Collecting Clinical Trial Data

According to Obviohealth.com, if you’re running a clinical trial, you’re undoubtedly looking to perform an analysis of your data. Whether it’s to learn what impact your study has had or see how you can improve your research practices, you’ll want to understand your data.

But how should you be collecting this information? Here are some great tips for collecting data in clinical trials.

1. Use Questionnaire Surveys and Patient-Reported Data (PRD)

Questionnaires and PRDs are the most commonly used ways to collect data in clinical trials. For primary data, you can use questionnaires (also called clinical questionnaires). On the other hand, you can use patient-reported data (PRD) to gather secondary data, such as data on the impact of a study.

The difference between these two options is that questionnaires ask open-ended questions to assess many different aspects of your trial patients’ situation. In contrast, PRDs ask patients questions based on their self-reports about how their condition is changing.

2. Using Proxy or Informant Data

If you collect more than just information, you need to integrate proxy or informant data: another person’s information. For example, if you want to see how long struggling with asthma and how much it costs your patients, you can ask them or their relatives about this.

These eyewitnesses will give you a more accurate and reliable picture of the situation and provide you with statistical data, such as the patient’s health care cost. If they are unavailable, you can use other information to make up for this, such as doctors’ reports of patients with asthma.

3. Using Patient-Reported Outcomes (PRO) Data

PRO data refers to information that is reported by patients themselves on how much exercise they do and whether it influences their condition or not. Studies using PRO data can answer questions about any aspect of your trial patients’ lives, enabling you to answer several important questions about your trial. They include queries such as; does exercise reduce short-term exacerbations? Does it prevent long-term complications?

To find out who responds best to intervention, you need PRO data. PRO is the most in-depth type of patient-reported outcomes (PROs) you can collect and use in your clinical trial.

4. Reviewing Ambulatory and Hospital Medical Records

In trials that involve more than one centre, it is rare for all records of patients in all centres to be collected simultaneously. Usually, records on each patient are collected piecemeal and as time allows during hospitalization and once the patient returns home.

However, you can use these incomplete records to create a baseline figure from which you can calculate variables such as asthma exacerbation rates and admissions. This is particularly useful if your trial involves people from different socio-economic backgrounds or ethnic groups.

5. Using a Statistical Modeling Program to Identify Subgroups with Specialized Needs

Statistical modelling programs can help identify subgroups in your trial for whom special attention should be paid. The statistical model helps identify patients who are likely to respond better or worse based on their risk factors.

To do this, they will precisely calculate the probability of being in a specific subgroup based on their characteristics so that you can work with groups of patients whose needs are specific. In these cases, the statistical model will help predict how the individual patient’s risk factors will affect their odds of progression towards an event (such as achieving an asthma exacerbation). This data can then be used to tailor your intervention accordingly.

6. Collection of Biologic Materials

Sample collection is the process of obtaining samples used in your trial. These biological materials are samples that include blood, urine, and other biological samples. If your trial involves testing a new drug or treatment, you will need to collect these samples so you can test whether a particular drug or treatment will work.

For example, if you are interested in gathering data about asthma over time, you will need to collect measurements such as spirometry from your study participants’ baseline and multiple time points. All this happens after the intervention has been completed.

When collecting biological material for these purposes, the sample collection process must be done following good clinical practices and with proper documentation of protocol adherence throughout the entire trial.

Collecting Clinical Trial Data Wrap Up

Clinical trials are a necessary evil in modern medicine. They allow researchers to test the effectiveness of new treatments in a specific group of patients (clinical trial), or they can be used to study the side effects of a new drug (observational study). While both of these methods have their benefits and limitations, the reality is that doing a clinical trial is a long and challenging process. We hope that these tips have helped you collect data even more effectively.