A mind for digital therapeutics: Considerations for DTx clinical trials in CNS indications

Advances in computing power, improvements in internet access and mobility, and the widespread use of smartphones have rapidly digitised many aspects of our daily lives over the past decade. As providers and patients have become more comfortable in the online and digital care frame, such tools have become increasingly popular in psychiatry, neurology and behavioural health. In particular, the growth of digital therapeutics (DTx) has great potential to impact the central nervous system (CNS) space.

DTx deliver evidence-based therapeutic intervention using software to prevent, manage, or treat medical disorders or disease. Because of the evidence-based nature of DTx, in many cases a clinical trial is required to demonstrate safety and efficacy. However, since such therapeutics are relatively new, there are many aspects to these clinical trials that differ from trials for traditional therapeutics, and which sponsors will need to consider.

Read the whitepaper to learn:

• How DTx can be utilised in the CNS therapeutic space
• DTx classifications and requirements in the US regulatory landscape
• Key clinical trial considerations for DTx, including:
  • Data strategy
  • Participant recruitment and retention
  • Patient safety
  • Endpoint selection and study objectives
  • Tokenisation and real-world evidence
  • The potential impact of payer coverage standards on clinical trial decisions