Compliance Concerns Slow Industry Uptake Of Cancer Patient-Reported Outcomes Tool

Potential need to reconcile physician-reported adverse event data with patient reports of symptom side effects is a concern for Merck; AstraZeneca’s experience using the PRO-CTCAE instrument in cancer trials shows the importance of educating study sites about the value of patient experience data.

Data Collection - Three Arrows Hit in Red Target

Regulatory uncertainty has some pharma industry sponsors wary about integrating a new patient-reported outcomes (PRO) instrument in their cancer trials.

At a US FDA/Critical Path Institute workshop April 25, a Merck & Co. Inc. executive said the company is concerned about potential compliance risks and global acceptance of the...

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

More from Clinical Trials

Clinical Trials Nonprofit Fights for Access Despite DEI Crack-Down

 
• By 

The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

Canada Cuts Red Tape With Single Ethics Review For Trials

 

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

More from R&D

Canada Cuts Red Tape With Single Ethics Review For Trials

 

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 

The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.