Real-World Data and Real-World Evidence in Pediatrics: Case Studies of Pneumococcal Vaccine and Tuberculosis in Children

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). RWE has the potential to supplement information derived from clinical trials, providing accessible data in a shorter time and at lower costs. This is especially relevant to pediatrics, where the evidence base to guide medication use in children may be insufficient. Studies using RWD offer the opportunity to assess long-term effects and the safety of medications that are used to treat pediatrics population (Lasky et al., 2020).

In the first session of this meeting, we discuss the pneumococcal conjugate vaccine. Since 2006, WHO has recommended that all countries should incorporate pneumococcal conjugate vaccines in routine immunization schedules for children aged less than 2 years and has prioritized their introduction in countries with high child mortality rates and/or high rates of human immunodeficiency virus (HIV) infection (Bangham et al., 2013). This session will be dedicated to results from clinical trial and the evidence from a study in Indonesia.

Second session discuss the topic of tuberculosis (TB) in children. Pediatric TB deserves prompt identification and treatment because children are at a significantly higher risk than adult of developing the active form of the disease (Tersigni et al., 2021). This second webinar session will focus on the evidence from clinical trial and the results from real-world studies for TB treatment in children.

 

Objectives

The goal/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 vaccine development of pneumococcal conjugate vaccine and the treatment of TB in children.
3. Sharing valuable information on methodologies of clinical trial and real-world studies related to the vaccine development of pneumococcal conjugate vaccine and the treatment of TB in children.
4. Discuss the potential for further research in pneumococcal conjugate and the treatment of TB in children.

 

Topic of the Online Meeting

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

Topic   : “Real-World Data and Real-World Evidence in Pediatrics:

Case Studies of Pneumococcal Vaccine and Tuberculosis in Children”

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

 

Real-World Data and Real-World Evidence in Pediatrics:

Case Studies of Pneumococcal Vaccine and Tuberculosis in Children

 Link Zoom: https://bit.ly/RWDRWE04

 

Time	Topic	Speaker
13.00-13.05 (5’)	Opening	MC
13.05-13.10 (5’)	Welcome	Dr. dr. Eti Nurwening Sholikhah, M.Med.Ed., M.Kes. (Head of Department of Pharmacology and Therapy, Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada)
13.10-13.30 (20’)	Results from Clinical Trials on Pneumococcal Conjugate Vaccine	Prof. Dr. dr. Sri Rezeki Hadinegoro,  Sp. A(K) (Chair of ITAGI-Faculty of Medicine, Universitas Indonesia)
13.30-13.50 (20’)	Real-World Data and Real World Evidence on Pneumococcal Conjugate Vaccine in Indonesia infants	Dr. dr. Ari Prayitno, Sp. A(K) (Faculty of Medicine, Universitas Indonesia)
13.50-14.10 (20’)	Discussion Session 1	Moderator Dr. dr. Rustamadji, M.Kes. (Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada)
14.10-14.30 (20’)	Clinical Trials on Pediatric Tuberculosis Treatment	dr. Rina Triasih, M.Med.(Paed), Ph.D., Sp. A(K) (Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada)
14.30-14.50 (20’)	Real-World Data and Real-World   Evidence on Pediatric Tuberculosis Treatment	Dr. dr. Retno Asih Setyoningrum, Sp.A(K) (Faculty of Medicine, Universitas Airlangga)
14.50-15.10 (20’)	Discussion Session 2	Moderator Dr. dr. Rustamadji, M.Kes. (Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada)
15.10-15.15 (5’)	Closing	MC