Clinical Trial Design
And Recruitment

1. We work closely with patient representatives who have HTA experience to review the target product profile of the client’s asset.

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

3. Gap analysis with emphasis on patient-relevant aspects via an online survey and interviews with patient experts

4. Discussion and review of recruitment and retention strategy

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

This results in a highly patient-relevant study design in terms of HTA and clinical outcomes, which captures patient needs and preferences for efficient recruitment and retention.

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

The FDA hosts Patient Listening Sessions where patients and their advocates can share their experiences and perspectives with FDA staff. EMA published a case study scientific paper in 2022 on The Added Value of Patient Engagement in Early Dialogue at EMA.

Recruitment and retention are often negatively influenced by the logistics of the trial and frequent visits to the investigator’s site, which disrupt a patient’s 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 on the benefit of patient engagement in clinical trials

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 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.

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

PCORI offers a free training package called Research Fundamentals to help people understand and participate in patient-centered outcomes research.

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.

CISCRIP provides clinical trial resources including brochures, videos, and webinars including on important topics like The Importance of Diversity in Clinical Trials.

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 the design of clinical trials offers many opportunities beyond successful patient recruitment and retention. Examples of patient involvement in clinical trials include critical review of primary and secondary clinical trial endpoints, patient-reported outcomes, and the patient’s perspective on benefit-risk assessment. However, all of this requires resources, time and budget. Getting early buy-in from senior management is key to increasing 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 about “their” participation in the clinical trial. Don’t forget the patient experts you worked with when the collaboration is over.

Prepare final reports that include information on which suggestions will be implemented, which will not, and why. It is a good idea to agree on feedback to the patient experts involved before the clinical trial begins. Again, the patient experts and investigators will probably be able to tell you best what they would like to know from this exercise.

• Slow patient enrollment in clinical trials remains one of the key hurdles to tackle in clinical development.
• The reality is that unnecessary high patient burden, suboptimal study design, inadequate recruitment strategies and below average patient communication are all contributing factors.
• By listening to patients, learning from patients and co-creating with patients during the clinical trial lifecycle you can make a difference!

• patient2site was developed to enhance patient enrollment in clinical trials using state-of-the-art technology combined with personal contact with the patients at all times.

patient2site: Enhancing Patient Enrolment in Clinical Trials

patient2site is our patient recruitment solution that combines technology with unmatched patient engagement services to create successful patient recruitment strategies, trial awareness, and boosted enrollment. Contact us today to start the discussion to increase enrollment in your clinical trials.

Key differentiators:

• Developed and implemented by patient engagement experts together with patients
• GCP / FDA & IT-Security compliant online recruitment process & technology
• Turns around standard recruitment workflow and puts patients in the driver seat
• Modular set-up which makes it ideally suited to rescue patient recruitment in slow recruiting studies
• Continuous optimization process to achieve the best potential for clinical trial recruitment
• Embedded  in our full suite of patient engagement services to provide a holistic approach on involving patients in drug development
• Increase diversity in clinical trials by offering a low barrier to entry for patients to contact the clinical trial team