In 2017, 60% of the warning letters issued by the Food and Drugs Administration (FDA) were result of lack of data integrity. Referring to which, it is clear, how important is data integrity in any clinical trial. To address the importance of data integrity for good clinical practices, FDA and Medicines and Healthcare Products Regulatory Agency (MHRA) having been taking considerable measures by conducting workshops and discussing concerns of all the stakeholders across the world.
Achieving data integrity is not rocket science. A set of pre-defined standards and best practices can help you acquire necessary and unbiased data. Using these best practices will also ensure the reliability, quality and purpose of the data. For example, if data is collected for oncology trials, it should help to examine its effects throughout the process and keep a track of them which can be better managed with the help of reliable data. But with the advancement of technology, the data collected by companies is also increasing exponentially. This is making it difficult for organizations to maintain the integrity of humongous amount of data as there are multiple factors which may influence the data. How can companies come over the gap? Let’s have a look at some of them and how can organizations overcome these hindrances:
1. Errors in blinding
Earlier, the trials were mostly paper-based which made it easier to keep the results blind. Blinding or blind is a method of keeping the specifics of a clinical trial secret from the participants of the trial for optimal results. But as the times have changed, many elements are now part of the clinical trial system, which may unblind the results of a trial and expose them to unknown biases.
To blind a clinical trial, interactive response technology (IRT) is like a virtue. IRT is a software which introduces activities, such as randomization, into the system of clinical trials to ensure blinding. It helps organizations to maintain integrity throughout the process, right from the collection of data to final analysis, to identify any manipulation in the sequence of events. Interactive Voice Response Systems (IVRS) or internet based, Interactive Web Response Systems (IWRS) are some of the examples of IRT.
To keep the data unbiased, all the stakeholders who are involved in the trial must make sure that the blind is enforced at each step. A well-planned approach is a key to maintaining the blind in clinical trials. The schedule of the clinical trial must be examined thoroughly to identify elements which may unblind the trial. Any system or document which may reveal the process must be efficiently managed by the organization. If any errors are found, they must be addressed immediately.
2. Data management
As it is well known, ensuring and maintaining the quality of data is highly important for error-free clinical trials. The best way to manage the quality is by developing well-planned case report forms (CRFs). If the CRFs do not define the roles and responsibilities clearly for the trial, it may lead to inadequate data, thus, compromising the trial. To avoid this, the access and control of end-to-end data must only be with the clinical investigator. Also, while managing the CRF data, it is important to ensure that the collected data is accurate and has a reliable source of origin. The personnel handling of data should also abide by the rules of blinding.
Apart from this, what type of data (for example, safety data, ECGs, vital signs etc.) should be collected from the clinical trial must be clearly defined during the earlier stages of the trial. If the trial involves high-level of risk, the importance of data should also be assigned and documented. System specifications, data management SOPs, guidelines, and work instructions should be made aware to all the stakeholders in the research by providing training sessions on each function. Once the trial is over, the CRF should be directly sent to the clinical site via electronic means and should be kept away from the stakeholders to retain its authenticity.
3. Lack of Resources
Often, organizations have limited resources when it comes to conducting studies which can turn into an obstacle. In such cases, instead of building in-house expertise, organizations should focus on finding the right outsourcing vendor. The focus on finding the right vendor has increased after the release of good clinical practices under ICH E6(R2).
Selecting a vendor requires thorough assessment of their capabilities regarding handling the clinical trials. Apart from the infrastructure and resources, evaluation of their approach, documentation and training will help you understand how the vendor can protect the integrity of your data. Even if the vendor is well-known, it is a good practice to evaluate their approach and compare it with other vendors, just to be on the safer side.
Considering the request for proposals (RFPs) before selecting a vendor is always a good decision as it helps you understand the ecosystem of the vendor. It also helps to understand if the vendor can meet the requirements of the trial or not. The practice is highly recommended by regulators.
4. Audit Trails
Audit trails are necessary to improve compliance and the overall effectiveness and quality of the system. Without conducting audit trails, an organization might end up facing challenges during the trial.
The trails also help to review and verify the activities of the trial and store them for future references. Audit trails information helps clinical investigators to assess the products effectively but the inability to decode this information may lead to unknown challenges. Audit trails may also disclose some of the discrepancies of the system, if any.
There are many ways to maintain the integrity of data produced from a clinical trial. It is the obligation of the organizations to protect the data by taking the right measures. For this, the roles of those involved should be properly defined along with the process and the technology used. Also, the process should be well-planned and documented to meet the goal. All of this must be done prior to the start of study as once the study has commenced it may become difficult to backtrack. A Regulatory expert in clinical monitoring can help you manage your data and maintain its accuracy. Be compliant with your data to stay ahead of the competition.