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Janssen Clinical Innovation Challenge: Transforming (Long-Term Extension) Studies

Janssen Clinical Innovation Challenge:
Transforming (Long-Term Extension) Studies

Janssen Clinical Innovation (JCI) is a team within Janssen Research & Development, LLC, leading efforts to develop and implement new approaches to improve the clinical trial process for all stakeholders: patients, trial sites and the healthcare industry at large. To do this, we work internally and externally to find the most suitable solutions for identified challenges, pilot the solutions and where appropriate, bring them into the Janssen clinical trial practice. In this pre-Request for Proposal (pre-RFP) challenge, we invite interested companies to submit proposals to us which would help improve the conduct of clinical trials including long-term extension (LTE) studies.

For a variety of reasons, some clinical trials are designed to have a long-term extension phase which follows the primary phase of the trial.  The challenges in different studies, including LTE studies, are often the same, regardless of the treatment intervention or target population, and may include:

  • In the case of LTE, keeping study participants engaged and interested over a long period of time sometimes with little activity
  • Capturing high quality data in a way that is convenient for the participants
  • Easing the burden on the healthcare professionals involved in the study
  • Reducing the ever-increasing overall costs of research

Digital health technologies, telemedicine and novel operational models offer a great deal of promise to address these challenges. The purpose of the JCI Innovation Challenge is to seek creative approaches to help solve one or more of these challenges with the application of innovative services and technologies.

 

Innovation Opportunity  

  • Engage with JCI team  to discuss the possibility of further evolving the proposed solution(s) under a funded contract.*
  • Together with JCI, explore possible opportunities to pilot and deploy solutions into Janssen clinical trials (with further funding from the study teams).

*Potential collaborators will be required to follow Janssen’s procurement process. Any collaboration will be subject to a mutually-agreed written contract. See general terms, below, for full details

 

A typical study may look as the examples below. Rather than just an individual study, please consider a portfolio of similar studies and how your proposed solution would scale from use in a single study to being re-used in up to 10 studies over the next 5 years.

Challenge Case Study 1:

Objective: Reducing Burdens in Pediatric Long-Term Extension (LTE) Studies

Background

Fictional compound and background information, for innovation challenge purposes only.

Number of patients

̴ 90

Number of countries

̴ 10

Number of sites

̴ 55

Patient population

Pediatrics (2 to 17 years of age) transitioning from the main study (i.e. no patient/site recruitment required)

Type of study

Long-term extension (up to 4 years in duration)

Investigational product type

Biologic

Investigational product dosing

8 times a year

Additional challenge: weight-based dosing (i.e. regular subcutaneous dose may have to be adjusted based on weight and weight is assumed to fluctuate, potentially as often as from one dose to the next and there may be multiple devices to provide the relevant dose)

Total number of visits

32 (8 visits/year for 4 years)

Data collected / frequency

1. Number of participants with treatment emergent adverse events (TEAEs) and the TEAEs severity (mild, moderate, severe) (8 times/year - at each visit)

2. Number of participants with clinically significant changes in clinical laboratory tests (hematology, serum chemistry) (3 times/year, at visits 1, 4, and 7)

3. Number of participants who developed antidrug antibodies to the investigational product (8 times/year - at each visit)

Frequency of data collection

8 times/year (each visit) for Data collected items No. 1 and 3 above

3 times/year for Data collected item No. 2 above (at visit 1, visit 4, and visit 7)

Assumptions

Average percentage of drop-outs during LTE

20 percent after 1st year

Patient compliance

Data entry compliance tracked

Study sourcing

In house (outsourced in non-core countries if needed)

 

Considerations

  • How can we ease the burden of participating in the LTE for the patients and / or parents/guardians?
  • Are there opportunities for innovative ways to provide (deliver and /or administer) the relevant weight-based doses to the patients aside from coming to the study site, given that there may be multiple devices to provide the relevant dose and the need for cold-chain/temperature monitoring during the delivery to the patients?
  • Are there opportunities to generate and / or collect the necessary data via innovative ways that pose minimal burden on the patients and parents/guardians?
  • Are there opportunities to get patients and / or parents/guardians to interact with investigators remotely to assess patients’ well-being and / or disease’s progression?
  • How to develop templates, technologies and standard that can be created once and re-used in other similar studies in the portfolio? Help us understand the efficiencies during such scale-up.

 

Challenge Case Study 2:

Objective: Operationalizing a Rollover Long-Term Extension (LTE) Study (in which patients from multiple parent studies continue to be treated in one LTE program / protocol spanning multiple indications).

Background

Fictional compound and background information, for innovation challenge purposes only

Number of patients in LTE rollover (total)

1000+

Number of patients per parent study (average)

̴ 200

Number of parent studies from which patients will roll over

5+

Number of countries

̴ 15

Number of sites

̴ 250

Patient population

Adults (18+ years of age) transitioning from the parent study (i.e. no patient/site recruitment required)

Indication

Multiple indications per protocol

Type of study

Long-term extension (up to 4 years in duration)

Investigational product type

Biologic

Investigational product dosing

Per parent study, up to 8 times a year, subcutaneous injection

Total number of visits

Up to 32 (8 visits/year for 4 years)

Data collected / frequency

1. Number of participants with treatment emergent adverse events (TEAEs) and the TEAEs severity (mild, moderate, severe) (8 times/year - at each visit)

2. Number of participants with clinically significant changes in clinical laboratory tests (hematology, serum chemistry) (3 times/year, at visits 1, 4, and 7)

3. Number of participants who developed antidrug antibodies to the investigational product (8 times/year - at each visit)

Frequency of data collection

Up to 8 times/year (each visit) for Data collected items No. 1 and 3 above

3 times/year for Data collected item No. 2 above (at visit 1, visit 4, and visit 7)

Assumptions

Average percentage of drop-outs during LTE

15 percent after 1st year

Patient compliance

Data entry compliance tracked

Study sourcing

In house

Considerations

  • How could a rollover LTE ease the burden on the patients and the sites in terms of the setup and participation?
  • Operationally, how would the setup and execution of the rollover LTE differ from the setup of conducting the individual LTEs separately, with particular focus on database requirements (eCRF, lab, IWRS, ePRO, etc.) and systems (CTMS, eTMF, regulatory, etc.)?
  • How would the rollover LTE resource use differ from the resource use of conducting the individual LTEs separately? Please specify the difference in resource use in percentage terms and provide explanation for any differences. (Resource is either of the following: cost, labor, time)

 

Challenge Case Study 3:

Objective: Improving overall study experience for patients and sites while efficiently capturing high quality data.

Background

Fictional compound and background information, for competition purposes only

Number of patients

1000+

Number of countries

15+

Number of sites

55+

Patient population

Adults (18+ years of age)

Type of study

Double blind placebo controlled

Investigational product type

Biologic

Investigational product dosing

8 times a year

Total number of visits

32 (8 visits/year for 4 years)

Data collected / frequency

Various safety data

Various efficacy data

Various PROs

Active and passive capture of data via biosensors, speech and other such tools

Considerations

  • How can we ease the burden of participating in the study for the patients and / or caregivers?
  • Are there opportunities to generate necessary data via innovative ways that pose minimal burden on the patients and / or caregivers?
  • Are there opportunities for innovative ways to provide (deliver and /or administer) the medicine to patients aside from coming to the study site, given the need for cold-chain/temperature monitoring during the delivery to the patients?
  • Are there opportunities to get patients / caregivers to interact with investigators remotely to assess patients’ well-being and / or disease’s progression?
  • How to best integrate various data streams in near real-time to assist in timely decision making, safety monitoring and overall coordination of study workflow?

 

What to focus on:

We are looking for innovators with the best ideas (big or small) for services, technologies, or solutions to operationalize the above Case Studies as efficiently and resource (cost, labor, time)-effectively as possible, with particular focus on the following:

1. Novel operational models

  • Virtual trial methods
  • Innovative ways of delivering / distributing the investigational product and all related trial supplies to patients globally
  • Use of telemedicine to facilitate remote eVisits

2. Data capture

  • How can we most efficiently capture trial-generated data, including lab data
  • Role of connected health sensors

3. Participant engagement

  • How do we best keep participants informed and engaged, particularly during the long-term extension phase
  • Participant-facing technology solutions
  • Participant-facing services

4. Engaging the local / community healthcare professionals

  • What roles can local HCPs, community clinics, etc. have in the LTE process?

5. Cost effectiveness

  • Define the business case – what efficiencies and cost savings can we achieve with the proposed new methods vs. standard practice?

Your submission does not need to address all of the challenges described here. We are also interested in best-in-class solutions to solve parts of the case studies, not just all-encompassing concepts. Ideally, your submission would offer solutions to at least two of the case studies presented.

Timeline 

Proposals Open
    Now

Submission Deadline
    September 30, 2018

Partners Shortlisted for F2F* Presentations
    October 8, 2018

F2F* Presentations In Barcelona, Spain
    October 18, 2018

Winner(s) selected
    November 30, 2018

*Remote/web presentations can be accommodated

 

Application process

A panel of reviewers will evaluate proposals based on their ability to meet the following criteria:

  • Number of case studies for which solutions are provided
  • Scientific/technical excellence
  • Feasibility/practicality, with particular emphasis on:
    • Global reach / capabilities (including Help Desk accessibility in all relevant languages and translation of patient-facing documents)
    • Global data transmitting capabilities, including in regions where data-transmission coverage may be challenging
  • Perceived impact
  • Clarity on milestones and deliverables
    • Quality of team and resources
    • Budget estimation of case studies for which solutions are provided

Deadline to apply is September 30, 2018

Before submitting your proposal, please review the guidelines for submissions, including the general terms.

By submitting the requested information (“Proposal”) as part of this challenge, you on behalf of yourself and/or your company (“Applicant”) agree to abide by these Application Terms.

You also agree that the personal information you provide Janssen R&D LLC as part of your proposal will only be used to evaluate your submission and further contact you. This information may be shared with representatives of Janssen R&D LLC affiliates for review purposes.

If you submit any personal information about yourself or relating to another individual to us, you represent that you have the authority to do so and to permit us to use the information in accordance with the applicable Privacy Policy for your country/region.

If you wish to access, correct or delete your personal information or wish to withdraw your request you can do so by contacting: [email protected]

You agree that by contacting our submission mailbox, you consent to the transfer of your information to countries outside of your country of residence, including the United States, which may provide for different data protection rules than in your country. You may withdraw your consent at any time.  

Apply Now! Proposals or questions can be sent by email to
[email protected]