4^th International Conference on Clinical Trials September 11-13, 2017 San Antonio, Texas, USA
(10 Plenary Forums - 1 Event)

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.

Outsourcing of clinical trials presents the US Food and Drug Administration (FDA) and companies with new issues around quality and responsibilities. By properly transferring responsibilities to contract research organizations (CRO) sponsors can eliminate some potential problems. As sponsor has to indicate what specific responsibilities they are transferring to the CRO in writing. Anything that’s not specifically described in writing is deemed to be retained by the sponsor

Globalization, outsourcing and increasing complexity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies.

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 major steps in clinical trial supplies are 1)Placing an order for clinical trial supplies, 2) Manufacturing of clinical trial supplies, 3) Blinding of clinical trial supplies, 4) Obtaining comparators, 5) Packaging, 6) Labelling, 7) Documentation, 8) Expiry dating, 9) Dispatch of supplies, 10) Disposal of clinical trial supplies.

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.

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

The future of clinical trials illustrated as follows. Access and engage the patient online – Attract patients to the trial – Consent patients & convert to subjects – Remotely manage subjects & collect data. The sponsor plans to engage the patient through social media, such as Facebook, and regular e-mail updates in order to attract the patient to the trial, and once the patient agrees to learn more about the trial, the sponsor mails the patient a package containing mobile health devices, which collect medical diagnostic data and sends that data to the sponsor.  The patient turns on the tablet, which contains an electronic consent and a video of a physician explaining the clinical trial in detail. Humanization in digital media is believed to be an effective tool that is used to communicate with patients. During the clinical trial, the subject is able to access live physicians either virtually or through nearby medical community centers. Remote nurses visit the subject at their homes to collect samples.  In addition, the patient uses the mobile health device to automatically upload study data directly to the sponsor's EDC database.

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.

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.

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.

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.

HIV clinical trials are research studies done to look at new ways to prevent, detect, or treat HIV. Clinical trials are the safest and fastest way to determine if new medical approaches to HIV prevention or treatment are safe and effective in people. All the medicines used to prevent and treat HIV in the United States were first studied in clinical trials. Examples of HIV clinical trials are, studies of new medicines to treat HIV, studies of vaccines to prevent or treat HIV, 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.

Diabetes/Diabetes mellitus describes a group of metabolic diseases in which the person has high blood glucose, either because insulin production is inadequate, or because the body's cells do not respond properly to insulin, or both. Patients with high blood sugar will typically experience polyuria, and they will become increasingly thirsty (polydipsia) and hungry (polyphagia). Clinical trials are conducted for both the Type 1 and Type 2 diabetes.

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.

Clinical trials also known as clinical research studies that follow a pre-defined plan or protocol. Researchers design clinical trials (Clinical study designs) to answer specific research questions related to a medical product. Clinical trials, particularly those looking at new drugs, often start after successful animal studies. The most promising treatments then move into clinical trials.

There are four categories of clinical trials. The fourth occurs after the FDA has cleared a certain drug or therapy and continues to track the safety of the treatment. Phase 1, Phase 2, Phase 3 and Phase 4. A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. Test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. By taking part in clinical trials, participants can not only play a more active role in their own health care, but they can also access new treatments and help others by contributing to medical research. 

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

The drug discovery process involves identifying a suitable target that is a molecule or a protein receptor that is specifically associated with a disease condition or pathology. Once a target is identified, the next step involves understanding how the target plays a role in the disease process. This is followed by testing of the target against different known and new compounds to identify either one or several ‘lead compounds’ which interact with the target and show the potential to either neutralize or slow the disease process.

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. The part of the development process in which the candidate drug is thoroughly investigated, optimized, and prepared for testing in humans is referred to as the ‘preclinical phase’. During the clinical phase of development, the efficacy and safety of a drug candidate is investigated in patients

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.

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

Postmarketing studies required or agreed by a sponsor that are conducted after FDA has approved a product for marketing. FDA uses postmarketing study commitments to gather additional information about a product's safety, efficacy, or optimal use. Agreements with sponsors to conduct postmarketing studies can be reached either before or after FDA has granted approval to a sponsor to market a product.