Electronic Case Report Form (eCRF) for Clinical Studies in Oncology

Electronic Case Report Form (eCRF) for Clinical Studies in Oncology

Electronic Case Report Form (eCRF) para estudios clínicos en oncología

If you need an eCRF system, you can contact us at info@klindat.com

Cancer is one of the leading causes of mortality worldwide, and its prevention and treatment have been a major priority in clinical research.

Also, one of the greatest challenges in oncology clinical research is the heterogeneity of the disease. Cancer is a complex disease that can manifest itself in many different ways, and the response to treatment varies widely among patients, depending on their personal characteristics, and tumor subtype.

This makes it difficult to develop effective treatments for all patients, and that is why oncology clinical research has focused in recent years on personalized medicine, which focuses on the specific characteristics of each individual.

In this article we will explain the main types of oncology clinical research studies, and see how Electronic Case Report Forms (eCRFs) are used to manage data in a more efficient, and secure way.

Types of clinical studies in oncology

The main types of oncology clinical research studies include the following:

1. Observational studies

Observational studies consist in observing patients and record their data without experimentally intervening in their treatment.

These studies are used, among other purposes, to identify possible connections between risk factors, biological characteristics, and cancer. They are also used to understand how cancer affects different populations and how the disease develops over time.Types of observational studies include cohort studies, case-control studies, and cross-sectional studies.

  • Cohort studies: These studies observe a group of people with a specific type of cancer to analyze their tumor evolution. The treatments administered, and their results can also be examined.
  • Case-control studies: These studies compare a group of people who have a particular cancer (cases) with a group of people who do not have the disease (controls) to determine if there are risk factors associated with the disease.
  • Cross-sectional studies: These studies collect data from a population at one point in time to identify characteristics, and risk factors that may be associated with cancer.

2. Experimental studies

When conducting an experimental study, investigators intervene in the patients’ treatment to evaluate the effectiveness of a particular treatment for cancer. Types of experimental studies include randomized, non-randomized, and phase I, II, III and IV clinical trials.

  • Randomized clinical trials: These studies randomly assign patients to receive the investigational treatment, an existing treatment, or placebo. Then, researchers compare the results between treatment groups to determine if there is a significant difference in treatment efficacy.
  • Non-randomized clinical trials: In this type, patients are assigned to a treatment group based on certain characteristics, such as the stage or grade of the cancer, or the patient’s age. Then, as in the previous type of experimental study, investigators compare the results to determine differences in treatment efficacy.
  • Phase I: These are the first-in-human clinical trials to evaluate the safety, and appropriate dose of a new treatment.
  • Phase II: In this phase, the objective is to determine the efficacy of the treatment in a larger group of patients and may provide additional information on safety, and appropriate dosing.
  • Phase III: These are multicenter, randomized clinical trials conducted in a large number of patients to confirm the efficacy, and safety of the treatment.

The variety of research methods and designs together with the increase in the number of patients diagnosed with cancer, and the need for close monitoring of their treatment, has made accurate data collection increasingly important.

In the past, paper-based CRFs were used for this purpose, but given the development of new technologies, electronic CRFs (eCRFs) have become commonly used, and fundamental tools in clinical research.

In this article, we will explore the features of this electronic tool for data capture and processing, the typical fields and sections of this application, and some examples of its use in oncology studies.

Features of the Electronic Case Report Form

An eCRF is a software application used to collect and store patient data in a clinical study.

Some of the important features of an eCRF are as listed below:

  • Design: it should have a simple design that is easy to use, and understandable to medical staff. In addition, it should be adaptable to different types of cancer and stages of disease. The eCRF should include fields for patient demographic information, clinical data such as date of diagnosis, cancer stage, type of treatment, and test results, as well as information on the patient’s quality of life.
  • Real-time data collection: data is collected in real time and stored electronically. This allows for faster response to changes in patient status, and research results.
  • Data quality standards: these standards should be included to ensure accuracy and consistency of the information collected. Criteria for inclusion and exclusion of patients in the study should be clearly defined, as well as methods for data collection and validation of information.
  • Accessibility: data can be accessed from anywhere with an internet connection. This allows investigators and doctors to access patients’ information remotely.
  • Privacy and security: the eCRF must comply with medical data privacy and security regulations to ensure the confidentiality of patients’ information. This includes protecting information such as name, medical record number, address and social security number, as well as clinical data.
  • Traceability: the traceability of an eCRF refers to the ability to track and verify the origin, history, and record of all data entries and modifications that have been made. In other words, it is about ensuring that every piece of information that is recorded in this application can be completely and accurately tracked and traced. To ensure the traceability of an eCRF, a variety of techniques and tools can be used, such as detailed documentation of data collection procedures, the use of time tags and logs for each data entry, and the implementation of data tracking and quality control systems.
  • Compatibility with technology: the data collection tool should be compatible with the technology used in data collection and analysis, such as database management systems and statistical analysis software.
  • Additional functionalities: eCRFs can also have other functionalities such as alerts and reminders for patient visits and medication tracking.

Fields and sections of an Electronic Case Report Form

An Electronic Case Report Form is composed of fields and sections (or forms) that are used to collect specific information. These fields can be of different types, such as text, numbers, dates, or image upload buttons. The fields are used to collect specific information that can be used later for data analysis.

Some fields that can be used in eCRFs are as listed below:

  • Text field: this field is used to collect textual information, such as responses to open-ended questions or notes. Text fields can include a variety of formatting options, such as the length of text allowed.
  • Numeric field: this field is used to collect numeric information, such as laboratory test results. Numeric fields can also include formatting options, such as the number of decimal places displayed.
  • Multiple choice field: this field is used to collect information when multiple response options are offered. For example, a multiple-choice field could be used to collect information about a patient’s previous symptoms or illnesses.
  • Date field: this field is used to collect information about dates, such as a person’s date of birth or the date of a test.
  • File upload field: this field is used to collect information on attached documents, such as a photograph or a scanned report.

The different types of information are separated into forms, which are a way of organizing fields in an eCRF. Forms are used to group related fields together and make it easier to organize information for later analysis.

The examples indicated below are some of the forms used in oncology studies:

  • Patient information: basic patient information, such as age and gender, is collected.
  • Medical history: this section collects information on the patient’s medical history, such as previous pathologies and chronic diseases.
  • Medical record: this is composed of aspects related to the patient’s disease, such as diagnosis and previous treatments. In the case of cancer, data is collected on biopsies, surgeries, radiotherapies, and systemic treatments received so far.
  • Medication: the medications taken by the patient are recorded, including the name, dosage, and frequency.
  • Medical procedures: details the medical procedures the patient has undergone, including the date of the procedure.
  • Test results: the results of the different techniques carried out to determine the patient’s disease status are reflected here. In oncology studies with solid tumors, radiological tests (CT scans and/or MRIs) are fundamental.

Tumor registry: One of the uses of eCRFs in oncology

Tumor registries are an example of the use of eCRFs in oncology studies.

Tumor registries are an important tool for evaluating the efficacy of cancer treatments. These registries collect information on patients diagnosed with cancer, including demographics, type and stage of cancer, treatment received, and drug safety and efficacy outcomes.

One of the ways in which tumor registries are used is through survival studies. These studies evaluate the length of survival of patients after cancer diagnosis and treatment. Information from tumor registries is used to determine the number of patients who have survived for a specific period after treatment, which helps to evaluate the efficacy of treatment.

In addition to survival, tumor registries are also used to evaluate the cancer recurrence rate which refers to the reappearance of cancer after initial treatment. These registries collect data to identify risk factors associated with cancer relapse, which helps doctors develop treatment plans with better outcomes.

These registries also help to establish trends in cancer diagnosis and treatment. Through this tool, the most common types of cancer and the populations most affected by this disease can be detected and identified. This helps doctors and health policy makers to develop strategies to prevent and treat cancer.

Tumor registries require the use of a powerful and secure database, accessible via the internet, and for this reason, eCRFs are the perfect tools for this type of projects where a large volume of clinical data is collected.

What criteria are used to evaluate the efficacy of cancer treatments?

Another example to illustrate the usefulness of eCRFs in oncology clinical studies is the measurement of the efficacy of antineoplastic treatments by radiological assessment.

One of the most common efficacy measurements in oncology is the use of the RECIST criteria for radiological response assessment of solid tumors (e.g., sarcomas, ovarian cancer, etc.).

The RECIST criteria applied to tumor evaluation is a standardized measurement system used to assess tumor response to treatment in clinical trials and in clinical practice.

The acronym RECIST stands for “Response Evaluation Criteria in Solid Tumors” and is a set of rules for measuring changes in tumor size.

The RECIST criteria are based on the measurement of the maximum tumor diameter on magnetic resonance imaging. The diameter in the axial plane of the tumor is measured and an assessment of response is made based on the decrease in tumor size.

Tumor response is classified into four main categories: complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). CR is defined as complete disappearance of the tumor; PR is defined as a decrease in tumor size by at least 30%; SD is defined as a decrease in tumor size of less than 30%, but no increase in size; and PD is defined as an increase in tumor size or the appearance of new lesions.

The RECIST criteria are widely used in clinical trials to evaluate the efficacy of potential new treatments that could be incorporated into standard clinical practice as well as existing treatments. In the case of evaluation of long-standing treatments, the goal is to assess tumor response to determine the need for changes on a patient-by-patient basis.

How does an eCRF help tumor assessment using RECIST? An eCRF of an oncology study will contain a specific form to record tumor measurements and subsequent responses to treatment.

This form collects measurements of the target lesions at baseline (before study treatment), and then radiological re-evaluations usually performed every 6 to 8 weeks, in order to observe on CT/MRI scans whether there has been a decrease in lesions.

Additionally, an eCRF allows DICOM radiological images to be uploaded to the cloud for quick and secure review by an expert radiologist. This central review brings great value to the research as it confirms the results obtained at each site locally.

Conclusion

Electronic Case Report Forms (eCRFs) are a fundamental tool for clinical data management in cancer research.

Since oncology studies have very specific needs, it is necessary that eCRFs are capable of handling and recording large amounts of information accurately and efficiently.

In this regard, Klindat offers a highly specialized and customizable clinical data and medical imaging management tool designed specifically for oncology research (ideal for tumor registries, any type of observational study, and clinical trials).

With its advanced and flexible platform, Klindat enables researchers and sponsors to customize and adapt their eCRFs to meet the specific needs of their studies, allowing them to collect, manage, and analyze data and images more efficiently and rigorously.

All in all, Klindat is a highly recommended eCRF option for oncology studies, helping to meet the highest standards of quality and accuracy in clinical data collection.

If you need an eCRF system, you can contact us at info@klindat.com

Share This Post

More To Explore