How to determine Accuracy in Research?

Summary

An accurate and precise clinical trial can contribute to standardize medical practice, raise the quality of patient care, and improve the organization of a health service, thus having the potential to save lives, report benefits in improving the quality of life of patients, contribute to changes in disease management patterns, as well as sometimes modify important health indicators. These results provide elements that facilitate clinical decision making based on the best available evidence.

Recommended reading: Top 10 Clinical Research Organizations

The Impact of Clinical Trials on Healthcare Quality

In this context, as a CRO team, it is important to verify compliance with the activities that are carried out before, during and after the study to ensure its accuracy. These activities are mentioned below:

1. It is paramount that from the beginning of the execution of the research, the objectives of the study should be established to know what we want to achieve and thus improve the overall accuracy of the data.
2. Another important aspect is communication because, if this is effective, it significantly improves the results; therefore, good communication strategies should be established and implemented between the sponsor, CRO, ethics committees, investigators and participants.
3. Now, the most important thing as CRO is the Monitoring since it seeks, through the design and implementation of methods, processes and procedures to ensure, to a large extent, the follow-up and evaluation of the implementation, execution and closure of research projects, achieving the conduct of studies with high quality standards.

Objectives and Techniques in Effective Study Monitoring

The purpose of monitoring a study is to verify that:

• In general, everything described in the protocol is fully complied with, which is verified in the baseline, routine and final visits that are analyzed and approved within the “Monitoring Plan”.
• The rights and welfare of the subjects are protected: at this point we refer to the verification of the informed consent, which is a document that defends the right of patients to decide, respects their autonomy and legitimizes the doctor-patient relationship. This in turn gives us confidence that the data provided by the subject will be truthful.
• The data obtained in the study are accurate, complete and verifiable from the cross-checking of source documents.
• It is important to verify that the inclusion and exclusion criteria have been met because if they are correctly defined, they increase the likelihood that the trial will generate reliable results.
• SDV (Source Data Verification) is an essential tool to ensure the quality of clinical trial data. By verifying source documents, you can uncover flaws and errors that might otherwise go undetected until after the reports are submitted. In addition, it is necessary to avoid overload by simplifying and facilitating the data entry process to avoid errors.
• For this, it is also unavoidable to have the use of digital platforms with updated validation certificates, which allow the data recorded in them to provide accurate and consistent results with the source documents.
• The control and handling of the investigational product is adequate as it helps to prevent deviations and protocol violations by not complying with the necessary storage requirements or mistakenly applying the product to the wrong subject.

Don’t forget to check: Accuracy vs. Precision vs. Reliability

Ongoing Training and Improvement in Clinical Research Practices

All adverse events should be reported whether or not they are related to the investigational product and the monitor should verify that there are no AEs/SAEs that may have gone unnoticed and there should be consistency between HCs, CRFs, reporting forms and notifications.

4. The conduct of the study should comply with the approved protocol and its amendments, with the GCP Guideline, and with ethical requirements and relevant legal regulations.

5. Generate automated error reports and ensure that these are corrected in a timely manner.

6. Continuous training of the investigators and the CRO team on the processes to be performed and where reinforcement is required, so that previously identified errors are not made.

Resources

1. PPD Inc – The Growing Role of CROs in Clinical Trials
2. Novotech CRO – The A-Z of CROs: Understanding their Vital Role in Advancing Clinical Research
3. PPD – What Is a CRO?