In considering the future of Clinical Research, we must draw from the past. We have come a long way in clinical research with implementation of more technology such as use of eCRFs, electronic regulatory submissions, electronic drug accountability, etc. These changes have made a huge impact in how we conduct business. They have allowed research trials to be run more efficiently and have reduced our timelines, allowing new drugs to be approved faster. However, with trials becoming more complex this is not without its challenges. This pace that we are operating under will continue with more competition with vendors who provide these services as well as the current vendors as they seek to improve processes. Not all systems that have been …show more content…
While much of the population including older generations have been adapting to the use of computers and iPads, some of the newer systems have challenges. We have all seen the frustration in the coordinators face when they resort to contacting help desks to resolve issues as some of the issues are time consuming fixes. Vendors and sponsors really must focus on more user acceptance testing as well as practice to ease the site and patient frustrations. I foresee patient focus groups getting involved to help develop systems that are friendly for …show more content…
The workforce at the sites is now becoming younger, and many sites do not have any requirements for education level for Coordinators. While there are some who do have some medical courses and training, sites seem to be hiring less experienced coordinators due to lack of interest and low pay grades. The impact of this is quality at sites is going down. With risk based monitoring being adapted, it is becoming more difficult for the monitors to oversee what is occurring at the site in some cases. While PIs have oversight, often they are too busy to ensure adequate training, so it falls on the monitor. New less experienced sites are coming in to research, and this has presented challenges with the monitors having to hand hold. Even though basic training is the site/PI responsibility, I believe in the future, sponsors may consider requiring additional trainings for staff beyond GCP to ensure that sites understand how to run a trial efficiently, basic requirements for the study, and a fundamental understanding of the regulations. The cost of developing a drug has skyrocketed, and if sponsors require additional trainings this may result in less site errors that gravely impact the time to approval and the quality of the
... clinical trial comparing two treatments is in progress, and a physician has an opinion about which treatment is better. This duty creates a barrier to the enrollment of patients in randomized clinical trials.
The data utilized for trial analysis are maintained anonymous, however the trial management data carry personal identifiers for conduct of study and to ensure patient safety. The patient source data is encrypted and password protected allowing access to authorized personnel and prevents transfer to electronic media device. The list of authorized personnel will be maintained in the Trial Master File. The audit trails captures all activities pertaining to conduct of clinical trials and tracks changes performed to data. The date and time stamp used impede chances of misuse. On completion of the trial, the data will be locked using DMS file locking facility to prevent tampering of
information using the internet. Today patients are encouraged to be active in their care. Patient
Unfortunately, the quality of health care in America is flawed. Information technology (IT) offers the potential to address the industry’s most pressing dilemmas: care fragmentation, medical errors, and rising costs. The leading example of this is the electronic health record (EHR). An EHR, as explained by HealthIT.gov (n.d.), is a digital version of a patient’s paper chart. It includes, but is not limited to, medical history, diagnoses, medications, and treatment plans. The EHR, then, serves as a resource that aids clinicians in decision-making by providing comprehensive patient information.
Van Doormaal, J. E., Mol, P. G., Zaal, R. J., Van Den Bemt, P. M., Kosterink, J. G., Vermeulen, K. M., & Haaijer-Ruskamp, F. M. (2010). Computerized physician order entry (CPOE) system: expectations and experiences of users. Journal of Evaluation in Clinical Practice, 16(4), 738–743. doi:10.1111/j.1365-2753.2009.01187.x
The 2010 Institute of Medicine (IOM) Report- The Future of Nursing described the role that nurses have in the current and future US health care environment (IOM, 2011). This report was completed at a time when the Affordable Care Act had been passed and a new emphasis was being put on interdisciplinary healthcare teams, care coordination, value-based payment systems, and preventative care (IOM, 2011). Nursing is the largest profession in health care and with an aging baby boomer populace, the expanded role of nurses will be critical in meeting the growing healthcare burdens (Sisko et al., 2014).
Encompassed within the boundaries of this research paper, I will outline the rationale of constructing and implementing a publicly accessible patient portal for a healthcare organization. I will examine the utility, purpose and the technology requirements. Furthermore I will identify key employee involvement and the project tasks to make it operational and conclude with the highly probable benefits that the organization can expect to profit from its use. Despite all of the challenges presented in this paper, the benefits of this project has the potential to provide the organization a substantial return on investment (ROI) as highlighted by Heath Bell when he articulated, “portals are expected to be a key conduit for engaging patients in their care and getting them important health care information as quickly as possible” (Bell. 2012)
Throughout many generations the success of medicine has been dog-eared throughout history, from penicillin being created through colonized bacteria on an agar plate to chemotherapy being used to combat the ailments of cancer, we as a society rely a great deal on the effectiveness of medicine. Due to this realization one can agree that it is imperative that the medications that are being distributed and placed on the pharmaceutical market are tested and analyzed at all angles and perspectives to ensure they work effectively and successfully resulting in moderate to no side effects. The progressive industry of medicine has greatly increased since the early nineties thanks to the advancement in medical technology making
The health care system and nursing practices are undergoing rapid changes, which are as well becoming complex. Preparing nurses balance these changes is a significant challenge. The Institute of Medicine (IOM) report explored how nursing profession has to change to bring out a more solid health care system. As a result of these changes, the Institute of Medicine (IOM) decided to examine “Future of Nursing, Leading change and Advancing Health” (Creasia & Fribery, 2011). This paper will discuss the impact of the 2010 IOM report on nursing Education, nursing Practice with emphasis on primary care, its effects on present nursing practice, and the nurse’s role as a leader.
The goal of the model is to ensure that the latest research findings and best practices are quickly and appropriately incorporated into patient
A major hurdle in this academic career that I hope to have is going to be the lack of expertise in the designing, implementation and evaluation of clinical trials.
Paul J., Seib R., Prescott T. The internet and clinical trials: background, online resources, examples and issues. J Med Internet Res. 2005; 7(1):e5
When it comes to working in a stressful environment while maintaining efficient, human, and profession-al conduct, I’m highly competent. In addition, my communication skills are sharp, as is my abil-ity to retain information and remember people. Thanks to my schooling and my keen interest in the industry, my research skills will keep my knowledge of the industry and practices up-to-date. In fact, taking in new material is a joy. The Clinical laboratory science field is vast and ever-changing, something I’m both excited and prepared to deal with. For this reason, I intend to re-main on top of advances in the field.
My future plans are to become a biomedical scientist. Biomedical scientists serve in all levels of health science research from basic science working with cell cultures to human clinical trials experimenting the most cutting-edge breakthroughs to maximize human quality of life. I am interesting in researching rare diseases. There are many rare diseases that affect small proportions of the population and unfortunately go unnoticed for reason. Unfortunately, usually it is because therapeutic agents for these diseases would have a much smaller market than therapeutics for common diseases. There is an immense need for research attention to ultimately improve clinical outcomes in patients of rare diseases because many are a lifelong chronic prognosis and are genetic and non-modifiable by lifestyle factors and are lacking of often absent of current treatment options. The government helps by socializing the solution by having money set aside by public National Institute of Health (NIH) to research ‘orphan diseases’. An example of one such program from the NIH is Orphan Products Natural History Grants Program.
Information and Communication Technology (ICT) has been shown to be increasingly important in the education or training and professional practice of healthcare. This paper discusses the impacts of using ICT in Healthcare and its administration. Health Information technology has availed better access to information, improved communication amongst physicians, clinicians, pharmacists and other healthcare workers facilitating continuing professional development for healthcare professionals, patients and the community as a whole. This paper takes a look at the roles, benefits of Information and Communication Technology (ICT) in healthcare services and goes on to outline the ICT proceeds/equipment used in the health sector such as the