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  ["project_title"]=>
  string(126) "ALL-EMBRACED: clinicAL triaLs web-sErvice to Modify eligiBility cRiteria and pre-screening viA artifiCial intElligence methoDs"
  ["project_narrative_summary"]=>
  string(671) "Clinical trials (CT) are fundamental in the process of testing a drug or treatment. Today there is a duty to increase the inclusiveness of CTs, overcoming their main limitation: non-representative recruitment caused by inappropriate and restrictive inclusion criteria that results in the exclusion of many population sub-types. ALL-EMBRACED intends to propose solutions to this criticality through the development of a free of charge web platform, integrated with Artificial Intelligence (AI) and Machine Learning (ML) tools, in order to optimize the process of selection and recruitment of representative patients of the general population by clinicians and CT-managers."
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    ["last_name"]=>
    string(7) "Redolfi"
    ["degree"]=>
    string(70) "PhD in Imaging & Medical Physics, Paris-Saclay University (France)"
    ["primary_affiliation"]=>
    string(30) "IRCCS Fatebenefratelli Brescia"
    ["email"]=>
    string(28) "aredolfi@fatebenefratelli.eu"
    ["state_or_province"]=>
    string(7) "Brescia"
    ["country"]=>
    string(5) "Italy"
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      string(72) "PhD, Information Engineering, Università degli Studi di Brescia (Italy)"
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      string(59) "MSc in Psychology, Università degli Studi di Parma (Italy)"
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  ["project_ext_grants"]=>
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    ["label"]=>
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  }
  ["project_funding_source"]=>
  string(49) "Data Science for Health 2023 (Fondazione Cariplo)"
  ["project_date_type"]=>
  string(18) "full_crs_supp_docs"
  ["property_scientific_abstract"]=>
  string(1634) "Background: Traditional CTs often struggle with restrictive eligibility criteria, limiting the diversity of participants and making it difficult to generalize findings to broader populations.

Objective: Our project will investigate the impact of relaxing some eligibility criteria on the target CT population and will provide a new state-of-the-art pre-screening service based on AI methods.

Study Design: The project is structured in four Work-Packages (WPs). WP1 will create the IT infrastructure for the web platform, GDPR/HIPPA compliant and with a state-of-the-art data-encryption standard (SSH-256, AES-256). WP2 will collect micro-data and aggregated data from general population and CTs databases and create reliable synthetic data. WP3 will evaluate the relaxation of the eligibility criteria and biomarkers thresholds. WP4 will develop a web prototype for clinical and research settings.

Participants: Micro-data and aggregated data of the general population from national and international data repositories will be collected. We will also undertake a meticulous examination of the eligibility criteria and clinical outcomes from real world CTs databases.

Primary and Secondary Outcome Measure(s): With its new web-based tool, the project aims to improve the design and organization of CTs recruitment, reflecting in a more accurate way the population characteristics of the general population affected by the same pathology.

Statistical Analysis: Natural Language Processing (NLP) and ML techniques, Large Language Models and eXplainable AI techniques (SHAP) will be used during each WP."
  ["project_brief_bg"]=>
  string(3173) "CTs must be designed and conducted to test the efficacy of drugs or diagnostic treatments. The eligibility criteria are essential requirements for the success of CTs [1,2] and have a direct impact on the results of each CT. Inappropriate eligibility criteria lead to insufficient recruitment, which is a major reason for the failure of many CTs. In a majority of therapeutic areas, a typical trial needs to double the planned enrollment period to reach the recruitment target, and even then, about of 40% of sites in a multicentre trial will enroll too few patients compared to what was planned, while 10% will not enroll a single patient. [3,4] In addition, recently the US Food and Drug Administration (FDA) has indicated that certain populations are generally excluded from CTs without sound clinical rationale. Restrictive trials do not fully capture the efficacy and safety of the drug in the populations that will use the drug after approval [5]. Despite the FDA’s proclaims, problems with CTs participation persist, and certain groups continue to be underrepresented. Excessively restrictive eligibility criteria, including modifying cut-offs values, limit patients’ access to potentially beneficial treatments. In addition to the strict eligibility criteria, the pre-screening procedures also contribute to the unsatisfactory participation rates. Indeed, a considerable amount of time is required to identify the eligible patients ("pre-screening"), as much of the clinical information required for this process is available in the patient's EHR as unstructured free text or in scanned documents, that are not easily searchable by clinicians with existing technologies.[6] This factor can lead to distortions in terms of representativeness and inclusivity. 

The key ambition for ALL-EMBRACED project is to create a unified framework that simultaneously combines and improves the capabilities that available tools capture separately, i.e.: CT design optimization and patient pre-screening. The ALL-EMBRACED unified framework will integrate a variety of data, including general population micro-data affected, real-world CT data and validated synthetic data. ALL-EMBRACED will utilize advanced AI algorithms to identify eligibility criteria that are most likely to safely expand CT access for patients without compromising the clinical outcomes. ALL-EMBRACED will use a dynamic and adaptive design that will allow refinement of future CT design based on analysis of retrospective similar CTs. ALL-EMBRACED will also propose adjustment of the eligibility rules to actively optimize the an in-fieri CT study, in case a CT is not be able to enroll the initially defined total number of patients, without compromising its clinical outcomes. 

In the long run, the platform could grant to clinicians the selection of the most representative populations from the available EHRs that will be uploaded in the web-portal and that reflects the general population characteristics. The ALL-EMBRACED platform will be able to “converse” fluently in natural language with CT-Managers and Physicians, with a deep clinical understanding in pre-screening patients."
  ["project_specific_aims"]=>
  string(1516) "The ALL-EMBRACED project aims to revolutionize CT design with a focus on inclusivity, safety, and transparency through advanced AI technologies. The main goal of the project is to introduce a web-platform designed to craft CTs in a way that can reflect the diversity of the general population in most CTs. The tool will be completely free of charge for all end-users (i.e.: researchers, clinicians, and CT managers). Our ultimate goal is to propose an effective way to formulate more evidence-based criteria to speed up the CT process.

The overarching objectives are:

    • Evaluation and optimization of eligibility criteria for any CTs

    • Exploitation of AI/ML data-driven techniques  

    • Assessment of the safety implications of broadening eligibility criteria

    • Web-platform prototype development

    • Collaboration with experts to ensure the effectiveness of the prototype 

    • Dissemination of the project findings through peer-reviewed open-access publications, position papers, and presentations at national and European forums.

    • Fostering the professional and training skills 

The ALL-EMBRACED framework will be based on the principles of “Responsible Research and Innovation (RRI)” and “Findability, Accessibility, Interoperability, and Reusability” (FAIR) to ensure that the expected outcomes of the project are socially beneficial and inclusive, environmentally sustainable, and ethically justifiable."
  ["project_study_design"]=>
  array(2) {
    ["value"]=>
    string(8) "meth_res"
    ["label"]=>
    string(23) "Methodological research"
  }
  ["project_purposes"]=>
  array(2) {
    [0]=>
    array(2) {
      ["value"]=>
      string(34) "research_on_clinical_trial_methods"
      ["label"]=>
      string(34) "Research on clinical trial methods"
    }
    [1]=>
    array(2) {
      ["value"]=>
      string(28) "research_on_comparison_group"
      ["label"]=>
      string(28) "Research on comparison group"
    }
  }
  ["project_research_methods"]=>
  string(1861) "The ALL-EMBRACED framework will be multi-pathology, because it will be based on data concerning several Non-Communicable Diseases (NCD). In detail the ALL-EMBRACED will focused on:  Choroidal Neovascularization; Diabetes Type 2; Hypertension (High Blood Pressure); Kidney transplant; Heart transplant; Liver transplant; Metabolic syndrome; Multiple Sclerosis; Partial Seizure; Psoriasis; Multi-site Seborrheic Dermatitis; AD Dementia; Mental Health disorders (Depression, Schizophrenia, BPD). The data sources can be divided in two sections. 

    • The microdata and the aggregated data (prevalence, incidence, years lived with the disease) for the general population affected by NCDs, obtained from national and international repositories (e.g.: ISTAT, EUROSTAT, GBD/IHME). 

    • CT data, in particular eligibility criteria (both inclusion and exclusion) and outcome measures. IRCCS-FBF will provide individual outcome measurements for  CTs conducted (e.g.: interventional and observational studies). The IPD data requested from YODA project will be added to this dataset. Additional data for CTs will be obtained from CT reports downloaded from clinical databases (clinicaltrials.gov and ISRCTN). 



The creation of the synthetic datasets will be done via Synthea, a tool that  can generate and make downloadable synthetic subjects for different pathologies, based on results from academic publications and statistical institutions. Individual data from the YODA project will not be used in the generation of synthetic data, but will only be used as comparative data to check the reliability of the Synthea’s data. No individual data from YODA project will be downloaded or shared with external users, as also stated in the disclosure agreement. Additional information on this topic is provided in the supplementary document."
  ["project_main_outcome_measure"]=>
  string(1110) "ALL-EMBRACED focuses on improving eligibility criteria so that the CT population is representative of the general population. The IPD data requested from YODA project will be collected on several CTs where the clinical conditions of interest will be among these NCDs: Diabetes type II, hypertension, multiple sclerosis, partial seizure, psoriasis, (seborrheic) dermatitis, AD, dementia, bipolar disorder, depressive disorders, schizophrenia and schizoaffective disorder. The primary and secondary outcomes will vary depending on the different CT studies and the pathologies investigated. However, in general, the primary and secondary outcomes of these CTs concern the evaluation of the efficacy of a given drug (depending on the pathology) by performing clinical tests and monitoring contraindications in subjects to ensure their safety. The clinical tests, collected at different time points as biomarkers that mimic disease progression, are specific to each pathology, and allow comparison between CTs of the same NCD. An additional outcome is pharmacokinetics, which is tested with blood sample analysis.  "
  ["project_main_predictor_indep"]=>
  string(1208) "The inclusion and exclusion criteria of several CTs (similar in pathology and clinical endpoints, but different in eligibility criteria) will be our main predictors for ML and SHAP analysis and will allow defining how to broaden the criteria for future CTs. 

Each NCD has specific neuropsychological scales that were collected at several time points and compared with the baseline measurements to evaluate the efficacy of the drug of interest. For example, in CTs concerning AD, the main biomarkers are ADAS-cog, MMSE, DAD and CIBIC scores. Psoriasis has different scales to be collected and evaluated, such as PASI, IGA, DLQI, PSSD and PGA. Relevant neuropsychological tests in CTs related to mental disorders are instead YMRS, MADRS, HAM-D, GAD and CGI. 

Other independent variables, which are in common among the NCDs, include socio-demographic variables (e.g.: sex, age, education, physical activity, and others), clinical data (e.g.: BMI, diastolic/systolic blood pressure, and others) and biological data (e.g.: TAU, ABETA, C-Protein, and others) from blood, urine or other sources. Clinical and biological data were usually collected to verify the insurgence of possible adverse events. "
  ["project_other_variables_interest"]=>
  string(565) "Other variables of interest can be instrumental derived biomarkers (e.g.: MRI post processing, EEG post processing, ECG post processing, and others). ECG, for example, is usually collected together with biological sample during physical examination and laboratory measurements for drug safety inspection. 

The additional variables we will use are those related to the improvement of future CT. Indeed, it is also possible to extract features from similar CTs, aggregated according to the tested drugs, to the administration modalities and treatment duration."
  ["project_stat_analysis_plan"]=>
  string(2304) "The ALL-EMBRACED project will make extensive use of classical statistical methods and ML tools. In a first step, normalization and scaling will be performed to account for different measurement units. In addition, the original CT population will be compared with the sociodemographical characteristics of the general population before starting any simulations to relax the eligibility criteria to increase the representativeness of a CT. This will be done using the Fisher’s exact test, the Chi-squared tests, T-test, the Wilcoxon–Mann–Whitney test depending on the specific distributions of the samples and the typologies of the variables.

The most important aspects of originality of ALL-EMBRACED lies in the adoption of the “SHapley Additive exPlanations strategy” (SHAPLEY) libraries with regard to the eligibility criteria and the broadening of the threshold values.[10] The SHAPLEY technique has recently been proposed in the field of machine learning (ML) as a principled approach to quantify the marginal contribution of individual features and data. SHAPLEY is used in many ML tasks because it enables the explainability of models (e.g.: Logistic models, Generalized Liner Models, Support Vector Regressors, MLP-regressors, or others). The SHAPLEY value is a way to measure the contribution of each eligibility rule in the selection of the patients for a specific CT. It will be calculated by taking the average of the marginal contributions of the criterion to all possible subsets of the criteria. The marginal contribution of a criterion is computed by the difference in the outcome when the criterion is included in a subset and when it is not.[8] In this context, the SHAPLEY value will be used to evaluate the importance of different criteria for selecting patients for CTs. We will use a python library to estimate the SHAPLEY values using Monte-Carlo sampling, because calculating the values for all possible subsets of eligibility criteria would be computationally prohibitive, also on the HPC centre of the IRCCS-FBF.

The ALL-EMBRACED approach we will use is innovative because allows to reach the population representativeness using an explainable data driven approach, controlling for clinical outcomes and patient safety using multiple in-silico simulations."
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      ["label"]=>
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  ["project_timeline"]=>
  string(1326) "ALL-EMBRACED is a two-year project started in April 2025 and it is structured in four main Work-Packages (WP). WP1 (M0-M2) will create the IT infrastructure underpinning the web platform. WP2 (M0-M8) will aim to collect micro-data from the general population, “real-world” CT data and create possible synthetic data. WP3 (M6-M20) will be dedicated to identifying which are the eligibility criteria that can be relaxed and the threshold values of biomarkers expanded to increase the target population of a CT. This will be done through data-driven tools combining Natural Language Processing (NLP), ML, Large Language Model (GPT3.5 turbo), and eXplainable AI techniques. Finally, WP4 (M12-M24) will concern the development of a prototype able to perform the actions previously described with a continuous involvement of end users and patients. The final result will be a tool usable both in clinical and research settings, completely free of charge for all end-users (i.e.: researchers, clinicians, and CT managers). Four deliverables are expected to be compiled in the second year of the project, describing the safety of broadening of inclusion criteria and thresholds, the pre-screening service and how the end-users (Physicians, CT-manager, CT-sponsor, general population) can benefit from all of ALL-EMBRACED services."
  ["project_dissemination_plan"]=>
  string(1026) "Our broad strategy is to disseminate findings and results through journal publications and oral-presentations as well as through open-source software repositories to ensure widespread access to our methods as well as open data (embracing the FAIR principle) to promote the reproducibility.

Specific mechanisms we will use are: i) publications in prestigious journals, i.e.: Nature, Nature Comms, Journal of Biomedical Informatics — we have a track record of publication in all these venues; ii) Presentations at conference, i.e.: European Congress of Clinical Investigation, International Conference on Harmonisation of Requirements for Registration of Pharmaceuticals for Human Use, and others; iii) Education and public engagement; iv) Software dissemination: we have a tradition of web-based dissemination of open-source software [11,12] and our group is available via GitHub; v) as ALL-EMBRACED services mature, we will seek follow-on funding for translational research to sustain the web-platform free of charge."
  ["project_bibliography"]=>
  string(3313) "
[1] Balki I, Amirabadi A, Levman J, et al. Sample-Size Determination Methodologies for Machine Learning in Medical Imaging Research: A Systematic Review. Can Assoc Radiol J. 2019;70(4):344-353. doi:10.1016/j.carj.2019.06.002
[2] Su Q, Cheng G, Huang J. A review of research on eligibility criteria for clinical trials. Clin Exp Med. 2023;23(6):1867-1879. doi:10.1007/s10238-022-00975-1
[3] Lamberti MJ, Wilkinson M, Harper B, Morgan C, Getz K. Assessing Study Start-up Practices,
Performance, and Perceptions Among Sponsors and Contract Research Organizations. Ther Innov Regul Sci. 2018;52(5):572-578. doi:10.1177/2168479017751403
[4] Goldman DP, Berry SH, McCabe MS, et al. Incremental treatment costs in national cancer institute-sponsored clinical trials. JAMA. 2003;289(22):2970-2977. doi:10.1001/jama.289.22.2970
[5] http://resource.nlm.nih.gov/9918249008406676
[6] Berger ML, Curtis MD, Smith G, Harnett J, Abernethy AP. Opportunities and challenges in leveraging electronic health record data in oncology. Future Oncol. 2016;12(10):1261-1274. doi:10.2217/fon-2015-0043
[7] Redolfi A, Archetti D, De Francesco S, et al. Italian, European, and international neuroinformatics efforts: An overview. Eur J Neurosci. 2023;57(12):2017-2039. doi:10.1111/ejn.15854
[8] De Francesco S, Crema C, Archetti D, et al. Differential diagnosis of neurodegenerative dementias with the explainable MRI based machine learning algorithm MUQUBIA [published correction appears in Sci Rep. 2024 Jan 18;14(1):1603]. Sci Rep. 2023;13(1):17355. Published 2023 Oct 13. doi:10.1038/s41598-023-43706-6
[9] Crema C, Buonocore TM, Fostinelli S, et al. Advancing Italian biomedical information extraction with transformers-based models: Methodological insights and multicenter practical application. J BiomedInform. 2023;148:104557. doi:10.1016/j.jbi.2023.104557
[10] Il Idrissi M, Chabridon V, Iooss B. Developments and applications of Shapley effects to reliability-oriented sensitivity analysis with correlated inputs. Environmental Modelling and Software. 2021;143. doi:10.1016/j.envsoft.2021.105115
[11] https://neugrid2.eu
[12] https://newpsy4u.eu
"
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  ["data_use_agreement_training"]=>
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  ["certification"]=>
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  ["request_data_partner"]=>
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data partner
array(9) {
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  string(15) "johnson-johnson"
  [1]=>
  string(15) "johnson-johnson"
  [2]=>
  string(15) "johnson-johnson"
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  [4]=>
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  [6]=>
  string(15) "johnson-johnson"
  [7]=>
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  [8]=>
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}


pi country
array(0) {
}


pi affil
array(0) {
}


products
array(19) {
  [0]=>
  string(3) "n-a"
  [1]=>
  string(8) "razadyne"
  [2]=>
  string(9) "risperdal"
  [3]=>
  string(6) "invega"
  [4]=>
  string(16) "risperdal-consta"
  [5]=>
  string(7) "topamax"
  [6]=>
  string(8) "spravato"
  [7]=>
  string(8) "concerta"
  [8]=>
  string(8) "invokana"
  [9]=>
  string(7) "tylenol"
  [10]=>
  string(6) "motrin"
  [11]=>
  string(6) "vermox"
  [12]=>
  string(7) "stelara"
  [13]=>
  string(7) "tremfya"
  [14]=>
  string(8) "remicade"
  [15]=>
  string(8) "tracleer"
  [16]=>
  string(7) "opsumit"
  [17]=>
  string(7) "uptravi"
  [18]=>
  string(15) "invega-sustenna"
}


num of trials
array(1) {
  [0]=>
  string(3) "199"
}


res
array(1) {
  [0]=>
  string(1) "3"
}