Background

Data related to patient health status and/or the delivery of health care routinely collected from a variety of sources have been defined as Real-World Data (RWD) by the FDA. On the other hand, Real-World Evidence (RWE) is described as clinical evidence about the usage and potential benefits or risks of a medical product derived from an analysis of RWD. 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). In oncology, RWE refers to evidence derived from the use and analysis of real-world data, which are data obtained outside the context of conventional randomized controlled trials (Khozin et al., 2017).

Traditionally, physicians have relied heavily on clinical evidence most notably from randomized controlled trials to guide their clinical decision making. Nowadays, clinicians have access to a wealth of additional data generated from sources outside traditional research settings, such as remote monitoring devices, wearables, disease registries, electronic health records, and claims and billing activities. Data obtained from these electronic health records, cancer registries, and other RWE sources can produce valuable insights into treatments and clinical outcomes in daily practice.

Randomized clinical trials and RWE are complementary, and the area of Oncology especially benefits from RWE to guide clinical decision making across the patient journey. Key benefits include cancer screening and diagnosis, optimal treatment choices (including personalized medicine) and disease management such as dosing and treatment of side effects (Petracci et al., 2021). The capability of RWE to create a more robust view of the benefits and risks of oncology treatments among all patients eligible for therapy is critically important. It can complement, augment, and extend our understanding of when and how to use new treatments while offering longer-term insights that can drive continued medical innovation (Christian, 2021).

In this webinar, we discuss the treatment of chronic myelogenous leukemia (CML) with Imatinib using evidence from clinical trials worldwide and results of real-world study in Indonesia. Another session is dedicated to lung cancer with focus on Afatinib and Gefitinib. These two drugs are included in The National Comprehensive Cancer Network (NCCN) recommendations for Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Mutations.

 

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 oncology.
3. Sharing valuable information on methodologies of clinical trial and real-world studies related to oncological treatments.
4. Discuss the use of real-world data and real-world evidence and the exciting potential for cancer therapy.

 

Topic of the Online Meeting

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

Topic   : “Real-World Data and Real-World Evidence in Oncology”

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. Academia
8. Members of IPMG (International Pharmaceutical Manufacturers Group)
9. Members of GP Farmasi (National Association of Local Pharmaceutical Manufacturer Companies)
10. Other participants

 

Meeting Agenda, Saturday 18 December 2021

“Real-World Data and Real-World Evidence in Oncology”

Link Zoom: https://bit.ly/RWDRWE02

Time	Topic	Speaker
13.00-13.10 (10’)	Welcome	Head of Department of Pharmacology and Therapy, Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada
13.10-13.30 (20’)	Clinical Trials on Imatinib in chronic myelogenous leukemia (CML)	Dr. dr. Ikhwan Rinaldi, Sp.PD-KHOM, M. Epid, M.Pd.Ked (Dr. Cipto Mangunkusumo Hospital /Faculty of Medicine, Universitas Indonesia)
13.30-13.50 (20’)	Real-World Study of Imatinib in chronic myelogenous leukemia (CML)	Dr. dr. Ibnu Purwanto, Sp-PD-KHOM (Dr. Sardjito Hospital/Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada)
13.50-14.10 (20’)	Discussion Session 1	Moderator dr. Dwi Aris Agung Nugrahaningsih, M.Sc., Ph.D. (Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada)
14.10-14.30 (20’)	Clinical Trials of Afatinib and Gefitinib in Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Mutations	dr. Sita Laksmi Andarini, Ph.D., Sp.P(K) (Persahabatan Hospital/Faculty of Medicine, Universitas Indonesia)
14.30-14.50 (20’)	Real-World Study of Afatinib and Gefitinib in Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Mutations	Dr. dr. Kartika Widayati, Sp.PD – KHOM (Dr. Sardjito Hospital/Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada)
14.50-15.10 (20’)	Discussion Session 2	Moderator dr. Dwi Aris Agung Nugrahaningsih, M.Sc., Ph.D. (Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada)
15.10-15.15 (5’)	Closing	MC

 

References

Christian, J. (2021). Real-World Evidence Is Key to Accelerating Oncology Approvals. Future Oncology, 27(4), SP123–SP124.

Khozin, S., Blumenthal, G. M., & Pazdur, R. (2017). Real-world Data for Clinical Evidence Generation in Oncology. Journal of the National Cancer Institute, 109(11), 1–5. https://doi.org/10.1093/jnci/djx187

Petracci, F., Ghai, C., Pangilinan, A., Suarez, L. A., Uehara, R., & Ghosn, M. (2021). Use of real-world evidence for oncology clinical decision making in emerging economies. Future Oncology, 17(22), 2951–2960. https://doi.org/10.2217/fon-2021-0425

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