Trial and Error

Beth Harper explains the correct procedures needed to ensure a successful clinical study.

NGP. Clinical trials are becoming more complex, with larger patient groups, and are often conducted internationally. How can pharmaceutical companies ensure that trials proceed in a timely and cost-effective manner?
Beth Harper. Assuming a well-designed protocol is in place, two critical success factors are selecting the right sites for the study and setting them up for success. An overhaul of the traditional approach to site selection, feasibility assessments, recruitment planning and site training processes is needed to ensure that investigative sites, the suppliers of the subjects and data, have not only the experience and capabilities but the interest, resources, infrastructure, willingness and commitment to conduct the trial. This involves going way beyond the typical and often perfunctory transactions with the sites and adopting a true collaboration mindset to partner with our site suppliers in new and different ways.

NGP. How have methods of patient enrolment/recruitment changed in the last few years?
BH. Technologies such as web-based recruitment techniques and electronic health records that facilitate more efficient patient identification and pre-screening have emerged in the last several years. Beyond that the tactics themselves haven’t changed dramatically but there is a greater recognition that methods need to be tailored and customized to the particular region, culture and specific site. The ‘one size fits all’ approach doesn’t work and sponsors are starting to do a better job to marry the ‘top down’ study level recruitment ideas and initiatives with the ‘bottoms up’ site level needs to identify and implement the tactics in a more focused, meaningful and cost-effective manner. There is a huge push in the industry to develop and document clear, action-oriented, site-level recruitment plans so that the resources, requirements, tactics and timelines can be clearly communicated and recruitment expectations managed across all the important stakeholders.

NGP. What specific challenges are companies facing with regard to clinical site selection and improving site performance?
BH. The age-old challenge that sponsors continue to face is the fact that the majority of sites don’t deliver on their enrolment commitments. Or stated another way, some 30 percent of the sites are responsible for delivering 70 percent of the evaluable patients. The root causes of this problem relate back to the way the industry traditionally selects sites and conducts study feasibility assessments. A questionnaire which asks how many patients can be enrolled is not only ineffective, but doesn’t fulfil the spirit of the ICH GCP Guidelines which stipulates that “The investigator should be able to demonstrate a potential for recruiting the required number of suitable subjects within the agreed recruitment period,” (Section 4.2.1). We are starting to see sponsors and CROs transform their feasibility forms to conversations and working with their sites to conduct more robust enrolment validation exercises prior to confirming site selection decisions.

NGP. What tools and technologies are available to help companies optimize their clinical trial research?
BH. The industry is turning greater attention to the use of modelling and simulation tools to facilitate better data-driven decision making during the country allocation and site selection processes. Tools such as the Recruitment Funnel Planner and Quick Trial Modeler developed by my colleagues at Synapse Analytics for example, help to facilitate the evidence based enrolment validation exercise I describe above and allow for a ‘what if’ scenario planning during the early trial planning stages.

More sophisticated e-communication tools that streamline sponsor-site communications, and facilitate document and information exchange are continuing to emerge. Personalized communications platforms such as Lattice Connections developed by my colleagues at Animedix Clinical for example, are bringing new and creative ways to train and engage sites in more meaningful ways. 

While technology is a great enabler of many processes, we can’t lose site of the fact that clinical research is still a people business. To help foster productive sponsor-site relationships a number of sponsors are going back to the basics of training their staff in what I like to refer to as ‘GeCPs’ or good effective communication practices. Investigative sites (and research subjects for that matter) still need and value the personal touch no matter how sophisticated the technologies become.

Beth Harper is the President of Clinical Performance Partners, Inc., a clinical research consulting firm specializing in diagnosing, troubleshooting and preventing site and enrolment performance problems. Beth leverages her 25 years experience to help foster more productive sponsor-site relationships and enhance the clinical trials process.