Project 1: Comprehend common behavior patterns in different clinical trials, considering perspectives such as subject safety, study endpoints, and others. Project 2: Develop an algorithm(s) for the identification of "Duplicated Subjects".

Project 1: Comprehend common behavior patterns in different clinical trials, considering perspectives such as subject safety, study endpoints, and others. Project 2: Develop an algorithm(s) for the identification of "Duplicated Subjects".

Background:Clinical trials represent a cornerstone in advancing medical knowledge and healthcare interventions. As the volume and complexity of clinical trial data continue to grow, there is a critical need to understand and optimize the quality, behavior, and integrity of this data. The proposed research project by Cyntegrity aims to comprehensively investigate quality tolerance limits, data behavior, and duplication probability in clinical trials across diverse therapeutic areas, phases, and trial types. The background of this project stems from the increasing challenges associated with managing and interpreting vast datasets within the context of clinical trial quality. By leveraging advanced data science techniques and statistical methodologies, the research seeks to unravel patterns, benchmarks, and probabilities that significantly impact the reliability and precision of clinical trial outcomes. The significance of this project is multiform. It addresses critical needs in current practices and contributes to the advancement of clinical trial research and data management in the following ways. Objective:Firstly, the clinical trial design will be optimized. Understanding benchmark quality tolerance limits will enable the optimization of clinical trial designs, leading to more efficient studies. Secondly, it enhanced the data quality and reliability. Insights into data behavior and statistical distributions will enhance the accuracy and reliability of predictive models, fostering more dependable clinical trial data. Thirdly, the investigation into duplication probability directly impacts patient data integrity, minimizing risks associated with duplicate records and improving overall data management practices. Overall, by disseminating findings through publications and collaboration with the scientific community, the project aims to contribute to the advancement of industry standards, fostering continuous improvement and innovation in quality control of clinical trial research.Study Design:The study is composed of data management and statistical analysis. Study data will be categorized according to phases and therapeutical areas. Based on the requirements of quality tolerance limit such as rate of adverse event, lost to follow-up, missing endpoint, etc., data from various studies is converted into a standardized format which is used in calculating the matrices on site, country, and study level. To understand the best model for study in different stages and therapeutical areas, multiple distributions are tested on matrices and summarize the best parameter set for each group of study type. Primary and Secondary Outcome Measure(s):The primary outcome of the project is to determine the best distribution that either the site or center monitor can follow during clinical trials. Comparing the selected distribution with the study data can assess whether a study is under control or not. Regarding patient duplication detection the primary outcome is to assess the similarity between the given patient and all the patients in the database. For both topics, we will not take the secondary endpoint into account because the purpose of the research is to develop a new method of data management. We are not going to investigate/compare etc. product efficacy/safety etc.Statistical Analysis:The goodness of fit and patient similarity is evaluated by numeric analysis approach, Anderson-Darling statistic, and significant test. By patient similarity, the statistic test defines the threshold of identity. Regarding the quality tolerance limit, some matrices depend on the number of study days. The numeric analysis approach can identify the pattern of the time series variable and then use statistical tests again to evaluate the goodness of fit. Moreover, considering the hypothesis of the best-fit distribution, the researchers assess if the quality tolerance limits are under the same scenario as the best-fit distribution.

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"Title": "NOVARTIS-CLCZ696B2314", "Description": "A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction" },{ "PostingID": 4069, "Title": "NOVARTIS-CAIN457A2307", "Description": "A randomized, double-blind, double dummy, multicenter study to assess the safety, tolerability and long-term efficacy of intravenous (10 mg/kg) and subcutaneous (300 mg) secukinumab in patients with moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab Secukinumab Trial Analyzing the potential of intravenous administration To Upgrade the REsponse in psoriasis (STATURE)" },{ "PostingID": 4082, "Title": "NOVARTIS-CVAL489E0108", "Description": "Multinational, multicenter, double-blind, randomized, active controlled, parallel group study comparing the efficacy and safety of long-term treatment with valsartan, captopril and their combination in high-risk patients after myocardial infarction" },{ "PostingID": 4085, "Title": "NOVARTIS-CFTY720D2302", "Description": "A 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase" },{ "PostingID": 4086, "Title": "NOVARTIS-CENA713D1301", "Description": "A 24-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Evaluation of the Efficacy, Safety, and Tolerability of the Once-daily Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease (MMSE 10-20)" },{ "PostingID": 4095, "Title": "NOVARTIS-CLBH589D2308", "Description": "A Multicenter, Randomized, Double Blind, Placebo Controlled Phase III Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma" },{ "PostingID": 4121, "Title": "NOVARTIS-CLDK378A2201", "Description": "A Phase II, Multicenter, Single-arm Study of Oral LDK378 in Adult Patients With ALK-activated Non-small Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib" },{ "PostingID": 4137, "Title": "NOVARTIS-CRAD001A2309", "Description": "Efficacy and Safety Study Comparing Concentration-controlled Everolimus in Two Doses (1.5 and 3.0 mg/Day Starting Doses) With Reduced Cyclosporine Versus 1.44 g Mycophenolic Acid (as Sodium Salt) With Standard Dose Cyclosporine in de Novo Renal Transplant Recipients" },{ "PostingID": 4138, "Title": "NOVARTIS-CRAD001 B201", "Description": "An Exploratory Evaluation of Early Use of Everolimus (EVE) on Tacrolimus (TAC)-Based Immunosuppressive Regiment vs. Mycophenolate Sodium (MPS) on Cytomegalovirus (CMV) Infection in Renal Transplant Recipients." },{ "PostingID": 4139, "Title": "NOVARTIS-CRAD001 B251", "Description": "An Exploratory Evaluation of Early Use of Everolimus (EVE) on Tacrolimus (TAC)-Based Immunosuppressive Regiment vs. Mycophenolate Sodium (MPS) on Cytomegalovirus (CMV) Infection in Renal Transplant Recipients." },{ "PostingID": 4151, "Title": "NOVARTIS-EGF20008", "Description": "An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects with Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving HERCEPTIN-Containing Regimens" },{ "PostingID": 4154, "Title": "NOVARTIS-EGF104900", "Description": "A Randomized, Multicenter, Open-Label, Phase III Study of Lapatinib in Combination with Trastuzumab versus Lapatinib Monotherapy in Subjects with HER2-positive Metastatic Breast Cancer whose disease has progressed on Trastuzumab-Containing Regimens" },{ "PostingID": 4155, "Title": "NOVARTIS-EGF30001", "Description": "A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Phase III Study of Oral GW572016 in Combination with Paclitaxel in Subjects Previously Untreated or Advanced or Metastatic Breast Cancer" }]