Clinical trial

Not only do these reports empower doctors to make better clinical decisions during patient encounters, but sharing the information with peers, colleagues and research facilities provides valuable, actionable information to improve quality of care for all patients around the globe. Endocrinologists can benefit from…

Deputy Commissioner for Medical Products and Tobacco. Before the commissioner assumed any roll at the FDA, he was a professor of medicine and vice chancellor for clinical and translational research at Duke University. In addition, he also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research…

Monitoring of different Clinical Research enables research ethics boards to ensure that, the standards that they approve in theory are being applied in practice [1] [2]. It has been suggested that such review has to be performed regularly and that it include monitoring of a variety of aspects of research, such as the consent process, adherence to the approved protocol and data integrity [1] [3]. 1. Weijer C, Shapiro S, Fuks A, Glass KC, Skrutkowska M. Monitoring clinical research: an obligation…

In 2008, Tengion was an emerging biotechnology company with great potential in the field of regenerative medicine. This field of medicine focused on developing an alternative way to repair or replace tissue and organs by extracting patients’ own cells, growing the new tissue in a lab, and translpanting it back into the patient. This new way of treatment offered many benefits, including reduced post operative complications, yet, it also brought forward unforseen challenges to overcome. With…

Introduction Due to the complex nature of the needs of the elderly in the emergency room setting, there has been a movement to identify such high-risk patients through the initial triage in the emergency room. One such example is the Identification of Seniors At Risk (ISAR). The ISAR is used as a screening tool to expeditiously identify patients 65 years and older who are at risk for adverse outcomes while in emergency room setting as well as post–ED visit. The tool includes a six validated…

animal testing. Once the animal trials are performed and proven safe, human trials should be necessary before being released onto the market. Animal testing is necessary, as proven by the drug BIA 10-2474. On January 22, 2016, a report was released by Forbes magazine stating that a human trial conducted without previous animal testing resulted in the death of six trial participants. This proves that animal testing increased the safety of a human participating in trials for the benefit of…

impact the quality of US healthcare, patient information must be captured, updated, and shared with all stakeholders in a timely and effective manner to not only ensure universal access to quality data, but also to extend essential information to key clinical decision makers. For EBM to be successful, developers must devise standards for medical records, including content, terminology,…

The main purpose of research is to know the truth and to benefit the subject and the society In addition, research aims to generate knowledge and differentiate between good and bad. Scientific misconduct provides a week scientific foundation for clinical work, creates inconsistencies, inefficiencies, endangers the medical practice, and creates endless idiosyncrasies (Neema,…

Physicians objective is to find a legal team, preferably within the HCO that could examine the legislators of the AG’s decision. Furthermore, the LMH ethics committee prefers to find an on-staff volunteer lawyer with clinical experience. Ultimately, all ethics committee members unanimously convey that they want to change to happen. The question remains how community involvement in addressing the issue shall be the most effective. The topic of DNR is necessary for the elderly with chronic illness…

The use of biological human tissue is directed by various legal regulations. Understanding these rules and how to obtain meaningful informed consent is essential for researchers and laboratorians to maximize the tissue’s potential for research, to respect the patients’ and subjects’ participation while avoiding lawsuits and destruction to valuable specimens. Regarding laws and regulations (Drabiak-Syed 2010), the Common Rule, included in the Code of Federal Regulations, establishes protection…