Medical Affairs and Postmarketing Studies Go Together Like Peas and Carrots

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Postmarketing studies help companies expand their product knowledge, even after the launch window has passed.  For example, dedicated or non-dedicated postmarketing study teams may leverage Phase 4 research to gather additional safety data as a condition of regulatory approval. Or, companies may develop postmarketing studies to evaluate the impact of long-term product use.  Still other life science organizations may generate late-stage studies as a way to demonstrate cost-effectiveness.  Regardless of their end goal, companies can gather information to fulfill these diverse objectives through prospective interventional or observational studies or through retrospective data collection methods. Continue reading

Investigator Initiated Studies: Composing Cross-Functional Evaluation Committees

Natalie DeMasi, clinical development and medical affairs researcher
By Natalie DeMasi,
Research Analyst

Approving investigator initiated studies (IIS) is a multi-step process that can be both time-consuming and complicated.  Once an investigator submits an IIS proposal, one pivotal step is for the team’s evaluation committee to assess the proposal for scientific merit, alignment with corporate strategies and investigator credentials – as well as budget and compliance aspects. Continue reading

From Phase 3 to Post-Marketing Studies: The Journey of Aripiprazole IM (Abilify Maintena)

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Schizophrenia is a complex psychological disease state that distorts patients’ cognitive and emotional responses. Patients may experience positive symptoms such as delusions, hallucinations or disorganized thought patterns. Patients may also exhibit negative symptoms like those typically associated with depression; things like lack of pleasure in everyday life and lessened emotional range. The World Health Organization estimates that schizophrenia affects up to 24 million individuals globally. In the US, an estimated 1% of the adult population — 2.4 million — have schizophrenia. Continue reading

Phase IV Patients Are a Virtue

Finding patients in a very specific disease state is difficult enough, but in the shadow of Phase III, it’s nearly impossible.  In fact, next to Phase IV, Phase III patient enrollment looks easy.  Phase IV patient recruiters are stuck competing not only with their competitors’ large-scale Phase III trials, but also with their own company’s later-stage studies. Continue reading

Accelerating Phase 4 Clinical Trials a Matter of Improving Enrollment

David Richardson, pharmaceutical commercialization and launch expert
By David Richardson,
Director of Research

Phase 4 clinical trials not only serve to gather valuable data surrounding drugs’ safety, tolerability and real-time effectiveness, but also to test potential new indications, develop stronger marketing profiles, gain payers’ favor and prove superiority over competitors’ products. While many phase 4 trials are conducted at the requirement of regulatory agencies, many are conducted simply to help boost products’ profiles. Needless to say, these trials can be particularly pertinent to the success, or failure, of a product regardless of the reason. Continue reading

Dedicated Resources for Investigator Initiated Trial Management are Critical

Ryan McGuire, lifecycle management tactics expert
By Ryan McGuire,
Research Team Leader

Pharmaceutical companies are growing more strategic in their investigator initiated trial (IIT) selection. As Research and Development organizations have sharpened their focus on mission-critical pre-approval clinical development studies, external investigators have become a critical channel to answer post-marketing product profile questions. But even as clinical resources concentrate on earlier phase work, IIT proposals do not organize, review, approve and manage themselves. Continue reading

Phase II Outsourcing Now Accounts for 63% of R&D Budgets

Clinical development outsourcing budgets have steadily risen since 2008, but Phase II outsourcing has grown at a faster rate than any other phase, according to our recent clinical development study. Patient recruitment, complex setup requirements, and the need for global coordination point to a continuation of outsourcing trends. The study, “Clinical Operations: Benchmarking Per-Patient Trial Costs, Staffing and Adaptive Design,” found that on average, companies outsourced Continue reading