Akademik Veri Yönetim Sistemi
SEZERMAN O. U. (Yürütücü)
UFUK 2020 Projesi, 2021 - 2021
Strengths
a. The objectives are clearly described and address an important clinical need
c. The concept was rationalized by sound and convincing arguments
d. The concept to predict the responsiveness to lithium of individuals at risk of developing bipolar disorders by
analysing the expression signature of their blood mononuclear cells before the disease is manifested is novel
f. The concept is relevant for the advancement of personalized medicine of bipolar disorders
g. The quality of the project consortium is good and include experts with recognized clinical expertise and first hand
knowledge in direct programming of nervous cells and in advanced gene expression profiling and analyses. Some of
the partners are also involved in SMEs activities in relevant fields, which will be instrumental to move the project
activities toward product development. The added value of the proposed transnational collaboration is high.
Weaknesses
b. The proposed approach and methodology is not described in sufficient detail to assess quality. Insufficient detail
is provided on the criteria that will be used to standardize the samples to be analyzed and on the omics strategy and
informatics platforms which will be used for their analyses. It is also unclear whether the study will include
responsive and non-responsive bipolar patients as controls.
e. The technology proposed is expensive and it is not clear whether the study may be conducted with the resources
requested. The time schedule is appropriate
Clear and Pertinent. Response to lithium is low (around 30 to 40%)
Methodology: Case-control study that selects around 300-400 subjects. It is the first step to explore the role of the
biomarkers studied.
The future clinical application seems narrow. Test offsprings of patients with BPD to predict in advance whether
they will be respondents to lithium in case they develop BPD (Early intervention or detecting lithium response
before the illness started)
The objective of this proposal is worthy of investigation and from a scientific point of view will certainly increase our
understanding of the biological bases underlying lithium response in bipolar patients. However, the novelty of
looking at biomarkers of lithium response is low given that several projects and consortium are working on this
topic since several years (e.g. see projects ongoing from the ConLiGen consortium).
Sample size is not very clear. It seems that no a-priori power analysis was conducted. IT is mentioned that 20-40
samples will be initially selected for iNSC generation and then this number may be increased. From a statistical point
of view, analyzing 20 or 40 participants could have a strong implication. This point is crucial for the project to be
successful and should be based on well defined criteria. Nonetheless, depending on the number of expected sample
to be studied, the costs may largely vary, especially considering as example RNAseq analyses.
The team has the skills required for conducting this project but its feasibility is not clear given that there are
basically no robust novel preliminary data and the sample size is not clear.
It is mentioned that healthy controls and their healthy offsprings will be enrolled. However, how will be the data
coming from these two groups analyzed in the context of the patients with Bipolar disorders? This issue and their
relevance is poorly described.
Expected results are described in generic terms (e.g. to identify pathways, to identify novel markers, etc). Some
preliminary data would have guided more specific targeted hypotheses.