By Anna Rose Welch, Editorial & Community Director, Advancing RNA
Ensuring that sponsors and investigative sites are on the same page when it comes to recruitment is one of the key issues standing in the way of a timely trial. In this segment of Clinical Leader’s “virtual” roundtable, our recruitment experts discuss some of the tactics sponsors can turn to in order to open up communication with sites and ensure that timely recruitment is a priority for all involved.
AR Welch: Which aspect(s) of the recruitment process is/are the most difficult to achieve or plan for, and what could be done to address these issues early and avoid bottlenecks?
Patient recruitment begins with identification of the correct sites; so, having a thorough understanding of the strengths and weaknesses — as well as the motives for participation — of each investigator in your site network is of prime importance. It’s also vital to recognize that each trial, each situation, is unique. You have to be in a position to respond to changing conditions, including increasing competition for patients, in order to recruit both sites and patients and get the trials started on time. — Marc Hoffman, MD, CMO, Theorem
Much of the success a sponsor has on recruitment programs comes down to the performance of the investigative sites. There are many potential factors that influence a site’s ability to enroll patients effectively and on time, including site enthusiasm, investigator interest, competing studies, number of studies the site is conducting (which impacts CRC availability), patient sources, and referral patterns. Sponsors need to ensure that sites have the support necessary to be successful. It’s important to ask sites about their experience working with external recruitment support providers and gauge their openness to this type of support. Indeed, a growing number of sponsors are bringing on recruitment service providers to develop centralized multi-faceted campaigns designed to support sites in their recruitment efforts. Sponsors can also play a significant role in site success as well by adjusting their expectations for sites, both operationally and contractually. During the contract process, sponsors can mandate things like:
- Sites must utilize the services being provided by the external recruitment provider
- Sites must respond to any inbound inquiries and referrals within 48 hours
- Sites must update enrollment reports with the recruitment provider on a weekly basis
— Dan McDonald, director, business development, DAC Patient Recruitment Services
Sponsors have a hard time planning for the attrition that can happen at the site level once patients have been recruited, pre-qualified, and sent directly to sites for further vetting. There is too much expectation that the ratio of referred-to-randomized patients is a one-to-one correlation. If sites are actively engaged in the recruitment effort, the cost per randomized patient will decrease significantly. If sites are disengaged, feel that the study is too difficult, or have higher paying studies under way, referral processing will suffer, which leads to a much higher cost per randomized patient. Sponsors need to be tactfully assertive with sites from the beginning so that sites understand that properly supporting the patient recruitment effort is required to help both the site and the overall study. — Roger Smith, SVP, global clinical operations, Acurian
Not all patients who are interested, willing, and referred to an investigator site show up for their screening visit. It may help to provide prompt follow-up reminders directly to patients via their preferred opt-in method and to offer travel assistance to patients and caregivers. Screening patients at investigator sites is not always practical, so creating a model for study screening at home or at a pharmacy near a patient and caregiver may speed enrollment. At times, protocol amendments could require alterations to recruitment strategies and tactics, which may take weeks or longer to implement and have an effect on recruitment trajectory. Prospective stress-testing of various IE criteria and protocol scenarios should be done to determine a range of recruitment timeline durations. — Kurt Mussina, VP and general manager, Frenova Renal Research
Tune into the other articles in this "virtual" roundtable below: