Postmarketing clinical research has also become a key feature of product lifecycle management. Phase III b/IV trials are increasingly being used in company specific initiatives to provide strategic guidance in areas such as pay or approval and reimbursement, indication expansion, franchise development and marketing. . Regulatory bodies have responded swiftly; the FDA now requires mandatory surveillance data submission for drugs under increased scrutiny, and the EMEA is close to implementing similar strategies as part of drug policy harmonization initiatives for phase IV trials. The pharmaceutical industry has recently endured intense speculation and negative publicity as a result of high profile product withdrawals caused by inadequate safety profiles.
Postmarketing Clinical Research uses detailed case studies and market scenarios to examine the latest issues surrounding phase IV trial applications. The potential to leverage competitive advantage with postmarketing research is assessed by measuring the implications for formulary access, product marketing, and indication expansion and reimbursement coverage. The latest regulatory developments affecting postmarketing clinical research, use case studies to evaluate recent phase IV trial implementations and understand the competitive potential of successful trial. US Government initiatives have almost doubled the number of post-approval commitments since 2003-2004, following growing numbers of black box warnings and late-stage drug withdrawals. The EMEA and FDA will continue to harmonize regulatory approaches for phase IV monitoring and study commitments in areas of common interest, including pandemic vaccines, medicines for children, rare diseases and cancer medicines. Big Pharma companies conducted 145 (75%) of the 243 industry trials publicly registered with the FDA between 1998-2007. Of these trials, 109 were independently undertaken by big pharma as strategic initiatives. Average Big Pharma patient numbers (1743) far exceeded those of mid-tier biopharma companies (952). The implementation of a networked model of stakeholder involvement has become crucial to the success of drug developers by enabling access to new development platforms and facilitating effective trial management/sponsorship. Active controls featured in 71 industry-sponsored trials, the majority of which were conducted under randomized, open label, parallel assignments. Of the 14 registered trials for medical devices, seven were undertaken with active control comparators in an interventional setting.
The pharmaceutical industry has recently bound to examine key issues as regulators and companies increasingly apply postmarketing surveillance to justify product positioning and long term safety/efficacy profiles, financial investment in phase III b/IV trials will grow at a relatively higher rate than other stages of clinical development.
New Regulatory Policies:
The FDA will soon require mandatory submission of phase IV surveillance data over a large patient population. In addition, products approved on the grounds of accelerated procedures, or those which incorporated surrogate endpoints/biostatistical modeling techniques in early phase data, will require further commitment studies after conditional approval.
Impact on Lifecycle Management:
Marketing and product labeling companies are under pressure to justify claims through postmarketing study data submission, whilst indication expansion development strategies require postmarketing product data submission to support applications for extended approval.
Importance of Trial design/Management:
With multiple applications for trial data, trial design and management is crucial in identifying potential issues or adjustments as early as possible. Proactive adaptive designs and electronic data capture techniques are necessary for the ongoing analysis of collated datasets. Will the rising significance of postmarketing research cause pharma and biotech companies to restructure? And To what extent will the increased regulatory demands over postmarketing data collection and submission impact the pharma industry?