[Press release] MD Anderson and Bayer collaborate to create symptom assessment questionnaires in clinical trials
From the press release
MD Anderson News Release 1/23/2015
When cancer patients take part in a clinical trial to develop new therapies, they and their physicians want to know how they will feel and function during treatment. A new collaboration between Bayer and The University of Texas MD Anderson Cancer Center will go straight to the patients to learn how certain investigational new drugs affect them. The project will involve the use of questionnaires to assess how a drug may impact a patient’s disease-related symptoms.
“Fit-for-purpose patient-reported-outcome (PRO) measures are an invaluable resource for helping us to better understand how patients are actually being affected by new therapies,” said Charles Cleeland, Ph.D., chair of symptom research at MD Anderson. “This will be especially important in the developmental pathway of new drugs, given that these PRO measures will enhance information about treatment tolerability and potential symptom-reduction benefit earlier in the drug development process.”
The information will be beneficial in further evaluating the drug if it progresses to later stages of clinical development and is tested in larger numbers of patients. The importance of having data on the symptom burden or benefit conferred by therapy is often not recognized until late in that process.
“For patients and their physicians, knowing the probable effects of a treatment can help with decisions among treatment options when therapeutic outcomes are similar but symptomatic effects are not,” said Cleeland.
- registry and results database of publicly and privately supported clinical studies of human participants conducted around the world
Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following:
- Disease or condition
- Intervention (for example, the medical product, behavior, or procedure being studied)
- Title, description, and design of the study
- Requirements for participation (eligibility criteria)
- Locations where the study is being conducted
- Contact information for the study locations
- Links to relevant information on other health Web sites, such as NLM’s MedlinePlus® for patient health information and PubMed® for citations and abstracts for scholarly articles in the field of medicine.
Some records also include information on the results of the study, such as:
- Description of study participants (the number of participants starting and completing the study and their demographic data)
- Outcomes of the study
- Summary of adverse events experienced by study participants
- More information at ClinicalTrials.gov
- Learn about clinical trials
- MedlinePlus® Clinical Trials Information
MedlinePlus is a Web-based health information service of the National Library of Medicine. It explains health topics using language that is easy to understand. Visit the Clinical Trials page (also available in Spanish) or the interactive tutorial on clinical trials (also available in Spanish) to learn more about clinical research and find answers to common questions.
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