Clinical trials although methodically planned, can hit unexpected roadblocks steering them off course. From resource shortages and unforeseen service needs to contractual issues, recruitment problems and adverse events, these challenges can bring even the most carefully planned trials to a grinding halt. With strict deadlines, limited budgets and often tight resources, it can be difficult to determine the exact problem to navigate around, particularly when time is of the essence. These challenges however don’t have to signify the end of the road, a rescue study if executed promptly to address a trials specific needs can be the intervention required to ensure your research is resilient against unexpected setbacks moving forward, to get your study back on track and set up for success.
What is a Rescue Study?
A rescue study in clinical research is an urgent intercession initiated when a clinical trial encounters significant challenges or shows early analysis indications that it may not demonstrate required drug efficacy. These challenges often include questionable data quality and integrity, regulatory non-compliance, missed deadlines, and overall mismanagement. The aim of a rescue study is to swiftly address and rectify these issues, ensuring the trial can proceed effectively. This may involve revising the trial's plan, enhancing participant recruitment and management, ensuring accurate data collection, and resolving any operational or resource-related difficulties. The goal is to safeguard the investment in the trial and guarantee the reliability of the results.
How to Rescue a Clinical Trial
Getting a study back on track involves several key steps. Firstly, a thorough evaluation is required to identify the specific issues plaguing the trial, then develop a detailed rescue plan tailored to these issues. This might include the points listed above, as well as improving participant retention, reallocating resources effectively, streamlining communication among all stakeholders for better coordination, and steps to ensure quality data. The rescue plan could include revising the trial design where necessary, enhancing participant recruitment strategies, and ensuring accurate and reliable data collection methods are in place. A Statistical Consultant can ensure advanced data validation techniques are employed, re-evaluate the statistical analysis plan, and potentially advise on implementing an adaptive trial design if required, which can be pivotal. These approaches help in rectifying data integrity issues and adapting the trial design to changing conditions, thus ensuring the robustness of the trial outcomes. Additionally, addressing operational or resource-related difficulties is essential to get the trial back on track.
Once the clinical trial is back up and running, it’s important to continuously monitor the trial’s progress and make necessary adjustments to keep it aligned for success. The objective of the rescue study is not just to salvage the investment in the trial, but also to guarantee the reliability and validity of its results. As this process can often be complex, consulting with external experts or partnering with a specialized Clinical Research Organization (CRO) experienced in rescuing clinical trials can be beneficial. The success of a rescue operation depends on a tailored approach and proactive management.
Planning and Preparation
Early intervention is crucial when setting in motion a rescue study for a clinical trial. Often, the trial may already be facing considerable delays, making it priority to regain progress rapidly and effectively. A thorough comprehension of the entire trial process and the specific areas requiring intervention is essential.
Here are some important considerations to keep in mind when mapping out your rescue study strategy:
- Allocate sufficient time and gather necessary information for obtaining approval from management before engaging with the existing central lab.
- Gather internal support for the rationale behind the rescue.
- Evaluate and plan for the impact on all stakeholders involved.
- Clearly outline and understand your budgetary needs.
- Establish timelines and develop transition plans.
- Gather information on data type, data updates needed, types of validation to be performed, whether data is locked/unblinded/to be reopened, and number of reports and types of reports to get generated.
In selecting a rescue Clinical Research Organization (CRO), it's important to choose one that aligns with the specific requirements of your rescue study. Each clinical trial has unique needs, and the chosen intervention should be customized to meet these specific requirements.
The Additional Regulatory Challenges Once Rescue is Needed
When a clinical trial enters a rescue study phase, it’s no surprise this will also mean several additional regulatory challenges, each necessitating careful management to ensure the trial's compliance and integrity.
These can be summarized in six key areas:
-
Protocol Amendments
Rescue studies often require significant changes to the initial trial protocol, and these amendments must undergo a rigorous approval process with regulatory bodies. This process, while essential for maintaining scientific rigor, can be time-consuming and requires precise alignment with regulatory standards. -
Informed Consent
Updating informed consent documents are necessary to reflect the altered conditions of the study, ensuring that participants are fully aware of and consent to the new terms. This step entails additional ethical reviews and approvals, emphasizing the protection of patient rights and safety. -
Frequent updates to regulatory agencies
The shift to a rescue phase also often leads to increased scrutiny from regulatory agencies. These bodies may demand more frequent updates and in-depth information about the trial's progress, specifically focusing on the effectiveness of the measures implemented to address the initial issues. This heightened oversight ensures that the trial remains compliant with regulatory requirements throughout its altered course. -
Data integrity
Another significant challenge is ensuring the integrity and continuity of data collected both before and after the rescue intervention. Regulators will scrutinize this data closely, assessing the validity of the trial's outcomes, especially if the rescue plan involved substantial modifications. -
Multiple regulatory agencies
For trials that span multiple regions, aligning the rescue strategy with the diverse regulations of different countries presents an additional layer of complexity, which is one of the reasons seeking the help of an expert or specialist CRO can be beneficial. Each region has its unique set of regulatory demands and approval processes, which must be carefully navigated to maintain compliance across all jurisdictions. -
Transparency
Lastly, the entire process demands a high level of transparency and detailed reporting. Regulatory bodies require comprehensive accounts of why the rescue was necessary, the steps taken to rectify the issues, and the outcomes of these interventions. The ethical implications of changes made during the rescue phase must be meticulously considered, focusing on patient safety, data validity, and the scientific integrity of the trial. Successfully working your way through these multifaceted regulatory challenges requires a deep understanding of the regulatory requirements, effective communication with relevant authorities, and diligent planning and documentation throughout the rescue process.
Help Your Chosen CRO Succeed
To assist your chosen CRO in a smooth handover with no further delays, it’s important to supply them with all of the information and data they need in a transparent and detailed format, so they can understand the current state of your clinical trial.
Our team of specialists suggest you supply the following details:
Data Pertaining to the Rescue Study
- Comprehensive list and details of all involved sites, including their locations and the status of their IRB/ethics approvals.
- Progress updates for each site's initial setup, encompassing contract details and IRB/ethics status.
- Current status of active sites, particularly those with enrolled patients.
- Information on any new sites or countries being considered for inclusion.
- Current status of grant payments, specifying what has been paid and what is pending.
Information on Patient Management
- Detailed reports on site and patient monitoring activities, including any data gathered to date, requirements for additional monitoring or sample collection, and plans for future monitoring.
- An overview of patient engagement strategies, including the effectiveness of existing tools, potential enhancements, and patient-centered approaches like travel assistance and reimbursement methods.
Regulatory and Data Protection Information
- Details about legal representation within the European Union.
- Agreements related to data controller and processor roles under GDPR.
- Information on the ownership and status of insurance policies.
Conclusion
Recovering a clinical trial with a rescue study can feel often feel complex, but with a comprehensive reassessment of the trial, addressing issues such as data integrity, regulatory compliance, and operational efficiency, along with incorporating a tailored strategy, which may include protocol amendments, enhanced participant recruitment, and revised data collection methods, the trial can be realigned towards its original objectives.
The involvement of a specialized Clinical Research Organization (CRO) with expertise in rescue operations can be beneficial, offering the guidance and resources necessary to navigate a trial through the unexpected roadblocks. The process requires a high degree of transparency and regulatory rigor, particularly when faced with the additional regulatory challenges during a rescue study. By meticulously planning and preparing for these challenges, maintaining open communication and detailed reporting, a trial can not only be salvaged but also placed firmly back on the road to delivering valuable scientific insights and advancements.
Have a clinical trial where your drug efficacy is in doubt?
At Quanticate, our experienced team of experts are on hand and ready to step in, assess the situation and implement effective strategies to rescue studies facing difficulties, by working collaboratively across our biostatistics, programming and medical writing departments. For more information contact us and speak to a member of our team.
