Publication: Reasons for non-participation of Turkish patients in international clinical trials
Abstract
Amaç: Türkiye, daha önce bir klinik çalışmaya katılmamış hasta sayısının yüksek oluşundan dolayı, klinik araştırma alanında dikkati üzerine çeken bir ülkedir. Klinik araştırma alanındaki artan önemine rağmen hasta alım süreci çeşitli sebeplerden ötürü çok güç olmakta ve bu durum araştırmaların ciddi ölçüde zorlanmasına neden olabilmektedir. Klinik çalışmalarda Türk katılımcıların algılarının anlaşılması açısından, bir proje tasarlanmış ve uygulamaya konulmuştur. Yöntem: Araştırıcılara, aktif uluslararası klinik çalışmalara katılmaya potansiyel hastaların çalışmaya uygunluğu ve var ise reddetme nedenlerini prospektif olarak girecekleri bir anket kitapçığı verilmiştir. Sekiz şehirden toplam 39 araştırıcı bu ankete katılmıştır. Araştırıcılar sürmekte olan uluslararası çalışmalar için aday olan 410 hastanın bilgilerini vermişlerdir. Bulgular: Toplam 410 hastadan 306’sı çalışmalar için uygun bulunmuştur; geriye kalan 104 hasta dahil etme ve dışlama kriterlerine veya çalışmaya olası uyum problemine dayalı olarak uygun bulunmamıştır. Uygun bulunan 306 hastanın 80’i bilgilendirilmiş gönüllü olur formu imzalamayı reddetmiştir. Bir klinik araştırmaya katılmayı reddetmenin en çok rastlanan iki nedeni hastanın yakınlarının etkisi (%36) ve advers olay riskidir (%27,8). Diğer nedenler ise ek vizitlere/testlere gerek duyulması (%18,9), aktif olmayan ajanlarla yani plasebo ile tedavi edilme riski (%15,2) ve bilinmeyen ürünlere randomize edilme riskidir (%12,7). Sonuç: Hasta ve yakınlarındaki “kobay algısı”, belirsizliğin verdiği sıkıntılar, çalışmanın ek külfetleri ve bilgilenme ve onam ile ilgili endişeler klinik araştırmalara hasta alımının önündeki engellerdir.
Objective: Turkey is an emerging country in terms of clinical research with a large population of patients not previously exposed to clinical trials. Despite its increasing importance in the clinical research field, the recruitment process is very difficult for various reasons and may become a serious research limitation. A project was designed and implemented with a view to understanding the perceptions of Turkish participants to clinical trials. Methods: Investigators were given a questionnaire booklet to complete with information about all patients that were potentially eligible for active involvement in international clinical trials. A total of 39 investigators from eight cities participated in the survey and they provided information on 410 patients who were candidates for ongoing international trials. Results: A total of 306 out of 410 patients were eligible for the trials; the remaining 104 patients were ineligible based on inclusion and exclusion criteria, and physician estimation on patient’s compliance. Of the 306 eligible patients, 80 refused to sign an informed consent form. The two most common reasons for refusing to participate in a clinical trial were the influence of patients’ relatives (36.7%) and the risk of adverse events (27.8%). These were followed by the need for additional visits/tests (18.9%), the risk of being treated with inactive agents - i.e. placebo- (15.2%), and the probability of being randomized to unknown products (12.7%). Conclusion: Patient barriers for enrollment include the ‘guinea pig’ perception held by patients and/or relatives, anxiety caused by uncertainty, additional demands of the trial, and concerns about information and consent.
Objective: Turkey is an emerging country in terms of clinical research with a large population of patients not previously exposed to clinical trials. Despite its increasing importance in the clinical research field, the recruitment process is very difficult for various reasons and may become a serious research limitation. A project was designed and implemented with a view to understanding the perceptions of Turkish participants to clinical trials. Methods: Investigators were given a questionnaire booklet to complete with information about all patients that were potentially eligible for active involvement in international clinical trials. A total of 39 investigators from eight cities participated in the survey and they provided information on 410 patients who were candidates for ongoing international trials. Results: A total of 306 out of 410 patients were eligible for the trials; the remaining 104 patients were ineligible based on inclusion and exclusion criteria, and physician estimation on patient’s compliance. Of the 306 eligible patients, 80 refused to sign an informed consent form. The two most common reasons for refusing to participate in a clinical trial were the influence of patients’ relatives (36.7%) and the risk of adverse events (27.8%). These were followed by the need for additional visits/tests (18.9%), the risk of being treated with inactive agents - i.e. placebo- (15.2%), and the probability of being randomized to unknown products (12.7%). Conclusion: Patient barriers for enrollment include the ‘guinea pig’ perception held by patients and/or relatives, anxiety caused by uncertainty, additional demands of the trial, and concerns about information and consent.