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Previous Speakers

Luke Stewart

Luke Stewart

Saama Technologies USA USA

Lauren E Ballina

Lauren E Ballina

Clinical Research Fastrack USA

Sergio Guerrero

Sergio Guerrero

Clinical Research Center Mexico

Lennox Graham

Lennox Graham

Howard University USA

F. Buck Willis Galveston

F. Buck Willis Galveston

Clinical Research Foundation USA

Melanie Flores

Melanie Flores

IntegReview IRB USA

Terri Hinkley

Terri Hinkley

Association of Clinical Research Professionals (ACRP) USA

Brian M Toglia

Brian M Toglia

Tanner-Ibbotson, Inc USA

Euro clinical trials 2019

About Conference


It’s an honor to welcome all the participants across the globe to be a part of "9th International Conference on Clinical research and clinical trials'' during March 18-19, 2019 at Paris, France. The theme of conference is “Innovative advancements in global clinical research and clinical trials”
Clinical research and clinical trials 2019 would be a great opportunity for people associated with clinical research, clinical trials, pharmacology, pharmacy practice, clinical pharmacy, pharmacovigilance & drug safety, to represent their research works. Associating with the International conference will be an incredible opportunity to interact with the eminent personalities in the field of Clinical research and clinical trials and know more about the advancements in the field.

 

Sessions

Clinical research & clinical trials: academic perspective

Clinical research is branch of medical science that discover the efficacy and accuracy of medicine, medical devices and treatment. This includes systemic, observational and experimental biomedical studies. Clinical research plays a major role in the prevention of disease state, treatment, diagnosis and cure of various health disorders. This involves a period of events from pre-clinical animal testing to several stages of drug development. Pre-clinical reviews and non-clinical studies is a phase of pre-clinical research that starts before clinical trials. Treatment research includes an intervention they are medication, psychotherapy, new approaches to surgery. Prevention research looks for more effective ways to prevent diseases and disorders. Diagnostic research is the practice of expecting for more effective ways to identify disorder condition. Screening research is to find the better ways to detect several diseases and health disorders. Quality of life trials ways to enhance comfort and quality of life for individuals with a chronic illness. Genetic studies target to upgrade the forecast of disorders by establishing and comprehension how genes and illness may be relate.

 

Clinical trials conduct

Clinical trials are observations on clinical research. Prospective behavioural research studies on human beings to answer particular queries on biomedical or behavioural interventions. This creates data on safety and efficacy. In master protocol, multiple experimental treatments are tested in only one trail. Clinical trial protocol is used to describe and supervise the trail. This protocol contains a definite study plan to assure safety and health trails and to give a correct template for trail conduct to inspector. A clinical trial involves new drugs are classified into five phases. Each phase of the drug compliance is treated as a separate clinical trial. The drug-development process will move forward through all four phases. Phase 0 – pharmacodynamics and pharmacokinetics in humans (testing within 10 to 15 people). Phase 1 – screening for safety (testing within a small group of people 20 to 80 people). Phase 2 – establishing the efficacy of the drug (testing with a larger group of people  100 to 300 people). Phase 3 – final confirmation of safety and efficacy (testing with a large group of people 1000 to 3000 people). Phase 4 –safety studies during sales (post marketing studies describes additional information including the treatments risk, benefits, and optimal use).

 

Clinical data management

Clinical data management assures collection, integration and availability of data at acceptable quality and cost. It leads to the making of high-quality, reliable, and statistically sound data from clinical trials. The data management plan explains the activities to be conducted in the processing data and used for description of data sources, data handling process and data control procedures. Clinical trials using an electronic CRF database design and also using paper CRF. Validation rules are electronic analysis explains in advance which make sure the integrity and uniformity of the clinical trial data. An electronic CRF is used data entry is drifting out towards the inspector site where the clinical trials are conducted. Samples which are collected during clinical trial they are sent to be a single central laboratory analysis. The CRF collects adverse events disclosed during the conduct of the clinical trial, there is a separate process which make sure that serious adverse events are disclosed quickly. The clinical data manager must make sure that data is reconciled between these processes.

 

Clinical research on different diseases

Clinical Trials for various substances and disorders are directed for evaluating at least one medication for treating an infection, disorder and moreover discovering appealing to keep the improvement or repeat of an illness or condition. This includes solutions, antibodies, or way of life changes, among different methodologies. Clinical trials on behaviours, mental, eating and sleeping disorders. Clinical trials for diabetes and cardiovascular diseases, Clinical trials for Alzheimer’s, Trials on pulmonary/respiratory diseases, Research and studies on wounds and injuries, Acquired immune deficiency syndrome, Gynaecological Infections, Infectious Colitis and HIV Infections.

 

Ethics in clinical research

Research ethics includes the fundamental ethical principles of various topics involving research and scientific research. Medical ethics is a system of moral principles that apply values to the practice of clinical medicine and in scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. Privacy for research participants is a concept in research ethics which states that a person in human subject research has a right to privacy when participating in research. Shared decision-making in medicine (SDM) is a process in which both the patient and physician contribute to the medical decision-making process. Health care providers explain treatments and alternatives to patients to provide the necessary resources for patients to choose the treatment option that best aligns with their unique cultural and personal beliefs.

 

Drug discovery & development

Drug target is the naturally existing cellular or molecular structure involved in the pathology of interest that the drug-in-development is meant to act on. It is the process to discover a new drug and bringing a drug to the market once a lead compound has been identified through the process of drug discovery. Drug Discovery & Development is these days a cloud-based, intellectual solution which analyses scientific knowledge and data to unveil known, unknown & hidden connectivity that can help increase the vast possibilities of scientific development. It is used by pharmaceutical companies, medical device companies and academic institutions to assist with new drug target identification and drug re-purposing. Microbes compete for living space and nutrients. To survive in these conditions, many microbes have developed abilities to prevent competing species from proliferating. Microbes are the main source of antimicrobial drugs. The elucidation of the chemical structure is critical to avoid the re-discovery of a chemical agent that is already known for its structure and chemical activity.

 

Patient-Centric clinical trials

Patient centricity will also bring about faster evolution and improvement of the products, technologies and services being utilized by patients in clinical trials. This is due to the more real-time feedback culture. This will in turn create industry pressure for improvement, movement and more agility in responsiveness than ever before. Not only has patient centricity disrupted the way we design clinical trials but it will also disrupt its business and outsourcing decisions. Patient-centric drug development also offers a huge opportunity to define meaningful outcomes from the patient perspective, as a way to ensure the needs and priorities of patient populations are reflected in research.

 

Pharmacoepidemiology

Pharmacoepidemiology is the study of the implementation and effects of drugs in many numbers of people and it produces an estimate of the probability of beneficial effects of a drug in a population and the probability of adverse effects. It can be called a bridge science spanning both clinical pharmacology and epidemiology. Descriptive epidemiology explains disease and may consist of calculating rates. Studies of drug use would generally fall under descriptive studies. Analytic epidemiology contains two types of studies they are observational studies and experimental studies. Clinical pharmacology is to produce a risk benefit assessment by effects of drugs in patients that assessing the probability of adverse effects on populations.

 

Pharmacovigilance & drug safety

Pharmacovigilance is the science and detection of relating activities, assessment, understanding and prevention of adverse effects or any other drug-related problem. Individual Case Safety Report is one of the fundamental principles of adverse event reporting.  The triage phase of a potential adverse event report, it has the great significance to determine the "four elements" of a valid ICSR are present they are -an identifiable patient, an identifiable reporter, a suspect drug, and an adverse event. Signal detection includes a range of techniques. SD is an essential part of drug use and safety supervision. The WHO defines a safety signal as: "Reported information on a causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously". A risk management plan is a documented plan that explains the risks occurred with the use of a drug and how they are being controlled.  The risks described in an RMP fall into one of three categories: identified risks, potential risks, and unknown risks. Clinical trial reporting also known as SAE (serious adverse event) reporting from clinical trials, safety information from clinical studies is used to establish a drug's safety profile in humans and is a key component that drug regulatory authorities consider in the decision-making as to whether to grant or deny market authorization for a drug.

 

Pharmacogenomics

Pharmacogenomics is the study of genome in drug response.  It deals with the influence of acquired and inherited genetic variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms with pharmacokinetics and pharmacodynamics. There are several known genes which are largely responsible for variances in drug metabolism and response. The focus of this article will remain on the genes that are more widely accepted and utilized clinically for brevity. They are Cytochrome P450s, VKORC1, and TPMT. Patient genotypes are usually categorized into Ultra-rapid metabolizer, Extensive metabolizer, Intermediate metabolizer, Poor metabolizer. A potential role pharmacogenomics may play would be to reduce the occurrence of polypharmacy. It is theorized that with tailored drug treatments, patients will not have the need to take several medications that are intended to treat the same condition. Toxicogenomics is a sub discipline of pharmacology that deals with the collection, interpretation, and storage of information about gene and protein activity within a particular cell or tissue of an organism in response to exposure to toxic substances.

 

Oncology clinical research

Oncology is a branch of arrangements with tumours. Integrative oncology deals with the brain, body, and soul. That is the reason numerous experts, including medicinal specialists, have grasped the quickly extending field of integrative oncology, which merges the best of customary and option medications. The science of clinical trials in oncology evolved to include phase I dose‐finding trials, phase II studies to establish efficacy in a single tumour type, phase III trials comparing standards of care with potential advances in care, and phase IV studies to extend safety and activity data in a post‐marketing scenario. Immuno-oncology treatments enact our invulnerable framework, making it ready to perceive growth cells and destroy them. Since tumour cells are altogether different from ordinary cells in the body, the resistant framework attacks them when it can remember them. Neuro-oncology assesses and treats individuals with essential and optional tumours of the cerebrum, spinal line, and the layers encompassing the mind and spinal rope (meninges).

 

Stem cell & Genetic clinical research

Stem cells are biological cells that can differentiate into other types of cells and can divide to produce more of the same type of stem cells. They are found in multicellular organisms.  In adult organisms, stem cells and progenitor cells act as a repair system for the body, replenishing adult tissues. In mammals, there are two broad types of stem cells: embryonic stem cells, which are isolated from the inner cell mass of blastocysts, and adult stem cells, which are found in various tissues. Genetics is the fundamental basis of any organism so understanding of genetics will provide a powerful means to discover hereditary elements in disease etiology. In recent years, genetic studies have shifted from disorders caused by a single gene (e.g. Huntington’s disease) to common multi-factorial disorders (e.g. hypertension) that result from the interactions between inherited gene variants and environmental factors, including chemical, physical, biological, social, infectious, behavioural or nutritional factors. Molecular genes were known to exist on chromosomes, chromosomes are composed of both protein and DNA, and scientists did not know which of the two is responsible for inheritance.

 

Medical and clinical case reports

Medical Case Reports delivers a focused valuable collection of cases in all disciplines so that healthcare professionals, researchers and others can easily find clinically important information on common and rare conditions. The journal mainly focuses on symptoms, signs, diagnosis, treatment, and follow-up of patient disease in different areas. Diabetes case report- Diabetes is a chronic metabolic disease that occurs when the human body is not able to produce enough of the hormone insulin or because cells do not respond to the insulin that is produced. High blood sugar produces symptoms of frequent urination, increased thirst and hunger. Cancer case reports- In 2012, an estimated 14.1 million new cases of cancer occurred worldwide more than 4 in ten cancers occurring worldwide are in countries at a low or medium level of Human Development Index.

 

Innovations in clinical study designs

Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research involving human beings. The goal of a clinical study is to assess the safety, efficacy, and the mechanism of action of an investigational medicinal product or procedure, or new drug or device that is in development, but potentially not yet approved by a health authority. It can also be to investigate a drug, device or procedure that has already been approved but is still in need of further investigation, typically with respect to long-term effects or cost-effectiveness. A randomized controlled trial is a type of scientific experiment which aims to reduce bias when testing a new treatment. An adaptive clinical trial is a clinical trial that evaluates a medical device or treatment by observing participant outcomes on a prescribed schedule, and modifying parameters of the trial protocol in accord with those observations.

 

Globalization of clinical trials

The globalization of clinical research is a relatively recent phenomenon, in which many of these studies are taking place on a global scale, with a significant increase of clinical trials in developing countries. The largest clinical trials average annual growth from 2005–2012 occurred in Asian (30%), and Latin American/Caribbean (12%) regions; other geographic regions had growth rates less than the world average (8%). The largest average annual growth occurred in lower-middle income (33%) and low-income (21%) regions. Emerging economies from low-middle income countries had the largest country-specific growth; other countries included South Korea, Japan, India, Brazil, and Turkey. With the globalization of clinical trials, it becomes necessary to strengthen legal and ethical guidelines for guaranteeing the research participants‟ integrity. Some observers noted, more than a decade ago, that studies were being run in developing countries without concerns regarding adherence to the international ethical principles. The process of globalization of clinical trials, therefore, can be advantageous because, for example, it gives to access to new treatments to participants; however, it requires discussion and the monitoring of ethical questions related mainly to ensuring the integrity, welfare and safety of the research participant; to the frames of reference of bioethics, such as autonomy, beneficence, justice and fairness.

 

Future & innovations of clinical trials

Clinical trials for the advancement of new medications are and their most part started and financed by industry. There are additionally numerous clinical trials started by scholarly clinical scientists. Whether started by industry or by scholastic clinical examiners clinical research is frequently performed in national, European and overall consortia, which can now and then, be expansive ones. Clinical research brings up significant moral and security issues. The security of members in a clinical trial is of vital significance. As an outcome, clinical research is exceedingly controlled. To encourage coordinated efforts crosswise over fringes, numerous parts of this control are blended at the European level additionally around the world.

 

Clinical pharmacy and pharmacy community

Clinical pharmacy is the branch of pharmacy in which doctor of pharmacy provide patient care that optimizes the use of medication and promotes health, wellness, and disease prevention. Clinical pharmacists care for patients in all health care settings but the clinical pharmacy movement initially began inside hospitals and clinics. Clinical pharmacists often work in collaboration with physicians, nurse practitioners, and other healthcare professionals.  Clinical pharmacists are a primary source for valid information and advice regarding the safe, appropriate, and cost-effective use of medications. A pharmacy is the place where most pharmacists practice the profession of pharmacy. Community pharmacies usually consist of a retail store front with a dispensary where medications are stored and dispensed. Pharmacies are typically required to have a pharmacist on-duty at all times when open. It is also often a requirement that the owner of a pharmacy must be a registered pharmacist.

 

Chronic disease state management

Chronic diseases are long-term conditions that usually progress slowly over time. This includes conditions such as heart disease, diabetes, chronic kidney disease, asthma and chronic obstructive pulmonary disease (COPD), depression, and arthritis, among many others. Chronic Disease Management (CDM) is on-going care and support to assist individuals impacted by a chronic health condition with the medical care, knowledge, skills and resources they need to better manage on a day to day basis. This may include regular visits and support from your family physician, other primary care provider, community-based programs or referrals to specialist programs and services.

 

Market Analysis

Clinical research:
Industry Insights
The global clinical trials market size was valued at USD 40.0 billion in 2016 and is expected to grow at a CAGR of 5.7% over the forecast period. Key drivers impacting the market growth are globalization of clinical trials, development of new treatments such as personalized medicine, augmenting evolution in technology, and boosting demand for CROs to conduct clinical trials. CROs diversified expertise as compared to pharma companies with respect to performing clinical trials in wide array of geographies and development of drugs in specific therapeutic areas are few factors responsible for the growing demand for the CROs in pharmaceutical segment.
According to BioOutsource, the demand for biosimilars testing is expected to increase in the U.S. This is attributed to the fact that the FDA finally started addressing the lack of clear guidance with regards to biosimilars, specifically how the developers should prove that their drugs are similar to that of the originator product. In January 2015, Hospira submitted one of the biosimilar versions of Epogen (Epoetin Alfa) and the result of the review in the U.S. is anticipated from the FDA within a year.
 

The geographical distribution of clinical trials is slowly shifting from developed nations to emerging countries. The rising cost of clinical trials and difficulty in patient recruitment has led biopharmaceutical companies to shift towards regions such as central and Eastern Europe, Asia Pacific, Latin America and Middle-East for cost efficiency and quick patient recruitment.Emerging countries also possess greater disease variation compared to west, where traditional diseases are growing. The greater disease variation among the developing countries helps biopharmaceutical companies to perform clinical trials from rare diseases.
Digitization in biomedical research is paving the way for growth of global clinical trial market. Adoption of Systems like EDC is also helping companies to better manage their patient data which ultimately reduces the monitoring cost and help in better patient compliance. Digitization also helps in meeting the stringent regulations by maintaining patient data records which ultimately helps in reducing clinical trials process errors.
Phase Insights
Clinical trials market, based on phase is classified as Phase I, Phase II, Phase III and Phase IV trial services. The Phase III trial service segment held the largest market share in 2016 and is expected to grow at a lucrative CAGR during the forecast period. Phase III trials are most expensive ones, as they involve huge subjects, and pose a challenge for the co-coordinator.
Phase I evaluates the tolerability or PK of the molecules as the end-point to approve the trial. In addition to this, other studies such as drug-drug interaction and food effect is also necessary to be performed.
Phase II studies are performed in two parts; in first part the dose range exploration is done along with efficacy studies while in further studies the dose is finalized. In case of oncology, Phase II studies act as pivotal trials.
In Phase III trials, long term safety studies are performed for registration. In June 2015, Aeterna Zentaris selected Ergomed for its Phase III studies. The UK based CRO is likely to help the company in conducting the efficacy studies for Macrilen, which is used for adult growth hormone deficiency.
Phase IV studies also known as post marketing surveillance studies are done after the molecule is launched in the market. Initially, the molecule is launched in small number and data is collected to validate its safety on general population.
Study Design Insights
The interventional study design is the most prominent method of conducting clinical trials across with globe. According to statistics provided by the U.S. FDA, over 126,000 trials are currently being conducted by means of this method. Furthermore, increasing innovation and evolution of treatment is predicted to contribute towards growth of the expanded access trials segment. For instance, various oncology drugs are routinely administered to patients prior to its approval by the U.S. FDA and considered as a part of expanded access trial.
Increasing demand of expanded access program owning to the ongoing demand for treatment of serious disease ailments in anticipated to lead towards this segment’s growth. A significant rise in expanded access program across all the regions has been observed, due to greater disease variation and increasing pressure from social media to both regulatory authority and drug companies. Initiatives are being taken by drug companies such as Johnson & Johnson, which started a pilot program for compassionate use of their unapproved cancer drugs.
Indication Insights
Based on indication, the oncology segment is anticipated to witness the fastest growth. According to various sources, more than USD 38.0 billion is currently spent by the healthcare industry towards preclinical and clinical development of oncology therapy products. Hence, it is anticipated to grow at a lucrative CAGR and contribute over USD 15.0 billion towards the clinical trials market by 2025.
Pain management is identified as the most lucrative segment over the forecast period owing to the increasing incidence of chronic conditions that may lead to severe pain. Furthermore, the rising investigation for new Non-Steroidal Anti-Inflammatory Drug (NSAID) and analgesic molecules is expected to be the vital impact rendering driver for this segment’s growth. In the study, pain management has been further classified into chronic and acute pain, wherein acute pain is expected to witness the fastest growth.
 

Past Conference Report

Clinical Trials 2018 Report
We gratefully thank all our wonderful Keynote Speakers, Speakers, Conference Attendees, Students, Organizing Committee Members, Associations, Sponsors, Exhibitors and Media Partners for making Clinical Trials 2018 Conference the best ever!
 
The 7th International Conference on Clinical Trials, hosted by the Conference series LLC Ltd was held during September 24-26, 2018 at San Antonio, USA based on the theme “An Insight into Innovative Approaches in Global Clinical Research and Clinical Trials”. Benevolent response and active participation was received from the Organizing Committee Members along with Scientists, Researchers, Students and leaders from various fields of Clinical Research & Trials, clinical research entities, medical groups, related associations, societies and also from government agencies, pharmaceutical, biomedical and medical device industries.
 
Conference series LLC Ltd expresses its gratitude to the conference Moderators, namely Lauren E Ballina, Katja Reuter and Geraldine E Baggs for taking up the responsibility to coordinate during the sessions. We are indebted to your support.
 
Similarly we also extend our appreciation towards our Chairs and Co-Chairs of the sessions for 3 days, namely Oleg V Tcheremissine, Sarah Attwood, Colleen Hoke, Richard Entsuah and Jing Bao
 
The conference was initiated with the Honorable presence of the Keynote forum. The list includes:
 
John P Neal, PCRS Network, LLC,  USA
Diana L Foster, Society for Clinical Research Sites (SCRS), USA
Ayad Abdul-Ahad, A3 Pharma Counselling Ltd, UK
Nicki Norris, Symphony Clinical Research, USA
Colleen Hoke, Objective Clinical, USA
Clayton Dehn, Clinical Trials of Texas, Inc., USA
Milan C Satia, Ethicare Clinical Trial Services, India
Jacob Joseph, Harvard Medical School and VA Boston Healthcare System, USA
The meeting reflected various sessions, in which discussions were held on the following major scientific tracks:
 
Drug Discovery and Development
Clinical Research & Clinical Trials
Clinical Study Designs
Conducts of Clinical Trials
Patient-Centric Clinical Trials
Research and Trials on AIDS / Cancer / Diabetes
Clinical Trials on different Diseases
Clinical Data Management and Statistics
Globalization of Clinical Trials
Innovations in Clinical Trials
Future of Clinical Trials
CRO/ Sponsorship Clinical Trials
Outsourcing in Clinical Trials
Clinical Trials Site and Supply Management
Medical and Clinical Case Reports
Pharmacovigilance and Drug Safety
Post-marketing Surveillance
A very special Thanks to our Sponsors, Ad-Sponsor and Exhibitors to have bestowed and their faith in collaborating with us to make this event a fruitful one. We hope you continue your support in our future endeavors.  
 
Aqumin, LLC, USA
CMM Global Inc., USA
Aurotech Inc, USA
Drug Lifecycle Tracking Application (DLTA), USA
Conference Series offers its heartfelt appreciation to organizations such as The Pharma Times, Select Science, Pharma Voice, Sci Doc Publishers, Technology Networks, Pharma Focus Asia, Pharmaceutical Tech, Clinical Biometrics, Event listing sites of San Antonio, and other eminent personalities namely Oleg V. Tcheremissine, David M Vulcano, Clayton A. Dehn, Milan Satia and Entsuah Anthony Richard who supported the conference by promoting in various modes online and offline which helped the conference reach every nook and corner of the globe.
 
With the grand success of clinical Trials 2018, Conferenceseries LLC LTD is proud to announce the "9th International Conference on Clinical Research and Clinical Trials 2019" to be held during March 18-19, 2019 at Paris, France.

For More details visit: https://clinicaltrials.pharmaceuticalconferences.com/

To Collaborate Scientific Professionals around the World

Conference Date March 18-19, 2019 |

For Sponsors & Exhibitors

[email protected]

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Journal of Clinical Trials Journal of Clinical Research & Bioethics Journal of Clinical Case Reports

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