As acceptance for patient-reported outcomes (PROs) grows among regulatory agencies worldwide, life sciences organizations increasingly look to these self-reported measures to round out clinical trials.
According to a report by pharmaceutical intelligence firm Cutting Edge Information, 66% of surveyed companies report implementing PRO measurements during clinical trials. Among those respondents, signs and symptoms metrics are most often used, followed by health-related quality of life (HRQoL) PROs.
Nine key patient-reported metrics range from self-reported signs and symptoms to patient satisfaction levels to reports and ratings of healthcare. Each of these metrics is useful in its own right and can be a best-fit depending on the purpose of proposed clinical studies. Among surveyed companies, the majority report using eight of the nine PRO metrics during clinical trials. Ninety four per cent of those using PROs use signs and symptoms metrics, followed by HRQoL measures.
“Self-reported symptoms are popular because they are often valuable in cases where there is no available biomarker — especially in therapeutic areas such as pain management,” said Victoria Cavicchi, research analyst at Cutting Edge Information. “Meanwhile HRQoLs are among the longest-standing PRO metrics, first used in 1980s oncology trials.”
“Patient-Reported Outcomes: Infusing the Healthcare Consumer Voice into Clinical Development and Reimbursement,” available here, shows the percentage of companies measuring specific PRO metrics by company size. Key findings from these report data include
- the largest percentage of all company sizes (Top 10, Top 50 and small pharma organizations) report using signs and symptoms PRO metrics
- all Top 10 companies surveyed use PROs metrics to track signs and symptoms and patient satisfaction. As shown in the overall trend, the smallest percentage of surveyed Top 10 companies tracks reports and ratings of healthcare, at 22%
- all Top 50 companies surveyed report measuring signs and symptoms, health-related quality of life, physical functioning and quality of life (QoL).
Cutting Edge Information’s PROs report 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
- 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/.