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. 2024 Mar 19;14(3):e075547. doi: 10.1136/bmjopen-2023-075547

Table 2.

Barriers and facilitators to increasing diversity in EPCTs

Category Barrier Facilitator
Patient factors EPCTs require intensive time commitment from trial participants, which may deter involvement None discussed
Participants may have to undertake ‘self-driven’ referrals and require the motivation and courage to initiate discussions regarding EPCTs with their clinician
  • Educate potential participants regarding the EPCTs that are available to them

  • Educate clinicians to enable them to approach and recruit participants to EPCTs

A perceived lack of transparency may result in those from underserved groups being unlikely to participate in an EPCT
  • Provide potential participants with testimonials from other participants

  • Describe the need for diversity in the EPCT to those from underserved groups and the importance of participating

It is important for participants to ask questions about the EPCT when discussing their potential participation, but participants may not ask questions, and clinicians may not encourage them, due to a lack of time
  • A list of potential questions can be given to participants to prompt them during a consultation with their doctor/clinician

There is a lack of awareness of EPCTs among underserved groups
  • Discussions around participating in an EPCT should be initiated as early as possible, ideally by the GP

  • Education to improve awareness, both for patients and clinical staff

  • Permit use of trial databases to allow participants to locate EPCTs (eg, Experimental Cancer Medicine Centres in cancer)

  • Patient advocacy groups could be established to assist in relaying information to underserved groups in a balanced manner

Those from underserved groups may have concerns around the safety of participating in an EPCT
  • Communicate the level of risk associated with the EPCT with the participant

  • Provide detailed information about what is already known about study treatment

  • Provide detail as to what is unlikely to happen to participants (eg, death, paralysis)

  • Educate patients to help improve their perception of EPCTs

Patient factors/trial design and implementation Many centres that recruit to EPCTs are located in the centre of major cities which may be challenging for certain populations to access
  • Referrals can be made from community hospitals

  • Provide reimbursement to trial participants and their carers for travel and subsistence costs

Trial design and implementation A lack of diversity in trial staff and researchers may deter participants from taking part
  • Increase the diversity of staff who undertake and run EPCTs

Eligibility criteria may inadvertently reduce the diversity of the trial sample
  • Engage with a patient or diversity representative to review eligibility criteria

Approaching underserved groups to participate in an EPCT requires extra resources
  • Additional funding and time may be required to recruit those from underserved groups

EPCT, early-phase clinical trial; GP, general practitioner.