Research Methodology.Responses to Specific DSEN Queries.Capacity Building. CAN-AIM Demonstration Project.

One of the primary objectives of CAN-AIM is to develop and validate new methods that will enhance the analyses of prospective studies of drug safety and effectiveness.

In 2011-2014, the methodology experts among our team members, together with our trainees and collaborators, have continued active research on the development, validation and applications of novel statistical and epidemiological methods directly relevant to CAN-AIM objectives.

Specifically, our recent research activities focused mostly on two major methodological challenges, essential for the validity, accuracy and/or efficiency of the analyses of prospective, observational, longitudinal post-marketing studies of real-life safety and effectiveness of medications: (i) improvement of the accuracy of drug exposure modeling; and (ii) controlling for biases due to different sources of confounding.

In addition, we have initiated research, with our trainees, on more specialized, and relatively less studied, methodological issues frequently encountered in real-life studies of adverse or intended effects of drugs, related to (iii) reducing residual confounding, due to mis-modeling the confounder effects; (iv) exposure measurement errors; and (v) accounting for measurement problems or uncertainty regarding the outcomes.

[button align_button=’right’ a_fffect=’BounceIn’ delay=” link=’’ background=’#26ADE4′ color=’#FFF’ hover_bg_color=’#17699e’ hover_border=’#1d9cd6′ hover_text_icon_color=’#fff’ icon=”]Read more…[/button]
[display-posts category=”response-to-specific-dsen-queries”]

View ALL

Capacity building in the area of drug safety and effectiveness research is one of the top priorities of the CAN-AIM team.

Given our focus on enhancing, validating and real-life applications of the advanced interdisciplinary methodology for prospective observational studies, and the analytical challenges involved in the conduct of such studies, this goal has been mostly addressed through research training of both PhD students and post-doctoral fellows in the fields of Epidemiology and Biostatistics.

CAN-AIM’s capacity building activities have and will continue to focus on the training of highly qualified personnel (HQPs) We consider HQP training and building future capacities to be our top priorities. The rich and varied clinical and methodological expertise that exists within our Team, combined with the extensive supervisor/mentoring experience of it’s members, will create excellent opportunities for interdisciplinary training and inter-university co-supervision.

[highlight]In total, 6 research trainees, 2 post-doctoral fellows and 4 PhD students have been directly involved in the conduct of specific DSEN-related research and/or development and validation of new statistical methods essential for the analyses addressing DSEN.[/highlight]

We have carried out the CAN-AIM ‘demonstration project’ on ‘Comparative Effectiveness of anti-Tumor Necrosis Factor agents versus traditional Disease-Modifying agents in reducing orthopedic surgery in rheumatoid arthritis.

Preliminary results, based on Quebec data analyses, were provided to DSEN in the Fall of 2013.

A manuscript, that summarizes these results, has been submitted to the peer-reviewed journal Arthritis Care and Research in May 2014. Briefly, we analyzed a cohort of new-onset RA patients, identified from Quebec’s physician billing and hospitalization databases from 2002-2008; who were beneficiaries of the provincial drug plan.

Their data were linked to the pharmacy dispensation database. We used a series of multivariable Cox regression models with time-dependent variables representing alternative measures of cumulative effects of past use of: 1) methotrexate (MTX), and 2) other disease-modifying anti-rheumatic drugs (DMARDs), quantified over different time windows. In parallel with the Quebec analyses, we have been working on similar datasets from Manitoba, Nova Scotia, Ontario, and British Columbia.

This involved considerable efforts necessary to clean the data, as well as to homogenize variables definitions and analytical methods across the 5 provinces. We have finalized the data cleaning and coding programs for each province, and will be able to carry preliminary analyses from each province within the next 8 months.

Overall, the demonstration project confirmed the CAN-AIM team’s abilities and skills in both (i) using advanced methodology to address a challenging issue regarding drugs’ effectiveness and (ii) efficient and productive networking/collaboration of investigators, research trainees and staff from 5 provinces.

Read more…