Ensure continuation of care

You should monitor any adverse events until they are fully resolved or managed.

For interventional studies, all subjects should receive a smooth transition back to an acceptable level of standard care. If no proper standard care is accessible by subjects (for example, because they are illegal migrants), researchers should develop strategies that will enable continuity of care, such as referring subjects to free services offered by NGOs (non-governmental organisations). ^(1,3)  

Whether researchers should provide subjects with continuous access to research interventions (e.g. an experimental drug) after a study ends is subjected to a lot of debate. This should be assessed on a case-by-case basis, dependent upon various factors such as: ⁽⁴⁾

• budget
• availability of other treatment / intervention options
• regulatory restrictions regarding the clinical use of unlicensed / unproven treatments
• safety of using unlicensed / unproven treatments and availability of safety monitoring
• participants’ expectations

In Malaysia, ‘compassionate use’ of unlicensed drugs may be allowed by the Ministry of Health when no other effective treatment is available for a patient. ⁽⁵⁾ 

Establish a future point of contact →