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The 2016 International Council for Harmonization (ICH) E6 (R2) Addendum to the Good Clinical Practice guideline recommends the following:

  1. Sponsors must incorporate a risk management plan across the clinical lifecycle
  2. They must evaluate all clinical trial processes and technology (and retool them for proactive risk mitigation)
  3. Design a robust process to ensure data quality, patient safety and reliable trial outcomes

Risk management is also important from a compliance point of view and can help sponsors and CROs improve the efficacy of trials. It requires a lifecycle approach – right from the time of trial conception or draft protocol stage.

To design a reliable and robust risk management plan, it helps to involve the whole study team that includes members from departments such as clinical operations, data collection, data management, project management, regulatory affairs, quality affairs, pharmacovigilance/drug safety, medical affairs, and statistics.

A data-driven quality management process is critical to reduce risks during clinical trials.

At ComplianceQuest, we recently published a whitepaper titled ‘Integrating Quality into the Clinical Workflow’.

To learn more about running a quality-centric clinical trial process with next-generation automation and proactive risk management – download the whitepaper here:

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Adopting a Risk-based Approach

Some of the critical processes for a risk-based approach include:

  • Reporting adverse events to the sponsors (and regulatory authorities) in a timely manner
  • Using technology to drive risk management processes
  • Identifying and evaluating risks that affect data quality, patient safety, and achieving the study goals
  • Prioritizing the risks based on the likelihood of their occurrence, the impact, the ability to detect the risk on time

Further, to be able to control risks, sponsors and CROs need to be able to:

  • Assess risk indicators appropriately
  • Fix thresholds when corrective/mitigation measures need to be initiated during the study
  • Assign responsibilities for risk management

7 Key Challenges to Clinical Research

The entire process of clinical research is filled with risks. This is obviously because of the nature of the task; any R&D process is fundamentally a series of experiments with data captured at every stage for evaluation and insight gathering.

Additionally, there is also uncertainty due to the economic, political, and regulatory environment, requiring CROs and sponsors to keep track of evolving compliance requirements in different geographies while managing patients, supplies, and the trial process itself. Covid-19 accelerated the adoption of technology and digital transformation of the clinical trial process, but brought with it a new set of processes including virtual trials.

Overall, CROs need to have a documented risk management plan for the following aspects:

  1. Patient Recruitment: Identifying the right kind of patients (and optimal number of such patients) is critical to the success of a clinical trial. But this is also one of the biggest challenges. In addition to not finding enough patients volunteering for the trial or the volunteers not being the right profile, a third problem is the high drop-out rate due to their inability to commute to trial sites. To some extent, decentralization of trials (virtual and hybrid trials) along with remote monitoring have eased the situation, but not completely.
  2. Trial Design: Right from the design stage, CROs and sponsors must ensure that the trial process is simple enough for patients to understand while complying with all the complex regulatory specifications. This includes capturing data, following a well-documented SOP to perform the trial and having action plans in place when things go wrong.
  3. Compliance: Clinical research is a highly regulated industry and any non-compliance can lead to recalls and/or penalties, sometimes followed by lawsuits. When trials are spread across different geographies, keeping track of the local regulatory requirements also becomes mandatory.
  4. Professional Trial Subjects: Some patients end up volunteering for multiple trials and can lead to the credibility of the study being questioned. Therefore, knowing the patients and ensuring they are not part of other studies is another responsibility of the CROs and sponsors.
  5. Trial Master File: Capturing the entire trial process end-to-end and creating a trial master file is not only a complex process requiring cross-functional involvement. It is also a regulatory requirement and needs to be created, stored and managed in easily accessible format to be shared with regulatory authorities, as and when required. At ComplianceQuest, we recently published a blog on the importance of an eTMF to power up your clinical documentation, increase quality and mitigate risks.
  6. Data Quality: New technologies such as apps, electronic patient-reported-outcome (ePRO) tools, and wearable devices provide easy access to data and makes the process of data collection simpler.However, they also raise concerns about technical and clinical validation, according to a McKinsey study. The onus is on the sponsors and CROs to make sure that data quality is validated across the lifecycle.
  7. Proactive Change Management: When clinical trials are virtual or hybrid (part virtual, part on-site), the sites and investigators need appropriate tools as well as training to be able to work on different platforms for different studies. Change management requires the establishment of an operating model as well as capability across teams and functions to minimize risks.

Integrating Quality Management and Risk Management into the Clinical Trial Workflow

Overall, both sponsors and CROs will benefit from implementing an integrated system to manage quality, risk and clinical trial processes, end-to-end.

Several of our customers at ComplianceQuest have benefited from using both our EQMS and CTMS solution in an integrated fashion. Both the ICH clinical practice and the GCP guideline recommend that we use systems and procedures that assure quality and automate risk management in every phase of a clinical trial.

The sponsor is responsible for implementing and maintaining quality assurance and risk management — ideally by implementing a next-generation EQMS. Having data at the core of the entire process plays a key role in proactive risk management, while also increasing quality across the clinical workflow.

To know more about how ComplianceQuest’s CTMS and EQMS solution can help with risk management for sponsors and CROs, request for demo here: https://www.compliancequest.com/online-demo/

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