Audience Key The icons below appear throughout the manual and are intended to highlight specific sections that are most useful for readers as it relates to their role in the clinical trial process .
Sponsor Contract Research Organization ( CRO )
Multi-center study Single-center study
Describing the Participant Journey
In broad terms , the participant journey refers to the process by which an individual navigates a health care system or systems . Mapping this journey is a helpful way to gain insights into the areas where services are provided successfully and where this could be improved . The ethos of clinical trial design is increasingly embedded in patient centricity , and journey mapping has become an important tool that designers of clinical trials can draw upon to better understand how they are meeting the needs of their participants , and where there are gaps . Ultimately , this tool helps improve the design , planning and implementation of research studies . Key components of a participant journey in the context of clinical research participation include :
+ + Goals : an individual ’ s motivations or the health outcomes they hope to achieve . For example :
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Motivations : altruism , speed a cure for Parkinson ’ s disease , advance research , help a loved one
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Health outcomes : desire for a better delivery mechanism for medication , wanting to improve the quality of the daily lived experience , or wanting to experience fewer motor or non-motor symptoms
+ + Off-ramps : challenges that may prevent individuals from achieving their goals and prompt them to exit the roadmap of clinical research participation . For example :
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Not hearing back from clinical trial teams ; not being able to attend appointments on weekends or after work hours ; not being provided educational materials in comprehensible / lay terms ; not having transportation to and from appointments ; not having materials translated into an individual ’ s native language ; not being able to take regular medications while participating in a trial or study
+ + Touchpoints : encounters that an individual may have with an organization throughout the participant journey , including both advertisements and human interactions . For example :
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Viewing a clinical trial posting on Fox Trial Finder ( foxtrialfinder . org ); calling a toll-free telephone number and speaking with a clinical trial coordinator ; checking in with a receptionist at the clinic ; meeting the study principal investigator or coordinator for the first time
Identifying and Engaging Key Stakeholders
Key stakeholders are individuals and organizations that have an interest in or are affected by your clinical trial and its results . 3 It is important to bring key stakeholders into the clinical trial design process as early as possible , as they can provide insights on participant or site goals , and potential off-ramps and touchpoints throughout the clinical trial process . In addition to study sponsors , key stakeholders that should be involved in the design process include :
+ + Trial team representatives : individuals who represent the clinical trial sites implementing your study . To identify these representatives , start by making a list of the characteristics or infrastructure required for successful study implementation ( e . g ., access to the target population , support group connections , partnership with a clinic ). Then reach out to institutions that have those characteristics and gauge their interest in consulting on your protocol as part of a key stakeholder working group . One or two individuals from each institution should be invited to participate as part of a study working group and may include :
–Principal – Investigator –Study – Coordinator
3 https :// www . cdc . gov / std / Program / pupestd / Identifyingpercent20andpercent20Determiningpercent20Stakeholders . pdf
4 Accelerating Clinical Trials : Best Practices for Recruitment and Retention