Harmonization might lead to a reduction in the number of clinical trial sites, but the number of sponsor companies conducting trials will increase as harmonization addresses “the cost piece”
The US FDA’s Innovative Science and Technology Approaches for New Drugs (ISTAND) program is helping validate digital technologies for use in clinical programs is a credit to the agency
ACRO’s AI/ML Committee is figuring out ways to work together without compromising competitiveness or trade secrets
Parexel GPT, other incremental uses of AI would lead to “something quite transformational” over the next few years
Initiatives like the Melloddy project are laudatory, but are impeded by fears among sponsors “that I'm giving away my crown jewel”
Increasing move for clinical trial design to support reimbursement decisions amid rising pressure on drug pricing globally, for example the Inflation Reduction Act (IRA) in the US
Real-world evidence (RWE) acceptance increasing, particularly for rare diseases, where regulatory agencies are recognizing “in that context, that is perhaps the gold standard”
ICH has been “incredibly powerful in allowing us to get medicines approved and available to more patients, more rapidly on a global basis.”
"Data is imperfect when it's a secondary outcome” and data disparity present challenges globally, including in India but the scope for RWE in India is immense

Parexel Execs On Regulatory Harmonization, AI Impact, RWE Challenges

Opportunity For RWE In India