Doctors often have a misconception that a Phase IV study is a Post Marketing Surveillance (PMS)study. I remember having discussions with friends to clarify that if a phase III protocol is repeated after marketing a product, it does not become a PMS. They are different types of studies both conducted after marketing of the drug. The new rules have amply clarified the issue.
The New Drugs and Clinical Trials Rules 2019 were made effective early this year. As per common practice with all new rules, explanations were asked for from many individuals, especially those who had not kept track of the goings on in the FDA bhavan in Delhi. So the regulatory authority has been proactive in issuing an FAQ for the new rules. When both are read together, almost all issues are settled.
The new rules have devoted the whole of Schedule five for Post Market Assessment. It clearly divides post marketing assessment into
A. Phase IV (Post marketing) trial
B. Post marketing surveillance study or observational or non-interventional study for active surveillance
C. Post marketing surveillance through periodic safety update reports
The close similarity of wording however does lead to some confusion which the FAQ has tried to address though not completely.
For Post marketing trial the words used are “……Such trial will be conducted under an approved protocol with defined scientific objectives…..”
For observational and non interventional study the words are “Such studies are conducted with a new drug under approved conditions of its use under a protocol approved by Central Licencing Authority with scientific objective” but inclusion and exclusion are as per pack insert.
The FAQs # 29 and 30 are in response to whether permission of the Central Licencing Authority is required for observational and non-interventional study. The answer is a No and Yes !!!!
Answer # 29 says “In case of observational/non-interventional study/clinical study of a drug which is not a new drug, no approval from the CLA is required. However, for confirmation that the study protocol is truly a protocol for an observational/non-interventional study, it is advised that the applicant should submit the protocol to the CLA and wait for its response. Otherwise, after initiation of such study without prior approval of CLA, if it is considered by CLA not to be truly an observational/non-interventional study/clinical study of a drug which is not a new drug, regulatory action as per the provisions of the New Drugs and Clinical Trials Rules, 2019 will be enforced.” Which means we may start such a study without CLA permission but at risk
However answer # 30 starts with “Yes. Such studies are conducted with a new drug under approved conditions of its use under a protocol approved by Central Licencing Authority with scientific objective…..”
It further says “However, the regulatory provisions and guidelines applicable for clinical trial of a new drug are not applicable in such cases as the drugs are already approved for marketing”
I need more clarity on this. What are the guidelines that are not applicable? Does it mean
• No Ethics Committee permission
• No CTRI registration
• No need to follow Good Clinical Practice
• No compensation
• No Samples
Can someone throw some light please?
Dr Vishwas Sovani (Nov 2019)