Pharmacovigilance Agreements: Negotiating Safety Data Exchange Timelines: To Agree to Disagree? That is the Question.

Pharmaceutical companies often enter into contractual arrangements with other companies to advance the development or expand patient access of licensed medicines. These partnerships include specific agreements detailing the exchange of safety-related data between the companies. Such agreements are used to fulfil regulatory reporting obligations, thereby ensuring timely awareness of potential safety considerations and formal maintenance of clinical trial applications and marketing authorisations. The authors conducted potentially the first benchmarking survey of contracts covering safety data exchange within the pharmaceutical industry. Data were analysed to establish the most common types of safety data exchanged, and the associated data exchange timelines. These data may provide an opportunity for companies to assess how their own timelines compare with others, and to consider whether there are actions they may take that could potentially improve negotiation and procedural efficiency. Ninety percent of the recipients responded to the survey, providing information from 378 individual contracts which included data from clinical trials and from postmarketing sources. Results showed less variability in the safety data exchange timelines of clinical trial ICSRs compared to the timelines of postmarketing ICSRs; these results may reflect greater harmonisation of regulatory reporting requirements for clinical trials. The variability captured in the benchmarking data reflects the challenges that contribute to the complexity of safety data exchange agreements between partner companies. The goal of the survey was to serve as a basis for future research and pursuit of additional insights that foster transparency. The aim was also to encourage the consideration of alternative approaches to address some of the challenges that we identified. Use of technology could facilitate the process of recording, tracking, and monitoring of safety data exchange within a partnership, improve efficiency through real time monitoring, and provide further insights. A proactive approach to developing agreements is essential for improved patient access and to maintain patient safety.

Challenges of Perceived Self-Management in Lupus.

OBJECTIVE: Systemic lupus erythematosus is a chronic autoimmune disease with varied and unpredictable levels of disease activity. The ability to self-manage lupus is important in controlling disease activity. Our objective was to determine levels of patient activation toward self-management in lupus. METHODS: We used baseline results from the MyLupusGuide study, which had recruited 541 lupus patients from 10 lupus centers. We used the Patient Activation Measure (PAM), a validated self-reported tool designed to measure activation toward self-management ability, as our primary variable and examined its association with demographic, disease-related, patient-provider communication and psychosocial variables captured in our study protocol. Univariable and multivariable linear regressions were performed using linear mixed models, with a random effect for centers. RESULTS: The mean ± SD age of participants was 50 ± 14 years, 93% were female, 74% were White, and the mean ± SD disease duration was 17 ± 12 years. The mean ± SD PAM score was 61.2 ± 13.5, with 36% of participants scoring in the 2 lower levels, indicating low activation. Variables associated with low activation included being single, having lower physical health status, lower self-reported disease activity, lower self-efficacy, use of more emotional coping and fewer distraction and instrumental coping strategies, and a perceived lack of clarity in patient-doctor communication. CONCLUSION: Low patient activation was observed in more than one-third of lupus patients, indicating that a large proportion of patients perceived that they are lacking in lupus self-management skills. These results highlight a modifiable gap in perceived self-management ability among patients with lupus.