Analyzing insights and trends from past years can help a research site plan for success along with learning potential new strategies for identifying and securing the first study in a new Therapeutic Area.

“At Elligo, we’re on track to see approximately 800 study opportunities this year,” said Riley.

The last two years—2017 and 2018—the top therapeutic areas by study included neurology, dermatology, gastroenterology and psychiatry. The factor driving study volumes in these areas is directly linked to key patent expirations and the subsequent race to produce biosimilars and generics. The FDA also launched initiatives to expedite the drug review process and prohibit manufacturers from holding market exclusivity. Several sources indicate that generic drugs marketed accounted for revenue of $200 billion in 2015 and are projected to nearly double by 2021 to $380 billion.

 Sites interested in becoming involved in generic studies must self-identify with the FDA to run generic drug trials pursuant to GDUFA (the Generic Drug User Fee Amendment of 2012).

Over the past five years, study protocol criteria have become increasingly stringent in terms of the target patient populations. There has been a drastic reduction in the number of straight-forward, high volume, easy to enroll diabetes, hypertension and triglycerides studies of the recent past.

Mallory envisaged, “We’ll continue to see a rise in these more challenging studies and indications as the next level of illness or disorder.”

This change can be attributed to the fact that the target level of care and management for these diseases is well established. For some indications, such as hypertension, many studies show that dietary and lifestyle changes, for some patients, can be as effective as certain medications for lowering blood pressure.

“For this reason, there’s more funding being poured into these next level of medical conditions within the same realm, such as resistant hypertension, uncontrolled diabetes, refractory gout or fatty liver disease,” Mallory explained.

Inclusion criteria are more stringent in finding patients who may qualify for these types of studies. In an uncontrolled hypertension study, for instance, the target is patients who may have failed three different classes of hypertensive agents, which is more challenging than an essential hypertension study.

Multiple pharma companies are developing diversity strategies so that minority populations are not under-represented in clinical trials. To identify and secure these studies, sites need to have the appropriate patient database. Mallory recommends that sites engage with under-represented patients in their community by participating in local health fairs and other community events.

The increase in the number of studies in a specific disease is directly influenced by the lack of understanding the disease. To illustrate, the pathology of gout is understood but the management of chronic gout is very poor, increasing the number of studies
in that area. Developing different modalities requires more targeted therapies which ultimately lead to stricter inclusion/exclusion criteria.

Another trend the industry is witnessing is more rigorous specialty requirements. As clinical trials become more difficult, the need for medical specialists to be involved increases. General practitioners are often no longer the primary treatment provider. Sites that work to build relationships with specialists in their communities may have the opportunity to partner on studies or be considered as a referral source.

“Building relationships with local physicians can assist sites in branching out into other areas,” said Mallory.

Consolidation by sponsors/CROs is also impacting the clinical trial space. Reasons for mergers include sharing pipeline development costs and diversification, partnering in marketing efforts and eliminating competition.

Tax reform in 2018 had major implications. The boost in additional funds freed up by the tax cut enabled biopharma companies to explore other strategies and areas. In this changing landscape, sites can remain competitive and stay ahead of the curve by accelerating an aggressive business development strategy.

Increase the number of contacts at pharma companies and CROs. Have a strong business development advocate for your site to cultivate the most productive relationship. Be proactive in keeping the lines of communication open and do not hesitate to ask questions.

“With CROs, I would say engaging early, even during the pre-awards stages of studies can be a really beneficial way to build rapport and trust with the potential new contacts. Conferences are a great way to interface, especially with CROs,” Mallory advised.

The anticipation is that corporate consolidation at the sponsor/CRO level will promote a change in engagement strategies.  “Sponsors/CROs are becoming a lot more data driven. And they’re using more automated processes,” she said.

Starting at the recruitment level is also a good strategy for connecting with companies.  “Keep track of your recruitment data and showcase it, demonstrate that you produce good data. Stay persistent,” Mallory advised.  “As companies grow larger, they are
relying more on site-networks in order to streamline their operations.”

Strategies in identifying and securing clinical study leads consistently changes as the investigative site landscape evolves in response to the overall industry. Part 1 of the 2-part series highlights a few of the growth areas in therapies as well as strategies to customize for your business needs as you continue to plan for 2019.

Further information on this topic is available. Contact a ClinEdge specialist at 857-496-0054, or