PHARMA NEWS, MULTICHANNEL & CROSSCHANNEL MAKETING

Voluntis et Roche réinventent l'accompagnement des patients atteints de cancer grâce aux solutions digitales D’importantes étapes ont été franchies dans la mise au point de ZEMY, solution compagnon digitale développée depuis 2015 par Roche Pharma France en partenariat avec Voluntis afin d’améliorer l’accompagnement des patientes atteintes de cancer du sein. 

The FDA, in an effort to bring promising new therapies to patients as quickly as possible, has introduced a spate of shortcuts to speed up the approval process. Those programs are working as intended, new research finds, but drug companies are often loath to fulfill their obligations.

The big idea behind the FDA’s accelerated drug approval program is that regulators will OK a promising drug based on clues that it will improve patient lives, so long as pharma companies later carry out larger trials to confirm those hints of efficacy. But looking at four years of data, a team of researchers found that only 50 percent of those trials actually took place within three years of approval.

Furthermore, 44 percent of such trials were not the placebo-controlled variety considered to be the gold standard but rather relied on the same surrogate measures used to win a quick approval, leaving each drug’s true value unclear. This was particularly striking for cancer drugs, accounting for 80 percent of studied approvals, which were cleared based on how well they shrank tumors, not how long they kept patients alive.

Further Reading:

• “GAO Report: FDA Expedites Drug Approvals, But Its Postapproval Oversight Stinks!”; http://sco.lt/89j3Zp
• "FDA is Lax in Enforcing Law Regarding Prescription Drug Postmarketing Studies"; http://bit.ly/1PoqAsY

Drugs recently approved around the world to fight cancer increased patients' overall survival, but benefits vary depending on the drug, a new study shows.

Researchers looked at the 62 cancer drugs approved in the U.S. and Europe between 2003 and 2013 and found they extended survival by an average of about 3.5 months.

But nearly a third of the drugs lacked evidence to suggest they increased survival when compared to alternative treatments.

"Our results point to the notion that new cancer treatments may not always provide patients with greater clinical benefits, or lower risks, over existing treatments," wrote senior researcher Dr. Elias Mossialos, of the London School of Economics and Political Science, in an email to Reuters Health.

The risk-benefit ratio of new drugs is especially important if people are concerned, for example, about whether the cost of a drug would make it difficult for a person to complete the treatment regimen.

Writing in JAMA Oncology, Mossialos and colleagues point to growing questions about the value of new cancer medicines. While the drugs' high costs may be a barrier to access, they note, some people argue the high prices are justified if the treatments offer large benefits.

A lack of solid data on new drugs' benefits and risks makes it difficult to evaluating their value.

Further Reading:

• “Oncologists Say Cancer Drug Advertising Fosters Misinterpretation of Efficacy by Patients”; http://sco.lt/8Imgdd
• Meanwhile other “Oncologists Not Concerned About DTC ‘Over Promising’ Efficacy”; http://sco.lt/6BEXT7
• “Rosy Oncology Drug Outlook for Years & Years to Come”; http://sco.lt/8ZTgC9

Le laboratoire LEO Pharma lance un nouveau site web dédié aux patients atteints de cancer et aux professionnels de santé : oncothrombose.fr.

Results

A three-stage, conceptual model for assisting clinicians to more effectively address the challenges of recognizing, exploring, and managing cancer patients’ emotional distress in the clinical encounter was developed. To enhance and enact recognition of patients’ emotions, clinicians can engage in mindfulness, self-situational awareness, active listening, and facilitative communication. To enact exploration, clinicians can acknowledge and validate emotions and provide empathy. Finally, clinicians can provide information empathetically, identify therapeutic resources, and give referrals and interventions as needed to help lessen patients’ emotional distress.

Conclusion

This model serves as a framework for future research examining pathways that link clinicians’ emotional cue recognition to patient-centered responses exploring a patient's emotional distress to therapeutic actions that contribute to improved psychological and emotional health.

Practical implications

Specific communicative and cognitive strategies are presented that can help clinicians better recognize a patient's emotional distress and respond in ways that have therapeutic value.