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Reimagining Clinical Trials

Mohammed Ali, Global Head Digital Trials, Global Clinical Operations, Boehringer Ingelheim
Mohammed Ali, Global Head Digital Trials, Global Clinical Operations, Boehringer Ingelheim

Mohammed Ali, Global Head Digital Trials, Global Clinical Operations, Boehringer Ingelheim

One of the biggest hurdles within clinical development in the pharmaceutical ecosystem is the time it takes to get a drug to market. On average, it takes approximately 10 years to get a product to market; about 47% of that time is spent on the clinical development phase alone. During this time, it is also very possible that an organization may redefine success up to 5,000 times from discovery to approval before that one drug. Considering the horological investment needed, this translates to a tremendous amount of patient hours, which contribute to bringing of this new novel drug to market. Given this enormous partnership, it is pharma’s onus to help bridge this gap and accelerate therapies to ensure we can deliver for the true partners in clinical research- the patients.

The traditional clinical trial model entails pharmaceutical firms to work with CROs, or large academic research institutions, as well as leveraging internal resources, to identify and onboard sites to initiate study start. A complete global multi-site ramp up can take up to 12-24 months. Furthermore, statistics show that approximately 48% of the sites will fail to meet the recruitment targets. This is due to a myriad of reasons, such as the wrong population in scope, difficult inclusion/exclusion criteria, as well as lack of understanding trial needs by the site. However, one of the biggest reasons is due to access to a clinical research site, this lack of access is because less than 30% of patients live within 2 hours of a brick and mortar site. Furthermore, of the aforementioned 30% of patients, only one-third of them are aware of the existence of a clinical trial, and only 3% of patients from this population will participate in a trial. These are dismal figures when one considers the patient population in its entirety.

 Decentralized clinical trials (DCTs) are a novel approach towards the opportunity for participation in clinical research. DCTs will accelerate the speed of enrollment; data capture and study close out with broader access to patients and automation of data delivery 

Advancements in technology have accelerated patient’s access to information. Patients are savvier than they once were. They can now capture their sleeping patterns, steps completed in a day, food journals, heart rate, blood glucose levels, order medications, make appointments online (et cetera) - all at the swipe of a screen. They have the internet at their fingertips and information is available to them 24/7/365 in a matter of seconds. Patients have grown accustomed to, and expect, greater levels of access and convenience during their care journey. Pharmaceutical firms are incorporating the use of technology into many facets of their business to continue to be focused on patient-centricity.

Decentralized clinical trials (DCTs) are a novel approach towards the opportunity for participation in clinical research, for all stakeholders (principal investigators, subinvestigators, patients and research coordinators). DCTs allow for the site less development of a non-central investigator/coordinator network connected with mobile technology, digital health devices, telemedicine, and mobile nursing. They are said to bring the concept of what many physicians call the “medical home” to reality to the patients’ doorstep. Leveraging a DCT model, they help achieve this gargantuan task across the industry.

Bringing clinical trials into the patient’s home creates broader access for patients to the biomedical research process, creating a continuous culture of learning from patient experience within the participation in clinical trials. DCTs will accelerate the speed of enrollment; data capture and study close out with broader access to patients and automation of data delivery. This results in a study population that more closely resembles the real world, which currently is an issue in most research studies, as it does not truly reflect the adequate demographic distribution of patients that is representative of the population. It also ensures that our drug development process within the pharmacy industry remains truly patient-centric not in just operating it during development but also for the population it serves post-development into marketing.

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