Strategic planning for your site’s growth and success depends on tracking industry trends and developments. This part 2 of the article brief series delves deeper into specific therapeutic areas, different approaches to consider when identifying new studies, and increasing your research site’s expertise to sponsors/CROs and patients.
In forecasting trends for medical indications, it is important to consider the various drivers behind the flow of research and development spending. A lack of approved therapies in a certain indication is a major one. There has also been a shift in what disease stage sponsors/CROs are targeting. Top forecasted indications include atopic dermatitis, IBD/Crohn’s/Ulcerative Colitis, Alzheimer’s and NASH, one of the leading causes of liver transplants. There are challenges for each of these indications and strategic approaches to navigate them.
“NASH is not well understood from a therapeutic, non-surgical intervention standpoint and it’s also an indication where the industry has seen a huge increase in the number of trials over the last few years. That makes a large numberof sites want to break into this indication,” Riley said.
Typically, NASH protocols are complex with liver biopsies being required in the patient screening phase. A strategy sites may consider, if interested in conducting NASH studies, is to leverage a combination of non-intrusive bio-markers as part of their pre-screening strategy to drive efficiency and drastically reduce screen failure rate.
Currently, there is a shift towards treating patients suffering with pre-Alzheimer’s as well as patients at the complete opposite of the spectrum whose symptoms include behavioral issues with agitation. To break into these medical conditions, sites must understand Qualified Raters, scales used to track disease progression, and rates. Protocol and sponsor requirements are mandating for neurologists and psychiatrists to serve as Sub-Is (Sub-Investigators) to ensure that medical professionals with
specific competencies are providing oversight.
“Those investigators having an active practice is going to be a huge plus,” said Riley. “Build and maintain a trusted referral network as well as your site’s patient population. This tactic builds your site’s infrastructure and will qualify you for more studies.”
There are a few challenges to be aware of in securing your first study and recruiting patients in a new Therapeutic Area. The first, determining which clinical studies to pursue and secure with the sponsor/CRO; second, identifying a new Principal Investigator (PI) to work with on the study; and third, working with an untapped patient population that may/may not be informed of clinical trials. It is important to understand new PIs require training in the conduct and management of clinical trials and this can be a significant time commitment and staff resources. Assess the new PIs investment and commitment in the overall clinical trial process, as well as their understanding of the role and responsibilities.
Leverage your overall research experience as a site to bypass potential sponsor concerns about a research naïve or research
limited PI.
“Be strategic in your approach to finding new research physicians. Identify potential practices in your area,
contact them and host lunch and learns. Help them build experience by starting as a Sub-I,” Riley recommended.
To maximize your site’s chance of being awarded competitive studies, consider which potential investigator has the appropriate access to patients. Understand what the sponsor/CRO expectations are for the “ideal” site. Obtaining a target “site” profile will assist you in evaluating if your site’s strengths, experience and staff align with the sponsor/CRO needs.
For sites electing to work with a new PI, be open to studies in a new therapeutic area. Look for synergies such as overlapping
patient populations, similarities in trial designs and complementary therapeutic areas.
“Growing your patient access is key to landing and successfully enrolling your first new study
in a therapeutic area,” said Riley.
Raise awareness of your research site through exhibiting at local health fairs and community events, newsletters, referrals, traditional advertising channels such as billboards and public transportation placards, and a smart online presence. Update
your website regularly as it is a venue for showcasing your expertise in certain areas as well as an educational resource for
industry professionals and patients. Use social media channels constructively.
Strategies to implement to enter into a new therapeutic area include:
- showcasing deep research experience to de-emphasize where your site is indication naive
- highlighting your infrastructure
- pointing to positive recruitment metrics from studies in similar populations
- featuring all available recruitment resources including your database, practice affiliations and referral networks
The above strategies will also help you in addressing and completing feasibility study questionnaires received by sponsors/CROs
for a specific study. It’s important to answer all questions on these feasibility surveys.
“You want to show sponsor/CROs that you can translate your success in other areas to their particular study.
That you’re a great fit. Elaborate on your results,” Riley advised.
Position your site for success in 2019 by taking heed of trends established in the past year and trying new approaches. Trends include an increase in generic drug studies, a tightening of study criteria, a rise in the next level of illness and disorder studies, pharma population diversity strategies, stricter medical specialty requirements and consolidation of sponsors/CROs.
Increase your opportunities of breaking into top therapeutic areas by accelerating an aggressive business development strategy, tracking and showcasing recruitment data, identifying and connecting with research physicians, engaging with under-represented patients, strengthening your database, keeping your website up to date, and advertising via traditional channels as well as digital/social media. The relationships you build today will help your site secure studies to sustain your site’s pipeline tomorrow.