Digital Health in Clinical Trials: Innovation in Gastroenterology

Digital Health in Clinical Trials: Innovation in Gastroenterology

Gastroenterology clinical trials play an important role in the collective effort to diagnose and treat gastrointestinal diseases. IVD CROs that developed experience in conducting clinical trials in gastroenterology and other areas of the healthcare sector also need to stay up to date with the latest technology developments. The implementation of digital health in clinical trials has the potential to improve research processes and contribute to public health.

In this article, we will give an introduction to gastroenterology clinical trials and to digital health implementation. Then, we will focus on how digital health can be applied in the field of gastroenterology and how using digital health can improve the outcomes of a clinical trial

Gastroenterology Clinical Trials

Gastroenterology is the field of medicine that studies the diseases that affect the esophagus, stomach, small intestine, colon and rectum, pancreas, gallbladder, bile ducts and liver, which are called the gastrointestinal (GI) organs. Some of the conditions studied and treated by gastroenterologists are colon cancer, hepatitis, peptic ulcer disease, colitis and irritable bowel syndrome, among others.

The global gastrointestinal drugs market is expected to reach U$D 86.96 billion in 2026, giving an indication of how active the gastroenterology field is. Gastrointestinal diseases are relatively common and considered by the Pan American Health Organization (PAHO) as causes of a high level of premature mortality in low- and middle-income countries.

Clinical trials are research studies conducted by medical device and drug manufacturers or Contract Reasearch Organizations (CROs) as part of the development process of new diagnostic tests and treatments. Therefore, gastroenterology clinical trials are the starting point of any advancements in the global effort to treat GI diseases.

Gastroenterology clinical trials include the planning and implementation of research studies which aim to attest the safety and efficacy of a new medical product to treat gastrointestinal diseases and conditions. For example, if a medical device company is developing a new endoscopy tool that has the potential of improving the diagnosis of gastrointestinal diseases, a clinical trial will be conducted before the device can be considered safe for use and compliant with health regulatory bodies regulations.

Clinical trials are complex processes that may involve literature review and equivalence with similar devices that are already on the market. Most clinical studies, however, rely primarily on data collected from patients who volunteer to take part in the study. Planning and executing a clinical trial might vary depending on the medical field, and gastroenterology also has its particularities. In the main section of this article, we will explore how using digital health in clinical trials can facilitate these complex processes. First, let’s have a look at the definition of digital health.

 

What is Digital Health?

Digital health refers to the use of digital resources, devices or platforms to conduct healthcare activities. This includes a very wide range of products and services, such as telemedicine, wearable devices, online resources, mobile applications and even virtual reality. During the global Covid-19 pandemic, digital health became more popular as it aided healthcare providers to continue working while keeping social distancing.

Digital health is not limited to online communication, though. Technology-enabled solutions are employed in all areas of healthcare, from pre-market clinical trials to remote symptom monitoring. As technology becomes more and more advanced and patients’ confidence in it grows, we expect to see even more digital health developments in the next years.

Digital Health in Gastroenterology

In the field of gastroenterology, digital technologies can also be used in many ways. After the pandemic, it became clear that digital health transformed the gastroenterology landscape. Virtual abdominal exams, for example, can be conducted through telemedicine. Patients treating digestive diseases can report symptoms and disease progression through online communication channels and get advice from doctors remotely and promptly, improving quality of life.

One major change in the gastroenterology practice introduced by digital health implementation is AI-assisted endoscopy. The advantages of applying Artificial Intelligence to endoscopy exams are to improve the detection of lesions and diseases with computer algorithms that are created with that aim, and to help doctors take quick decisions during the exam.

How Digital Health can Improve Clinical Trials in Gastroenterology ?

After an introduction to the gastroenterology field and to the implementation of advanced technology in healthcare, you are ready to dive deeper into the application of digital health in clinical trials, which are our field of expertise. In general, clinical research benefits immensely from the right use of online communication tools, data management software and remote monitoring devices.

This is true also in gastroenterology clinical trials. As we have seen, this field of medicine deals with GI diseases and any medical device manufacturer or pharmaceutical company must conduct clinical trials before having a gastrointestinal disease drug or device approved to be marketed. Digital health can be used to improve many stages of gastroenterology clinical trials.

Clinical Trial Planning with Digital Health

In our articles, we always highlight the importance of a carefully designed clinical trial plan. Digital health can be used to improve the first stages of a clinical study. Using existent data from previous gastrointestinal studies, Machine Learning (ML) can generate new study simulations, allowing researchers to optimize treatment development and predict barriers to be overcome.

Patient Recruitment and Engagement with Digital Health

Another crucial stage of a clinical trial that can be enhanced by digital health is patient recruitment and engagement. Social media can be used to optimize patient recruitment and reach only the people who might be genuinely interested in a gastroenterologist clinical trial. Moreover, tools such as eConsent and remote patient monitoring can improve the overall participant experience, reducing the burden on patients and increasing retention rates. If you want to know more about eConsent in clinical trials and remote patient monitoring, you are more than welcome to explore our articles on the subject.

Clinical Data Collection and Management with Digital Health

Machine Learning and data management software can also be used to improve patient data collection and analysis. Automating data capture and interpretation reduces the risk of human error and accelerates the process, allowing researchers to manage larger amounts of data in a shorter amount of time without losing quality.

These are some examples of how digital tools can be used in clinical research. The same way it can improve gastrointestinal healthcare (diagnosis and treatment), digital health can also improve planning and implementation of clinical trials. This includes the use of telemedicine to communicate with patients and remote monitoring, which are already becoming more popular, but also less known and more advanced tools such as AI and ML powered software to collect and analyze data.

Innovation in Gastroenterology Clinical trial

Recommendations to Implement Digital Health in Clinical Trials

In this article, we have shown how implementing digital health technologies can enhance not only gastrointestinal diseases diagnosis and treatments, but also the clinical trials which are necessary to bring innovation to this medical field subspecialty. We know that conducting clinical trials can be complex and adapting to new developments is not an easy task for everyone. This is why we would like to conclude this article with some of our tips on implementing digital health in clinical trials, based on our years of practice making the most of the newest digital tools.

  •  Trust the experts: to have the best outcomes, the team working in a clinical trial that relies on any kind of digital tool must include data analyst professionals and other specialists who are knowledgeable on the specific software being used.
  •  Fight lack of trust with transparency: not everyone, especially when we consider patients, will trust digital tools and online platforms to hold and process their data. This is understandable, as it might be something too new and that some people are not used to. Be as transparent as possible about how the data is collected and stored and ensure that patients know that you use safe and effective data protection strategies.
  •  Keep it human: chatbots and eConsent tools can improve patient recruitment and retention, but if overused they can also have a negative impact on participant engagement. Implementing digital health in clinical trials should be a balanced process that does not affect the patient-centric approach. Digital tools should be there to aid human communication and care, not to replace them.
  • Do your research: because this is a promising area that is likely to attract more and more researchers’ interest, there are already many digital health solutions available on the market. Before deciding on one, make sure to check how adequate to your clinical study it is and if it has been sufficiently evaluated and tested. Sometimes, other researchers may have already conducted studies on the use of a particular solution, and you can find articles which give overviews on their efficacy.

By partnering with an experienced CRO, medical device manufacturers and pharmaceutical companies can save time and money when conducting gastroenterology clinical trials.

Summary

  • Gastroenterology is the field of medicine that studies the diseases that affect the gastrointestinal (GI) organs.
  • Gastroenterology clinical trials are the starting point of any advancements in the global effort to treat GI diseases.
  • Digital health refers to the use of digital resources, devices or platforms to conduct healthcare activities.
  • Digital health has transformed the gastroenterology landscape.
  • It can improve gastrointestinal healthcare (diagnosis and treatment), as well as planning and implementation of clinical trials
  • Some recommendations when implementing digital health in clinical trials are to be transparent about data collection and prioritizing human connection.
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