1. Pink Sheet
  2. >>Pathways & Standards
  3. >>Review Pathways

The Perils Of Ignoring Patients In Drug Development

 
• By Francesca Bruce

Lack of early patient involvement in trial design can lead to burdensome studies, inappropriate endpoints, and in some cases clinical failure, delegates heard at a recent regulatory meeting.

Patients and trial
Early patient involvement in drug development can help secure success • Source: Shutterstock

Patient involvement in drug development from the early stages is no longer a “nice to have” but is essential for securing clinical success. Not adequately involving patients can lead to selection of the wrong endpoints, erroneous assumptions about unmet need and trials that are too burdensome for patients to take part in, according to Jo Dewhurst, director of therapeutic expertise at contract research organization ICON.

“Regulators are always telling developers to engage with them as soon as possible, but the same principle needs to be...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Review Pathways

How Will Regulatory Filing Winds Blow Globally For Elevidys Following Patient Deaths?

 
• By Francesca Bruce

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
• By Eliza Slawther

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Engage With HTA Body NICE Before Submitting MAA, UK Govt Tells Companies

 
• By Neena Brizmohun

The government has explained how to navigate the UK’s regulatory and market access funding mechanisms.

US FDA Acting Drug Center Chief Corrigan-Curay Retiring, Senior Staff Remake Continues

 
• By Derrick Gingery

The news coincides with rumors that Commissioner Martin Makary soon will name a new Center for Drug Evaluation and Research director.

More from TOPRA

European Expedited Programs & Harnessing HTA

 
• By Francesca Bruce

European regulators are exploring their interactions with health technology appraisal bodies to improve expedited programs that aim to get medicines to patients more quickly.

Expedited Programs: Overworked Staff & Financial Motives

 
• By Francesca Bruce

A shortage of staff and expertise at regulatory agencies as well as tough eligibility criteria can impact expedited programs and their capacity to help deliver quicker access to innovative products.

‘Industry Failing On Evidence Generation,’ US FDA’s Califf Says Of Accelerated Approvals

 
• By Francesca Bruce

As a “laborious” hearing at the Food & Drug Administration on whether to withdraw the accelerated approval for Covis’s pre-term delivery drug Makena, FDA chief Robert Califf commented that industry is not doing enough to provide the evidence required for the fast-track approval pathway.