Recruitment to clinical trials
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Recruitment to Clinical Trials:. What are the Strategies for Success?. Adwoa Hughes-Morley. How easy is it to recruit to clinical trials?. Across all contexts (McDonald et al, 2006) 53% of trials are awarded an extension 45% recruit less than 80% of their target

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Recruitment to clinical trials

Recruitment to Clinical Trials:

What are the Strategies for Success?

Adwoa Hughes-Morley


How easy is it to recruit to clinical trials

How easy is it to recruit to clinical trials?

  • Across all contexts (McDonald et al, 2006)

    • 53% of trials are awarded an extension

    • 45% recruit less than 80% of their target

    • 31% of trials recruit successfully

  • In the pharmaceutical sector (Barnes, 2006)

    • 80% of all trials fail to meet their recruitment target

  • In primary care (Bower et al, 2007)

    • 29% recruit according to schedule

  • We don’t know about the scale of the problem for mental health trials


Consequences of under recruitment

Consequences of under recruitment

  • Unrepresentative sample = lack of external validity

  • Reduction of statistical power = increased probability of type II error

  • Inhibits the development of reliable evidence and delays adoption of effective interventions.

  • Costly

  • Is it ethical?


Barriers to recruitment spaar et al 2009

SYSTEM RELATED

Lack of study staff

Multi-centre trials

Inexperienced/inefficient governance bodies

Availability of the intervention

INDIVIDUAL

Treatment preferences of health care providers

Patient aversion to randomisation

Barriers to recruitment (Spaar et al, 2009)

TRIAL-DESIGN-RELATED

  • Doubted scientific rationale of trial question

  • Doubted relevance of the trial question

  • Complexity of the trial

  • Restrictive eligibility criteria


Strategies used to improve recruitment to rcts treweek et al 2010

Open RCT versus blinded RCT

Placebo versus other comparator

Other change to trial design versus conventional RCT design

Modification to the consent form or process

Opt-out consent versus opt-in consent

Consent to experimental care versus usual consent

Consent to standard care versus usual consent

Refusers choose treatment versus usual consent

Physician modified consent versus usual consent

Participant modified consent versus usual consent

Financial incentives for participants

Telephone reminders

Modification to the training given to recruiters

Greater contact between trial coordinator and trial sites

9. Modification to the approach made to potential participants

Educational video versus standard information

Educational video with written information versus written information

Telephone screening versus face-to-face screening

Enhanced recruitment package versus standard recruitment package

Enhanced recruitment package with baseline data collected by telephone versus standard recruitment

package

Enhanced recruitment package with recruitment at churches versus standard recruitment package

Clinical trial booklet with standard information versus standard information

Home safety questionnaire with trial invitation versus trial invitation

Positive framing of side effects versus neutral framing

Negative framing of side effects versus neutral framing

Interactive computer presentation of trial information versus audio-taped presentation

Writing treatment effect is 'twice as fast' in trial information versus writing 'half as fast'

Total information disclosure versus standard disclosure

Electronic completion of screening questionnaire versus standard paper completion

Oral completion of screening questionnaire versus standard paper completion

Strategies used to improve recruitment to RCTs(Treweek et al, 2010)


Which recruitment methods have evidence of effectiveness

Which recruitment methods have evidence of effectiveness?

  • Telephone reminders to non-responders (Nystuen 2004)

  • Opt-out procedures requiring potential participants to contact the trial team if they do not want to be contacted about a trial (Trevena 2006)]

  • Open label trials rather than blinded (Avenell 2004; Hemminki 2004)


Cadet recruitment

CADET Recruitment


Acudep trial

ACUDep Trial


Why was recruitment in these trials successful

Why was recruitment in these trials Successful?

  • GP practice database searches

  • Broad inclusion criteria

  • Simple study procedures

    • (assessments not lasting more than 1.5hours)

  • Identifying problems early through close monitoring

  • Compensating for under-recruitment, by over-recruiting elsewhere

  • Telephone follow ups (CADET)

  • The MHRN and PCRN involvement

  • Ensuring adequate therapist capacity


Barriers to recruitment in your trials

SYSTEM RELATED

INDIVIDUAL

Barriers to recruitment in your trials

TRIAL-DESIGN-RELATED


Recruitment to clinical trials

Adwoa Hughes-Morley

[email protected]

01392 725794

Mood Disorders Centre

University of Exeter, Washington Singer Laboratories, Exeter, EX4 4QG.


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