Sasongko Teguh Haryo, Othman Nor Hayati, Hussain Nik Hazlina Nik, Lee Yeong Yeh, Abdullah Sarimah, Husin Azlan, Van Rostenberghe Hans
Human Research Ethics Committee, Universiti Sains Malaysia, Department of Paediatrics, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia.
Human Biology Division, School of Medicine, International Medical University, Bukit Jalil, 57000 Kuala Lumpur, Malaysia.
Malays J Med Sci. 2017 Aug;24(4):1-4. doi: 10.21315/mjms2017.24.4.1. Epub 2017 Aug 18.
The use of placebo-controlled trials in situations where established therapies are available is considered ethically problematic since the patients randomised to the placebo group are deprived of the beneficial treatment. The pharmaceutical industry and drug regulators seem to argue that placebo-controlled trials with extensive precautions and control measures in place should still be allowed since they provide necessary scientific evidence for the efficacy and safety of new drugs. On the other hand, the scientific value and usefulness for clinical decision-making may be much higher if the new drug is compared directly to existing therapies. As such, it may still be unethical to impose the burden and risk of placebo-controlled trials on patients even if extensive precautions are taken. A few exceptions do exist. The use of placebo-controlled trials in situations where an established, effective and safe therapy exists remains largely controversial.
在已有既定疗法的情况下使用安慰剂对照试验被认为存在伦理问题，因为被随机分配到安慰剂组的患者被剥夺了有益的治疗。制药行业和药品监管机构似乎认为，只要采取了广泛的预防措施和控制措施，安慰剂对照试验仍应被允许，因为它们为新药的疗效和安全性提供了必要的科学证据。另一方面，如果将新药直接与现有疗法进行比较，其对临床决策的科学价值和实用性可能会高得多。因此，即使采取了广泛的预防措施，让患者承担安慰剂对照试验的负担和风险可能仍然是不道德的。确实存在一些例外情况。在已有既定、有效且安全的疗法的情况下使用安慰剂对照试验在很大程度上仍存在争议。
