Envisioning the Future of Clinical Research
Clinical Research in 2025 May 28th, 2000, my first day working in clinical research. A lot of time, a lot of experiences, a lot of changes. Everyone who has worked in clinical research has passed thru many changes. However, in my experience, clinical research main activities have not changed in its essence, changes have been done in the how but not in the what. And clinical research is not the one which generates the changes. Changes come in response to those external forces directly related such as changes in medicine, pharmacology, economy, society, environment and changes in the people way of living, thinking or fall sick. Principal changes have been done in the use of technology to facilitate
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A sponsor will still be focused in ensure all data collected is accurate, real and reliable. Timelines and competition will lead to look for ways to work and achieve objectives in less time. However, this increasing request of achieve results in less time, will lead to a different way to work. Subjects will be completely replaced by data, having all the required information as the focus; detailed supervision of sites performance will be replaced by a remote monitoring in which taking risks will be the focus. It is important then to work in having sites completely autonomous and well trained in the way data is collected and recorded. The work of the clinical research associate will be focused in the selection of the most appropriate sites and in their preparation to develop a protocol and transmission of the real objective of clinical research, develop accurate medications to ease human life. Understanding the why will ease the understanding and acceptance of …show more content…
Let´s review three areas in which, in my opinion, will be the main changes:
1. Remote Monitoring: Risk based monitoring will be the way research companies will be working in 2025. Sites will be completely responsible and accountable of the data collected and Sponsors must ensure site is adequately prepared to be the one to complete quality control and quality assurance tasks. Supervision will be based in the raw data, and performance evaluation will be done based on the revision of tendencies. Sponsor responsibility will be in the selection and preparation of sites. Regulatory documents will be shared electronically.
2. Remote participation: Distances will not be a problem. Study visits and procedures will be done via video conference; data will be recorded by the subjects and transmitted to the site. Exams could be performed by standard machines used in the standard of care. Medication intake will be monitored remotely with technological devices and artificial machines will be the reminders. Consent forms could be
IRBs review all aspects of the researchers' project: the study design, the recruitment process, the participant population, the informed consent document and process, the risk/benefit ratio, privacy and confidentiality, data storage and protection, and safeguards for vulnerable participants (University of St. Francis, n.d.). In this way, participants' rights are protected because the effort is made even before the research begins. The review process ensures that participants are chosen fairly and adequately and the information collected during research is safeguarded through collection, use, and storage. Research using human participants is such an important part of medicine that it is imperative it is performed in a way that its intrigue is not compromised. The Institutional Review Board Process Applying for exempt research study approval from the IRB at the University of St. Francis involves submitting a copy of the work, an application, and a statement explaining why the researcher believes the study would be exempt from expedited or full-level IRB review approval.
This technology assist the nurse in confirming patients identify by confirming the patients’ dose, time and form of medication (Helmons, Wargel, & Daniels, 2009). Having an EHR also comes with a program that allows the medical staff to scan medications so medication errors can be prevented. According to Helmons, Wargel, and Daniels (2009) they conducted an observational study in two medical –surgical units one in the medical intensive care (ICU) and one in the surgical ICU. The researchers watched 386 nurses within the two hospitals use bar code scanning before they administrated patients’ medications. The results of the research found a 58 % decrease in medication errors between the two hospitals because of the EHR containing a bar code assisted medication administration
In many lives, change is constantly happening. The economics, cultural values, and social ideals are different today from many years ago. For example, men many years ago rely on literature, libraries, and endless hours of searching for sources in order to make speeches and write stories, and they also had different modes of transportations such as trains. On the other hand, in today’s society, it is easier to find sources and to do research because of the advanced technology, and it is also unchallenging to travel due to the innovations of cars and airplanes. With this being said, it is idealistic that change has a positive impact on society due to the advancement of technology and new methods of transportations, and those changes attribute
When caring for patients it is fundamentally important to have a good selection of up to date evidence Based Practice clinical articles to support research strategies, this allows professionals to assemble the most resent and accurate information known which enables them to make decisions tailored to the individual’s plan of care. It is essential to have clinical expertise and have the involvement from the individual patient, they must have full engagement and incorporation in order to have the accurate evaluation.
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.
For nursing, research has played a major role in the way clinical practice is done. Research has allowed nurses to provide appropriate care to patients. It allows them to perform their job by providing them the tools and information they need in order to make the decisions on the concerns for caring the patient (Polit & Beck, 2006). Moreover, research can also take focus on the workers themselves in order to improve the practice both on a professional and personal level. An example of a study conducted by King, Vidourek, and Schweibert of University of Cincinnati created a study to determine if there is a correlation between ...
The discipline has made enormous advances over the past century. It has evolved from primarily being a task-orientated role to a profession which provides knowledgeable service encompassing evidence-based practice./ knowledgeable
Data and statistics that will likely be collected and what exhibits or tables will be produced from this data
Tunis S., Stryer D., Clancy C. Increasing the Value of Clinical Research for Decision Making in Clinical and Health Policy. JAMA. 2003;290(12): 1624-1632
Additionally, Mastering the IS in a clinical environment is essential for a student inorder for them to be able to access, understand and apply evidence base practise throughout their career. (Staggers, Gassert, Curran,
In order to provide regulation and education to clinical research professionals, many industry specific associations were developed. The Association of Clinical Research Professionals (ACRP) was develop in 1976. The mission of ACRP is to “improve quality in clinical research by directly impacting the professionals conducting clinical trials” (‘About ACRP’, n.d.). ACRP accomplishes this mission through providing its members with a code of ethics to uphold, partnerships and affiliations with industry leaders, additional research certification opportunities, a job bank, and award recognition for exceptional clinical research studies (‘About ACRP’,
Clinical Research is a field that is expanding at an exponential rate due to the inception of new medical technology and increased demand on non-invasive medical procedures. The evolution of clinical research traverses a long and fascinating journey. From the first recorded trial of a vegetarian diet in biblical times to the first randomized controlled of trial of streptomycin in 1946, the history of clinical trials covers a wide array of trials. A clinical research associate (CRA), also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials.
There should be advancements in the facility health education in the society to encourage the culture of the discovery and research supporting healthcare. The clinical manager should foster the system of supporting all the activities responsible for exemplary health science research. There should be training seminars for the existing medical practitioners to inculcate more special techniques required for the primary care services. The training would expand the knowledge of the medical professionals to provide effective services for the
Additionally, this association emphasizes collaboration between physicians and members of other professions working on applications of scientific methods in clinical practice and research. Overall, the goal of ACS is to encourage professional development, scientific stature, ethical standards, and collegiality of clinical scientists. Current Issue: The Association of Clinical Scientists has a highly regarded journal known as Annals of Clinical and Laboratory Science,
Introduction PAGEREF _Toc402618681 \h 4 Background PAGEREF _Toc402618682 \h 5 Aims and Objectives PAGEREF _Toc402618683 \h 5 Methods PAGEREF _Toc402618684 \h 6 Project Timeline PAGEREF _Toc402618685 \h 8 Team Qualifications PAGEREF _Toc402618686 \h 10 Conclusions PAGEREF _Toc402618687 \h 10 References PAGEREF