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Patient Data Access in Clinical Trials

Jan Aertgeerts2022-10-10

Data transparency has become an imperative. Healthcare is no exception. Get to know our take on patient data access.

The modern pharmaceutical industry requires a data-centric approach.

In order to develop a data-centric approach, you need to overcome the challenges associated with accessing and storing large amounts of data.

First, let’s examine the nature of clinical trial data. At the start of a clinical trial, patients are randomly assigned to either an experimental arm (where they receive a drug) or a control arm (where they receive a placebo). The goal is to evaluate how well the drug works by measuring patient outcomes such as:

• reduction in seizures (for epilepsy trials)

• increases in walking distance (for multiple sclerosis trials)

• reduction in tumor size (for oncology trials)

This requires collecting large volumes of structured and unstructured information from sources such as medical records, lab results, patient questionnaires, etc. Data is collected throughout the trial at multiple sites where patients are being treated. In addition, for safety purposes there is ongoing monitoring during active treatment as well as reporting after treatment has stopped. This can create additional challenges for collecting and managing data from all these different sources.

You need to be able to store this complex mix of structured and unstructured information — and make it accessible across your organization so that it can inform your next clinical trial design or product development efforts.

Data accessibility in your own organization is a base necessity, but what about giving data back to the patients that participate in clinical trials?

A patient centric approach to clinical research

A patient-centric approach can yield real value for patients, for the companies that employ them and for society at large.

Patient centricity is a shift from the traditional clinical trial model to one where patients are viewed as critical partners in the clinical research process. Patient-centric trials are designed to give patients additional control over the data generated by their medical treatments. The goal of this approach is to improve quality of care, increase the return on investment (ROI) of clinical trials and enhance patient engagement throughout the drug development process.

Clinical trial participants benefit from access to their own health data

Participating in a clinical trial can be an arduous process. Take, for example, a patient who is taking part in a study of migraines at Columbia University Medical Center. The patient has to travel 120 miles round-trip every other month for the study, which requires follow-up phone calls and periodic tests including MRIs and blood work. In addition, the patient has to keep track of the frequency of migraines and symptoms like nausea or sensitivity to light over weeks at a time.

Giving patients such as this one access to their own health data not only helps them better understand what’s going on with their bodies during the trial but also helps them engage with the potentially stressful process — leading them toward better outcomes while reducing dropout rates.

Unlocking access to patient data in clinical trials

The clinical trial process is a complex one — and one of the most important things to consider is patient data. Clinical trials are often run by several different partners, including contract research organizations (CROs) and hospitals.

Patient data is an asset, and patients should have control over it. The value of having access to this kind of information cannot be understated — allowing patients to easily access their own data not only has the potential to lessen the burden on doctors and other healthcare professionals, but also empowers patients by giving them greater access to their own health information.

The accessibility and transparency of patient medical records plays an important role in the clinical trial process today. It is crucial for pharmaceutical companies to establish a new way of interacting with patients; as well as facilitate better communication and better quality care.

The right to privacy for patients is not only a basic human right, but it can protect them from potential harm. And by providing patient access to their own information, pharmaceutical companies can create tools that promote transparency. This will increase patient participation, improve the quality of care they receive during research trials, and allow them to make more informed decisions about their health.

Accessibility and transparency are the cornerstones of new regulations that provide better access to patient information; however, there is still a major lack in data sharing across healthcare systems and between patients and healthcare providers. Either because interoperability is too complex or because proprietary solutions are used by hospitals or other providers. As a result, patients may be unable to take possession of their medical records even when they have requested them; preventing them from properly authorizing the use of their information in clinical trials as well as undermining confidence in the entire process. It’s vital for pharmaceutical companies collaborate with researchers on how best to manage this process and respect patients’ rights while remaining compliant with regulations.

About the Author

Jan Aertgeerts is a Salesforce Certified Technical Architect (CTA) and Managing Director at Harrier. Jan is passionate about building secure, high-performance technical solutions.

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