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Can Clinical Trials Be Rebuilt Based on Patients’ Needs?


Technology is taking over as a leading actor in pharma. This is making “customer-centric” the new word of order for the industry’s digital revolution. In their turn, clinical trials are not immune to the looming changes. 

Patients, as highly digitalized, empowered consumers are redefining pharma’s paradigm and pushing forward new questions. Can pharma companies rebuild clinical trials around patient needs? A recent report by Reuters Events presents an interesting insight into this question.

Stakeholders’ Growing Importance in Clinical Trials

Pharma will have to become more customer-centric to survive the rising digital era. This is why consumers’ needs (or in this case, the stakeholders’) are being taken into consideration. 

Pharma has been collaborating with other companies to improve the processes of clinical trials. Yet, there is one stakeholder to consider: the patient. One way to undergo this is to enable and empower the patients to join the conversation on clinical trials.

To get more accurate data, pharma organizations can cooperate with different disciplines. However, for this to succeed, companies must learn from technology partners aside from a clinical setting. These can share new ways of working, introducing pharma to new insights.

The good news is that technology partners are increasingly taken into account on the side of healthcare. One of the main goals is to deconstruct internal processes for the benefit of the stakeholders. The experiences that other industries went through will help pharma trace its map to digital transformation.

In that sense, the FDA (Food and Drug Administration) has issued guidance on how to enhance clinical trial diversity. It promotes the broadening of the eligibility criteria for clinical trials. There is also a recommendation on the burdens that participants face when participating in these initiatives.

When it comes to the digital spectrum, the FDA is working on solutions to help companies integrate real-world data (RWD). This refers to data taken from:

  • Electronic records;
  • Claims; and 
  • Social listening. 

But to also consider real-world Evidence (RWE) and include it in the context of regulatory decision-making. 

These two forms of data can be a future substitute for a control arm in clinical trials and other studies.

What Impact Will This Have?

Actually, it has already begun having an impact on clinical trials as we’ve known them. Thanks to the pandemic, the concept of DCP (Decentralized Clinical Trials) came to the front. And new solutions, such as protocol changes arose. As a result, patients have reported a change in their participation.

Here, patients’ needs constitute, once again, a matter of consideration. According to Munther Baara, VP, Product Strategy and Innovation from EDETEK, one of the main points is to make protocol design and data collection flexible. The data can be collected in silos and analyzed in real time.

Of course, for this to succeed, the right people need to onboard in the process. That way, there can be a deeper look at the trials’ design. In the future, they can be fit to achieve better research objectives. Further ensuring a better design around the patients.

Pharma’s Digital Responsibility

According to a Reuters Events report, this is a change taking shape from over 20 years ago. In 2019, before the pandemic, electronic and paper case report forms were already the most common sources of clinical research data. Nonetheless, this changed from 2020 onwards. Now the use of remote and virtual support has increased significantly.

The presence of technological elements such as the following will have a greater role by 2023:

  • Smartphones;
  • Mobile health;
  • Wearable devices; and 
  • Electronic health.

These elements will become important sources of data and information for pharma in the coming times.

Here enters the matter of digital responsibility that pharma has. Not only are we referring to investment, but also to how this path to digitalization will be traced by the industry.

From the perspective of Cindy Hoots, Chief Digital Officer, CIO from AstraZeneca starting small while thinking big is a good start. She emphasizes the fact that pharma made a significant change in embracing the “new normal”.

Despite the progress, Hoots also adverts pharma companies to avoid becoming enamored with the word ‘digital’. More specifically, to look at technology as a new way of working. Thus it’s everybody’s responsibility to learn more about how tech evolution can impact the industry for the best.

Do you need to explain to the patients how a clinical trial will undergo? You can do it through a simple explainer video.

With the help of MedExplainer, you can explain the full process to the participants of a clinical trial in 90 seconds or less

Book a meeting with our team today to learn more.

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