Clinical Trials

The Clinical Trials dossier is designed help clinical teams within pharmaceutical companies make better decisions faster. The resources in this dossier are structured like an FAQ page, addressing questions that Medical Directors, Clinical Trials Stakeholders, and other decision makers may ask. Each question is addressed with a selection of bespoke, fit-for-purpose checklists and discussion guides, timelines, links to relevant slides in The Playbook, relevant FDA guidance, publications, and other useful resources.

The objectives of these resources are to:

  • Support the implementation of digital clinical measures into clinical trials by creating additional ‘how to’ resources
  • Overcome common sources of fear, uncertainty, and doubt that can hold clinical trials teams back
Study Design FAQ Landscape

We’ve mapped the most common FAQs in clinical trials with the order in which they should be asked and answered, and in line with clinical trials chronology. Each FAQ is also tagged with who needs to be involved in the conversation to ensure a good decision. Download here.

How will this endpoint benefit our trial?

The resources below will help you answer this question. Download here.

View relevant Micro-Playbook.

Can this digital endpoint be suitable for label inclusion?

The resources below will help you answer this question. Download here.

Patient Focused Drug Development Guidance 3 public workshop discussion documents:

  • Discussion Document. Download here.
  • Discussion Document – Appendices. Download here.
  • Walton et al. (2020). View here.

Also, see Measurement dossier here.

What is the level of regulatory acceptance of this digital endpoint?

The resources below will help you answer this question. Download here.

Another useful resource is DiMe’s library of digital endpoints currently being used in industry sponsored trials of new medical products. View here.

Are our peers and/or competitors doing it?

DiMe’s library of digital endpoints tracked digital endpoints being used in industry sponsored trials of new medical products. View here.

Do we need a 510(k) clearance to use this digital sensing product?

The resource below will help you answer this question. Download here.

Is this digital clinical measure validated?

The resources below will help you answer this question. Download here.

Other resources:

  • Micro-Playbook. View here.
  • CTTI Library of Feasibility Studies to reference validation studies for your measure. View here.
How does this clinical digital measure affect other development activities for this drug?

The resource below will help you answer this question. Download here.

What additional infrastructure is needed to support deployment of this digital clinical measure?

The resources below will help you answer this question. Download here.

View relevant Micro-Playbook here.

How will this affect our data management structure?

The resources below will help you answer this question. Download here.

View relevant slide from The Playbook here.

What operational considerations do I need to keep in mind during technology selection?

The resources below will help you answer this question. Download here.

View Micro-Playbook here.

How do we get patient input so we can select the right digital sensing product?

The resources below will help you answer this question. Download here.

Patient focused drug development guidance (FDA). View here.

Who is responsible for what in the pharma / vendor relationship?

The resource below will help you answer this question. Download here.

How do I successfully implement this connected sensor product into my trial?

The resources below will help you answer this question. Download here.

View Micro-Playbook here.

How do I pick the right connected sensor technology for my needs that also meets the patients’ needs?

The resources below will help you answer this question. Download here.

View Micro-Playbook here.

How do I fit this into my overall trial timeline?

The resources below will help you answer this question. Download here.

View Micro-Playbook here.

How do I ensure this is logistically feasible in my region?

The resource below will help you answer this question. Download here.

How do I approach vendor onboarding?

The resource below will help you answer this question. Download here.

Does the data output from the digital sensing product meet the needs of our data management and biostats teams?

The resource below will help you answer this question. Download here.

How can I minimize the risk of delaying the trial timeline?

The resource below will help you answer this question. Download here.

What red flags could be raised to regulators?

The resources below will help you answer this question. Download here.

Other resources:

Regulatory Proof Points in the Pharma Exec dossier. View here.

Will this make it harder to enroll or retain diverse participants?

The resource below will help you answer this question. Download here.

Will this cause confusion/frustration at the clinical sites?

The resource below will help you answer this question. Download here.

Who is going to support questions the study participants may have on how to use the digital sensing product?

The resources below will help you answer this question. Download here.

View Micro-Playbook here.

How can we minimize patient and site burden?

The resource below will help you answer this question. Download here.

Event Panel: How the heck do I get this to work in my clinical trial?

ICYMI Listen to the panel of experts from this Tour of Duty who collaborated to create the resources in this Dossier as they share their perspectives on the challenges and the opportunities to advance the use of digital clinical measures (excerpted from our launch event on April 30, 2021).