The aim of the Clinical Trials Grant (CTG) is to enable the clinicians to carry out clinical trials for the development of novel therapies, interventions and diagnostics, focusing on healthcare needs.

There are two schemes under the CTG:

(I) CTG-Industry Collaborative Trials (CTG-ICT)
(II) CTG-Investigator-Initiated Trials (CTG-IIT)

Eligibility:

Each grant application must be led by a Clinical Principal Investigator who has to fulfil the following eligibility criteria listed below. Only one Principal Investigator (PI) is allowed per application.

Must fulfil HSA’s requirements for PIs who are conducting clinical trials. Pls refer to HSA website for guidelines on conducting clinical trials.
http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Clinical_Trials/Overview/Introduction_to_Clinical_Trials.html
PI must be clinically qualified (i.e. with MD/MBBS/BDS) and preferably with post-graduate clinical training and experience.
PI to hold a primary appointment in a local public hospitals/public health institutions/national specialty centres/public universities/Academic Medical Centres and salaried by the institution.

Be an independent PI with a demonstrated track record of research as evidenced by the award of nationally competitive funding (international funding to be considered on a case by case basis) or substantial publication record.

Have a laboratory or clinical research program that carries out research in Singapore.

Hold a minimum of 9 months employment with a local Singapore institution, and fulfilling full time residency in Singapore over a period of the calendar year.

No outstanding reports from previous NRF, BMRC, NMRC grants and other national grants.

Research Themes:

The CTG is open to application on all research themes. However, there will be strategic consideration for applications which focus on the following priority areas:

Cardiovascular diseases
Neurological and sense disorders
Infectious diseases
Diabetes mellitus and other metabolic/ endocrine disorders
Cancers

(I) CTG-Industry Collaborative Trials (CTG-ICT) scheme

Description

This scheme supports ICTs that involve both clinician and company contributing intellectual inputs and funds to conduct the trial and developing novel or pre-existing therapies/drugs/medical device for new indications.

This scheme does not support trials that are fully funded/sponsored by companies. Such trials typically do not require the clinicians’ intellectual inputs as the clinical trial protocol has already been designed by the company, and the clinicians’ involvement is more for subject/patient recruitment.

Prerequisites

The prerequisite for application is PI’s ability to obtain industry contribution of at least 70% (cash or in-kind) of the Total Project Costs (TPC). The TPC and industry contribution will be based on the Research Collaborative Agreement (RCA) between the host institution (HI) and the industry partner.

-    In IGMS, pls ensure that:
    (i) the industry contribution is clearly indicated in Section 3 of the proposal in the application form and
    (ii) the RCA is uploaded in the “Other Attachments" section/tab. The RCA should clearly indicate the budget information (PI and industry contribution, and the TPC as reflected in the proposal).

- Pls note that:
(i) the admissible in-kind drug cost contribution from the industry partner is limited to equivalent to the non-drug cost contribution (pls refer to slide 16 of NMRC May 2018 Grant Call Roadshow slides for an example of the calculation). http://www.nmrc.gov.sg/content/dam/nmrc_internet/nmrc2.0/roadShows/NMRC%20May%202018%20Grant%20Call%20Roadshow%20Slides.pdf

(ii) If the project is awarded, the PI/HI will be required to:

ensure that the industry contribution is met at the completion of the awarded project.
submit yearly reporting on the industry contribution (Refer to the “Guidelines for Annual Reporting of Industry Contributions” to complete “Industry Contribution Form” with supporting documents e.g. receipts, invoices), together with the annual progress report.

Industry Contribution Form
Guidelines for the Annual Reporting of Industry Contributions

Funding Quantum and duration

The scheme will cover up to 30% of the TPC inclusive of 20% indirect costs.
Funding quantum for each project is open and for a duration of up to 5 years.

Review Process

All applications will undergo a streamlined review process and the assessment criteria include the following:

Scientific and clinical merit of proposal
Track record of applicants
Focus on HBMS 5 priority therapeutic areas
Address unmet clinical need in SG with good potential to be implemented in local healthcare system
Agreement with industry partner on IP
Result in technology transfer, talent and/or capability building which SG would like to gain (or strengthen SG’s position in points 3 and 4)
Lead to some form of return on investment for SG (e.g. healthcare savings, discounted price for use of therapy, royalties, further contribution to research activities etc

The review process will take about 2 months after application endorsement by HI.

Grant Call Frequency/Submission

This scheme is open for application throughout the year,i.e. no formal grant calls will be held.

Submission and Deadline

In the CTG-ICT scheme, PI will submit a Letter of Intent (LOI) application. Pls complete all sections of the online application form in IGMS, and sections in the proposal template which are highlighted in blue colour.

If the application is shortlisted, the PI will then be required to complete and submit the rest of the sections in the proposal template.

Applicants can submit their proposals at any time. It is mandatory for all applications to be submitted and endorsed by the HI’s Director of Research (DOR) via IGMS. Internal Host Institution submission deadline may apply, please check with your Research Office for more information.

(II) CTG-Investigator Initiated Trials (CTG-IIT) scheme

Description

This scheme will support IITs of both early and late phase which are initiated and driven by clinicians who are interested to conduct trials on novel or pre-existing drugs/medical device/interventions for new indications.

No minimum company contribution, however, applications with industry contribution would have higher priority.

For applications with industry contribution, in IGMS, pls ensure that:

(i) the industry contribution is clearly indicated in Section 3 of the proposal in the application form and

(ii) the RCA is uploaded in the “Other Attachments” section/tab. The RCA should clearly indicate the budget information (PI and industry contribution, and the TPC as reflected in the proposal).

(iii) Pls note that if the project is awarded, the PI/HI will be required to:
- ensure that the industry contribution is met at the completion of the awarded project
- submit yearly reporting on the industry contribution (Refer to the “Guidelines for Annual Reporting of Industry Contributions” to complete “Industry Contribution Form” with supporting documents e.g. receipts, invoices), together with the annual progress report.

Industry Contribution Form
Guidelines for the Annual Reporting of Industry Contributions

Funding Quantum and duration

Funding for each project is capped at $1.5mil (inclusive of 20% indirect costs) for a duration of up to 3 years. Projects with duration of more than 3 years will be evaluated on a case-by-case basis.

Review Process

All applications will be evaluated through a two stage review process comprising a peer review stage followed by a Local Review Panel (LRP). The assessment criteria include the following:

Scientific and clinical merit of proposal
Track record of applicants
Focus on HBMS 5 priority therapeutic areas
Address unmet clinical need in SG with good potential to be implemented in local healthcare system, and commitment from HI to implement if the IIT results are promising
Involve local IPs and formation of businesses
Lead to some form of return on investment for SG e.g. healthcare savings, discounted price for use of therapy, royalties, further contribution to research activities etc)

The review process will take about 6 months after application endorsement by HI.

Grant Call Frequency

Proposals are to be submitted via IGMS in response to formal NMRC CTG-IIT grant calls in May and in Nov.

Submission and Deadline:

In the CTG-IIT scheme, applications are to be accompanied with:

A letter of support from HI and also from the PI’s Head of Department to show their commitment to adopt the IIT outcome
In-kind support from the HI (could include EOM, equipment and OOE support from grants received by the HI e.g. NMRC Centre Grant, Clinical Research Coordinator Funding Award, or internal funds)

It is mandatory for all applications to be submitted and endorsed the HI’s Director of Research (DOR) via IGMS by 30 November 2018, 5pm. Internal Host Institution submission deadline may apply, please check with your Research Office for more information.

Please ensure that all online submissions are endorsed by the corresponding HI’s DOR by the closing date. We will not entertain any late submissions or submissions from individual applicants without HI’s endorsement.

Download

Please download the CTG Application Guide and Application Templates for the above information and instructions to apply.