What are the top trending therapeutic areas for clinical trial sites? Study protocol criteria has become increasingly stringent in terms of the target patient populations and there’s been a dramatic reduction in the number of straight-forward, high volume, easy to enroll diabetes, hypertension and triglyceride studies of the past. Additionally, the era of big data and analytics is in full swing. “The heightened focus on specialized drugs and the rising cost and inefficiencies associated with clinical research will cause sponsors and CROs to rely on a more diverse set of clinical research centers than ever before. This, in part, will prompt clinical research centers of all types to increase investment in developing their own infrastructure, including people, processes, and technology, to standardize across trials and help accelerate end-to-end trial execution.” http://www.appliedclinicaltrialsonline.com/four-trend-predictions-2019
“There’s a lot of competition between sites looking to be awarded trials,” commented Kirsten Joseph, Lead Business Operations Coordinator, BTC Network. “Successful sites do research around available studies in order to position themselves for success.”
In 2017 and 2018, the top therapeutic areas by study volume included neurology, dermatology and gastroenterology, driven by 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. Sites who did their homework to identify sponsors actively working on trials in their key target area landed study opportunities. The following is a high-level overview of these trending Therapeutic Areas and the types of investigators needed and requirements that need to be met for participation in relevant studies:
Dermatology
PIs (Principal Investigators) or Sub-Is (Sub Investigators) involved are almost always dermatologists. From time to time, allergists or immunologists are accepted in their place.
Gastroenterology
For less severe indications, general practitioners and internists can serve as the PI. For more severe indications, Gastroenterologists are required. Sites also need access to facilities which can perform a variety of procedures and diagnostics including imaging (such as a fibroscan), biopsies and endoscopies at regular intervals during the study.
Neurology
Neurologists serve, at the very least, at the Sub-I level and typically have active practices and/or a strong, trusted referral network and a robust database. They must also have Qualified Raters for common scales such as ADAS-cog, ADC-ADL, CIBIC+, MMSE and NPI. Sites need access to imaging capabilities such as MRIs, PET, CT, etc. Access to a pharmacy with an experienced team is key. Additionally, site staff must be well versed in procedures such as lumbar punctures and be able to communicate effectively and compassionately with patients.
Strategies in identifying and securing clinical study leads consistently change as the investigative landscape evolves in response to the overall industry. To learn more about how we can connect your quality site to top trending studies, contact us.
