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’.