Author(s): Bharath B. C., Balamuralidhara V., M. P. Gowrav

Email(s): baligowda@jssuni.edu.in , bharathgowda9961@gmail.com , gowrav@jssuni.edu.in

DOI: 10.5958/0974-360X.2021.00210.9   

Address: Bharath B. C.1, Balamuralidhara V.2*, M. P. Gowrav3
1Regulatory Affairs Group, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysore- 570015, Karnataka, India.
2Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysore- 570015, Karnataka, India.
3Lecturer and NSS Programme Officer, Department of Pharmaceutics, JSS College of Pharmacy, S. S. Nagara, Mysuru- 570015.
*Corresponding Author

Published In:   Volume - 14,      Issue - 2,     Year - 2021


ABSTRACT:
Real-world data contains the information regarding patient health condition and the delivery of health care routinely gathered from the various sources. Usually the information gathered based on the Electronic medical records (EMRs), Product and disease registries, Patient-generated data including in home-use settings etc… Real-world evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. The RWD and RWE is having wide range of applications such as, it helps to reduce the cost of the product approvals, identifying the new uses of the existing product and improving the clinical practices for using drugs and medical products. These types of data are useful for the regulatory decision making. The use of real World Evidence is also having some potential challenges in regulatory decision making for the medical product communications. The RWD and RWE can be utilized by FDA to screen post market wellbeing and adverse events, and it is also used by medical product developers to support clinical trial designs and observational studies to enhance advanced, new treatment approaches. These RWD & RWE are very useful and time saving, the data generated from the RWD is accurate, and by this we could come up with new uses of the drug products, which are already exists in the current market.


Cite this article:
Bharath B. C., Balamuralidhara V., M. P. Gowrav. Role of Real World Data and Real World Evidence in Regulatory Decision Making. Research J. Pharm. and Tech. 2021; 14(2):1177-1182. doi: 10.5958/0974-360X.2021.00210.9

Cite(Electronic):
Bharath B. C., Balamuralidhara V., M. P. Gowrav. Role of Real World Data and Real World Evidence in Regulatory Decision Making. Research J. Pharm. and Tech. 2021; 14(2):1177-1182. doi: 10.5958/0974-360X.2021.00210.9   Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-2-106


REFERENCE:
1.    Real-World Evidence [Internet]. Available from: https:// www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
2.    U.S. Department of Health and Administration F and DA. Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics Guidance for Industry. Off Commun Div Drug Inf Cent Drug Eval Res Food Drug Adm [Internet]. 2019;(May 2019):1–8. Available from: https:// www.fda.gov/media/124795/download
3.    Wong JL. Real World Evidence Collaboration and Convergence for Change Big Data, Digital and Tech-and Real World Applications and Implications for Industry. 2019;(May). [Internet]. Available from: https://www.emwa.org/media/3036/5c-big-data-digital-biomarkers-and-emerging-data-sources-j-wong.pdf
4.    RWE Navigator/Introduction to understanding and using RWE/ Sources of real-world data [Internet]. Available from: https://rwe-navigator.eu/use-real-world-evidence/sources-of-real-world-data/
5.    Zachary Brennan. FDA Will Allow Observational Studies to Support Effectiveness Determinations, New Framework Says [Internet]. Available from: https://www.raps.org/news-and-articles /news-articles/2018/12/fda-will-allow-observational-studies-to-support-ef
6.    FDA. Framework for FDA’s Real-World Evidence Program. FDA Framework [Internet]. 2018;(December). Available from: https:// www.fda.gov/media/120060/download
7.    Hubbard T, Paradis R. Real World Evidence: Executive Summary A New Era for Health Care Innovation. Netw Excell Heal Innov [Internet]. 2015; (September):1–19. Available from: https:// www.nehi.net/writable/publication_files/file/rwe_issue_brief_final.pdf
8.    Belson A. Regulatory applications of real world evidence. 2017; Available from: https://www.thejournalofprecisionmedicine.com/ wp-content/uploads/2018/04/JPM-MARCH-APRIL-2018-Belsen.pdf
9.    Bipartisan Policy Center. Expanding the Use of Real-World Evidence in Regulatory and Value-Based Payment Decision-Making for Drugs and Biologics. 2019;(August). Available from: https://bipartisanpolicy.org/wp-content/uploads/2019/08/Health_ Innovation_Real-World_Evidence_Report_R04.pdf
10.    Ph.D JE, Manning M, Onwudiwe NC, Tenenbaum K. Real World Evidence: Implications and Challenges for Medical Product Communications in an Evolving Regulatory Landscape. Available from: https://www.jdsupra.com/legalnews/real-world-evidence-implications-and-80730/

Recomonded Articles:

Author(s): Bharath B. C., Balamuralidhara V., M. P. Gowrav

DOI: 10.5958/0974-360X.2021.00210.9         Access: Closed Access Read More

Author(s): R. Amudha, R. Nalini, D R. Alamelu, V. Badrinath, M. Naveen Sharma

DOI: 10.5958/0974-360X.2017.00495.4         Access: Open Access Read More

Author(s): S. Narendren, A.Manimaran, V.M.Chandrasekaran, B.Praba

DOI: 10.5958/0974-360X.2017.00026.9         Access: Open Access Read More

Author(s): Ankita Ramkrupal Singh, Ravi Tiwari

DOI: Not Available         Access: Open Access Read More

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags