Digital Clinical Trials

A combination of Blockchain and IoT in a solution is considered a happy marriage with AI-ML being cherry on the top. In the below text I will try to highlight how digital technologies like Blockchain, AI-ML and IoT can streamline the current process of Clinical Trials.

Introduction

Clinical Trials have been an important part of the human history as well as evolution. They have been around since the beginning of civilization I believe but history marks the start of systematic trial in the middle of 18th century. The technology has advanced by leaps and bounds since then but the clinical trial methods haven’t been able to keep up the speed.

The current process is so complex that the Pharma companies employ CROs (Clinical Research Organizations) to conduct a clinical trial for the drug they have created. Even with the help of these specialists, it can sometimes take more than 10 yrs to finish trial of a medicine before it is deemed fit for mass usage. This has reduced to some extent in the recent years with the usage of latest digital technologies but it still remains quite a daunting task.

Primary Actors

One of the primary reasons for this complexity is the number of different actors involved to make a trial happen. To list the most important ones

• Pharma Company
• Clinical Research Organizations
• Hospitals
• Regulatory Authorities
• Doctors
• Individual Participants (ranging from a few to few thousands)

Major issues

Other than the complexity of the actors clinical trials also faces the below issues

• Maintaining a paper trail for all the activities happening during the course of trial.
• Proving the efficacy of drug on different types of population across the world
• Patient recruitment and retention remains one of the top factors influencing the overall cost to conduct the trial
• Getting the hospitals to come onboard and retain them for the duration of trial
• Data security to avoid misuse

The list can go on and on. However, we have seen some major advancements in technology which can simplify the process overall.

Opportunity for Digital Technologies

• Mining data in new ways to better select the patients populations to be
  enrolled in the trials using various AI-ML techniques available
• Using wearable and latest IoT techniques to capture patient data with an option for BYOD (Bring Your Own Device) for monitoring vitals
• Use Blockchain for data protection and privacy
• Blockchain could be used to monitor compliance, on part of all actors
• Using AI-ML to predict which patients are likely to drop out early and who are more reliable
• Incentivizing the participants using a Blockchain based token
• Using IoT to monitor patients and advise patients to take the dosage of medicine. Various innovations happening in this area.
• Using Blockchain to integrate the disjoint applications used across different hospitals and other participant organizations

Conclusion

Speeding up a clinical trial can save millions for the Pharma companies and as we can see the possibilities are limitless. The regulatory bodies are also opening up to the use of Digital technologies which is a very good news for people working in this domain.