A COMPARATIVE STUDY: HOW WERE CLINICAL RESEARCH ACTIVITIES AFFECTED IN THE FIRST YEAR OF THE PANDEMIC COMPARED TO THE PREVIOUS YEAR?

Yıl 2022, Cilt: 24 Sayı: 2, 303 - 308, 31.08.2022

Recep Selim Şentürk , Halil Kara

https://doi.org/10.24938/kutfd.1074549

Öz

Objective: The main purpose of this study is to determine how clinical research activities in a Clinical Research Center in Ankara are affected by the Covid-19 pandemic.

Material and Methods: In the study, we compared clinical trial activities before the pandemic (March 2019-February 2020) and during the pandemic (March 2020-February 2021) for two 12-month time periods. Data were collected from site coordinators, with strict attention to the confidentiality of volunteer data. Data were grouped as the number of studies newly initiated, closed, and closed to enrollment; number of scheduled, unscheduled, delayed, missed, and telephone visits according to study protocols; number of new patients screened, screening failures, new patients enrolled in studies, number of patients who dropped out for various reasons and the number of direct or online monitoring visits.

Results: According to our study, while the number of newly opened clinical trials during the pandemic period was adversely affected, clinical trial patient visits were carried out successfully despite delays. Compared to the pre-pandemic period, an increase was observed in the number of patients newly screened and enrolled in clinical trials and also in the number of patients excluded from the study, while a decrease was observed in the number of screening failures. It was seen that there was a shift towards online methods in monitoring visits made during the pandemic period.

Conclusion: While clinical research centers around the world were adversely affected during the pandemic period, it was observed that the clinical research activities in the center where we conducted the study were carried out successfully despite the setbacks.

Anahtar Kelimeler

clinical trials, covid-19 pandemic, oncology hospital, cancer, clinical research center

Karşılaştırmalı Bir Araştırma: Önceki Yıla Kıyasla Pandeminin İlk Yılında Klinik Araştırma Faaliyetleri Nasıl Etkilendi?

Öz

Amaç: Bu çalışmanın amacı, Ankara'da bulunan bir Klinik Araştırma Merkezi'ndeki klinik araştırma faaliyetlerinin Covid-19 pandemisinden nasıl etkilendiğini belirlemektir.

Gereç ve Yöntemler: Çalışmada, pandemi öncesi (Mart 2019-Şubat 2020) ve pandemi sırasında (Mart 2020-Şubat 2021) klinik araştırma faaliyetlerini 12 aylık iki zaman dilimini karşılaştırdık. Veriler, gönüllü verilerinin gizliliğine dikkat edilerek saha koordinatörlerinden alındı ve yeni başlatılan, kapatılan ve hasta alımına kapanan çalıma sayısı; çalışma protokollerine göre planlı, plansız, gecikmeli, yapılmayan ve telefonla yapılan hasta vizitlerinin sayısı; taranan yeni hasta sayısı, tarama başarısızlıkları, çalışmalara kaydedilen yeni hasta ve çeşitli nedenlerle çalışmadan ayrılan hasta sayısı; doğrudan veya çevrimiçi izleme vizitlerinin sayısı şeklinde gruplandırıldı.

Bulgular: Çalışmamıza göre pandemi döneminde yeni açılan klinik araştırmaların sayısı olumsuz etkilenirken, klinik araştırma hasta ziyaretleri gecikmelere rağmen başarıyla gerçekleştirildi. Pandemi öncesi döneme göre tarama sayısı, klinik araştırmalara alınan hasta sayısı ve çalışma dışı bırakılan hasta sayısında artış, tarama başarısızlığında ise azalma gözlendi. Pandemi döneminde yapılan izleme ziyaretlerinde online yöntemlere doğru bir kayma olduğu görüldü.

Sonuç: Pandemi döneminde dünya genelinde klinik araştırma merkezleri olumsuz etkilenirken, çalışmayı yürüttüğümüz merkezdeki klinik araştırma faaliyetlerinin aksiliklere rağmen başarıyla yürütüldüğü gözlemlendi.

Anahtar Kelimeler

klinik araştırmalar, covid-19 pandemisi, onkoloji hastanesi, kanser, klinik araştırma merkezi

Kaynakça

• 1. World Health Organisation (WHO). Listings of WHO’s response to COVID-19. Accessed date: 24 January 2022: https://www.who.int/news/item/29-06-2020-covidtimeline.
• 2. T.C. Ministry of Health. COVID-19 (SARS-Cov-2 Infection) (Study of Scientific Board) General Information, Epidemiology and Diagnosis. Accessed date: 24 January 2022: https://hsgm.saglik.gov.tr/depo/covid19/Ingilizce/Rehber/COVID-19_Rehberi__Genel_bilgiler_epidemiyoloji_ve_tani_8.06.2020_eng.pdf.
• 3. World Health Organisation (WHO). WHO Coronavirus (COVID-19) Dashboard. Accessed date: 24 January 2022: https://covid19.who.int.
• 4. T.C. Ministry of Health. Pandemic Hospitals. Accessed date: 24 January 2022: https://dosyamerkez.saglik.gov.tr/Eklenti/36907, pandemi-hastaneleripdf.pdf?0.
• 5. Grand View Research, Inc. Clinical Trials Market Size, Share & Growth Report, 2021-2028. Accessed date: 24 January 2022: https://www.grandviewresearch.com/industry-analysis/global-clinical-trials-market.
• 6. Akan H. Current agenda in clinical trials. Türkiye'de Lösemi Lenfoma Miyelom Araştırmaları (LLM) Dergisi. 2019;3(1):1-3.
• 7. U.S Food and Drug Agency (FDA). Guidance on conduct of clinical trials of medical products during COVID-19 Public Health Emergency / Guidance for industry, investigators, and institutional review boards. Accessed date: 24 January 2022: https://www.fda.gov/media/136238/download.
• 8. Upadhaya S, Yu JX, Oliva C, Hooton M, Hodge J, Hubbard-Lucey VM. Impact of COVID-19 on oncology clinical trials. Nat Rev Drug Discov. 2020;19(6):376-7.
• 9. Medidata Solutions, Inc. Covid-19 and Clinical Trials: The Medidata Perspective Release 9.0. Accessed date: 24 January 2022: https://www.medidata.com/en/insight/covid-19-and-clinical-trials-the-medidata-perspective.