In the pharmaceutical world, standardization is king: it means much more than anything else. Complex processes as risk management in clinical trials require even more standardization.
TransCelerate, a non-profit organization involving about 20 pharmaceutical companies, initiated a project to standardize risk-based monitoring (RBM) and developed a unified approach.
As the result of this project, a Risk Assessment and Categorization Tool (RACT) has emerged. The RACT is a combined process and questionnaire which enables the clinical trial management team to evaluate study risks after being organized in 13 categories:
Today, many pharmaceutical companies of various sizes use the RACT for the assessment of risk level of a trial. The frequency of assessment is not predetermined, although many companies use it before a trial starts as well as for regular checkups during a trial.
Together with its standardization and broadness of risk topic coverage, RACT has a number of weak points:
- Subjectivity of each of answer. RACT requires that different professional groups answer the questions. However, each answer includes a large degree of subjectivity, because no strict criteria are defined as to what level of impact, probability or detectability to choose.
- Presentation of trial risk information is flawed. A mean of category risk scores builds a total trial risk score. Still, the mean hides the real value and weight of each of category. This is essential information, particularly in case of patient safety.“How can it happen that trials with a safety risk can get medium or low risk overall?” asks Ms. Schwarz from EMA.
- RACT is not collaboration-friendly. As an Excel file, it demands strict change history and the chance that files’ integrity or formulae get damaged is high.
- RACT requires strict document handling and a proper audit trail. This includes who has changes what and when; therefore, it is inconvenient.
- Complexity and amount of information user needs to deal with. The amount of information presented at once disturbs a user and makes it hard to pay enough attention to all facets of each question.
- Versioning for one trial. One needs to exercise care over additional different versions at different times during a clinical trial.
- Extensive process has to be followed. A process should be followed together with RACT itself, this process is described in RACT as a diagram, although to keep it in mind always and follow correctly in a large corporation is a large challenge on itself.
Obviously RACT is a very useful mechanism for study level risk assessments. Although it has a number of weak points, the solution to these issues lies in a more dedicated technical solution than a simple Excel file and in specialized presentation of trial risks.
Cyntegrity addressed these issues of TransCelerate version and based on it elaborated a free cloud-based system with additional audit trail, versioning and collaboration possibilities, is called @RACT(“attract” /əˈtrækt/) (ract.rbm.cloud). @RACT aims to capture, manage, edit and export your RACT questionnaires. Users can go through questions in “wizard mode” and be more objective, using specially elaborated strict criteria for assessment of impact, probability and detectability for each question.
The audit trail, the extended help system and the collaboration options will make your risk assessment simple and useful for your trials and for your patients.