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Modelling to support rational introduction of new drugs and regimens. Research Question #2 of 4: Application of models to maximize the probability of success in phase 3 clinical trials of new drug regimens (CLOSED)


Opening date -
Closing date -

 

Summary of funding available across the four research questions
 
Applications are invited for funding to support work on any of four research questions identified at the recent TB MAC meeting on 'Modelling to support rational introduction of new drugs and regimens'. Two awards of US$72,500 are available (ie the total funds available across all four research questions = US$145,000).
 
Title: Modelling to support rational introduction of new drugs and regimens
Reference: TB MAC RFA 3
Duration: Up to 9 months
Funds available: US$145,000 in total across all four research questions
Number of awards available: 2 (Two awards of US$72,500)
Submission opening date: Oct 13th 2013
Submission closing date: Nov 10th 2013
Decisions announced: Dec 9th 2013
Contact: Olivia Ross-Hurst Olivia.Ross-Hurst@lshtm.ac.uk
 
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Details of research question #2: Application of models to maximize the probability of success in phase 3 clinical trials of new drug regimens
 
Background
Currently, the development of new drug regimens for TB is held back because we cannot predict success until the end of a phase 3 trial. Our aim is to avoid late stage attrition and mitigate the risk of developing regimens that are of limited value in the TB health care system. Availability of quantitative models linking the connection between preclinical models, early clinical outcomes, and late stage durable cure is essential. In the near term, developing the connection between in vivo animal experiments and early clinical trials would provide a useful 1st step to the long term aim of building a comprehensive TB drug & disease model capable of identifying new regimens that are likely to be successful in phase 3 clinical trials.
 
Work Required
The goal of this research project is to develop models to maximize the probability of success in phase 3 clinical trials of new drug regimens. More specifically, as a first step we seek proposals to develop a model that links two or more categories of early experimental or preclinical data to results observed in later development. This could include establishing the link between results in animal models to predict the results of early clinical trials (i.e., 2-week or 8-week trials) or outcomes of late stage clinical develop (i.e., durable cure).

Aim
The aim is to develop a model to maximize the probability of success in phase 3 clinical trials of new drug regimens.

Objectives
1. To identify, obtain access, and organize relevant preclinical and clinical data to support the model development effort (the Gates Foundation will be able to assist with obtaining access to data)
2. Identify data gaps
3. To identify relevant model components & model building methodology
4. Develop model structure, fit data, explore goodness-of-fit and posterior predictive checks
 
Assessment criteria
All applications will be reviewed by expert reviewers. All applications to this research question will be scored against the following criteria:
  • Is the research question and plan well-described
  • Is the research team qualified to conduct this research
  • Is the budget and timeline appropriate for the proposed activity
  • Is the proposal likely to meet the aim and objectives outlined in the RFA
  • Is the dissemination and impact maximisation plan adequate
  • Does the proposal explain how models and data will be shared for maximum public utility
Deliverables
1) One manuscript (5-20 pages):
i) draft submitted to TB MAC by grant end date
ii) submitted for publication to an international peer-reviewed scientific journal by grant end date + 3 months
 
2) One presentation (15-30 slides):
i) submitted to TB MAC by the grant end date, and
ii) presented at a TB MAC or other international meeting/conference by grant end date + 6 months.

Mechanism

A contract will be issued from LSHTM either to an institution or to an applicant personally in the form of consultancy fees.
 
Standard terms
Work done with and for TB MAC is subject to a standard set of terms that require information sharing between all groups working within TB MAC. A full set of terms is available on request.
 
Eligibility
Members of the TB MAC Secretariat and Advisory Panel are not eligible for this award.
 
Format
Applications should include a proposal limited to three pages (excluding references, and with a minimum of 11 point font size). Proposals should include: (i) an introduction to the topic; (ii) description of previous work in the area by the applicants; (iii) description and justification of the intended approach; (iv) timeline for the proposed work; (v) budget and its justification. In addition, the principal applicant should provide a separate short bio-sketch (one page summary of qualifications, research interests, key funding publications and major sources of research support).

The closing date for applications has passed.