period of Support Requested

Up to a period of 3 years

Number of years:

  1. Key Words (Mandatory. Please provide maximum 6 key words)
  1. Field of Research

Please fill in the Health Research Classification (HRC) System below with reference to the list attached as Appendix 1 in the IRG Guide. The HRC System is adapted from MRC, UK.

(A) Health Category

You may select up to 5 categories from the followings. Please use the minimum number of codes to reflect the main focus of the research.

Blood / Musculoskeletal
Cancer / Neurological
Cardiovascular / Oral and Gastrointestinal
Congenital Disorders / Renal and Urogenital
Ear / Reproductive Health and Childbirth
Eye / Respiratory
Infection / Skin
Inflammatory and Immune System / Stroke
Injuries and Accidents / Generic Health Relevance
Mental Health / Other
Metabolic and Endocrine

(B) Research Activity Code

You may select up to 2 sub-codes from the followings, eg, 2.1.

1 Underpinning Research

1.1 Normal biological development and functioning

1.2 Psychological and socioeconomic processes

1.3 Chemical and physical sciences

1.4 Methodologies and measurements

1.5 Resources and infrastructure (underpinning)

2 Aetiology

2.1 Biological and endogenous factors

2.2 Factors relating to physical environment

2.3 Psychological, social and economic factors

2.4 Surveillance and distribution

2.5 Research design and methodologies (aetiology)

2.6 Resources and infrastructure (aetiology)

3 Prevention of Disease and Conditions, and Promotion of Well-Being

3.1 Primary prevention interventions to modify behaviours or promote well-being

3.2 Interventions to alter physical and biological environmental risks

3.3 Nutrition and chemoprevention

3.4 Vaccines

3.5 Resources and infrastructure (prevention)

4 Detection, Screening and Diagnosis

4.1 Discovery and preclinical testing of markers and technologies

4.2 Evaluation of markers and technologies

4.3 Influences and impact

4.4 Population screening

4.5 Resources and infrastructure (detection)

5 Development of Treatments and Therapeutic Interventions

5.1 Pharmaceuticals

5.2 Cellular and gene therapies

5.3 Medical devices

5.4 Surgery

5.5 Radiotherapy

5.6 Psychological and behavioural

5.7 Physical

5.8 Complementary

5.9 Resources and infrastructure (development of treatments)

6 Evaluation of Treatments and Therapeutic Interventions

6.1 Pharmaceuticals

6.2 Cellular and gene therapies

6.3 Medical devices

6.4 Surgery

6.5 Radiotherapy

6.6 Psychological and behavioural

6.7 Physical

6.8 Complementary

6.9 Resources and infrastructure (evaluation of treatments)

7 Management of Diseases and Conditions

7.1 Individual care needs

7.2 End of life care

7.3 Management and decision making

7.4 Resources and infrastructure (disease management)

8 Health and Social Care Services Research

8.1 Organisation and delivery of services

8.2 Health and welfare economics

8.3 Policy, ethics and research governance

8.4 Research design and methodologies

8.5 Resources and infrastructure (health services)

  1. Ethical Considerations and Containment

Fund disbursement is subjected to ethics approval if the project involves any of the below.

Please declare the participating institutions where study requiring ethics approval isconducted:

Please tick accordingly if programme involves any of the following:

a)Human Subject Yes No

b)Use of Human Material/ Yes No

Animal Tissues or Cells

from Primary Donors

(i.e. subject/volunteers recruited for project)

c)Use of Commercially Available Yes No

Human Material/

Animal Tissues or Cells

d)Animal Experimentation Yes No

e)Requirement for Containment Yes No

f)Multi-centre trial(s) Yes No

(If yes, please state all participating institutions/centres:

)

A copy of the ethics approval is attached(Please attach as Annex A, if applicable):

Yes No

  1. Scientific Abstract

In no more than 300 words, concisely describe the specific aims, hypotheses, methodology and approach of the research proposal including its importance to the furtherance of medical science, in particular clinical significance. The abstract must be self-contained so that it can serve as a succinct and accurate description of the research proposal. Note that the scientific abstract may be disclosed to other funding agencies, national regulatory bodies and external consultants which are involved in conducting market assessment and have signed a Conflict of Interest and Non-Disclosure Agreement.

  1. Lay Abstract

In no more than 300 words, concisely describe the specific aims, hypotheses, methodology and approach of the research proposal including its importance to the furtherance of medical science, in particular clinical significance. The abstract must be self-contained so that it can serve as a succinct and accurate description of the research proposal. Note that the lay abstract is different from the scientific abstract. It is targeted towards non-technical readers and may be disclosed to the media for the purpose of the announcement of the grant call results.

  1. Research Proposal

In no more than 15 pages (page limit excludes the reference section), include the following sections in the research proposal. Please use Arial font size 10 for all text.

13.1Background, Clinical Need & Significance

Please provide the background of the clinical need and its significance, including the following:

  • Current treatment options or tools/methods
  • Cost of current treatment options for patients
  • Specifically define the problem/treatmentgaps and shortcomingsof current treatment which the project intends to fill
  • Market size of this clinical need (eg. target patients, incidence and/or prevalence of clinical need, total amount spent per year to address this clinical problem, target segment of market (eg. premium or value))

13.2How the Research Furthers the Vision/Missions of NMRC

Define and describe specifically on indicators that will be achieved by the research and how they can further the vision/missions of NMRC.

NMRC’s vision is to translate research for better health.

NMRC’s missions are to promote excellence in translational and clinical research; nurture a vibrant research community of clinicians and enhance knowledge translation for better health and economic outcomes.

The impact of NMRC funded research should be assessed by better health outcomes*, medical practice and cost-effectiveness of healthcare delivery.

*includes survival, morbidity, quality of life

13.3Proposed Therapeutic/Medical Device Solution

13.3.1Overview of Solution

Please provide details of the proposed therapeutic/medical device solution proposed to meet the clinical need described above.

  • Describe the solution to the above clinical need
  • Describe the underlying scientific or technological techniques and/or principlesof the proposed solution
  • How proposed solution will be better than existing/emerging competing technologies
  • How the clinical trial will differ from or complement any relevant planned, ongoing or recently completed trials in Singapore or internationally
  • Technical challenges involved
  • Novelty of approach of proposed solution

13.3.2Specific Aims & Hypothesis

State concisely and realistically what the study intends to accomplish and what hypothesis is to be tested.

13.3.3Preliminary Studies/Progress Report

For NEW APPLICATIONS: provide an account of the Principal Investigator’s/Industry’s preliminary studies eg. proof-of-concept, proof-of-validation, feasibility studies / pilot trial, pre-clinical work,and any other information that will help to establish the potential of the proposed project and also exhibit the experience and competence of the investigator pursuing the proposed project.

For RESUBMISSION/APPLICATIONS that have been previously submitted to other NMRC research grants:In addition to an account of the Principal Investigator’s/Industry’s preliminary studies (please see “FOR NEW APPLICATIONS”), please provide a document itemizing how the current proposal has addressed past reviewers’/panel’s comments, and highlight new features or merits of the current proposal. (Please include reviewers’ report of previous unsuccessful application; rebuttal to the external reviewers; panel’s comments and response to the panel (where applicable) as Annex B.

13.3.4Methods/Approach

Describe the methodology and the protocol of the proposed clinical trial in detail, including the following (refer to statistical checklistfound in Appendix 2 of the CTG Application Guide for study design):

13.3.4.1Clinical Trial Phase(Phase 1,2,3 or 4)

13.3.4.2Study Design & Delivery

(i)Type of clinical trial(eg. paediatric/adult, healthy volunteers/patients/both, single-blind/double-blind, randomised/non-randomised, single agent, route of administration, imaging etc)

(ii)Proposed study interventions

(iii)Methods for protecting against other sources of bias (eg. blinding or masking. If blinding is not possible, please explain why and give details of alternative methods proposed or implications for interpretation of trials results)

(iv)List planned inclusion/exclusion criteria

(v)Duration of treatment period

(vi)Frequency and duration of follow-up and their justifications (please list the data elements/tests that are needed for follow-ups and justify)

(vii)Proposed outcome measures (primary and secondary) and how they will be measured at follow-up

(viii)Early stopping rule (for efficacy, futility and toxicity)

(ix)Procedures, situations or materials that may be hazardous to personneland the precautions to be exercised

13.3.4.3Sample Size and Statistical Design

(i)Provide a description of the power calculations (detail outcome measures on which these have been used, and give event rates, means and medians, etc, where appropriate; Provide justifications for the size of difference that the trial is powered to detect; Does the sample size calculation take into account the anticipated rates of non-compliance and loss to follow-up given below)

(ii)What is the planned recruitment rate? (how will recruitment be organised, over what time period, and provide the evidence that this rate is achievable)

(iii)Are there likely to be problems with compliance? (Provide anticipated compliance rate and explain on what evidence these figures are based and take into account issues such as toxicity, cross-over and co-morbidities)

(iv)What is the likely rate of loss to follow-up? (Explain on what evidence is the loss to follow-up rate based)

(v)Summarise the statistical analysis plan for the chosen design

(vi)Statistical justification for the sample size and the means by which data will be analyzed and interpreted

(vii)Potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims

13.4Regulatory Approval

Please refer to HSA guidelines for regulatory requirements, clinical trial conduct and drugs etc and ensure that all these are met.

Please select where appropriate.

Regulatory application has been submitted to regulatory bodies and awaiting approval eg. HSA, FDA (If yes, please state all regulatory bodies involved:)

Regulatory application has not been submitted, but regulatory bodies consulted on requirements and regulations on Clinical Trial conduct (If yes, please state all regulatory bodies involved:)

Regulatory application has been submitted and rejected by regulatory bodies (If yes, please state all regulatory bodies involved and reasons for rejection:)

13.5Economic Outcomes & Development Plans

Describe how the research team has planned for the therapeutic/medical device to be developed or commercialized.

For Co-D and IIT-L Schemes, please provide internal and/or market assessment reports, if available.

For IIT-E Scheme, please highlight the potential for applications and/or exploitation/commercialisation of results.

13.5.1Intellectual Property Management

Please describe how the Research Team intends to manage and exploit the intellectual property it has filed and/or intends to file for its research outcomes. You can provide a description of the team’s track record for the following to substantiate your description: (Basic information will suffice)

  • List patentable components (novel, non-obvious)
  • List number of patents filed, at which stage or already granted, and a brief description for each
  • Number of spin-out companies established, and a brief description for each
  • Income generated from commercialization of intellectual assets

13.6References

Please list thereferences in the ordercited in this proposal, including the titles. Attach references as an Annex 1.

13.7Role of Team members

Elaborate the roles of Lead Principal Investigator, Co-Investigators and Collaborators involved in the project. Specify the research background, technical competencies, role and contribution to specific deliverables and achievements that are relevant and necessary to ensure success for the proposed research. Please also provide the expected percentage effort within the project, as well as within his/her other work commitments for each member.

Note that Co-Investigators need to hold at least an adjunct position in a local public institution. Researchers from overseas institutions or private companies can only participate as collaborators. The terms of collaboration with overseas research institutions and private companies must conform to NMRC’s existing policies.

Name
/
Role in Project (e.g. PI, Co-I, Collaborator)
/
Institution
/
% Effort within Project[6]
/
% Effort Within Own Work Commitments[7]
Total
/
100%

* Additional rows can be added if required.

13.8Collaborations with industries

For each industry partner, please provide the following information. The research team members are advised to negotiate a Research Collaboration Agreement (RCA) with the industry involved.

(i)Title, name, designation and organisation

(ii)Objectives of the collaboration

(iii)State the extent to which the industry partner can share the research work entailed in the programme with the research teams. Is this industry partner replaceable by an alternate group/organisation?

(iv)Discuss the ownership of research findings due to the collaboration with the industry partner specified in (i). Please highlight any restrictions that may be imposed to the dissemination of such research results.

(v)In terms of quality of results and timescale, describe how the collaboration might be critical for the programme’s success. Explain if such this might be compromised in the absence of the collaboration.