More than anything else, standardization is king in the world of the pharmaceutical industry. Even more so for complex processes such as risk management, risk-based quality management (RBQM) and central statistical monitoring (CSM).
In 2013, TransCelerate BioPharma, an independent non-profit organization that enables a collaborative platform for biopharmaceutical companies, released a position paper outlining a methodology for risk-based monitoring (RBM). The RBM methodology reflects TransCelerate’s standardized and unified approach to improve speed, efficiency and capabiities in bringing novel therapies to the market.
As a result of this collaborative initiative, a Risk Assessment and Categorization Tool (RACT) was developed. The RACT incorporates a risk identification process and questionnaire which enable clinical trial management teams to evaluate study risks after organizing them into 13 categories:
Today, many biopharmaceutical companies of all sizes use the RACT for the assessment of risk levels of a clinical trial. Even though TransCelerate’s RBM methodology doesn’t predetermine the frequency of risk assessment, many companies use the RACT prior to trial start as well as during a trial for regular checkups.
Despite its standardized character and broad study risk scope, the RACT has some weaknesses.
7 Weak Points of TransCelerate RACT:
1. Subjectivity of Each Answer
The 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 the level of impact, probability or detectability to choose.
2. 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 when it concerns patient safety. “How can it happen that trials with a safety risk can get medium or low risk overall?” asks Ms. Schwarz from EMA.
3. Spreadsheets are Not Collaboration-friendly
The RACT as an Excel file demands strict change history management and the likelihood that the data integrity of files and formulas gets corrupted is high.
4. The RACT Requires Strict Document Handling and a Proper Audit Trail
This includes who has changed what and when; therefore, it is inconvenient.
5. 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.
6. Versioning for One Trial
Care needs to be exercised over additional and different document versions during the different stages of a clinical trial.
7. Extensive Process Has to be Followed
A process should be followed together with the RACT itself, this process is illustrated in the RACT by a diagram. Process alignment in a large organization is a big challenge on itself.
Regardless its weaknesses, no need to argue the fact that the RACT offers a very useful methodology for study level risk assessments. The way to address the common spreadsheet shortcomings is the deployment of dedicated technology in conjunction with a specialized user interface presenting the trial risks in a logical manner.
Cyntegrity’s modern cloud-based service @RACT (“attract” /əˈtrækt/) converts the TransCelerate version into a fit-for-purpose solution featuring audit trail, versioning and collaboration tools in addition to the original, Excel-based RACT. With reduced effort users can capture, manage, edit and export RACT questionnaires. The special “wizard mode” guides the user through the questions and responses are kept more objective by using the specially elaborated strict criteria for assessment of impact, probability and detectability for each of the questions.
The audit trail, the extended help system and the collaboration options dramatically simplify risk assessment routines and increase the value of clinical research outcomes.
Read also: Excel-based RACTs go to the Cloud (Applied Clinical Trials)
Tired of Staring at Rows and Columns? Escape the spreadsheet nightmare. See why @RACT is the new model for modern clinical trials. Try our free 30-day trial: https://cyntegrity.com/ract-pro/