Clinical Profiling: A Case Study

It is possible to know the clinical trials currently underway or patients enrolling online through registry and database of results from privately and publicly clinical studies of people carried out around the world.

Americans have access to and benefit from one of the most technologically advanced pharmaceutical systems in the world. However, this system is also very strict and tedious. The system this paper will evaluate is the United States Food and Drug Administration (FDA), more specifically, the FDA’s Center for Drug Evaluation and Research (CDER). Although, having access to this system can be frustrating to those that are in the pharmaceutical development industry or those that have illnesses and need the best drugs available in order to cope with their symptoms.

Phase 2 Clinical Studies - Helps determine the common short-term side effects and risks associated with the drug.

A computerized clinical database consists of clinical data for storing, retrieving, analyzing, and reporting of information (McCartney, 2012).

After the release of ResearchKit, Medidata revealed an open- source connecter linking the Apple ResearchKit to the Medidata Clinical Cloud. This integration will further help to use the data that is collected through the ResearchKit to improve the study designs. “Medidata has developed a mechanism allowing study builders to map the data generated from ResearchKit apps to studies in Medidata Rave” (NASDAQ:MDSO, 2015). The connection of software will give birth to a new level of productivity; expanding the quality, study designs, management and reporting of the clinical trials. “With the use of semantic web technology, a researcher will be able to create a data file using tags that identified which data items identified the researchers, the inclusion criteria, the aim of the study, the baseline tests to be performed, the details of the treatments to be compared and so on. And such data can be analyzed

Worldwide use of computer technology in medicine began in the early 1950s with the rise of the computers. In 1949, Gustav Wagner established the first professional organization for informatics in Germany. Medical informatics research units began to appear during the 1970s in Poland and in the U.S. Since then the development of high-quality health informatics research, education and infrastructure has been a goal of the U.S. and the European Union. (NYU graduate training program, 2010) Changes in the healthcare environment produced fundamental shifts in the delivery of healthcare. The altering landscape of healthcare is creating a huge demand for health data analytics. The growth and maturity of healthcare informatics over the past decade has been a prime catalyst in positioning the healthcare industry for the changes posed by reform measures. By understanding the process of analytics, clinical informatics specialists say healthcare providers have the insight necessary to make the process adjustments in the future.(Riskin, 2013)

The process used to pool the data together was clinical trial decision making. The main factors influencing this process consist of patient, provider, and treatment. Two studies specifically explored decision making by the patient. Education requirements impacted decision making since understanding the risks and benefits of clinical trials was the most important factor taken into consideration by the patient. Educational interventions were noted to have increased patient enrollment. (Biedrzycki, 2010).

Clinical decision making is a complicated process that depends on human capability to provide full attention to memorize, and create enormous amounts of data to all areas. IT systems are able to access information, arrange them, and recognize links between them. Clinicians often ‘know’ information such as a patient’s allergies, drug interaction and if that drug is on recall.

Medicine in the 21st Century has continued to push the boundaries of science to unthinkable limits, often fusing complex technological elements and concepts together to achieve great feats. Two major contributing factors that have increased the use of high-technology in modern day medicine are Evidence-based Medicine and Health-Informatics. One study completed at Ohio State University (2016) proved how beneficial combining high-technologies such as Health Informatics Tools (HIT) and Evidence-Based Medicine can be. "Achieving a vision of 'interventional informatics ' will requires us to re-think how we study HIT tools in order to generate the necessary evidence-base that can support and justify their use as a primary means of improving the human condition" (Embi et al, 2016). This synergistic effect is just one of many countless examples of the successful advancements in medicine today. These strings of successful advancements in medicine can almost certainly be linked to the progression of specific

The officer does not need to obtain a warrant in order to make an arrest. However, the officer is required to investigate what has happened. The officer at this moment he has reasonable suspicion, in other words there may have been a crime committed and the person the officer stops believes he or she may have committed that crime. With this we have the ability to detain and investigate. Now if the suspect takes off running and the police officer observes the suspect run into a house and shut the door. We still do not need to a search warrant or permission to enter. The police officer already has the knowledge that a robbery has taken place and the victim identified the suspect. The suspect has now fled. So there is knowledge he committed a

(Adams M. , 2013). ?Before a drug is introduced, regulators demand controlled clinical trials (on carefully selected homogeneous samples); but, once a drug is widely in service, they fail to engage in systematic monitoring of what happens in everyday clinical practice, with ?real? patients.? (May, 2004).

One major big data system implemented in healthcare today is Electronic Health Records (EHR). CMS.gov describes EHR as,

It is now accepted worldwide that before a drug is brought into routine use its efficacy, safety, and the balance between two need to be formally demonstrated. The efficacy of new drugs nowadays is almost invariably established with a technique known as ‘randomized controlled trial’.

Mrs. J. arrives at the emergency department with her 6 year old son, PJ, who has a history of Cystic Fibrosis (CF). He is febrile (101.7° F orally), BP 98/66, HR 122, RR 32 with the use of accessory muscles. Mother states PJ has, for the last five days, exhibited signs and symptoms of upper respiratory infection, runny nose, low grade fever, cough, and fatigue. He has lost 2 pounds over the past 5 days due to anorexia though he has not had vomiting. He weighs 36 pounds and height is 3’2”. Today, PJ became more lethargic and his fever was difficult to control with pyretics.

People who work in the information technology (IT) area of a biopharmaceutical company usually start either with an IT background and become interested in the biopharma field, perhaps because of the desire to help find cures for diseases, or they start in the clinical area and become more interested and involved in what IT can do for clinical research. Very few people actually start with the idea of working in IT for a biopharma company. This article focuses on the impact some of the major technologies introduced into the biopharma arena over the past few years. It also addresses IT-oriented clinical research professional needs to know about the various and numerous technologies in this field. And this article will suggest the need for “bridge people” who understand the industry, IT, and how to apply IT to the day-to-day needs of clinical research. Technology is an area of rapid change. It is an area where strong skills and the desire to keep up with innovation and change are essential for a good IT professional and/or bridge person. Although the pace of change makes it difficult for any IT-oriented person to keep up with the field, people must have industry knowledge to drive the adoption of new technology. In this day and age, even clinical research professionals who do not desire to become IT or bridge people must have an improved understanding of technological changes that will help them perform day-to-day work, as this work can no longer be divorced from the technology.