“Accelerated Approval Could Spur Development of Patient Reported Outcomes Tools”, Sutter, S. The Pink Sheet, Vol. 74 No. 13, Mar. 26, 2012
Summary: This Pink Sheet article reviews a subtle takeaway from the Oncologic Drugs Advisory Committee’s March 20 review of GlaxoSmithKline’s Votrient (pazopanib) for treatment of advanced soft tissue sarcoma that accelerated approval, with a post-marketing requirement to confirm clinical benefit in a difficult-to-treat population, could incentivize sponsors to develop instruments for assessing symptom improvement. View.. read more →
“Hearing the voice of the heart failure patient: key experiences identified in qualitative interviews.” Gwaltney, C., Slagle, A., Martin, M., Ariely, R., Brede, Y., British Journal of Cardiology, Mar. 2012
Summary: This article reviews a study in which qualitative interviews were conducted with chronic heart failure patients in order to identify key experiences that may be targeted as end points in future heart failure trials. It concludes that although some experiences are already widely captured in clinical and patient-reported heart failure assessments, others, such as.. read more →
“Give the Patient a Clear Voice”, Paty, J., Applied Clinical Trials, Feb. 2012
Summary: In this article, invivodata’s Dr. Jean Paty explains how all measurements and outcomes need to reflect what is happening with the patient. View Publication read more →
Life Science Leader publishes, “The Evidence For Endpoints: PROs And Beyond” by Jean Paty
Summary: In this article, Dr. Jean Paty, Co-Founder and Senior Vice President of Scientific, Quality and Regulatory Affairs for invivodata, inc. & Chief Scientist and Regulatory Advisor of PRO Consulting, discusses the key take-aways from the October 2011 FDA workshop & its implications to researchers using Clinical Outcome Assessments (COAs) in new medical product development. View Publication read more →
“A PROfessional Trial”, E. McCallister & S. Usdin, BioCentury, Dec. 2011
Summary: This article presents a compelling case study of Incyte Corporation’s recently approved Jakafi® (roxulitinib), the first drug to get symptom data on its approved label since the FDA issued its draft PRO Guidance in 2006. It reviews Incyte’s path to approval, which included early planning on the PRO component of their research, working with.. read more →
Measurement in Clinical Trials: Review and Qualification of Clinical Outcome Assessments Public Workshop; U.S. FDA, Oct. 19, 2011
Summary: On October 19, 2011 the FDA hosted a workshop that will change how developers of medical products select, evaluate, and provide evidence to support endpoints for their clinical development programs. Dr. Janet Woodcock, director, Center for Drug Evaluation and Research (CDER), made clear statements regarding instruments used to measure the efficacy, and sometimes safety,.. read more →
“Content Validity—Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 2—Assessing Respondent Understanding”, Patrick, B., Burke, L., Gwaltney, C., Kline-Leidy, N., Martin, M., Molsen, E., Ring, L., Value in Health, Oct. 2011
Summary: In this second of a 2-part ISPOR PRO Good Research Practices Task Force Report, the authors review the process for developing content and assessing respondent understanding of newly developed PRO instruments for medical product evaluation, specifically, the methods for conducting cognitive interviews that address patient understanding of items, instructions, and response options; and the.. read more →
Content Validity—Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 1—Eliciting Concepts for a New PRO Instrument, Patrick, B., Burke, L., Gwaltney, C., Kline-Leidy, N., Martin, M., Molsen, E., Ring, L., Value in Health, Oct. 2011
Summary: In this first of a 2-part ISPOR PRO Good Research Practices Task Force Report, the authors review the process for developing content and assessing respondent understanding of newly developed PRO instruments for medical product evaluation, specifically the elicitation of key concepts using qualitative focus groups and/or interviews to inform content and structure of a.. read more →
“The Patient Matters: Thanks FDA”, Paty, J., Applied Clinical Trials, Feb. 2011
Summary: In this ‘Closing Thought’ article, invivodata’s Dr. Paty reviews the impact of the FDA’s Final Guidance on Patient Reported Outcomes (2009) in terms of its effect in driving the biopharmaceutical industry to take note of the patient – to listen, understand, and document the patient’s perspective during medical product development. View Publication read more →
“Real-Time Patient Reporting Could Open The Door To FDA Inspection”, Dubin, C., Life Science Leader, Feb. 2011
Summary: invivodata’s successful DIARYpro and SITEpro study with Sucampo is highlighted in the February 2011 issue of Life Science Leader. In this article by Cindy Dubin, invivodata’s Gretchen Craig and Sucampo’s Dr. Raymond Panas discuss ePRO and the FDA inspections that resulted in the approval of Sucampo’s drug, Amitiza. View Publication read more →