Site Selection is arguably the most critical element to study success. You can have a “perfectly” designed protocol, an elegant and aligned CRF design, with a phenomenal team to execute the study. But, picking the wrong sites can upend your study or protract the execution of it and add hundreds of thousands if not millions to your study/program costs. The participation of investigators with direct therapeutic indication expertise and experience in conducting similar trials is essential to effective study execution and protecting patient safety.
The criticality of country and site selection is well-established, there are a significant number of additional variables that can blind a study team from making informed decisions. Furthermore, the increasing complexity of clinical trial designs in recent years requires the evolution of a multifactorial strategic process to country/site identification that accounts for a data-driven approach blended with organizational and site-level intelligence. In this article, we will cover Pharm-Olam’s comprehensive and multifactorial approach to Site Selection through the utilization of our proprietary DISCOVER 360 platform.
How do you choose research sites?
- The relationship-based approach to country and site identification has historically been dependent on leveraging key opinion leaders and associated recommended colleagues.
- Some PROs: This approach can provide initial benefits such as expert review of the protocol during development and connections to other investigators with matching expertise and experience to conduct the study.
- Some CONs: This strategy alone doesn’t always account for the access of these sites to surrounding patients indirectly competing for studies, the current standard of care alternatives, country and local regulatory guidelines impacting startup timelines or protocol requirements, the country infrastructure to handle import/export and equipment needs, country-specific prevalence and risk factors, and several other study-specific criteria outlined for success… to name a few
- The feasibility approach brings a data-driven approach to country and site selection, which is usually additive to the benefits received via the relationship approach.
- Some PROs: You reach out and engage a broader group of investigators, determine willingness/interest, the capability of sites, potential feedback on the protocol (if included), possible patient throughput, and can use to start to tier potential sites for engagement.
- Some CONs: Can only ask so many questions before you lose the audience/participation in the feasibility survey. It still only provides you a glimpse of the full picture necessary to select the best countries and sites for study inclusion.
At Pharm-Olam, we combine these two approaches, delivering the best of both worlds, and then we take it an additional ~15 steps further to truly put your study on a path to success.
Introducing Pharm-Olam’s DISCOVER 360 Platform
We infuse the power of relationship and feasibility approaches, with the power of our innovative DISCOVER 360 platform. Our comprehensive platform enables our team to rebalance the individual bias that historically plagues country/site selection. Instead, this platform makes the selection process a more comprehensive multivariate analysis that empowers a delivery strategy that accurately unlocks the enrollment potential of each country. In processing each trial through DISCOVER 360, we consider several study-specific variables. Our platform truly encompasses a wide variety of data, as depicted in our graphic above, and we will further highlight a few of these factors further below. If you want to learn the full benefits of the DISCOVER 360 platform, then schedule a time to speak with our team. In the meantime, enjoy some of the highlights included below.
DISCOVER 360 starts with considering the epidemiology for the indication(s) in the protocol. The goal is to determine the overall patient pool for a given country. This includes the incidence of the disease or condition being studied, as well as the specific demographics required by the study, but it doesn’t end there. We also consider additional study-specific elements that may influence indication risks. Examples include smoking rates in the context of a lung cancer trial or obesity rates with regards to gastric cancers that may be indicative of a country’s continued elevated disease epidemiology and rationale for inclusion or exclusion.
Understanding a country’s overall potential patient population alone is not enough to make an informed selection. Thus, we take it to the next level by factoring in the number of accessible patients to sites or as we term the patient funnel. The aim is to determine the likelihood of a patient being near a site as several industry reports have demonstrated travel as one of the significant barriers to subject participation in a clinical trial. Centralized healthcare, the presence of research centers, and the capacity of local hospitals to accommodate research are key factors – but considerations like that are only the beginning. Our DISCOVER 360 goes deeper to assess a selection of variables that helps identify where consolidated patient pathways exist that may have otherwise been inconclusive by raw epidemiology statistics. For example, in one of our advanced urothelial carcinoma studies in Turkey, we found that even though the country showed only average epidemiology figures, it offered an excellent patient funnel.
Treatment Options – Country Specific SOC
Thoroughly examining treatment options helps identify opportunities for increased investigator and patient enthusiasm, where the leading standard of care options may not be accessible or affordable to prospective patients. Notably, the ability to utilize these factors requires a combination of data regarding drug approval status coupled with country specialist insight that understands the criteria for full/partial reimbursement under national regulations. DISCOVER 360 harnesses both of these variables at the country level to detect where potential arbitrage-like opportunities may exist for studies.
Understanding the competitive landscape is a critical piece to the successful execution of any trial. Our DISCOVER 360 platform aggregates the latest available data to inform our clients on the trial density in each country to ensure we mitigate patient competition and maximize the results for your trial. There can exist direct and indirect competition, and we must be mindful of this during the selection process. Here, Pharm-Olam goes past the data available and taps into in-country relationships via our Country Managers and to provide intelligence to our Sponsors and thus even more value to the selection process for your study.
Country startup timelines are a critical element when considering the optimal country mix. As opposed to others who may offer unrealistic setup timelines to secure the business, Pharm-Olam provides its customers full transparency around the startup process for each country. This includes shedding light on standard setup timelines as per legislation in each country coupled with study-specific elements that may further impact the setup timelines in each country such as GMOs and non-SOC Radiology. Moreover, our DISCOVER 360 platform will automatically eliminate countries that are not eligible to participate in a trial due to issues with regulations such as consenting of unconscious patients, first in human trials, and more.
Historic Participation & Recruitment Performance
We also consider the levels of participation we have experienced with our studies in those countries. Including our historic successes as well as those of related studies conducted in the indication which are available to us through 3rd party datasets, allows our team to predict feasibility in a very informed manner. Without this variable, our country assessment would be theoretical conjecture instead of rooted in fact.
From time to time, clients may express trepidation about engaging some countries due to the perceived risk of doing business in that country. The DISCOVER 360 platform weighs both the geopolitical stability and the clinical trial audit history of each country. Geopolitical risk can influence the availability of patients as well as the ability to receive supplies and the costs associated with the study. The country’s audit history shines a light on industry stereotypes and may distinguish perception versus reality.
Finally, we look at the country’s infrastructure. The location needs to support the study fundamentally. At its most basic, we want to know whether there are enough local investigators and whether those individuals have the skillset, technology, or other attributes that we need to successfully and efficiently complete the study.
Understanding the Benefits to the DISCOVER 360 Approach
Pharm-Olam’s DISCOVER 360 Approach helps our sponsors achieve the best possible study outcomes. By leveraging our comprehensive multivariate analysis approach, we give our sponsors the right countries with the right factors to support study execution. We also find that the DISCOVER 360 platform leads to more accurate study timelines and budgets in addition to on-time enrollment and quality data.
However, the most significant advantage to DISCOVER 360 may be its most surprising – Pharm-Olam’s approach to country site selection is not common. Most other CROs recommend country/site strategies based mainly on their own internal resourcing availability – not the ones that are fundamentally best for the sponsor’s study. Pharm-Olam is different. We go the distance for our Sponsors and patients to help create a healthier world. For more information about our DISCOVER 360 platform, contact us today.