Advanced Clinical Trials and Clinical Research

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.

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

Nanotechnology ("nanotech") is the manipulation of matter on an atomic, molecular, and supra molecular scale. Nanotechnology as defined by size is naturally very broad, including fields of science as diverse as surface science, organic chemistry, molecular biology, semiconductor physics, micro fabrication, etc. The associated research and applications are equally diverse, ranging from extensions of conventional device physics to completely new approaches based upon molecular self-assembly, from developing new materials with dimensions on the nano scale to direct control of matter on the atomic scale.

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 u

Pharmacogenetics refers to how variation in one single gene influences the response to a single drug and Pharmacogenomics refers to how all of the genes (the genome) can influence responses to drugs. The general feature of these diverse lesions is that two nucleotides on opposite strands are joined covalently. Mutagenicity and carcinogenicity are clearly correlated.Understanding the specificity of mutagens in bacteria has led to the direct implication of certain environmental mutagens in the causation of human cancers

The Pharmaceutical industry's long successful strategy of placing big bets on a few molecules, promoting them heavily and turning them into blockbusters worked well for many years, but its R&D productivity has now plummeted and the environment’s changing. Regulators are becoming more cautious about approving truly innovative medicines

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.

Pharmacoepidemiology is the investigation of the way in which sub-atomic biomarkers change the clinical impacts of medicines in common people. Similarly as the essential exploration of Pharmacoepidemiology is the study of disease transmission, connected to the substance territory of clinical pharmacology, the fundamental art of atomic Pharmacoepidemiology is the study of disease transmission when all is said in done and sub-atomic the study of disease transmission particularly, likewise connected to the substance region of clinical pharmacology. Subsequently a considerable lot of strategies identified with the study of disease transmission are apply to sub-atomic Pharmacoepidemiology thinks about. Pharmacoepidemiology used to comprehend the intricate connection between medicine reaction and the immense number of potential sub-atomic and hereditary impacts on this reaction; an attention on cooperations among these elements and collaborations amongst qualities and condition.

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.

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.

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

Bioinformatics in Clinical Research 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 Behavioural 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.

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.

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

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.

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.

Outsourcing and Collaborative Research in Clinical Trialsbrings 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.

Gastrointestinal oncology refers to malignant conditions of the gastrointestinal tract (GI tract) and accessory organs of digestion, including the oesophagus, stomach, biliary system, pancreas, small and large intestine, rectum and anus. The symptoms relate to the organ affected and can include obstruction which leads to difficulty swallowing or defecating, abnormal bleeding. The treatment requires endoscopy, followed by biopsy of suspicious tissue. The treatment depends on the location of the tumor, as well as the type of cancer cell and whether it has invaded other tissues or spread elsewhere. These factors also determine the prognosis.

Since the Designing and development of a pharmacological product is a process, single organizations cannot take up the cost of research involved in it. Entrepreneurs willing to invest in the Pharma sectors can meet together and have an idea about the Pharma product, it’s effectiveness, it’s market potential and scope. Since the Pharma sector is booming in the recent market scenario, investors can have a great share of profits.