Deadline for brief study outline: May 28, 2012
Email email@example.com for study outline form.
Examples of relevant clinical research for this mechanism include, but are not limited to, the following:
Note that in each of the above examples, the study is designed to provide specific data that will be essential to design the subsequent definitive efficacy trial. In many cases, a control group is not necessary, nor preferable in order to achieve these objectives.
Budget: A maximum of $150,000/year for a maximum of 2 years / No indirect costs will be paid for these awards
The aim of the TREAT ALS Clinical Management Grant Program is to improve care and living with ALS with a focus on clinical, psychological and/or social management of ALS. Examples of relevant clinical management studies for this mechanism include, but are not limited to, the following:
BUDGET: A maximum of $100,000/year for a maximum of 2 years / No indirect costs will be paid for these awards
APPLICATION RECEIPT DATES FOR BOTH A. CLINICAL PILOT STUDIES AND B. CLINICAL MANAGEMENT GRANTS:
|Brief study outline||May 28, 2012|
|Request to submit full application||June 29, 2012|
|Submission of full application||September 10, 2012|
|Notification of award||November, 2012|
|Funds begin on receipt of all relevant signatures|
(1) SIGNIFICANCE: Does this study address an important problem? Has the applicant addressed both the significance of the eventual definitive clinical trial AND the significance of this study in providing knowledge needed to proceed to the definitive clinical trial? Is there a sufficient body of high quality preclinical or clinical research that supports the rationale for the proposed study? What is the potential impact of the proposed intervention on health care and quality of life? If the aims of the study are achieved, how will these results contribute to the design and implementation of the definitive clinical trial? For Clinical Management Grants, how will the findings impact the future care of patients? What are the hurdles to implementing the findings and how might they be overcome?
(2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
For the proposed preliminary study, reviewers will evaluate whether the approach is adequate in each of the following areas:
(3) INNOVATION: Are the aims of the study original? While the proposed study design, methods, and interventions may not necessarily be innovative, the underlying aims should represent an advancement in the field.
(4) INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? The reviewers should consider training and expertise in the clinical problem and the proposed intervention, and training and expertise in clinical trials. If a multicenter study is proposed, the reviewers should also evaluate the investigator's ability to organize and manage the research group.
(5) ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Have appropriate agreements with participating industry sponsors, if any, been established?
(6) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research.