SOURCE: Cutting Edge Information

Cutting Edge Information

July 07, 2015 09:18 ET

66% of Pharmaceutical Companies Implement Patient Reported Measurements During Clinical Trials, According to a Survey by Cutting Edge Information

RESEARCH TRIANGLE PARK, NC--(Marketwired - July 07, 2015) - In an era of increasing competition and rising payer demands, patient-reported outcomes (PROs) offer clinical teams and regulatory agencies a more complete look at a drug's effects and future success. According to a report by life sciences intelligence firm Cutting Edge Information, these patient-reported measures add to product value propositions as companies move through regulatory approval discussions, as well as pricing and reimbursement negotiations.

As acceptance of PROs grows among regulatory agencies worldwide, life science organizations leverage these endpoints to round out clinical trials. In fact, according to "Patient-Reported Outcomes: Infusing the Healthcare Consumer Voice into Clinical Development and Reimbursement," a recent study by Cutting Edge Information, 68% of clinical trials at Top 10 companies, 45% at Top 50 and 90% of trials at small pharmaceutical companies now implement PROs.

"Although PROs are increasingly embraced in the pharmaceutical industry, life science organizations must not rely solely on these measures to support regulatory approval," said Victoria Cavicchi, research analyst at Cutting Edge Information. "Teams should play a balancing act and incorporate the right mix of traditional clinical evidence with patient responses to build the strongest case for emerging products."

Often, gaining FDA or EMA approval for PRO endpoints can be difficult. In cases where the therapeutic endpoint can be measured as a biomarker or biological endpoint, agencies may choose to accept those endpoints over a PRO measure. However, PROs are instrumental in later pricing and reimbursement assessments, so clinical teams should look for opportunities to create a mix of biological and patient-reported endpoints.

"Patient-Reported Outcomes: Infusing the Healthcare Consumer Voice into Clinical Development and Reimbursement," available at http://www.cuttingedgeinfo.com/research/market-access/patient-reported-outcomes/, provides insights and metrics, collected through primary research, that patient-reported outcomes executives can leverage to:

  • Add PRO endpoints and measurements into clinical trials to add value to drug dossiers/payer discussions;
  • Develop and standardize in-house PRO development and implementation practices;
  • Determine best-fit PRO measurements as well as decide how many to use and how to leverage them in regulatory and reimbursement discussions;
  • Build and allocate resources to dedicated PRO teams; and
  • Understand emerging topics and trends in the PRO space, including the rise of ePRO technology and its impact on data quality.

To learn more about Cutting Edge Information's patient-reported outcomes research, please visit http://cuttingedgeinfo.com/.

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