Call for Abstract
8th International Conference on Clinical Trials, will be organized around the theme “Advanced Innovative Approaches in Global Clinical Research and Clinical Trials”
Clinical Trials 2019 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in Clinical Trials 2019
Submit your abstract to any of the mentioned tracks.
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Clinical trial is a part of clinical research that follows a regulated protocol, or plan of action. Clinical trials are primarily performed to get data on safety and efficacy of the new developed drug, this data is mandatory for further approval of the drug and to bring it into the market.
The clinical trials market has been estimated to reach USD 14.2 billion in 2016 and is projected to reach around USD 22 billion by the year 2021, growing at a CAGR (compounded annual growth rate) of 7.5%, during the forecast period 2016 to 2021. 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. Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to Federal agencies such as the National Institutes of Health, the U.S. Department of Defense, and the U.S. Department of Veterans Affairs. Doctors, other health care providers, and other individuals can also sponsor clinical research.
- Track 1-1Clinical research in academic level
- Track 1-2Trials on Biologics and biosimilars
- Track 1-3FDA conduct of clinical investigator inspections
- Track 1-4Meetings with the FDA—Why, When and How
- Track 1-5Misconducts of clinical trials
- Track 1-6Perils and Pitfalls of miscommunication in research
- Track 1-7Community outreach and education in clinical trials
- Track 1-8Pharma’s role in Bridging clinical research and health care
- Track 1-9Real world clinical trial strategies and results
- Track 1-10Informed consent for trials
- Track 1-11Preclinical research considerations
- Track 1-12Trends & perspectives in clinical research
- Track 1-13Brexit’s Impact on clinical research
Researchers discover new drugs through insights into a disease process that allow researchers to design a product to stop or reverse the effects of the disease. Once researchers identify a promising compound for development, they conduct experiments to gather information on how it is absorbed, distributed, metabolized, and excreted, best dosage, Side effects, how it interacts with other drugs and treatments and its effectiveness as compared with similar drugs.
Bringing one new drug to the public typically costs a pharmaceutical or biotechnology company on average more than $1 billion and takes an average of 10 to 15 years. Each drug undergoes a stringent process of discovery, development, approval and finally, public use.
- Track 2-1Challenges in drug discovery & development
- Track 2-2Novel technologies in drug discovery
- Track 2-3Technologies in novel drug delivery systems
- Track 2-4Drug discovery in preclinical research
- Track 2-5Scientific formulation advancements in practice
- Track 2-6Why formulation and delivery strategies fail
- Track 2-7Experimental and computational approaches
Clinical Operations have a lot of interaction with people in a range of other departments including Clinical Science, Clinical Quality Assurance, Data Management, Biostatistics and Regulatory Affairs to ensure that the data and information needed by these other departments is delivered so they can decide if a trial has been successful. The Clinical Operations function of a company is key to the delivery of clinical trials. Without this team no Clinical Research activity could be delivered. Clinical Operations teams are responsible for designing, planning and physically running Phase I – IV clinical trials. Many larger pharmaceutical companies have also looked at setting up strategic partnerships with Clinical Research Organizations to outsource some or all of their Clinical Operations activities.
Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms. Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses. Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
- Track 3-1Early clinical development: Operational strategies
- Track 3-2Misconduct and fraud in clinical trials
- Track 3-3Managing risk with contracts: Informed consent, Subject injury, Insurance & Indemnification
- Track 3-4Integrating quality into clinical trials
- Track 3-5Risk-Based monitoring
- Track 3-6Setting & managing priorities in a clinical project schedule
- Track 3-7Clinical trial project management platforms
- Track 3-8Translation of clinical trial documents – challenges, options and solution
- Track 3-9Streamlining R&D clinical trials operations
- Track 3-10Transforming clinical development
- Track 3-11Good clinical practice and inspection readiness
Patient recruitment and up-front enrollment planning are critical to drug development programs. Patient recruitment, if not adequately planned for, can extend your development timeline by a number of years. Retention of patients throughout the life of a clinical trial is essential in order to have complete data sets for your analysis and subsequent filings. In order to optimize both, you have to have a plan and it should take into account all stakeholders from senior management at the sponsor company and the CRO partners, to the sites and investigators and study volunteers. Cambridge Healthtech Institute’s Tenth Annual Enrollment Planning and Patient Recruitment conference will cover the topics one should consider when drafting and strategically implementing a patient recruitment plan for a clinical development program.
- Track 4-1Strategic enrollment planning
- Track 4-2Innovative approaches to patient recruitment & retention
- Track 4-3Data-driven recruitment and forecasting
- Track 4-4Incorporating data and patient insights into enrollment planning
- Track 4-5Reaching patients and improving recruitment operations using existing and/or innovative tools
- Track 4-6Harnessing the power of digital and social media to drive patient recruitment
Generally accepted principles suggest that patient involvement should extend well beyond consideration as research subjects. Patients are key stakeholders in all aspects of trial design & execution. 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. Although efforts are made to control risks to clinical trial participants, some risk may be unavoidable because of the uncertainty inherent in clinical research involving new medical products. It's important, therefore, that people make their decision to participate in a clinical trial only after they have a full understanding of the entire process and the risks that may be involved.
- Track 5-1Creating truly patient centric trials
- Track 5-2Patient centric approaches to clinical trials
- Track 5-3Patient perspective on research and health care
- Track 5-4Creating patient centric trials using disruptive approaches to overcome barriers
- Track 5-5Patient involvement in developing clinical trials
- Track 5-6Understanding the future of patient engagement in clinical trials
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. Clinical trials are typically conducted in four phases, each phase is considered as separate trial and, after completion of a phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase. Types of study designs are Meta-Analysis, Systematic Review, Randomized Controlled Trial, Cohort Study, Comparative Study, Case-control Study, Cross-sectional study, Case Reports and Series, Animal Research Studies, Test-tube Lab Research
- Track 6-1Design and end points of clinical trials
- Track 6-2Trial design: Formulation development, manufacturing and analytical testing
- Track 6-3Observational study designs
- Track 6-4Experimental study designs
- Track 6-5Randomized trial model
- Track 6-6Adaptive trial model
- Track 6-7Randomized placebo- controlled trials
- Track 6-8Maximizing trial success through Patient–Oriented study designs
HIV clinical trials are research studies that look at new ways to prevent, detect, or treat HIV/AIDS. Clinical trials are the fastest way to determine if new medical approaches to HIV/AIDS are safe and effective in people. clinical trials under way include studies of new HIV medicines, studies of vaccines to prevent or treat HIV, and studies of medicines to treat infections related to HIV.
There are several types of cancer clinical trials, including treatment trials, prevention trials, screening trials, and supportive and palliative care trials. Each type of trial is designed to answer different research questions and will help researchers learn things that will help people in the future.
- Track 7-1Challenges in conducting oncology trials
- Track 7-2Personalized cancer medicine
- Track 7-3Cancer biomarkers
- Track 7-4Feasibility and site selection in competitive immuno-oncology trials
- Track 7-5Studies on new HIV medicines
- Track 7-6Studies on infections related to HIV
- Track 7-7Trials on vaccines to prevent or treat HIV
- Track 7-8Benefits and possible risks of participating in HIV/AIDS clinical trial
- Track 7-9Benefits and risks of participating in cancer trials
Clinical Trials for different diseases and disorders are conducted for evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy) for treating a disease, syndrome, or condition and also finding ways to prevent the initial development or recurrence of a disease or condition. These can include medicines, vaccines, or lifestyle changes, among other approaches. Some examples of the diseases/disorders for which clinical trials conducting are Cardiovascular, Digestive system, Respiratory system diseases and other parasitic, viral, bacterial and fungal diseases. And Clinical Trials on behaviors, mental, sleep and eating disorders.
- Track 8-1Clinical trials for diabetes and cardiovascular diseases
- Track 8-2Clinical trials for Alzheimer’s
- Track 8-3Trials on pulmonary/respiratory diseases
- Track 8-4Clinical trials for rare diseases: Challenges and opportunities
- Track 8-5Research and Trials on behaviors, mental, eating and sleeping disorders
- Track 8-6Research and studies on wounds and injuries
- Track 8-7Studies on parasitic, viral, bacterial and fungal diseases
Medical imaging has increased exponentially in routine clinical practice. This has been reflected in a rapidly increasing use of medical imaging in clinical trials, through all phases. More recently this has culminated in a number of inter-disciplinary meetings with the various stake holders, including the FDA. Discover new technologies in medical imaging, and how to implement them in your clinical research. As the pharmaceutical, biotech and medical device industry continues to identify ways to improve and speed up product development, medical imaging plays a more significant role.
- Track 9-1Rise of imaging in clinical trials
- Track 9-2Medical imaging modalities
- Track 9-3Considerations regarding the use of imaging in trials
- Track 9-4Technology solutions to streamline imaging in clinical studies
- Track 9-5Imaging as a biomarker
- Track 9-6Standardization of imaging protocols
Clinical data management is the process of collection, cleaning, integration and management of subject data in compliance with regulatory standards. It is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials, this has been facilitated by the use of software applications that maintain an audit trail and provide easy identification and resolution of data discrepancies. CDM also supports the conduct, management and analysis of studies across the spectrum of clinical research. The ultimate goal of CDM is to assure that data support conclusions drawn from research. Achieving this goal protects public health and confidence in marketed therapeutics.
- Track 10-1Big data for clinical trials
- Track 10-2Digitalization of clinical trials
- Track 10-3Data visualization & Analytics techniques for clinical trial insights
- Track 10-4CRF/eCRF design and development
- Track 10-5Electronic data capturing systems
- Track 10-6SAS programming in data analysis
- Track 10-7Integrated technology platforms
- Track 10-8Data & Tech driven clinical trials
- Track 10-9Data types and data processing techniques
- Track 10-10Clinical data strategy and analytics
- Track 10-11Impact of real world data
- Track 10-12Artificial intelligence in clinical research
Clinical study design comprises the quantity of study volunteers, their segmentation based on varying factors, and their treatment throughout the clinical trial process. Study design is a key component of clinical trials, and the treatment of all patients directly impacts the statistical validity of data. Study group assignment has also been comprehensively improved in recent years. Researchers have found many benefits to randomized assignment versus observational assignment, based on characteristics like gender, age, race, etc. The randomized method has been found to yield more reliable results than observational study assignments.
In recent years, the use of Adaptive design methods in clinical research has become increasingly popular due to its flexibility and efficiency. Adaptive designs offer the potential to reduce study duration and patient exposure whilst maximizing the probability of a successful outcome. Another innovation in clinical trials is the Bucket design. Bucket trials are designed to utilize one particular drug and test that drug against a number of different diseases. The advantage of this approach is that patients with different diseases can be 'pooled' together under one larger trial instead of lots of smaller trials, thereby saving time and resource in a similar approach, and there are more innovations in clinical trials.
- Track 11-1Innovations in clinical technologies
- Track 11-2Disruptive technologies for data and trial management
- Track 11-3Sensors, wearables and digital biomarkers in clinical trials
- Track 11-4Remote trials and digital technology
- Track 11-5Mobile technologies in clinical trials
- Track 11-6How technology can enable Patient-Centric clinical research
- Track 11-7Global needs for mobile health and potential technologies
CRO (Contract Research Organization) is an organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices. CROs range from large, international full-service organizations to small, niche specialty groups. A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance. CROs also support foundations, research institutions, and universities, in addition to government organizations.
Sponsorship: In the conduct of clinical trials, a sponsor is an individual (institution, company or organization) that takes the responsibility to initiate, manage or finance the clinical trial, but does not actually conduct the investigation. A sponsor-investigator, on the other hand, takes on the responsibility as a clinical study sponsor and also conducts or oversees the clinical trial. Thus, a sponsor-investigator must comply with the applicable regulatory requirements that pertain to both the sponsor and the investigator
- Track 12-1Challenges and opportunities of Sponsors and CROs
- Track 12-2Hidden costs for sites and sponsors
- Track 12-3CRO selection and management
- Track 12-4Financial aspects of clinical trials
- Track 12-5CRO perspective on bridging clinical trial processes to Real-World health care
- Track 12-6Globalization & Outsourcing
- Track 12-7Outsourcing trends & strategies
- Track 12-8Mastering an outsourcing strategy
- Track 12-9Lean outsourcing models for clinical trials
- Track 12-10Understanding the outsourcing function
- Track 12-11Constructing your contract for maximum benefit
- Track 12-12Strategic and tactical clinical outsourcing
The conduct of clinical trials is one of the most expensive aspects of the development of new medicinal products. It is important, therefore, that the studies should produce high-quality data in the shortest possible time. More companies are trying to use single, larger, complicated trials in an attempt to gain the greatest amount of information about a product and thus reduce the lead time to market. A key element in ensuring this goal is the close cooperation between those responsible for the provision of the clinical trial supplies. The provision of clinical trial supplies is usually organized by a special group, often within the product development department, and it is prudent to discuss a proposed trial with this group at an early stage so that any potential difficulties can be identified and resolved.
The value of some study drugs can reach tens of millions of dollars, making it essential to avoid overproduction, oversupply, and inventory expiration. With the high costs and strict handling requirements for many biopharmaceutical products entering clinical development, the logistics of clinical trial supplies are more critical than ever.
- Track 13-1Protocol development, site selection, feasibility and management
- Track 13-2Data-driven feasibility, country selection, and site identification
- Track 13-3Develop a technology road map for your research site
- Track 13-4Site management innovation
- Track 13-5Modernizing your Site
CBI’s Clinical Trial Budgeting & Forecasting brings together CROs, sites, sponsors and vendors to collaborate on best practices for ensuring accurate and effective budgeting and forecasting in clinical trials. With growing complexities and shrinking tolerance for variance between forecasted and actual budget, it’s critical that internal and external teams work together to tackle the challenges and establish efficient processes. Join your trial counterparts in May to bridge the gap between finance and operations and address each player’s role in managing deviations including timeline delays, changes in study design, outsourcing and more.
- Track 14-1Innovative strategies for cost-efficient trials
- Track 14-2Working with sites: Budgeting and payments
- Track 14-3Strategies for efficient negotiation and contracting
- Track 14-4Contracting and resource allocation
- Track 14-5Phamracoeconomics
- Track 14-6Strategies for financial forecasting and budgeting
The value of some study drugs can reach tens of millions of dollars, making it essential to avoid overproduction, oversupply, and inventory expiration. With the high costs and strict handling requirements for many biopharmaceutical products entering clinical development, the logistics of clinical trial supplies are more critical than ever. Expert management begins with the clinical trial supply strategy, and ends with returns and destruction. Integration and coordination of many third-party vendors and technical systems is needed to verify that study drugs are available in sufficient quantity and quality at the various stages of clinical distribution. Clinical supplies management provides full traceability of drug supply from manufacturing to dispensation and destruction - making it a key factor in study success, as it avoids information gaps and reduces risks such as out of stock or expiration.
- Track 15-1Effective tracking, managing and distributing clinical supplies
- Track 15-2Tech tools for tracking and tracing clinical supplies
- Track 15-3Direct-to-Patient distribution: Meeting the patient’s needs
- Track 15-4Patient centered clinical trial material design and delivery
- Track 15-5Patient centricity and clinical supply
- Track 15-6Innovative supply management strategies
- Track 15-7Considerations for managing clinical supplies
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. Developed markets in the United States, Western Europe, Germany, and Japan still generate the lion’s share of clinical trial activity. Nearly 31% of the world's clinical trials are reportedly conducted outside of the United. According to the report China, Japan, India, and Korea are the most active settings for clinical trials among developing nations. It is predicted that Japan as the world’s second-largest pharmaceutical market by 2015.
According to the ClinicalTrials.gov the total number of studies registered in 2016 is 231,756. The percentage of studies registered from United States is 37%, Non-U.S is 47%. It is estimated to reach more than 280,000 study registries by 2017.
- Track 16-1Trends in the globalization of clinical trials
- Track 16-2Japan Clinical Trials
- Track 16-3Canada Clinical Trials
- Track 16-4UK Clinical Trials
- Track 16-5Europe Clinical Trials
- Track 16-6USA Clinical Trials
- Track 16-7Globalization of drug development
- Track 16-8Ethical and scientific implications
- Track 16-9Strategies for successful globalization of clinical trials
- Track 16-10Asia Clinical Trials
A case report is a means of communicating something new that has been learnt from clinical practice. It could be about an unusual or previously unknown condition, a rare presentation or complication of a known disease, or even a new approach to managing a common condition. A case report provides the detailed report of symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient and play major role in the field of medical research and evidenced based medicine. Moreover, case reports can serve as an early warning signal for the adverse effects of new medications, or the presentations of new and emerging diseases
- Track 17-1Cancer and HIV/AIDS case reports
- Track 17-2Breast cancer case reports
- Track 17-3Diabetes case reports
- Track 17-4Dermatology, gastroenterology, Nephrology, pulmonology and urology case reports
- Track 17-5Case reports in neurology, ophthalmology, obstetrics and gynecology
Bioethics is the study of the typically controversial ethical issues emerging from new situations and possibilities brought about by advances in medicine. It is also moral discernment as it relates to medical policy, practice, and research. Bioethicists are concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, clinical research, and philosophy etc. One of the first areas addressed by modern bioethicists was that of human experimentation. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was initially established in 1974 to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects.
Clinical research ethics are the set of relevant ethics considered in the conduct of a clinical trial in the field of clinical research. It borrows from the broader fields of research ethics and medical ethics. Quality of clinical trials depends on data integrity and subject protection. Good Clinical Practice (GCP) is the universal ethical and scientific quality standard for conducting clinical trials. The GCP standard applies to all aspects of the clinical trial process.
- Track 18-1Compliance and regulatory requirements in clinical research
- Track 18-2Bioethics: Case studies and ethical regulatory guidelines
- Track 18-3Ethics and patient’s rights
- Track 18-4Ethics & Human subject protection
- Track 18-5Value of ethics in clinical research
- Track 18-6Regulatory implications and opportunities with new technologies
- Track 18-7New regulatory flexibility driving positive industry change
- Track 18-8Navigating the clinical trials regulatory landscape
- Track 18-9Bridging regulations to Real-World health care
- Track 18-10Good clinical practice
- Track 18-11Ethical challenges in cancer clinical trials
The pharmacovigilance is related to collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products, and it is needed in different stages of product life cycle, and the safety surveillance and risk management. Information received from patients and healthcare providers via pharmacovigilance agreements, plays a critical role in providing the data necessary for Pharmacovigilance to take place, in order to market or to test a pharmaceutical product, adverse event data must be submitted to the local drug regulatory authority. Finally pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients by safety surveillance and risk management
- Track 19-1Priorities and needs of PV at different stages of a product life-cycle
- Track 19-2Challenges and opportunities in PV lifecycle management
- Track 19-3IT solutions for pharmacovigilance
- Track 19-4Safety surveillance and risk management lifecycle
- Track 19-5Innovations and trends in clinical drug safety