DECENTRALISED TRIALSBEST PRACTICE EVALUATION

Version 1March 2022

The DTRA Best Practice Rubric
The DTRA Best Practices Evaluation Rubric provides a consistent framework by which DCT(Decentralised Clinical Trials ) practices may be evaluated, in order to determine whether
they may be considered a ‘best practice’. Best practices will be organized across the trial
lifecycle:
Programme Planning | Trial Planning | Trial Set-up| Trial Conduct| Trial Close Analysis
Best practices are not intended to be explicit instructions for use. Instead, practices will aid
DCT stakeholders as they interpret and apply to their circumstances. The rubric dimensions
are interrelated and need to be considered holistically.

ProgrammePlanning
TrialPlanning
Trial Set-Up &Launch
Trial Conduct
Trial Close

To be considered a “best practice” all expectations of the rubric should be met.

1. EVIDENCE OF SUCCESSBEST PRACTICE RUBRICBest practices should have measurable and demonstrable success. This dimension isintended to consider whether there is a track record of successful outcomes from theuse of the practice, that can be examined. KPIs and tangible outcomes are at the heartof evaluating best practices for DCT.

2. IMPROVING PATIENT EXPERIENCE
DCT at their core should address the needs of patients, caregivers and therapeuticexperts. Uplifting the experience and engagement with these key stakeholder groups
should be demonstrable as a driving consideration for DCT best practices.

3. SITE IMPACT
Sites will have a continuing importance for DCT. The impact on sites should beconsidered with any new practice, including the practical implications of adoption andchange from todays working practices to increasing DCT.

4. OPERATIONAL AND TECHNICAL FEASIBILITY
DCT practices will often involve the use of new operational processes and technologies.
This dimension is intended to ensure that operational and technical aspects have been
considered fully, for ongoing support, resilience, security, integrity, scaling and reuse.

5. REGULATORY & ETHICAL COMPLIANCE
Best practices should appropriately consider global & local regulations and guidance. In
doing so they should also adhere to appropriate privacy, consent and sharing
guidelines, protect those stakeholders providing sensitive or personal data withsafeguards to ensure ethical safety and compliance for patients and care givers.

DECENTRALISED TRIALSBEST PRACTICE EVALUATION

Version 1
March 2022

1. EVIDENCE OF SUCCESSBest practices should have measurable and demonstrable success. This dimension
is intended to consider whether there is a track record of successful outcomes fromthe use of the practice, that can be examined. An unambiguous demonstration ofKPIs and tangible outcomes is at the heart of evaluating best practices for DCT.

CONSIDERATIONS AND GUIDANCE
The practice should demonstrate…

Guidance notes

The appropriate 'level' of detail inalignment with DTRA expectations

Reference DTRA Best Practices evaluation form. A template‘best practice’ has been documented, including the:qBest practice in the form of a checklist questionnaireqAdditional context regarding the best practice (e.g. whyshould it be considered a best practice, what is the value
to Sponsor / site / patients)q
Relevant case study in which the proposed best practice
was used

Availability of case studies whereby thepractice has been successfully
demonstrated

How was success measured?
q Consider both qualitative and / or quantitative values thatwere captured from successful implementation of the
proposed practiceq Consider size, relevance and future reuse of the selectedcase studies

Relevance to sponsors who aredeveloping new treatments, digital
therapeutics and devices

q Consider whether the scope of practices will be relevant to
new drug development, rather than generics, etc..
q Future recommendations may expand to include bestpractices for other organizations (e.g. sites, patients).

A breadth of applicability that isrelevant to drug development across all
study phases

q If proposed practices are overly specific to an individualphase, the relevance to the DTRA community will bediminished.

DECENTRALISED TRIALSBEST PRACTICE EVALUATION

Version 1March 2022

2. IMPROVING PATIENT EXPERIENCE
DCT at their core should address the needs of patients, caregivers and therapeuticexperts. Uplifting the experience and engagement with these key stakeholder
groups should be demonstrable as a driving consideration for DCT best practices.

CONSIDERATIONS AND GUIDANCE
The practice should demonstrate…

Guidance notes

The opportunity to reduce the numberof physical assessments and/or physicalsite visits and reduce the burden ofparticipation, whilst maintaining highrates of trial activity adherenceq Reduction of physical visits to the hospital can be a key
driver here, but it should be kept in mind that somepatients will prefer the hyper-care of a physical trial setting.
q Patient optionality is key to truly minimizing the burden ofparticipation.

Evidence of positive feedback from key
stakeholders.

q DCT practices are evaluated and receive positive approval
from stakeholders including Patient/Caregiver
Advocacy/Therapeutic experts.
q Teams should recognize that some patients may notconsider a DCT an optimal trial experience (e.g. patients forwhom the hyper-care of a clinical trial is desirable).
q Patient experience feedback and data should be collected
early and often throughout the trial

That patients are empowered withgreater access to information about thetrial, the schedule of events and theirrole in the conduct of the trial

q Supporting patients not only improves their experience, itenhances their ability to drive the desired study datacollection and compliance thus meeting the primary goalsof the study.
q Technology should employ design principles to allow datacollection (e.g. push notifications and reminders).
q Explain how technology has been leveraged to ensure
patients will have greater access to ad-hoc, remoteengagements with the site team

A seamless interaction with patient’s
ordinary care routine, whereverpossibleq Features are implemented in such a way that datacollection is integrated within patient’s daily routine (e.g.
application reminders, triggers, etc.).

The capacity to increase the diversity ofpatients recruitedq Diversity of patient populations (including age, gender,ethnicity, race) is a prime potential benefit of DCTs. Steps
should be taken to ensure trial design and recruitment
strategy provides enhanced opportunities for diverse
patient participation.
q IMPORTANT: Decentralization can also introduce a new
type of bias, towards adherent/motivated/technologicallyliterate patients. Steps should be taken to avoid this bias
wherever possible

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3. SITE IMPACT
Sites will have a continuing importance for DCT. The impact on sites should beconsidered with any new practice, including the practical implications of adoption
and change from today’s working practices to increasing DCT.

CONSIDERATIONS AND GUIDANCE
The practice should demonstrate…

Guidance notes

A net reduction in burden for bothpatients and sites

q Burden may increase in some areas and decrease in others.
Capture the details of this change.
q Easy to use systems, single platforms and access acrosssystems where possible.
q Reduce data entry redundances while supporting a single
point of source documentation.
q Reduce CRO Site Management time, CRA time on site, time
to issue resolution.
q increase risk-based monitoring without sacrificing patient
safety or data integrity.
q Trigger corrective action to data queries, non-compliance,
and issue identification early and resolve/re-train site
quickly.
q Reduced sponsor contacts across studies and disciplines.

Strong site compliance with minimal
training and support

q Technology should be simple to use, intuitive and require
minimal training
q If training is necessary, then it should be available "ondemand" through the life of the studyq Technical support from Helpdesks and protocol support
from CRAs in local language

High engagement and adoption levels
across sites.

q Sites are not defaulting back to traditional methods
q Measure and demonstrate improved uptake of newprocesses with visibility of the patient flow
q Operational performance by Sites includes, but is not
limited to, compliance with protocol, regulations, patient
safety, data quality and data integrity
q Demonstrate the benefits of improved engagement (e.g.
recruitment and retention) including site engagement andfeedback around operational and feasibility

Improved site staff experience andunderstanding of the benefits

q Positive experience working on DCTs vs traditional clinical
trials, demonstrated through feedback from stakeholders.

Clarity of the fiduciary responsibility toSites for clinical trial work using DCT

q Site Budgets should account for additional resources
required for sites to support DCT.
q Considerations may need to be made for referrals to/from
PI where Primary Care Doctor refers a patient and/or wherePI refers a patient to a virtual site if used.
q Payment considerations for example with regard toincrease remote SIV, site management call or remote
IMV/COV payments due to more SC time on calls.

DECENTRALISED TRIALSBEST PRACTICE EVALUATION

Version 1March 20224. OPERATIONAL AND TECHNICAL FEASIBILITY
DCT practices will often involve the use of new operational processes andtechnologies. This dimension is intended to ensure that operational and technicalaspects have been considered fully, for ongoing support, resilience, security,integrity, scaling and reuse.

CONSIDERATIONS AND GUIDANCE
The practice should demonstrate…

Guidance notes

A clear problem statement, addressing
specific challenges or needs, developed
during Programme Planning.

q Is the problem clearly defined? E.g.
o Reduce Patient/Caregiver burdeno Increase/Ensure Patient Safetyo Increase Patient Retention/Reduce Drop-Out
o Improve Data Quality/Integrityo Reduce/Eliminate manual entry/human error
q Identify all stakeholders who can help solve the problem(e.g., Vendor collaboration is key to risk/benefit analysis
with coordination of all DCT capabilities/services)?

A thoroughly defined strategy, including q Include only what is required, and:solutions to specific challenges oro Mitigate risks of both operational and technicalneeds, has been developed during Trial
challenges when considering multiple solutions
Planning.
o Align with data privacy guidance and data security
at the local country and site level (see dimension 5)
o Ensure blinding/unblinding requirements will not be
impacted by the solution(s)q Keep the end in mind and takes a holistic approach to DCTsolutions
q Ensure the solution is fit for use for the patient populationand does not require patients to have their own devices
and hardware in order to participate?
An implementation plan has beencreated and followed through Trial Setup and Launchq Document the Study Build Plan and Launch Plan
q Collaboratively modify the plans as neededq Ensure all stakeholders are aligned with the plan

Controlled delivery throughout Trial
Conduct phase with suitable tracking
and measuresq Document Roles/Responsibilities.
q Document how to measure performance and/orcompliance (Patient, Site, Vendor).
q Track issues and trends, improvements

Trial Close requirements have been
considered to allow for continualimprovement.

q Analyse operational data to assess evidence of impact anddefine future improvements.
q Analyse site and patient survey data to understandexperience and ID future improvements.
q Site survey / feedback process is built into the trialdeployment plan, including questions on implementation /
integration with other systems, ease of use, time to train,
troubleshooting / helpdesk experience and NPS score.

DECENTRALISED TRIALSBEST PRACTICE EVALUATION

Version 1March 2022

5. REGULATORY & ETHICAL COMPLIANCE
Best practices should appropriately consider global & local regulations and guidance. In
doing so they should also adhere to appropriate privacy, consent and sharing
guidelines, protect those stakeholders providing sensitive or personal data withsafeguards to ensure ethical safety and compliance for patients and care givers.

CONSIDERATIONS AND GUIDANCE
The practice should demonstrate…

Guidance notes

Local health authority vetting andacceptance compliance in the region
where it will be utilizedRegulatory Resources:
q Global Regulatory Authority Websites by Region

Compliance with relevant HealthAuthority and International guidance
and regulatory requirements

Aligns with all ICH guidelines with main focus on efficacy:q ICH E6-Guideline For Good Clinical Practiceq ICH E8-General Considerations For Clinical Trials

Consideration and alignment with any
applicable privacy laws

For example, check, verify and prove that the practice does
not contravene security rules
q (e.g., HIPAA)
q Aligns with GDPR guidelines
q Aligns with relevant study protocols and subject safety

That it does not lead to additionalburden to key stakeholders

Consider specific users
q any effect on efficiency or usefulness to the wider audience
including but not limited to site staff, patient/subject,sponsor/CRO, ethics committees, vendors, etc.?
q Determine level of burden and whether it will lead to safetyconcerns,
q Consider inefficiencies preventing any of the listed group's
ability to complete deliverables.