The new fashionable kid in the world of clinical trials is obviously DCT aka the Decentralized Clinical Trials. Like other dormant trends which catapulted in Covid, DCT startups attracted tons of venture capital money and every Big Tech wants a piece of the pie as well. So is DCT just a fad or is it the future of clinical trials? Here is my unbiased (Okay, slightly biased) view. Clinical trials as an Industry has been predominantly site focussed. This means the onus has always been on the site to screen, recruit and engage patients and also ensure a patient completes the trial successfully. Sites usually courts Sponsors and CRO’s with great promises and most of them don’t live up to it. Studies show 80% of clinical trials are delayed by at least a month and one-third of sites don’t enroll even a single patient. The magnitude of the problem will make more sense once I put a monetary angle. A sponsor typically spends north of $2B (yes it’s a B) and ten plus years to bring a drug to market. An approximate 75% of that time and money is spent on clinical trials. The cost adds up as trials get delayed and the opportunity cost of even a day's delay can be up to $6M. Moreover, losing a patient also means losing valuable data. Once a patient drops out of trial, the data collected from them is no longer valid, and the process will need to start again with a new patient. Ultimately all this means delayed access to life saving therapies. So, The BILLION $ Question - can DCT’s really solve this problem? Before we go there, Let me clarify that DCT doesn’t mean getting rid of sites. There are different flavors of DCT and the type of DCT is usually dictated by the type of study and the protocol design. For example an oncology study with expensive treatment devices is heavily site based versus a post marketing obesity study could be hybrid or a site-less trial. A hybrid trial participant could use a nearby health facility or Telehealth instead of a centralized site and could use devices such as wearables instead of an investigator manually collecting data at sites. So now let's talk about the Good, the Bad and the Ugly of DCT
THE GOOD
Sponsors can now recruit patients from anywhere and the patient's distance from the site is not a hurdle anymore. This is such a boon in case of trials for rare diseases where there is a very limited patient population.
Improved patient engagement as protocols can be designed to flow with patient lifestyle which also increases success rate for therapy completion.
Collecting patient data from devices such as wearables from home mimics a real world setting compared to collecting data from a controlled environment like sites. So improved access to Real World Data (RWD) and Real World Evidence (RWE)
THE BAD
Sponsors will now have a significant role in recruiting, onboarding and engaging patients as the dependency on the site reduces, This has traditionally been the forte of sites and relatively a new area for sponsors.
Delivering drugs and devices directly to patients brings a whole gamut of logistical and regulatory challenges compared to delivering to sites.
Trial subjects might end up interacting with multiple HCP’s like getting an MRI from an Imaging center, blood drawn from a local pharmacy and medication administered by a home nurse and so on. The patient record is now spread across multiple EMR’s and good luck trying to get a single view of the patient record.
THE UGLY
Sponsors and CRO’s legacy systems are already struggling to collect, harmonize and manage clinical data coming from a few hundreds of Sites.
The data collection points now moves from hundreds of controlled sites to multiple thousands of touch points. Also add other complexities such as drug delivery, medical device management, data privacy, regulatory challenges, etc.
Now imagine how the legacy and outdated clinical operations platforms are going to handle this new DELUGE OF DATA.
So, WHAT the heck is my opinion? TLDR; DCT’s are not just a hype and here to stay. Sponsors have learnt their lesson the hard way when they had to stop 70% of site based trials when Covid hit. They need to future-proof their trials for disasters and shutdowns. So it's better to embrace DCT sooner, However they also need to start thinking about the “Data Deluge” problem when they architect their next gen Clinical platforms. Few think they can circumvent this problem by dumping everything into a data lake, BUT how are you going to marry your data in the data lake with your outdated legacy clinical systems? As I say in my other articles, “Modern day problems need modern day solutions”. The next gen clinical platform needs to incorporate an efficient harmonization platform that can ingest and harmonize the external deluge of data from devices, social media, etc with your existing systems of record (CTMS, eTMF, EDC, etc). This way sponsors can reap the benefits of DCT quickly without having to rip and replace their existing investments. ------------------------------------------------------------------------------------------------------ Subash Rajavel is the founder and Chief editor at xGenom. He has 15 plus years of experience in Health care and Life Sciences. His primary focus are Patient centric solutions, Digital Health and Next-gen Clinical Trial solutions.
You can reach him at subash@xgenom.com
Comments