In the majority of cases, if a clinical study needs to be rescued, the root of the failure is people-related, such as inefficient communication and relationship between sponsors, sites and CROs, lack of patient education, awareness and engagement.
The aftermaths of these problems may appear on any stage of a clinical trial in such forms as falling significantly behind the enrollment plan or CROs failing to deliver results.
Issues involved may be related to data quality, site activation or any other performance malfunction. Furthermore, these issues may occur in outsourced as well as in-house studies.
Troubled study reasons
Here are some reasons for rescue situations that are typical for in-house studies whether or not they involve a CRO:
- overoptimistic upfront approach with insufficient time spent on planning
- rushed timelines for everyone to operate under
- no or insufficient analysis of previous experience in order to learn lessons from it
- overly complex protocols
- no clear coordination of responsibilities among those engaged in interaction with the site(s)
- lack of coordination across involved vendors.
The absence of adequate support, resources or training from sponsor may become the reason for sites to get quickly frustrated and overwhelmed by being hounded by different sponsor representatives with numerous requests, while at the same time their own questions remain unaddressed for a long time. Such disaccord may lead to the site(s) shutting down. This in turn shatters dramatically the study implementation, whereas being proactive in those areas may avert a rescue situation.
Checklist of questions for any clinical study stakeholder to ask themselves:
- Are CRO’s and sponsor’s expectations harmonized and synchronized with regard to key potential risk areas in the trial such as quality risks, enrollment, compliance and the like.
- Can the sponsor be reached with any potential issues before the latter aggravate?
- Do CRO’s processes allow to communicate issues to the sponsor, or is he supposed to discover them on his own?
- Are there any specific performance thresholds and metrics to be used in managing and monitoring involved risks?
- Do parties know the exact expectations for the roles they are to play in the risk management process?
When clearly defined and agreed upon in timely manner (upfront), these aspects make the collaboration process seamless and effective for all key stakeholders.
Steps sponsors can make to keep the study on track and safe from rescue measures
To define the acceptable ranges of CRO and sponsor operations, there should be KPIs (key performance indicators) to track, manage and evaluate crucial processes and responsibilities. For instance, setting KPIs on the initial stages of the recruitment process may increase the problem visibility and help detect them early.
Root cause analysis
Upon the appearance of any indications of things getting off track, a deep, root analysis of reasons should be performed prior to taking any measures to treat symptoms. For instance, when your enrollment is falling behind, if you rush to add additional sites and/or hire additional patient recruitment service providers without analyzing the root causes of the problem, the solutions applied are unlikely to have the desired effect.
The first step rescuers take is to gather detailed information for current situation assessment. This information can include key problems and efforts taken so far to solve them, and what processes fail or are performed badly (e.g. protocol compliance, site and/or CRO engagement, enrollment and/or retention, etc.)
Via a direct interview with the sites, it is possible to gather a lot of information about their difficulties and circumstances which wouldn’t let them perform well.
After having all the root issues identified, it is possible to select and map out most effective interventions and set priorities. In some cases, the implementation of these measures requires no third-party supervision, while others may require professional monitoring of all processes.
Time to pull the plug
When things get really bad, some sponsor may opt to transition to a new CRO. Nevertheless, in most cases, this measure is taken in cases of severe regulatory and safety compliance issues. But in general, sponsors try their best when addressing root problems in order not to terminate or put the study on hold lest to avoid the additional time, money and other resource investment into getting it back on track.
However, if sponsors don’t succeed in their efforts, and the CRO fails to demonstrate progress in addressing root issues, sponsors may contract another CRO to step in and take over the trial management. But prior to doing so, sponsors make sure the new CRO has fundamentally different approaches and procedures in dealing with root cause issues.
Nevertheless, the process of contracting a new CRO is regarded as a measure of last resort for most sponsors since it can delay the trial for several months and cause disruptions in communication with sites which will have to learn new processes. Thus, depending on the enrollment stage for the study, sponsors may choose to stick with their initial CRO, watching the processes closely and making a lot of interventions. Yet, after the study is over, they may choose not to contract that particular CRO for their future clinical studies.
When contracting Atlant Clinical CRO, sponsors can have peace of mind and be sure that no study rescue will be required during the clinical trials of their product(s). Our thoroughly developed procedures allow maintaining seamless interaction with sites, providing them timely assistance on any study-related issues and monitoring all clinical trial stages and processes.