Sign Up Now
Get instant access to over 1 million+ study documents
OR
Already registered? click here to login
By creating your account, you agree to our terms of service, privacy policy and student honor code.
¶ … Technology Aid in the Process of Clinical Trials
Capstone Project title: Using technology in managing data in clinical trials
We will start our paper by discussing "Clinical Data Management" or CDM, which is an important phase in clinical research. It is a process through which reliable, high-quality and statistically accurate data is generated from clinical trials. This drastically reduces the time taken by the process, from when drugs are developed to the time they are marketed. The CDM team members play an active role throughout the process, from the beginning to the end. They are required to have sufficient knowledge about the maintenance of CDM processes quality standards. There are several procedures in the process such as Case Report Form (CRF) and its annotation, data entry, designing a database, validation of data, management of discrepancies, medical coding, extraction of data and data locking. During a trial, these procedures are assessed regularly to ensure that they meet high standards. Currently, there is increasing pressure to improve the standards of CDM so that they can meet the requirements of the regulatory body and beat the competition through faster commercialization of the products (Krishnankutty et al., 2012).
Body
Industry Preparedness
We will argue that the industry seems ready to embrace the drivers...
For instance, a recent webinar by FDA described it, the biopharmaceutical industry is very slow to the adoption of electronic solutions which have the possibility to change the way clinical trials are conducted. However, Contract Research Organizations (CROs), some of the sponsors as well as investigative sites are convinced that a tipping point for the industry is close. To support this, a research carried out in the eClinical solutions market shows that a 13.8% annual growth rate is expected in the projects from 2014 to the year 2020, surpassing the 2014 estimate of $3 billion by 3.52 billion. Cloud-based solutions were included in this study (Morrison, 2015). The industry seems ready to embrace what many consider to be the drivers of change.
Big Data and Accessibility
Another argument we will put forward is that technology or cloud computing eases access and allows bid data analysis. Access is very important as far as effective data management in clinical trials is concerned. Accessing information fast and with ease allows those in charge of administration of the clinical trial to get what they require so that they can produce analysis and results that are accurate and concise. Particularly in clinical trials that are large, the large amounts of data used can make the process of data collection more stressful. The best part of big data…
References
Krishnankutty, B., Bellary, S., Kumar, N. B. R., & Moodahadu, L. S. (2012). Data management in clinical research: An overview. Indian Journal of Pharmacology, 44(2), 168-172. doi. 10.4103/0253-7613.93842
Morrison, R. (2015). Technology's Role in Clinical Trials. Applied Clinical Trials. Retrieved from http://www.appliedclinicaltrialsonline.com/technology-s-role-clinical-trials on 25 May 2016
Tang, P., Overhage, J., Chan, A., Brown, N., Aghighi, B., & Entwistle, M. et al. (2013). Online disease management of diabetes: Engaging and Motivating Patients Online with Enhanced Resources-Diabetes (EMPOWER-D), a randomized controlled trial. Journal of The American Medical Informatics Association, 20(3), 526-534. http://dx.doi.org/10.1136/amiajnl-2012-001263
Clinical Trial Management Systems Though all four systems of Clinical Data Management (CDM) seem to possess identical functionality, it appears that Perceptive Informatics is more useful, as it requires complex IT infrastructure for its functioning. CDM represents a crucial clinical research phase that generates superior, statistically sound, and reliable information from the clinical trial phase. This aids in drastically reducing the timespan between drug development and marketing stages. Clinical trial intends
Technology in Managing Data in Clinical Trials TECHNOLOGY IN CLINICAL TRIALS Incorporation of technology (electronic and digital technology that can utilize the internet or mobile devices) into the process of designing and executing studies in Clinical trials has been a slow process. Currently, individuals and various corporations have already incorporated such technology into their day-to-day lives and rely on electronic platforms. The aim of this paper is to provide a general
Technology in Managing Data in Clinical Trials TECHNOLOGY IN CLINICAL TRIALS Incorporation of technology (electronic and digital technology that can utilize the internet or mobile devices) into the process of designing and executing studies in Clinical trials has been a slow process. Currently, individuals and various corporations have already incorporated such technology into their day-to-day lives and rely on electronic platforms. The aim of this paper is to provide a general
Clinical Trials: Regulatory Considerations and International Harmonization Clinical trials are experiments that are carried out in clinical research. They are designed to provide knowledge on detection, prevention, and treatment of diseases as well as other biomedical interventions and new treatment discoveries. One important aspect of clinical trials is the generation of data on safety and efficacy, which require that sponsors get the approval of regulatory bodies and ethnic committees in every
Standards Technology Impact on Clinical Research and the Interrelationship of Uniform Data Format Standards With increasing robustness of technology, clinical programmers began realizing inefficiencies in metadata and recreation from scratch each time, in addition to overlapping data elements over research works. Further, they saw the numerous inconsistent techniques for collection of specific, seemingly-simple data elements. The most straightforward example conveying the above challenge is: defining subject gender (Female or Male) in
Taken in isolation, some of the new, minimally-invasive procedures are less expensive by far, when analyzed on a procedure-by-procedure basis, than previous significant surgical interventions, as demonstrated below: Procedure Cost Estimated duration of 'cure' CABG 5-7 years PCI (percutaneous coronary intervention 3-5 years Based on the above analysis, it would appear to be clear that a PCI is more cost-effective than CABG procedures. This may not be true when all costs are considered, however. The logic of