scholarly journals ImmunoCharge: Phase 4 Clinical Trial App for Pandemic Vaccination

2021 ◽  
Author(s):  
Debaprasad Mukherjee
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pharmaceutical Company ◽  
Clinical Data ◽  
Clinical Studies ◽  
Behavioral Interventions ◽  
Behavioral Studies ◽  
Question And Answer ◽  
New Treatments ◽  
Answer Format

Immuno-Charge is an application that focuses on collecting clinical data forclinical trial purposes and helps to fix appointments for vaccination. The application acts asa bridge between the user and pharmaceutical company as it provides required data to thecompany and provides an easy interface to use, both for user and company. It also keepsrecords and track of vaccines taken by users. Users must fill in the data that is provided tothem in a question-and-answer format. The limitation is that the authentication of the user'smedical data & symptoms is not done. The progress of immunization can be a long, complexprocess that regularly lasts 10-15 years and includes a combination of public and privateenterprise involvement. Vaccines are designed, tested, and directed in a really similar way toother drugs. Clinical trials are research studies or observations done in clinical research.Such planned biomedical or behavioral studies on human members are designed to answerspecific questions about biomedical or behavioral interventions, including new treatments(such as novel vaccines, drugs etc) and known intercessions that warrant encouragingthought about and comparison. Clinical studies provide information about measurement,safety, and feasibility.

Clinical Trial Data Management Software: A Review of the Technical Features

2019 ◽  
Vol 14 (3) ◽  
pp. 160-172 ◽  
Author(s):  
Aynaz Nourani ◽  
Haleh Ayatollahi ◽  
Masoud Solaymani Dodaran
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Management ◽  
Clinical Data ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Data Management System ◽  
Management Systems ◽  
Data Management Systems ◽  
Technical Features

Background:Data management is an important, complex and multidimensional process in clinical trials. The execution of this process is very difficult and expensive without the use of information technology. A clinical data management system is software that is vastly used for managing the data generated in clinical trials. The objective of this study was to review the technical features of clinical trial data management systems.Methods:Related articles were identified by searching databases, such as Web of Science, Scopus, Science Direct, ProQuest, Ovid and PubMed. All of the research papers related to clinical data management systems which were published between 2007 and 2017 (n=19) were included in the study.Results:Most of the clinical data management systems were web-based systems developed based on the needs of a specific clinical trial in the shortest possible time. The SQL Server and MySQL databases were used in the development of the systems. These systems did not fully support the process of clinical data management. In addition, most of the systems lacked flexibility and extensibility for system development.Conclusion:It seems that most of the systems used in the research centers were weak in terms of supporting the process of data management and managing clinical trial's workflow. Therefore, more attention should be paid to design a more complete, usable, and high quality data management system for clinical trials. More studies are suggested to identify the features of the successful systems used in clinical trials.

scholarly journals The case for introducing pre-registered confirmatory pharmacological pre-clinical studies

2018 ◽  
Vol 38 (5) ◽  
pp. 749-754 ◽  
Author(s):  
Olivia Kiwanuka ◽  
Bo-Michael Bellander ◽  
Anders Hånell
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Clinical Trials ◽  
Brain Injury ◽  
Network Analysis ◽  
Clinical Studies ◽  
Phase Iii ◽  
Phase Iii Clinical Trial ◽  
Phase Iii Clinical Trials ◽  
Experimental Drugs

When evaluating the design of pre-clinical studies in the field of traumatic brain injury, we found substantial differences compared to phase III clinical trials, which in part may explain the difficulties in translating promising experimental drugs into approved treatments. By using network analysis, we also found cases where a large proportion of the studies evaluating a pre-clinical treatment was performed by inter-related researchers, which is potentially problematic. Subjecting all pre-clinical trials to the rigor of a phase III clinical trial is, however, likely not practically achievable. Instead, we repeat the call for a distinction to be made between exploratory and confirmatory pre-clinical studies.

Heroin-assisted Treatment for drug dependents’ assistance / Los programas experimentales con heroina en la atención de la población drogodependiente

2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Alina Danet ◽  
Joan Carles March Cerdá ◽  
Manuel Romero Vallecillos
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Literature Review ◽  
Clinical Studies ◽  
Therapeutic Use ◽  
Medical Prescription ◽  
Calidad De Vida ◽  
Survey Results ◽  
Therapeutic Possibilities

Objetivo. Los ensayos clínicos con heroína (diacetilmorfina-DAM) han aportado al arsenal terapeútico disponible una alternativa en la atención a drogodependientes. El objetivo del presente artículo es conocer las experiencias y resultados clínicos de los estudios sobre el uso terapéutico de la heroina.Metodo. Revisión bibliográfica de los diferentes estudios y ensayos clínicos realizados hasta el presente a nivel mundial, sobre la intervención con pacientes dependientes de opioides. Se han consultado las bases de datos: EMBASE, ScienceDirect, Wiley-Blackwell, PubMed, Bio-Med Central, Medline, Ovid, y los descriptores «heroin», «diacetylmorphine», «clinical trial», «survey».Resultados. Se detectan 42 referencias, 16 presentan los resultados de ensayos clínicos de Suiza, Holanda, Alemania, Canadá, España y Reino Unido, comenzando con 1994. El resto de estudios se refieren a: captación y participación de los drogodependientes, mortalidad, calidad de vida, efectos secundarios y necesidad de nuevas investigaciones y ensayos clínicos.Conclusiones. Los estudios clínicos llevados a cabo hasta la actualidad muestran heterogeneidad en los métodos y variables empleadas, pero los objetivos son comunes (parten de evaluar los efectos del uso terapéutico de la heroina) y los resultados constatan la seguridad y efectividad de la prescripción médica de la diacetilmorfina. AbstractObjective. Clinical trials with heroin (diacetylmorphine) bring an alternative to the available therapeutic possibilities for addict people. The purpose of this article is to describe the experiences and results of clinical studies centered on the therapeutic use of heroin.Method. Literature review of studies and clinical trials, centered on the intervention with opiois- dependent patients. The databases consulted were : EMBASE, ScienceDirect, Wiley-Blackwell, PubMed, Bio-Med Central, Medline, Ovid. The descriptors : «heroin», «diacetylmorphine», «clinical trial», «survey».Results. The literature review revealed the existence of 42 references, of which 16 presented the results of clinical trials in Switzerland, Holland, Germany, Canada, Spain and United Kingdom, starting with 1994. Other references are centered on uptake and involvement of the drug, mortality quality of life/ side effects and need for further research and clinical trials.Conclusions. Clinical studies carried out until the present show heterogeneity in the methods and variables used, but the objectives are the same (based on assessing the effects of the therapeutic use of heroin) and the results confirm the safety and effectiveness of medical prescription of diacetylmorphine.

The future of clinical trials

2010 ◽  
pp. 45-47
Author(s):  
Perry Nisen ◽  
Patrick Vallance
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Alternative Medicine ◽  
20Th Century ◽  
Evidence Based Medicine ◽  
Evidence Based ◽  
Scientific Evaluation ◽  
New Treatments ◽  
Based Medicine ◽  
Short Section

Clinical trials are the bedrock of evidence-based medicine. Introduced in the mid 20th century, they heralded a move away from opinion and anecdote to a more scientific evaluation of new treatments. Indeed, it could be argued that it is the clinical trial and the application of scientific method to determine which treatments work that distinguishes ‘medicine’ from ‘alternative medicine’. The aim of this short section is to outline the way in which clinical trials are likely to evolve over the next few years....

scholarly journals Preferences of Adult Patients With Inflammatory Bowel Disease for Attributes of Clinical Trials: Evidence From a Choice-Based Conjoint Analysis

2019 ◽  
Vol 2 (1) ◽  
Author(s):  
Dallas Wood ◽  
Katherine Kosa ◽  
Derek Brown ◽  
Orna G Ehrlich ◽  
Peter D R Higgins ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Bowel Disease ◽  
Latent Class ◽  
Open Label ◽  
Monetary Compensation ◽  
Open Label Extension ◽  
Inflammatory Bowel ◽  
New Treatments

Abstract Background Clinical trial recruitment is the rate-limiting step in developing new treatments. To understand inflammatory bowel disease (IBD) patient recruitment, we investigated two questions: Do changes in clinical trial attributes, like monetary compensation, influence recruitment rates, and does this influence differ across subgroups? Methods We answered these questions through a conjoint survey of 949 adult IBD patients. Results Recruitment rates are influenced by trial attributes: small but significant increases are predicted with lower placebo rates, reduced number of endoscopies, less time commitment, open label extension, and increased involvement of participant’s primary GI physician. A much stronger effect was found with increased monetary compensation. Latent class analysis indicated three patient subgroups: some patients quite willing to participate in IBD trials, some quite reluctant, and others who can be persuaded. The persuadable group is quite sensitive to monetary compensation, and payments up to US$2,000 for a 1-year study could significantly increase recruitment rates for IBD clinical trials. Conclusions This innovative study provides researchers with a framework for predicting recruitment rates for different IBD clinical trials.

scholarly journals The role of a data manager at a clinical trial center: the experience of the Alessandria hospital, Italy

2020 ◽  
Vol 8 (1) ◽  
Author(s):  
Fabio Giacchero ◽  
Carolina Pelazza ◽  
Serena Panpa ◽  
Marinella Bertolotti ◽  
Tatiana Bolgeo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Clinical Studies ◽  
Reference Period ◽  
Job Description ◽  
Data Manager

Objectives: To define the Data Manager (DM) job description within the Clinical Trial Center (CTC) of the Alessandria Hospital (AO AL). To identify the number of authorized clinical studies after the implementation of three DMs in the CTC of the AO AL. Methods: The activities of the DM within the CTC of the AO AL take place in the activation, management and conclusion of clinical trials. The activities were monitored through specific indicators from June 01st, 2019 to May 31st, 2020. Results: During the reference period, an increased authorized studies were observed. Conclusion: The implementation of DMs in the CTC of AO AL has been demonstrated the importance of the figure itself, which, although it has not professionally recognized yet, is found to be fundamental in clinical research.

scholarly journals Motivation for and Barriers to Participation in Clinical Trials From the Perspective of Patients With Rheumatic Diseases and Chronic Musculoskeletal Pain

2018 ◽  
Vol 12 (1) ◽  
pp. 332-345
Author(s):  
Susann Vogt ◽  
Ingo H. Tarner ◽  
Ulf Müller-Ladner ◽  
Ramona König
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Rheumatic Diseases ◽  
Clinical Studies ◽  
Family Doctor ◽  
New Drugs ◽  
Patient Recruitment ◽  
Special Role ◽  
Willingness To Participate ◽  
Specialist Care

Background: Clinical studies are indispensable for the development and clinical introduction of new therapies. Particularly in the field of rheumatology, there is a high need for the development of new drugs because for most rheumatic diseases a curative treatment is not yet available. Furthermore, a large percentage of patients are not even treated adequately with approved treatment options. Treatment is particularly challenging for those entities that belong to the so-called orphan diseases because effective drugs have yet to be developed and approval of new drugs is difficult due to the fact that only small numbers of affected patients can be recruited for clinical trials. Despite the need for new developments and thus clinical studies, patient recruitment for clinical trials in Germany is generally difficult. Therefore, sponsors frequently use non-European study centers to enroll the necessary numbers of patients as inadequate patient recruitment leads to increased costs and delayed implementation of new medical knowledge. Objective: Given the overall limited recruitment rates for clinical studies in Germany, it was the aim of this work to gain insights into motivations for and barriers to participating in clinical trials in Germany from the patients’ point of view. Methods: Data was collected using a structured questionnaire in three groups of patients who are suffering from a rheumatic disease and are receiving specialist care. The completely anonymous questionnaire included a total of 32 questions, divided into four main topics. All questions could only be answered by yes or no or by selecting or not selecting a choice of the answer provided. Per question, proportions of patients selecting yes or no or any of the choices were compared between groups and between males and females. Results: It was found that there is a lack of education and knowledge about the nature and offer of clinical trials among patients with rheumatic diseases. This issue represents one of the main barriers to patient recruitment for clinical trials. In addition, a large proportion of patients are concerned about the possible adverse effects of study drugs and about being used as “guinea pigs”. While the internet and daily newspapers are rarely used for education regarding study participation, it became clear that the family doctor as a trusted person and possible network partner has a special role in improving patient willingness to participate in trials. Furthermore, interviewees hope for shorter waiting times at the doctor's office and a better, regular, more intensive medical care when participating in a clinical trial. Conclusion: Better and broader information of patients can be regarded as a key to better recruitment for clinical trials since many patients, on the one hand, have certain concerns about clinical trials but at the same time do see the potential for personal advantages when participating in a trial. Information events by patient organizations and specialist centers could be a way to reach out to patients and to break down barriers with regard to participation in clinical trials. Presentations by sponsors and established clinical trial centers and intensified networking with general practitioners and specialists could probably also enhance patient recruitment.

Clinical trials

2012 ◽  
Author(s):  
Philip Wiffen ◽  
Marc Mitchell ◽  
Melanie Snelling ◽  
Nicola Stoner
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Hospital Pharmacy ◽  
Trial Design ◽  
Research Development ◽  
Clinical Knowledge ◽  
Fundamental Part ◽  
Specialist Knowledge ◽  
Development Phases ◽  
New Treatments

Clinical trial regulations 108Licensing of a clinical trial 109Clinical trial development phases 110Trial design, randomization, and blinding 111European Clinical Trials Directive 112Clinical trials: hospital pharmacy guidance 114Ethical committees 116Clinical trials form a fundamental part in the research, development, and licensing of new medicines. Research of how the drug interacts in humans is essential to ensure safe and effective medicines are licensed as new treatments. It is an exciting and varied role at the cutting edge of modern research with trials ranging across all therapeutic specialities. Clinical Trial pharmacists are therefore required to have a broad clinical knowledge and a specialist knowledge of the regulations that clinical trials have to follow....

Placebo-Controlled Clinical Trials with Ergotamine in the Acute Treatment of Migraine

Cephalalgia ◽  
1993 ◽  
Vol 13 (3) ◽  
pp. 166-171 ◽  
Author(s):  
Carl Dahlöf
Keyword(s):  
Clinical Trials ◽  
Diagnostic Criteria ◽  
Clinical Data ◽  
Clinical Studies ◽  
Trial Design ◽  
Acute Treatment ◽  
Controlled Clinical Trials ◽  
Ihs Criteria

Although oral ergotamine alone or in combination with caffeine is widely used for the acute treatment of migraine, there is little evidence that it is significantly more effective than placebo. There are no placebo-controlled data to support the use of aerosol or suppository formulations. In addition, the recommended doses of ergotamine cannot be justified. Each formulation of ergotamine now should be tested in clinical studies performed according to the IHS criteria for trial design and in migraine patients fulfilling the diagnostic criteria of the IHS. Until these clinical data are available, no dear recommendations can be given for the use of ergotamine in the acute treatment of migraine.

scholarly journals Data Validation and Verification Using Blockchain in a Clinical Trial for Breast Cancer: Regulatory Sandbox (Preprint)

2020 ◽  
Author(s):  
Tomonobu Hirano ◽  
Tomomitsu Motohashi ◽  
Kosuke Okumura ◽  
Kentaro Takajo ◽  
Taiyo Kuroki ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Data Management ◽  
Clinical Data ◽  
Clinical Trial Data ◽  
Research Process ◽  
Current Data ◽  
Data Management System ◽  
Blockchain Technology

BACKGROUND The integrity of data in a clinical trial is essential, but the current data management process is too complex and highly labor-intensive. As a result, clinical trials are prone to consuming a lot of budget and time, and there is a risk for human-induced error and data falsification. Blockchain technology has the potential to address some of these challenges. OBJECTIVE The aim of the study was to validate a system that enables the security of medical data in a clinical trial using blockchain technology. METHODS We have developed a blockchain-based data management system for clinical trials and tested the system through a clinical trial for breast cancer. The project was conducted to demonstrate clinical data management using blockchain technology under the regulatory sandbox enabled by the Japanese Cabinet Office. RESULTS We verified and validated the data in the clinical trial using the validation protocol and tested its resilience to data tampering. The robustness of the system was also proven by survival with zero downtime for clinical data registration during a Amazon Web Services disruption event in the Tokyo region on August 23, 2019. CONCLUSIONS We show that our system can improve clinical trial data management, enhance trust in the clinical research process, and ease regulator burden. The system will contribute to the sustainability of health care services through the optimization of cost for clinical trials.

Sign in / Sign up

Export Citation Format

Share Document