Postmarketing studies - also known as Phase 4 studies - have become necessary for some products to maintain market authorization. But they have also become crucial tools to support product reimbursement data. Today, pharmaceutical companies conduct late-stage studies to investigate product effectiveness, health economic outcomes, product utilization and other key data not readily collected through Phase 3 trials.

Clearly, the important thing to keep in mind is that Phase 4 studies are performed on marketed products. This allows postmarketing study teams to innovate new trial designs beyond traditional randomized controlled trials (RCTs) to examine specific endpoints and to collect real-world data. Some of the new study designs include pragmatic RCTs, as well as advances in observational and retrospective studies.

Meeting Medical Affairs Objectives through Postmarketing Studies

Drug companies leverage postmarketing studies to fulfill a number of medical affairs objectives. Phase 4 studies help medical affairs teams resolve gaps in medical knowledge, as well as demonstrate potential new medical indications for products already on the market. Phase 4 studies also help companies collect real world data, which is often a challenge. Postmarketing research comes with its own unique challenges. Therefore, it’s important for companies to involve multiple teams in the postmarketing study process. These teams often include medical affairs, clinical development, legal and compliance groups.

Because postmarketing studies draw upon the expertise of several internal functions, pharmaceutical companies often struggle to determine the best place to house these important activities. For example, teams that work with vaccines may require monthly global prospective studies — and fall within the scope of medical affairs ownership. Phase 4 studies that do not target vaccines may not require the same activity levels. Likewise, companies may involve both clinical and medical affairs teams to support postmarketing research in non-vaccine therapies.

Who Oversees Postmarketing Study Operations?

When executing their postmarketing studies, companies rely heavily on medical and clinical expertise. Having multiple groups’ insights can be beneficial. But clearly delineating each team’s expected contributions to postmarketing study design and execution can be problematic. Different perspectives from various functions also contribute to the structure-related post marketing challenges that companies experience. Research and development groups might have developed a consistent framework for their clinical studies.

However, these frameworks may not be applicable to Phase 4 studies. On the opposite side, medical affairs may be more familiar with study needs but less familiar with clinical trial execution. Consequently, medical and clinical teams may each operate on somewhat of a learning curve as they discover what protocol designs work and which are less effective.

Postmarketing Studies and Real World Evidence

Real-world evidence is not new, but the pharmaceutical industry’s ability to get actionable results from it has improved. More than ever, tons of data are available to researchers. As data collection methods and technology improve, postmarketing study teams will be able to present detailed findings about product effectiveness, utilization and cost. Today, postmarketing studies have an opportunity to discern the real-time impacts of physician and patients’ healthcare decisions.

Since, Phase 4 studies have become a more exciting prospect for medical affairs team because the need for postmarketing research continues to increase. What’s even more interesting is the information that needs to be gathered. It’s not the same type of data collected from registration studies or randomized trials. Postmarketing studies look at real world evidence and how products impact healthcare, doctors’ practices and patients’ outcomes.

Improving HEOR through Postmarketing Studies

Another reason companies are conducting more postmarketing studies is to collect critical data to support payer needs. The healthcare landscape is shifting for increased accountability for outcomes data and patient-centricity. Drug companies conduct advanced postmarketing studies to collect cost-effectiveness data and patient subpopulation data needed to help prescribers select the best medicines for their patients.

Therefore, presenting strong HEOR data to payers has become critically important to the success of new drug launches. Drug companies have been using postmarketing studies to collect cost-effectiveness data. HEOR studies may be conducted by other US groups, such as market access. However, postmarketing studies may be used to monitor long-term effectiveness and safety that support HEOR goals.