Clinical Trial Design
And Recruitment

2. Full patient relevance review of the development plan and trial design

3. Gap analysis emphasizing patient-relevant aspects via online survey and interviews with patient experts

4. Discuss and challenge recruitment & retention strategy

5. Share findings with the client’s internal team along the way

This results in a highly patient-relevant trial design regarding HTA and clinical outcomes that captures patient needs and preferences for efficient recruiting and retention.

Decentralized clinical trials are here to stay and admedicum has experience in conducting patient advisory boards and focus groups to define the balance of decentralized clinical trials for different patient populations.

Both aspects are often negatively influenced by the logistics of the trial and frequent visits to the investigator’s site, which disrupt a normal routine or work.

Those logistical challenges and the COVID pandemic have led to a rise in decentralized clinical trials. Patient involvement in the clinical trial design is therefore highly recommended and has become common practice in the industry.

Evidence for patient engagement in clinical trials

How to Guide on Patient Engagement in Clinical Trial Design by PFMD

The DIA Patient Engagement Study reported reduced screen failure rates, faster patient recruitment rates, improved subject retention rates, reduced numbers of protocol amendments, and a greater number of patient-relevant endpoints as positive aspects of patient involvement.

The FDA Executive Summary Patient Engagement Advisory Committee leads you to further publications and materials that give guidance regarding patient involvement related to clinical trials.

The Tufts Center for Drug Development Impact Report reported that 57% of all protocols, across all phases, have at least one substantial global amendment. The most frequent changes stem from amendments associated with modifications and revisions to study volunteer demographics and eligibility criteria. Based on the additional time and costs, it seems more cost-efficient to reduce amendments by involving patients early on in the trial design and protocol discussions.

EUPATI’s article on collaboration in an oncology trial shows another good case study for insightful involvement of patients in an oncology trial by Sanofi in France.

The Patient Focused Medicines Development created a Patient Engagement Management Suite which acts as a global hub for practical tools to plan, assess and execute any patient engagement initiative.

The US-based Clinical Trials Transformation Initiative (CTTI) has also developed some useful tools:

CTTI Recruitment Tool Decision Tree for Optimizing Protocol Design provides a checklist that helps you to define “when” to involve other stakeholders.

CTTI Recruitment Tool helps you to prepare a strategy regarding which stakeholders to approach and for what reasons.

Keep in mind that stakeholder involvement means really giving patients a chance to understand and express themselves, rather than guessing what a minimally burdensome trial design is.

The patient knows best

Involving patients in clinical trial planning yields many opportunities beyond successful patient recruitment and retention alone. Examples of involving patients in clinical trials include the critical review of primary and secondary clinical trial endpoints, patient-reported outcomes, and the patient view on benefit-risk assessment. However, all of this requires resources, time, and budget. Therefore getting senior management buy-in early on is a key to success to increase enrollment in clinical trials.

Communicating to clinical trial participants

Remember that although there is an obligation to publish your clinical trial, this does not provide individual trial participants with information regarding “their” participation in the clinical trial. Please don’t forget the patient experts you worked with, once the collaboration comes to an end.

Prepare final reports containing information regarding what suggestions will be implemented, which ones will not, and provide reasons why. It is good to have agreement on feedback to involved patient experts before the clinical trial begins. And again, patient experts and investigators can probably tell you best what they would like to know from this exercise.

What aspects need to be addressed for optimal clinical trial recruitment?

• Patient burden
• Unnecessary long travel times for patients due to site locations
• Unnecessary long duration of study visits or study visits too frequent

Can any of these be replaced with remote clinical trial elements?

• Recruitment strategy
• Lack of awareness creation using all available channels (including landing pages, social media outreach, cross-border involvement, etc)
• Insufficient patient companion services
• Study design
• No reality check whether the patient truly exists (per in/exclusion criteria)?
• Unnecessary or suboptimally organized (practical/logistical) study procedures
• Patient communication
• Sub-optimal layman / patient-friendly and fully understandable information prior (to recruit), during (to retain), and after the clinical trial (to endorse)