Second of two parts

Successful delivery of medical outcome trials involves signifi­cant pre-planning to ensure the right strategy for conducting trials. A simple, direct protocol designed to answer the right question for all stakeholders and with targeted data that are easy to interpret is a corner­stone of success. Effective operational delivery depends on a critical combi­nation of ‘right path, right start and right patients’ in advance of trial ex­ecution.

The right path involves develop­ing appropriate country and site se­lection strategies based on targeted investigators, launch timing, regu­latory approval timelines, protocol suitability and medical management of subjects. A feasibility assessment to determine countries and sites with adequate patient population and ac­ceptable clinical trial performance and experience facilitates the start-up process and promotes meeting enrollment timelines and overall site performance. An integrated site model can simplify these intricate interdependencies and synchronize regulatory and ethics filings. In ad­dition, the monitoring methodology must be consistent with the protocol, designed to be as cost-sensitive as possible and implementing a com­bination of on-site and remote visits.

The right start depends on deter­mining realistic timelines for the first Site Initiation Visit in each country, developing a plan for recommended efficiencies, setting up templates and processes as soon as the trial is awarded, engaging sites early and maintaining their engagement.

Recruiting the right patients re­quires strategies for pre-identification of qualified patients, final strategy including direct-to-patient contacts, and materials development to both inform patients about the therapeu­tic area and maintain patient motiva­tion and participation. Considering the patients’ trial obligations has a direct impact on both recruitment and retention. Obtaining Informed Consent for direct patient contacts is essential.

Data-driven, evidence-based de­cision making can avoid unforeseen challenges with medical outcome tri­als. Proactive study planning across the trial continuum, beginning with the end in mind, is a proven and highly effective strategy for trial ex­ecution success.

Written by Guest Writer Patricia Steigerwald, MS, RN. Steigerwald is vice president, regional managing director of the Americas for Quintiles Real World Late Phase, providing strategic and operational oversight to ensure fit-for-purpose operational delivery of quality data, patient safety and regulatory adherence. She has nearly 30 years of clinical research experience, with more than 15 years in development and delivery of regulatory-compliant strategies for the conduct of real-world and late-phase programs across all therapeutic areas.

This article was reprinted from Volume 22, Issue 04, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns  focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>