2019 is here! In our latest blog series, we unpack four predictions for real-world evidence studies in 2019. First up is prediction 1: improved clinical and commercial collaboration.
Prediction #1: Improved Clinical and Commercial Collaboration
Starting with a prediction that’s both controversial and difficult to measure, expect 2019 to build on trends observed in 2018 for considerably greater cooperation and alignment between the two traditional organizational landmasses that exist in life-sciences companies. Although clinical will always be the scientific and operational steward of drug development and commercial will always be laser-focused on acceleration of product acceptance, a key byproduct of the 21st Century Cures Act in the US was the recognition that findings from controlled clinical trials aren’t optimal for supporting medical decision-making under actual practice conditions. As a result, this policy-based validation of the need to challenge RCTs as the methodological gold standard meant clinical development professionals should continue to be considerably more open to accommodating measures and outcomes within clinical trials that go well beyond what’s strictly necessary for regulatory approval. Anticipate advances in incorporating real-world clinical realities, economic measures, and patient-centric assessments (such as quality of life) for establishing product value in the eyes of key stakeholders and, in doing so, working collaboratively with colleagues.
Of course, even if mandated from the C-suite down and actively embraced by clinical and commercial professionals alike, perspectives, training, skill sets, and comfort zones vary considerably. Clients will continue to expect us to ensure balance in the design of clinical trials so that neither science nor strategy is compromised. In doing so, we will continue to referee truly passionate discussions over study end points, supporting analyses and data sources and critical operational considerations.
In this effort to address needs associated with both regulatory approval and market access, the common element is evidence: different types of evidence for different external stakeholders that allows us to ensure the right targets, data, and supporting processes are in place. We will be leveraging our unique multidisciplinary experience in supporting this shift toward increased organizational collaboration.