The drug development industry has seen a seismic shift in the past decade with regards to how investigative sites are identified and selected for clinical trials. Like many other aspects of our industry, site selection is benefitting from technology and a rapidly expanding pool of data which can be collated, parsed and utilized for determining the probability that a site will perform as needed during a clinical trial. Sponsors are increasingly looking at epidemiology studies, insurance claims, physician and investigator profiles and other data to determine disease prevalence, true accessibility to protocol-matching patients and past performance.
When it comes to site selection outside the United States though, the game changes considerably and the methods used often reflect a more traditional and sometimes even grassroots approach. Understanding which methods to use and resources available for each country takes significant experience and expertise.
There are some tried and true principles that should always be applied to establish a foundation for success when selecting sites:
– Get therapeutic experts and investigators involved early – before the protocol is finalized. Even the best investigators can’t enroll a patient who doesn’t exist.
– Interview sites; don’t just send out a questionnaire. The devil is in the details and speaking with sites directly can uncover nuances that may not come across in a faxed or emailed response.
– Establish a healthy mix of well-known and respected investigators, with lesser known investigators. Look for terrific clinicians with strong patient flow, but a lack of trial experience. Repeatedly, some of the top enrollers on global programs are newer, often enthusiastic investigators.
– An onsite visit may be necessary in some markets. Don’t underestimate the importance of visiting directly with sites. This is especially important in emerging market countries, where clinical trial experience may be less, infrastructural and logistical challenges can be found, and there is often a lack of electronic patient records.
– Leverage data to identify sites and validate your findings: Using insurance claims data, physician records, investigator data and more can help you determine where the target patient is located geographically and which investigators and physicians (referrers) are truly seeing the right patients for your study.
– Don’t overlook the clinical research coordinator (CRC). For sites outside the United States, ask about the availability of a CRC. Only about 15% of sites in markets like Brazil and India have a CRC on staff. Since CRCs are on the front line of recruitment, knowing about the CRCs is as important to enrollment success as any other factor.
– Always keep enrollment top of mind. While sites might appear to have the patients, many sites will not achieve optimal performance recruiting patients without outside support. Given the workload placed on a typical site-based CRC, it’s critical to have a proactive plan in place for site support. Include questions in your feasibility analysis about past experience with recruitment tools, effective and ineffective approaches and desired support.
Site selection requires a multi-faceted and layered approach. Sites are the backbone of any clinical study and, likewise, patient recruitment. Getting site selection right is the first step to on-time enrollment.
CASE STUDY: SITE FEASIBILITY AND SELECTION FOR STUDY OF PATIENTS CO-INDICATED WITH CARDIAC DISEASE AND GASTRIC ULCERS
- Highly complex patient population requiring atypical level of site assessment
- Rescue intervention needed to identify 35 viable sites within 45 days
- Many sites disinterested in being add-on sites
- Extremely short enrollment timeline remaining for sites
- Complex protocol design necessitating synergy between gastroenterologists and cardiologists to meet the endoscopy requirement
- Cardiologists have patients who meet study criteria, but are not equipped to perform endoscopies
- Gastroenterologists do endoscopies but do not generally see patients who meet study criteria
- Quickly identify high-performing sites with staff who are willing to commit to achieving enrollment goals
- Aggressively engage sites, build strong rapport with study staff, raise internal study awareness, and mitigate competitive challenges
- Geographic targeting
- Site feasibility assessment
- Targeted site list development
- Site selection
- 35 cardiology sites identified within 1.5 months