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Scientific Program
12th International Conference on Clinical Research & Clinical Trials, will be organized around the theme “Therapeutic Interventions Including Development and Clinical Trials of Drugs”
EURO CLINICAL TRIALS 2022 is comprised of 25 tracks and 1 sessions designed to offer comprehensive sessions that address current issues in EURO CLINICAL TRIALS 2022.
Submit your abstract to any of the mentioned tracks. All related abstracts are accepted.
Register now for the conference by choosing an appropriate package suitable to you.
BIMO - Bioresearch Monitoring Program - The Bioresearch Monitoring Program (BIMO) is the framework the Food and Drug Administration (FDA) uses to ensure the protection of research subjects and the integrity of clinical research data. The BIMO guidance manual gives clinical researchers instructions to follow to ensure compliance.
CRF - Case Report Form - A case report form is a paper or electronic questionnaire used in clinical trial research to collect dates from participants.
EDC - Electronic Data Capture - Electronic data capture refers to the method by which clinical research professionals gather data via a digital platform. An EDC platform assists with data management, allowing researchers to collect, enter, review and analyze data remotely, which can help sponsors bring devices to market faster.
GCP - Good Clinical Practice - Good Clinical Practice (GCP) is a foundation for all clinical research. This set of guiding principles ensures everyone who participates in clinical studies receives the protection they deserve. The fundamental principles of GCP have not changed since they were introduced more than 50 years ago. However, as the use of technology in clinical research has evolved to include electronic signatures, records and more, there are new considerations. Learn more about recent updates to GCP and how to apply them.
- Track 1-11. Pre-Clinical Research: Before testing a drug in people, researchers must find out whether it has the potential to cause serious harm, also called toxicity. The two types of preclinical research are: • In Vitro • In Vivo These researche
Refers to all or any research carried out on humans. It focuses on improving understanding of diseases, developing diagnostic methods and new treatments or medical devices to make sure better patient care. It’s much framed and a particular study protocol and is merely realized under certain conditions.
- Track 2-1Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for ex
- Parmacokinetics, measuring the effect of dose on rates of absorption and excretion of drugs from various body compartments;
- Pharmacodynamics, measuring the intended or unintended effects of dose on physiologic measures;
- Toxicology, measuring the effect of dose on histopathologic lesions in major organ systems;
- Reproductive and embryologic effects as a function of dose; and
- In vivo drug-drug interactions that might lead to attenuation or potentiation of intended or unintended effects of the treatment or that might affect the pharmacokinetics of the drugs.
- Track 3-1Prevention trials involve tests to find ways to prevent particular medical conditions or if people have them already, to prevent them from reoccurring. The emphasis of these studies might be on medicines, vitamins and minerals or lifestyle changes.
The goal is to determine whether or not the screening test saves lives and at what cost. The methods of detecting disease.
- Track 4-1Screening trials evaluate new tests for detecting cancer and other health conditions in people before symptoms are present. The goal is to determine whether or not the screening test saves lives and at what cost. The methods of detecting disease, often c
Diagnostic trials usually include people who have signs or symptoms of the disease or condition being studied. Refers to trials that are conducted to find better tests or procedures for diagnosing a particular disease or condition.
- Track 5-1A research study that evaluates methods of detecting disease.
Treatment trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people.
- Track 6-1Randomized, controlled clinical trials are separated into different phases based, in part, on the number of participants, and the interim goals for each phase. Phase I trials are the first step in testing a new approach in people. In these studies, resea
Care given to improve the quality of life of patients who have a serious or life-threatening disease. The goal of supportive care is to prevent or treat as early as possible the symptoms of a disease, side effects caused by treatment of a disease, and psychological, social, and spiritual problems related to a disease or its treatment. Also called comfort care, palliative care, and symptom management.
- Track 7-1Health related quality of life is increasingly used as an end point in clinical trials. Particularly, in diseases with a poor prognosis such as metastatic cancer, quality of life may be of major concern. However, clinicians are still reluctant to accept q
The following medical conditions are related to the study of genetic disease.
- Congenital Heart Disease
- Amyloidosis
- Antithrombin Deficiency
- Arginase Deficiency
- Bipolar Disorder
- Borderline Personality Disorder
- Bronchiectasis
- Celiac Disease
- Cerebral Ischemia
- Cholesterol Ester Storage Disease (CESD)
- Track 8-1Genetic testing is a type of medical test that identifies changes in genes, chromosomes, or proteins. The results of a genetic test can confirm or rule out a suspected genetic condition or help determine a person’s chance of developing or passing on a g
Epidemiologic studies can be used for many reasons, commonly to estimate the frequency of a disease and find associations suggesting potential causes of a disease. To achieve these goals, measures of disease (incidence) or death (mortality) are made within population groups.
- Track 9-1Epidemiology is the study of the distribution of diseases and other health-related conditions in populations, and the application of this study to control health problems. The purpose of epidemiology is to understand what risk factors are associated with
Expanded access is the use of an investigational new drug outside of a clinical trial in patients for the diagnosis, monitoring, or treatment of a serious disease or condition. In contrast, participants in clinical trials/studies are considered human subjects, whether they are patients or healthy volunteers.
- Track 10-1Expanded access may be appropriate when all the following apply: Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition. There is no comparable or satisfactory alternative therapy to diagnose, mo
Fixed trials consider existing data only during the trial's design, do not modify the trial after it begins, and do not assess the results until the study is completed.
- Track 11-1There are three characteristics of a binomial experiment. There are a fixed number of trials. Think of trials as repetitions of an experiment. The letter n denotes the number of trials. There are only two possible outcomes, called “success†and “fai
Controlled clinical trials provide scientifically valid evidence. But, in order to give valid Information, trials and are designed around a set of aims and hypotheses. This module will cover some of the basic designs, special trial management and data collection issues arising from the design, typical types of analysis, and the resulting statistical report.
Unit 1: Study Aims and Hypotheses
Unit 2: Basic Concepts in Design of Clinical Trials
Unit 3: Measurement
Unit 4: Trial Planning, Trial Management, Data Requirements
Unit 5: Randomization, Blinding, Placebos, Control
Unit 6: Measurement and study variables
Unit 7: Issues in Randomization
Unit 8: Statistical Report
Unit 9: A Web-Based Exam
Unit 10: Practical Exercise
- Track 12-1is the process of making something random, by chance. This can be applied in: Selecting a random sample of a population; or allocating units to different conditions with no order. In clinical trials, randomisation refers to the process of assigning a tria
A randomized controlled trial (or randomized control trial; RCT) is a type of scientific experiment (e.g. a clinical trial) or intervention study (as opposed to observational study) that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by randomly allocating subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group the experimental group receives the intervention being assessed, while the other usually called the control group receives an alternative treatment, such as a placebo or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control. There may be more than one treatment group or more than one control group.
The trial may be blinded, meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental bias
- Track 13-1Randomisation is the process of making something random, by chance. This can be applied in: Selecting a random sample of a population; or allocating units to different conditions with no order. In clinical trials, randomisation refers to the process of as
In a blind or blinded experiment, information which may influence the participants of the experiment is withheld until after the experiment is complete. Good blinding can reduce or eliminate experimental biases that arise from participants' expectations, observer's effect on the participants, observer bias, confirmation bias, and other sources. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. In some cases, while blinding would be useful, it is impossible or unethical. For example, it is not possible to blind a patient to their treatment in a physical therapy intervention. A good clinical protocol ensures that blinding is as effective as possible within ethical and practical constraints.
- Track 14-1A type of clinical trial in which neither the participants nor the researcher knows which treatment or intervention participants are receiving until the clinical trial is over. This makes results of the study less likely to be biased. This means that the
An open-label trial, or open trial, is a type of clinical trial in which information is not withheld from trial participants. In particular, both the researchers and participants know which treatment is being administered. This contrasts with a double-blinded trial, where information is withheld both from the researchers and the participants to reduce bias.
- Track 15-1Clinical trials are a key part of evaluating investigational treatments. People who volunteer to participate in clinical trials, along with investigators and study coordinators, are all key to a trial’s success. Often, clinical trials use a double-blind
Quasi-experiments are studies that aim to evaluate interventions but that do not use randomization. Similar to randomized trials, quasi-experiments aim to demonstrate causality between an intervention and an outcome.
- Track 16-1Using this basic definition, it is evident that many published studies in medical informatics utilize the quasi-experimental design. Although the randomized controlled trial is generally considered to have the highest level of credibility with regard to a
Well conducted and well managed trials are based on sound principals of project management, Training of personnel, quality monitoring control, and internal audits. his module will present management and control aspects of trials in the context of an integrated system. The Module concludes with a practical exercise.
- Track 17-1Completing any multi-part task requires organization, coordination, and discipline. Running a clinical trial is, of course, no different. From creating a plan, to communicating updates, to calculating risk, there are always many moving pieces, and solid p
Clinical research nursing is nursing practice with a specialty focus on the care of research participants. In addition to providing and coordinating clinical care, clinical research nurses have a central role in assuring participant safety, ongoing maintenance of informed consent, integrity of protocol implementation , accuracy of data collection, data recording and follow up. Care received by research participants is driven by study requirements and the collection of research data as well as clinical indications.
- Track 18-1Clinical research nursing is nursing practice with a specialty focus on the care of research participants. In addition to providing and coordinating clinical care, clinical research nurses have a central role in assuring participant safety, ongoing maint
- Advanced solid tumors
- Basal cell carcinoma
- Bladder cancer
- Breast cancer
- Cervical cancer
- Colorectal cancer
- Endometrial carcinoma
- Gastrointestinal cancer
- Track 19-1The "Journal of Cancer Research and Clinical Oncology" publishes significant and up-to-date articles within the fields of experimental and clinical oncology. The journal, which is chiefly devoted to Original papers, also includes Reviews as well as Editor
Medicines and Healthcare Regulatory Agency (MHRA) which trial a new medicine or an existing medicine for a different condition. The study can assess what doses should be given, how well the drug works in a population (its efficacy), how it works within the body (pharmacodynamics and pharmacokinetic properties) and any unwanted side effects. This enables a better understanding of trial drugs and wider access for patients to drugs for a given condition.
- Track 20-1Around the world, pharmaceutical companies conduct clinical trials to evaluate the safety and efficacy of their drugs. These studies are an necessary requirement to achieving regulatory approval so the drugs can be made available to patients.
Immunotherapy is used to fight off diseases such as cancer by stimulating or boosting the patient’s own immune system or giving man-made immune system proteins to attack cancer cells. Some types of cancers respond well to immunotherapy treatment alone while other cancers respond better when used in combination with other types of treatment such as chemotherapy.
Types of cancer immunotherapy or immunology include:
- Monoclonal antibodies (mAb) are engineered proteins that target tumor-associated antigens which in turn evokes an immune response to kill cancer cells
- Checkpoint inhibitor therapy targets immune ‘checkpoints’, key regulators of the immune system which cancer cells use to their advantage to protect themselves from immune system attacks. Cancer cells can often escape detection by interfering with these checkpoints on immune cells, notably T-cells. This type of therapy, usually antibody-based, essentially takes the ‘brakes’ off of the immune system and restores immune function by recognizing and destroying cancer cells. There are several checkpoint targets including PD-1 and CTLA-4 which are found on T-cells and PD-L1 found on cancer cells.
- Cytokines such as interferon interferes with the way cancer cells grow and multiply, stimulates the immune system, and encourages cancer cells to produce chemicals that evoke an immune response
- Vaccine therapy activates and stimulates the immune system to make antibodies to recognize and fight the disease
- Adoptive cell transfer such as chimeric antigen receptor (CAR-T) cell therapy in which the patient’s T-cells are extracted, genetically modified, and transferred back into the patient with the aim that these altered cells can now recognize and attack cancer cells
- Track 21-1The safety and effectiveness of new medications and new medical devices depends on clinical research to provide the Food and Drug Administration (FDA) with enough information to decide to approve or reject these products. Human testing, also known as a c
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This study is a randomized, double-blinded, and placebo controlled phase III clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Pvt. Ltd Company. The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the experimental vaccine in healthy adults aged 18~59 Years.
Primary Outcome Measures:
· Protection Indexes of Two Vaccine Doses for Symptomatic COVID-19 (Time Frame: 2 weeks after the second dose of vaccination)
· The protection rate of a two-dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed symptomatic COVID-19
Secondary Outcome Measures:
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Protection Indexes of One Vaccine Dose For Symptomatic COVID-19 (Time Frame: 2 weeks after the second dose of vaccination)
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The protection rate of, at least, one dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed symptomatic COVID-19 Two weeks after the last dose vaccination.
2.Protection Indexes of Second Vaccine Dose For Hospitalization, Disease Severity/and Death (Time Frame: 2 weeks after the second dose of vaccination)
- The protection rate of a two-dose of SARS-CoV-2 (Vero Cell) vaccine against rates of hospitalization, disease severity/and death two weeks after the second dose of vaccination
3.Protection Indexes of Two Vaccine Doses For SARS-CoV-2 infection (Time Frame: 2 weeks after the second dose of vaccination)
- The protection rate of a two dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed SARS-CoV-2 infection two weeks after the second dose of vaccination
4.Safety indexes of adverse reactions in 28 days (Time Frame: 28 days after the second dose of vaccination)
- The incidence of adverse reactions from the day of first vaccination to 28 days after the second dose of vaccination.
- Track 22-1This Phase III study is a global multicenter, randomized, double-blind,placebo controlled clinical trial to evaluate the efficacy, safety, and immunogenicity of therecombinant COVID-19 vaccine (Sf9 cells) in 40,000 participants aged 18 years and older who
This study is a randomized, double-blinded, and placebo controlled phase III clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Pvt. Ltd Company. The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the experimental vaccine in healthy adults aged 18~59 Years.
Primary Outcome Measures:
· Protection Indexes of Two Vaccine Doses for Symptomatic COVID-19 (Time Frame: 2 weeks after the second dose of vaccination)
· The protection rate of a two-dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed symptomatic COVID-19
Secondary Outcome Measures:
- Protection Indexes of One Vaccine Dose For Symptomatic COVID-19 (Time Frame: 2 weeks after the second dose of vaccination)
· The protection rate of, at least, one dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed symptomatic COVID-19 Two weeks after the last dose vaccination.
2. Protection Indexes of Second Vaccine Dose For Hospitalization, Disease Severity/and Death (Time Frame: 2 weeks after the second dose of vaccination)
· The protection rate of a two-dose of SARS-CoV-2 (Vero Cell) vaccine against rates of hospitalization, disease severity/and death two weeks after the second dose of vaccination
3. Protection Indexes of Two Vaccine Doses For SARS-CoV-2 infection (Time Frame: 2 weeks after the second dose of vaccination)
· The protection rate of a two dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed SARS-CoV-2 infection two weeks after the second dose of vaccination
4. Safety indexes of adverse reactions in 28 days (Time Frame: 28 days after the second dose of vaccination)
The incidence of adverse reactions from the day of first vaccination to 28 days after the second dose of vaccination.
Clinical Research on Pathology serves as translational bridges between basic biomedical science and clinical medicine with particular emphasis on, but not restricted to, tissue based studies. Clinical Research on Pathology Investigative diagnostic, prognostic, and biomarker studies with clear clinical relevance that advance our understanding of the mechanisms of human disease. In general, hypothesis-driven studies that are appropriately powered and validated will be preferred.
- Track 24-1Pathologists can play a vital role at every stage of a clinical trial – from design and the recruitment of participants, through to analysing results and ongoing monitoring and evaluation. As we enter a new era of precision medicine where treatments are
Trials of nutritional intervention in a wide range of health and disease states, preventive and therapeutic, are required. Not only has the emergence of chronic non-communicable disease (CNCD) with acknowledged nutritional pathogenesis created this imperative need, but so also have other conditions which, previously, had not been regarded as nutritionally based. Among the latter are health problems associated with ageing: the menopause, a decline in immune function, and a decline in cognitive function. At the same time, there is a new set of materno foetal and infant nutrition issues for investigation which relate to new food exposures and the long-term effects of nutritionally mediated gene expression.
- Track 25-1Trials of nutritional intervention in a wide range of health and disease states, preventive and therapeutic, are required. Not only has the emergence of chronic non-communicable disease (CNCD) with acknowledged nutritional pathogenesis created this impera