|EHR4CR CLINICAL RESEARCH SCENARIOS||EXPECTED BENEFITS TO PHARMA|
|1. Improved protocol feasibility assessment||
|2. Faster patient identification and recruitment||
|3. More efficient study conduct and reporting of serious adverse events (SAE)||
In the current healthcare environment, bringing a new drug to market requires not only to gain regulatory approval, but also a favourable decision from payers and health technology agencies. With the development of novel sophisticated health technologies and targeted therapies, clinical research has become more complex, time consuming, and costly. In parallel, there is a need to generate a larger amount of clinical evidence (including from the real world) to establish the safety, efficacy, and comparative effectiveness of innovative medicines for achieving regulatory approval and market access. Given the need to conduct more clinical trials, and more efficiently, the pharmaceutical industry has begun the modernization of its traditional model for drug development by integrating value-added innovative solutions to its clinical research platforms 1-4.
To assess the value of EHR4CR scenarios (either used distinctively or sequentially) compared to current practices, a robust cost-benefit assessment (CBA) was conducted from the perspective of pharmaceutical industry.
Using a state-of-the-art methodological approach, advanced simulation modelling, and best practices in health technology assessment, the EHR4CR CBA was conducted jointly with a multidisciplinary expert panel composed of EFPIA partners, academic partners, and expert health economists.
The CBA model used robust data, including a resource utilization assessment specifically conducted by EFPIA partners to estimate the actual person-time and related costs for performing each clinical research scenario under current conditions, and with EHR4CR solutions, relevant to Phase II-IV clinical trials in oncology. To reflect the high priority for Europe and for pharmaceutical industry, oncology was selected as an example and reference case for the CBA.
To assess the potential incremental financial value of EHR4CR services for pharmaceutical industry compared to current practices, the model assumes that the efficiency gains realized under EHR4CR conditions would translate into delivering innovative medicines to healthcare faster.
To calculate the potential incremental global financial benefit that could be generated by the pharmaceutical sector from EHR4CR services in oncology, the distribution of the global market values of oncology products (2012) was used 5. Uncertainty was managed with robust probabilistic sensitivity analyses. Statistical analyses were carried out to show any potential differences between EHR4CR solutions and current practices.
The EHR4CR CBA preliminary findings suggest that:
Further CBA analyses are planned to assess the full scope of EHR4CR benefits for the pharmaceutical industry.
In addition to the CBA which establishes the value of EHR4CR services compared to current practices, a budget impact analysis (BIA) will be developed to estimate the budgetary impact for the pharmaceutical industry of adopting EHR4CR services.
The EHR4CR CBA and BIA will provide useful tools to assist decisions relevant to the adoption of EHR4CR sustainable solutions at project completion.
A EHR4CR CBA scientific manuscript is planned for submission to a peer-reviewed scientific journal.