GPP is Not the Product Registry Equivalent of GCP

“This study will be conducted in accordance with the principles of Good Pharmacoepidemiology Practices (GPP)” …Really?  What does that mean?  Have you even read GPP?!  If you had, you wouldn’t be so quick to cite it in your protocol, especially the ‘Ethical Principles’ section.

What is GPP?

Let’s get this straight.  GPP is not the product registry equivalent of GCP.  GPP is a high-level scientific roadmap for ‘pharmacoepidemiologic research’.  If you ‘follow’ GPP, it means:

1. You have a protocol and it’s been assessed by an IRB/IEC
2. Responsibilities are well defined, and contracts are in place
3. Protection of Human Subjects? See point 1 above
4. Principal Investigator has overall responsibility for the study conduct
5. You need to collect, analyse and communicate the study results
6. Safety reporting is important
7. You should archive all study-related material for at least 5 years

Unlike GCP, GPP hasn’t been internationally endorsed by regulators and implemented into regulations. Meaning?  It’s not legally enforceable.  Non-compliance with GPP is not a regulatory risk.  It’s difficult justifying complying with something that you dont need to comply with and which brings no benefit.  On the plus side, GPP does provide guidance on the content of protocols and study reports for ‘pharmacoepidemiologic research’.  A definite plus when it was first published in 1996…not that helpful in 2019/2020…For example, for those of us in Europe:

• PRAGMATIC CLINICAL TRIAL? Follow ICH E6 for clinical trial protocol and ICH E3 for clinical trial report
• PRODUCT REGISTRY STUDY/ NON-INTERVENTIONAL STUDY? Use the EMAs study protocol and study report templates

[I’m a pharmacologist and even I had to Google ‘pharmacoepidemiologic research’.  How often do you sit in meetings that discuss the proposed ‘pharmacoepidemiologic research’? …Never!]

Ethical Standards for Real World Studies

My recommendation for real world studies that aren’t clinical trials (see examples) is to base the ethical principles of the study on the Declaration of Helsinki.  Why?  You are following a globally accepted set of ethical principles that form the ethical foundations for all medical research involving human subjects and:

• Protects the safety, rights and interests of research subjects
• Ensures the research subjects medical care is unaffected by the research
• Ensures the research is scientifically valid and described in a protocol that has received independent approval (IRB/IEC)
• Study results are published