Rescuing clinical trials
By following a procedure of analysis, planning,
execution and closure, a newly appointed contract
research organisation can turn around a failing
clinical trial.
Clinical trials are complex and must be well
performed under
GCP to ensure a successful outcome. GCP demands
satisfactory standards for design, conduct, performance,
monitoring, auditing, recording, analysis and
reporting, providing
assurance that the final data are credible and
accurate, and that the
rights, safety and well-being of trial subjects
are protected.
Poor performance can kill a clinical trial. Typical
deficiencies include
unsatisfactory trial-site placement, site management,
monitoring, data
management and contractual requirements. Successful
trials also need
realistic timelines, adequate resources, and maintaining
trust between
sponsor, contract research organisation (CRO)
and trial investigators.
To save a trial, a sponsor may be forced to appoint
another CRO, such
as Harrison Clinical Research (HCR). Trial rescue
proceeds with:
- Review and analysis. Sponsor and former
CRO provide
guidance to what did and did not previously
work. Critical
areas must be identified, analysed and potential
solutions
offered. HCR must respond rapidly and sensitively,
and be
flexible in preparing an action plan.
- Planning. Trial documentation from
former CRO is transferred to HCR project manager;
project management, recruitment, risk management
and training plans may need to be adapted. Recruitment
barriers have to be resolved with a detailed
transition plan. A standard operating procedure
(SOP) outlining these steps ensures that procedures
are consistent during the take-over process.
An accurate cost proposal to the sponsor is
key to further success; costs will be impacted
by trial stage, notably: status IRB/EC/regulatory
authority submissions; regulatory authority
requirements delaying trial start; status investigator
contracts; subject recruitment rate; status
monitoring; proportion data already entered
on database and status data cleaning.
- Execution and controlling. Sponsor
communicates change
of CRO to investigational sites. Execution is
facilitated by the
project manager who links each site with the
sponsor and
CRO, assists in decision making, and ensures
the agreed
deliverables are met in terms of scope, cost
and quality. HCR has identified critical success factors in rescuing
clinical trials:
- Cooperation with investigational sites
specialised in
relevant indication means faster recruitment.
- Long-standing relationship with IRB/EC/regulatory
authority plus intimate knowledge of contractual
requirements at trial site means quicker
study set-up.
- Experience in managing large trials in
relevant indication
means efficient use of time and resources.
- Highly experienced CRAs means positive
audits and
database lock to agreed timelines.
- Closure and completion. The ability
of a target-oriented
team to meet the transition challenges and execute
the action
plan enables successful completion and closure
of trial sites.
When rescuing a clinical trial HCR adopts a strategy
that begins
with meeting the sponsor, sharing and understanding
the expected
deliverables and outputs, and building a basis
for trust and effective
teamwork. Rescuing trials successfully offers
learning experiences for
both the sponsor and CRO and a sound basis for
performing clinical
trials well in the future. A trusting collaboration
is better prepared to
deliver ‘right first time’.
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Company profile
Harrison Clinical Research
For further information, visit: www.harrisonclinical.com
Tel: +49 89 126 6800
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