Direct to Consumer: Patient-Reported Outcomes - Pharmaceutical Executive

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Direct to Consumer: Patient-Reported Outcomes
New clinical endpoints mean exacting messages for patients.


Pharmaceutical Executive


Another formal publication is expected to address the growing interest in the study of health-related quality of life research, and to provide direction on the following topics:

  • conceptual definition of PROs
  • the value of PROs research
  • identification of disease areas for research
  • considerations for research, including instrument development and validation, statistics, and interpreting results.

PROs in Oncology The importance of communicating QOL information was noted well before the establishment of the Patient-Reported Outcomes Harmonization Group. In 1985, the Oncologic Drugs Advisory Committee (ODAC) recommended that positive effects on QOL endpoints could serve as the basis of approval for new agents. During the last 10 years, more than 110 new marketing claims have been approved by FDA. Of those, at least six have demonstrated evidence of disease-related symptom benefit through the use of PROs.

Growing interest A recent review of the literature confirms a growing interest in the study of QOL endpoints. In 1994, there were approximately 282 published articles on the subject. In 2004, that number had grown to more than 900. This trend is expected to continue in parallel to the study of new oncologic agents and new indications of existing products.

Available tools The use of supportive care drugs to help patients cope with disease burdens and side effects of treatments has paved the way for the use of PROs measurements in cancer clinical studies. A series of validated assessment tools, known as the Functional Assessment Cancer Therapy (FACT) scales, has been developed by David Cella, PhD and colleagues at Northwestern Medical School, to address the specific issues surrounding cancer treatment. Dr. Cella has developed disease-specific scales to address lung cancer (FACT-L) as well as symptoms of fatigue associated with cancer and its treatment (FACT-F).

Physicians and other healthcare professionals can use these tools now as they attempt to evaluate the effectiveness of treatments and optimize drug utilizations to combat the high cost of drug treatment.

Staking out value The use of FACT scales has helped the oncology market better appreciate the value of supportive care. Specifically, in the case of the treatment of cancer-related fatigue, the use of PROs has helped patients feel better about discussing symptoms like, "I feel tired" or "I'm not able to complete a full day of work."

Communicate QOL At the 2004 San Antonio Breast Cancer Conference, the Y-ME National Breast Cancer Organization presented a survey, which was conducted to assess the impact of fatigue on 750 participating breast cancer patients. Most of the findings were consistent with reported literature, stating that 96 percent of respondents experienced fatigue during cancer therapy, and roughly 92 percent after cancer therapy.

Surprisingly, this PROs survey also found that 74 percent of the respondents reported some level of cognitive impairment after completion of therapy; memory, verbal skills, word-recall confusion, and mental fog were all reported. The reported duration of these noted impairments lasted more than two years in roughly 28 percent of respondents, suggesting that there is an urgent need for long-term assessment and future research to measure the impact of breast cancer treatment on cognition.

As this example shows, the benefits of studying PROs extend beyond the clinical trial setting and into marketing as well. Evaluating PROs can support a brand's position in the market by enriching scientific literature about a product's disease category—thereby expanding the clinical knowledge of that brand.

Patient-provider communication A well-designed PROs study can help physicians ask patients the right questions. It also can help identify areas of discussion for future visits. For example, the use of a PROs symptom-relief scale may reveal the need to switch medication or titrate the dose of the current medication. Without the use of such a scale, the physician may not receive adequate feedback on the effectiveness of a certain medication. Thus, PROs enhance patient-physician communication and teach patients that active involvement in their care is acceptable and encouraged by their healthcare team.

Information gained from patients also can help align physicians' treatment goals with patients' desires and expectations for treatment. For example, a PROs treatment-satisfaction scale may provide insightful information on patient preferences for treatment, such as dosing frequency versus overall efficacy. Physicians may be surprised to learn that most patients value efficacy over dosing frequency.


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