eClinical Trial Management - Changing the Paradigm for Clinical...
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eClinical Trial Management - Changing the Paradigm for Clinical Trials to Find Newer Treatment Options for Patients

By Dr. Chirag Trivedi, Clinical Study Unit Cluster Head - India-South East Asia, Sanofi

Dr. Chirag Trivedi, Clinical Study Unit Cluster Head - India-South East Asia, Sanofi

Clinical trials are undertaken to find newer treatment options for the unmet medical needs of our patients.

Over the last two decades, use of technology in clinical trials has been continuously evolving. Initially, the adoption of technology wasn’t at a very fast pace as compared to some of the other industries like in the fields of IT, Finance, Banking, etc., but in the last 5 years, a significant advancement has been seen in its use for clinical trials. For sure, technology has made the designing, conduct, analysis and reporting of clinical trials better as well as faster.

Helping the Clinical Trial Protocol Designing

With more and more hospitals adopting digital technologies, like eHealth records (eHR), eConsultations, etc., the designing of clinical trial protocols have become more robust and data driven. Today, on the basis of the eHR data, protocols are designed to mimic the real world scenario for e.g., trial protocols are based on the patients’ disease characteristics. Application of technology has been helpful to evaluate whether a particular study design will be suitable for the intended patient population. Moreover, it also helps us to estimate the impact of any changes that we intend to introduce in the trial protocol. This has led to the study design being more robust, adapted to the intended patient population, and with lesser protocol amendments being introduced.

Boosting Clinical Trial Management Strategies

The conduct of clinical trials has been greatly benefited by the use of technologies. The clinical trial management systems that help in project planning, oversight, management, tracking, etc., have significantly evolved over the years and has added more robustness to the entire system.

"Artificial intelligence and machine learning is helping to write clinical study reports which helps in significant reduction in the overall timelines, while minimizing manual errors."

Significant advances are being made in the investigational product (IP) management too. Use of digital labeling of the IP is increasing which helps in its accurate tracking and accountability. Technology is also used to track the patient’s compliance to the IP.

Patient Reported Outcomes have played a significant role in evaluating some of the clinical trial outcomes. While digital patient diaries have been in use for some time now, use of wearables and other digital devices for measuring patient outcomes, has given it a completely new dimension. These devices have the capability of immediately transmitting patient data to his/her doctor. This helps in real time data availability, compliance tracking and more importantly, it helps the doctor to make timely interventions for any patient safety event.

With significant amount of data coming in from different digital sources, it is obvious that the role of big data analytics and artificial intelligence will increase. Over the last few years, risk based monitoring has gained significant importance in monitoring clinical trials. Based on the data analytics and identified risk triggers, it helps to focus immediately with timely interventions towards high risk areas. Moreover, it helps to take data driven decisions.

Artificial intelligence and machine learning is helping to write clinical study reports which helps in significant reduction in the overall timelines, while minimizing manual errors.

Enhanced Increased Patient Centricity

Patient is always central to whatever we do in a clinical trial. Digital technologies have helped the patients to get closer to clinical trials. Social media has played a big role in this. It has become easier for patients to find clinical trials for their diseases. Patients use their smart phones for connecting with the trial or their trial sites, for monitoring their health progress, for setting up reminders to take their study medications, or for reporting an adverse event.

Digital informed consent is increasingly gaining importance since it makes the informed consent process very easy and understandable for the patients. There has been a lot of data proving how digital consent is better in many aspects as compared to the paper informed consent. In this too, data analytics helps the doctors conducting the trial to understand their patients’ characteristics and to address their concerns, if any.

There have been some clinical trials, called as the virtual or site-less clinical trials, that has helped to move the trials to patients’ home. Sitting in the comfort of his/her home, all trial related activities are conducted at the patients’ home. The digitally labelled investigational products are shipped directly to the patient’s home and is digitally tracked. Patient data from digital devices is directly transmitted and recorded centrally, which is evaluated by the treating doctor who provides eConsultation and monitoring. While such studies have been done at a pilot level, this concept is rapidly evolving.

Where Do We Go from Here?

eClincial Trial management has offered very good benefits to the entire clinical trial process be it for enhancing patient care of for better trial design and management.

Technology is here to stay and its use is bound to increase. All stakeholders be it the Regulators, Doctors, Ethics committees, Pharmaceutical Sponsors, Contract Research organizations, patients, or civil societies, will have an equally important role in advancing this. Technology will definitely be an enabler to help us discover safe and efficacious treatment options faster and it will augment the human touch that helps to treat our patients!

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