Ensuring Data integrity in clinical trials compliance

Introduction-

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.

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 .

Data cycle

Ensuring data integrity is difficult and often  as a lot of resources from the manufacturer. Data integrity refers to electronic and paper raw data and 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.   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 authentication.

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.

References:-

• Freyr Solutions https://www.freyrsolutions.com
• https://selvita.com 

Student Name: Kavya Kalva

Student ID: 096/052023

Qualification: BSC 

e-Mail ID: kalvakavya123@gmail.com