Fighting MDR-TB and COVID-19 with Real-World Data and Real-World Evidence

Background

Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Real-World Evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWD can be analyzed to produce RWE on the usage and/or benefits and risks of a medication or a medical product. RWD and RWE offer the possibility to bring about novel insights on patients’ clinical care, regulatory decision-making, and health technology assessment. Detailed information on data sources, data standards, data reliability, how to generate evidence, and regulatory considerations can be found on FDA’s document titled Framework for FDA’s Real-World Evidence Program (U.S. FDA, 2018). Randomized Controlled Trials have limited external validity since the results from a study conducted in a specially selected homogeneous patient subpopulation, and carried out under ideal circumstances, may not necessarily extend well to the general (heterogeneous) patient population with complex care needs, multiple comorbidities, or concomitant medications (Katkade et al, 2018).

In this two years, the COVID-19 pandemic has further fueled real-world evidence analyses. COVID-19 also accelerated decision makers’ use and understanding of real-world evidence. Additionally, the gathering of RWE is the tenet of successful contact tracing, enabling us to understand and act quickly to manage and extinguish disease outbreaks. Practices such as social distancing, mask wearing, and hand washing have been informed mostly by data sources other than clinical trials (Khan and Pizzi, 2020).

In the first session of this webinar, we discuss the treatment of multi drug resistant tuberculosis (MDR-TB) using evidence from clinical trials worldwide and results of real-world study. Non-randomized, observational data and real-world evidence have a role to play in the development of policy recommendations on TB treatment by complementing Phase 3 trials in:

• addressing feasibility, acceptability, delivery strategies, and quality of life issues;
• generating data on special populations not customarily enrolled in clinical trials;
• evaluating safety and effectiveness in broader, more diverse populations; and
• providing additional data on post-marketing toxicities and adverse events (WHO, 2021).

Second session discuss the topic of vaccine for COVID-19. This second webinar session will focus on the evidence from clinical trial in Indonesia and the results from real-world studies around the world in COVID-19 vaccine. Many RCTs evaluating treatments and vaccines for COVID-19 are already in progress but the number of clinical questions of interest greatly outpaces the available resources to conduct RCTs. Therefore, there is growing interest in whether nonrandomized real-world evidence (RWE) can be used to supplement RCT evidence and aid in clinical decision making (Franklin et al., 2021).

 

 

Objectives

The goals/objectives of this online meeting include:

1. Increase understanding and awareness of the importance of real-world data and real-world evidence to improve quality in healthcare services, especially in daily clinical practice.
2. Providing an example of real-world data and real-world evidence in the treatment of MDR-TB and COVID-19 vaccine.
3. Sharing valuable information on methodologies of clinical trial and real-world studies related to the treatments of MDR-TB and COVID-19 vaccine.
4. Discusses the use of real-world data and real-world evidence and the exciting potential for further research in MDR-TB and COVID-19 vaccine.

 

Topic of the Online Meeting

Theme : “Real-World Data and Real-World Evidence”

Topic   : “Fighting MDR-TB and Covid-19 with Real-World Data and Real-World Evidence”

Method: Webinar conducted through Zoom Meetings and Youtube Livestreaming.

 

Participants

1. Staffs from the Ministry of Health (from several Directorates)
2. Staffs from BPJS Kesehatan (Healthcare and Social Security Agency)
3. Staffs from Badan POM (Indonesia National Agency for Drug and Food Control)
4. Members of PERSI (Indonesian Hospital Association)
5. Members of IDI (Indonesian Medical Doctor Association)
6. Members of IAI (Indonesian Pharmacist Association)
7. Members of IPMG (International Pharmaceutical Manufacturers Group)
8. Members of GP Farmasi (National Association of Local Pharmaceutical Manufacturer Companies)
9. Lecturer and students from Universities
10. Researcher
11. Health Consultant
12. Other participants

 

Meeting Agenda, 29 January 2022

Fighting MDR-TB and Covid-19 with Real-World Data and Real-World Evidence

Link Zoom: https://bit.ly/RWDRWE03

 

Time	Topic	Speaker
13.00-13.05 (5’)	Opening	MC
13.05-13.10 (5’)	Welcome	Head of Department of Pharmacology and Therapy, Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada
13.10-13.30 (20’)	Clinical trial on the treatment of MDR-TB	Dr. dr. Erni Juwita Nelwan, Sp.PD-KPTI, FACP, FINASIM, Ph.D. (Faculty of Medicine, Universitas Indonesia-Dr Cipto Mangunkusumo National Hospital)
13.30-13.50 (20’)	Real-world data and real-world evidence on the treatment of MDR-TB	Dr. dr. Soedarsono, Sp.P(K) (Faculty of Medicine, Universitas Airlangga-Soetomo Hospital)
13.50-14.10 (20’)	Discussion session 1	Moderator dr. Yolanda Dyah Kartika, M.Sc. (Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada)
14.10-14.30 (20’)	Clinical trial on COVID-19 vaccine	dr. Sita Laksmi Andarini, Ph.D, Sp.P(K) (Faculty of Medicine, Universitas Indonesia-Persahabatan Hospital)
14.30-14.50 (20’)	Real-world data and real-world evidence on COVID-19 vaccine	dr. Jarir At Thobari, D.Pharm., Ph.D. (Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada)
14.50-15.10 (20’)	Discussion session 2	Moderator dr. Yolanda Dyah Kartika, M.Sc. (Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada)
15.10-15.15 (5’)	Closing	MC

References

Franklin, J. M., Lin, K. J., Gatto, N. M., Rassen, J. A., Glynn, R. J., & Schneeweiss, S. (2021). Real-World Evidence for Assessing Pharmaceutical Treatments in the Context of COVID-19. Clinical pharmacology and therapeutics, 109(4), 816–828. https://doi.org/10.1002/cpt.2185

Katkade, V. B., Sanders, K. N., & Zou, K. H. (2018). Real world data: an opportunity to supplement existing evidence for the use of long-established medicines in health care decision making. Journal of multidisciplinary healthcare, 11, 295–304. https://doi.org/10.2147/JMDH.S160029

Khan, Z. M., & Pizzi, L. T. (2020, September/October). Let’s Get Real About Real-World Evidence [Editorial]. Value & Outcomes Spotlight, 6(5), 3.

U.S. FDA. (2018). Framework for FDA Real-World Evidence Program. U.S. Food and Drug Administration. www.fda.gov

World Health Organization. (2021).Report of the technical consultation on innovative clinical trial designs for development of new TB treatments. Geneva: Licence: CC BY-NC-SA 3.0 IGO.