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International Clinical Trials
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A patient-reported outcome (PRO) is a measurement based on a report that comes from the patient (ie, study subject) about the status of their health condition without amendment or interpretation of the report by a clinician or anyone else. A PRO can be measured by self-report or interview, provided that the interviewer records only the patient’s response. Symptoms or other unobservable concepts known only to the patient (eg, pain severity or nausea) can only be measured by PRO measures. PROs can also assess the patient perspective on functioning or activities that may also be observable by others, such as quality of life, time to pain progression, and time to deterioration of physical symptoms.
In 2016, the American Society of Clinical Oncology (ASCO) reported the FDA indicated that benefits in PROs can be the basis for full drug approval (1). While this is true and PROs are clearly the best way to collect patient data in clinical trials, the American Medical Association points out that other challenges exist that many oncology studies struggle to overcome: small patient numbers, very sick or terminally ill patients, high failure rates, and single-arm studies unique to the development of new therapies in oncology (2). For this reason, careful thought must go into designing and implementing PRO measures in the oncology clinical trial setting (3).
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News and Press Releases |
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ERT’s At-Home Cardiac Safety Assessment Ensures Clinical Trial Continuity
PHILADELPHIA – March 30, 2020 – ERT, a global data and technology company that captures critical endpoint data while minimizing uncertainty and risk in clinical trials, today announced a cardiac safety solution that helps biopharmaceutical researchers continue important clinical trials during current global ‘stay home’ mandates. The solution enables clinician-administered ECG readings ─ using ERT’s provisioned, FDA-cleared devices or other investigative site–owned equipment ─ to evaluate the safety of new vaccines and medical treatments from patients’ homes.
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Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services
DrugDev
With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents. Many clinical trials are hindered by inefficient, labor-intensive processes. Prolonged, inefficient activation can hamper investigator satisfaction and, ultimately, have a negative bottom-line impact for sponsors and CROs. In addition, the Sunshine Act is heightening the importance of financial disclosure in clinical trials. Without a robust financial disclosure strategy, sponsors cannot ensure that physician self-reported financial disclosure data are aligned with the payment data being reported through the Sunshine Act, increasing financial and regulatory risk.
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Industry Events |
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Clinical Operations in Oncology Trials West Coast
17-18 November 2020, Hilton San Francisco Airport Bayfront
Clinical Operations in Oncology Trials West Coast will be returning this April for another 2 day event full of thought-provoking presentations, discussions and roundtables. This years' conference highlights include the high-level, interactive immuno-oncology discussion panel where specialists from Shasta Bio Ventures, Abbvie and BeiGene shared their top tips on how to run successful and impactful immuno-oncology studies.
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