On October 23rd, 2014, we updated our
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Global technology makes mass production of pharmaceutical products possible, but also makes mass production of counterfeit products a reality and the growing currency of organised crime.
Global Internet technology makes instantaneous communication of important drug safety information possible around the world, but also facilitates instantaneous access to illicit “pharmacies” that are defrauding consumers and that disappear with the push of a “delete” button when a regulator investigates
The global economy supports new scientific disciplines that are taking us into the molecular world of genetics-based personalised medicine, but also fosters a world in which most people still die of infections for which we have not yet produced simple, effective, available therapies.
Global transport systems facilitate a world around which we can travel in ways about which our grandparents only dreamed, but also facilitates a world in which any microorganism, any radiation emitting device, or any intentionally contaminated product can be almost anywhere in the world in 24 hours.
Drug discovery, development, authorisation, marketing, and use in geographic isolation simply does not exist in the global world of today
Pharmaceutical products are global commodities
Pharmaceutical clinical databases are global resources
Dossiers are global and because regulators talk with each other earlier and more often today than ever before, companies can no longer choose to the same degree when they are being “global” and when they are being “local”
The public messages of companies are global. Patients and practitioners in most of the world know what companies are doing with their products in other parts of the world.
What they are claiming
When the products are available
What the companies are charging
And there is even more pressure for greater transparency
Sometimes adaptation of a practice is better than adoption of practice
Blessedly we are not all genetic or cultural clones of each other
What hasn’t harmonised
Pharmaceutical Laws and legal authorities of regulators
Cultural expectations – including risk tolerance and perception of what is meant by “benefit”
Product Reimbursement practices
Liability laws and practices
Product Promotion practices
Risk Communication and Risk Mitigation tools
Dates of MAAs submissions
Data in MAAs
Company marketing desires in different markets
Globalisation of Clinical Trials
A growing reality
Serving multiple purposes and goals
Has many positive aspects, but, like other results of globalisation, has some significant challenges
Clinical Trials Globalisation
Catalyst -- Time is money
Recruitment, enrollment of evaluable patients as quickly as possible
Driving trials to more parts of the world than previously seen, especially the so-called “emerging economies” (Eastern Europe, Latin America, and Asia)
Still most data in our MAAs come from non-emerging economies.
Acceptance of foreign clinical data
Code of Federal Regulation 312.120
Code of Federal Regulation 314.106
Can either be conducted under a US FDA IND or not under a US FDA IND
Investigator Qualifications – substantiated
Research Facilities – described
Study reports as for domestic and records accessible for US FDA inspection if needed
Acceptance of foreign clinical data
Declaration of Helsinki
Data must be applicable to the US population and US medical practice
CGP inspections in all parts of the world
Increased knowledge of various medical qualifications and medical practice legislation
Increased interactions with counterpart regulatory authorities around the world, especially if safety issues during clinical trials
Ethical standards, ethics committees, and documentation
How does one define “exploitation” and does it disqualify data – individual ethics versus population ethics. Are patients the “end” or a “means to an end”?
How does one define “standard of care” and what if it is “no treatment” because therapies are not available
How does one define legitimate “consent” in many social contexts different from one’s own
What is the perspective by which this is judged – local or reviewing authority
Especially when we get to the situation where the great majority of the data come from areas new to the clinical trials arena
Relevance of the treated population in the clinical trial to the US population and medical practice
Not a new issue. ICH E5 has grappled with this for years. (Is bridging the answer to the questions?)
Appropriate primary endpoints for desired claims, especially as we get into new biomarkers – must they population validated?
Cultural issues – food, dietary supplements, herbals
Globalisation of clinical trials is a growing reality
It has many apparent benefits, but also many significant challenges from a regulatory perspective
Requires significant discussion with regulatory authorities as product being developed
Companies need to know that these are the types of questions that will be asked more and more frequently as these data become more prominent
World is getting flatter and we are becoming more and more knowledgeable about each other’s systems and practices and are better able to make regulatory decisions for our own jurisdictions based on a global clinical trials database.