For Pharma companies
For Pharma companies
For Pharma companies
The use of patient-reported outcome measures (PROMs) as clinical trial endpoints is now mandated by regulatory bodies such as the Food and Drug Administration (FDA)1
To understand the effectiveness of novel treatments or devices from the patient’s perspective, pharma companies need high-quality and reliable PROMs that are comprehensive yet efficient.
PROMinsight offers a complete platform solution including a widely accepted suite of published and validated
PROMs2-4 helping you capture a range of patient-reported outcomes efficiently and easily for your clinical trial endpoints.
Overcoming the limitations of out-dated paper-pencil questionnaires, the PROMinsight platform can transform your trial outcomes, giving you an edge over competitors in the field.
CAT requires fewer items and 50-90% less time than paper-pencil questionnaires to arrive at equally precise scores, reducing burden for clinical trials with a large testing protocol.
With highly precise estimates and potential for large effect sizes, using CATs can reduce sample size requirements for clinical trials, resulting in substantial resource- and cost-savings.
With items tailored to a person’s level of the construct, testing is personalised. This increases test-takers’ motivation and improves data quality.
New items can be added to align with innovations in disease management or technology, and out of date items can be removed without threatening test validity. This ensures items remain relevant.
CAT mitigates the need for data entry and manual calculation of scores, saving valuable trial resources.
RetCAT and GlauCAT are currently enhancing PROM data collection in two clinical trials determining the patient-centred effectiveness of new treatment modalities for diabetic retinopathy and glaucoma at the Singapore National Eye Centre.
What if my trial has multiple sites?
Each site can use the same client login to access the tests and data from all sites will be stored together.
Are data secure?
Data collected on our CAT platform are encrypted and stored on a password-protected virtual private cloud server on Amazon Web Services (AWS) with mandatory access control, firewalled from the public network with regular, automated security patches. Data are backed up daily.
Our CAT platform complies with the technical requirements of HIPAA (Health Insurance Portability and Accountability Act) and GDPR (General Data Protection Regulation).
Are scores comparable between patients even if they answer a different set of questions?
Yes, they are comparable. Because the items in the item banks have been calibrated on the same scale (like a ruler) using modern psychometric methods, scores across patients are completely comparable.
We are not currently able to use CAT, do you have paper-pencil questionnaires?
Yes, we have a suite of valid, reliable and responsive paper-pencil questionnaires to assess quality of life and other outcomes in people with vision problems. Please visit https://prominsight.com/questionnaires/ for more information on these products.
1. U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes 2006; 4: 79.
2. Fenwick E, Khadka J, Pesudovs K, Rees G, Lamoureux E. Diabetic retinopathy and macular edema quality-of-life item banks: development and initial evaluation using computerized adaptive testing. IOVS 2017; 58(14): 6379-87.
3. Fenwick E, Barnard J, Gan A, Loe B, Khadka J, Pesudovs K, Man R, Lee S, Tan G, Wong T, Lamoureux E. Computerised adaptive tests: An innovative, efficient and precise method to assess the patient-centred impact of diabetic retinopathy. Transl Vis Sci Technol 2020; 9(7):
4.Fenwick E, Loe B, Khadka K, Man R, Rees G, Lamoureux E. Optimizing measurement of vision-related quality of life: a computerized adaptive test for the impact of vision impairment questionnaire (IVI-CAT). Qual Life Res 2020; 29(3): 765-74.