Top 5 Trends to develop your decentralized clinical trial strategy

Mansha Kapoor
December 26, 2022

Technology today has shrunk the globe to palm size. How could Medicine have been left untouched and unevolved? The best that could have happened in the evolution of life sciences is Decentralized Clinical Trials (DCTs). This tool has effectively and thoroughly pushed the traditional clinical trial practices out of usage. During the pandemic, uninterrupted care of patients, research, and rapid advancement, all the while maintaining social distancing, could only have been done with the adoption of DCTs. Beneficial therapeutics were manufactured and brought to the market in a quick double time due to the above-mentioned.  

Definition of Decentralized Clinical Trials (DCTs)

Decentralized Clinical Trial (DCT) is very different from traditional clinical trials that do things in phases. Things evolve slowly and gradually before medicine can be okayed and put into production. It works in stages where- Phase 1 establishes drug safety and its appropriate dosage. Phase 2 would involve slowly increasing the dose. And phase 3 would have the engaged patient under observation for side effects and efficacy in curing an ailment.   A lot of time and energy is lost in collecting data from participating patients, for it is not beamed directly.  Specialist intermediaries are deployed explicitly for the collection of data from engaged patients. This results in time leaks. DCTs are very appropriately referred to as “direct-to-participant trials”. There is no intervention or involvement of any in-between person for patient engagement, delivery and administration of study medication, and acquisition of trial results between the study team and the patient or subject; as the volunteer is referred to.

These trials adhere to the following template:
  1. It considers the data collected from remote patients via telemedicine or telehealth. They rope in local healthcare providers for the delivery, and administration of the investigational product and specimen collection.
  1. Electronic systems, biometric devices, high-speed internet connection, electronic wearables, and digital health technologies are employed for patient recruitment and acquisition of their consent. 
  1. These trials can either be owned and managed solely by sponsors or outsourced by pharmaceutical companies to their vendors. The vendors then carry out the entire process of the trial, and patient-reported outcomes are assessed and incorporated.  The companies are responsible for the manufacture and marketing of the resultant therapeutics.

In short, Decentralized Clinical Trials can be summed up as clinical trials wherein technology and local healthcare providers ensure smooth and cohesive data flow from the recruited patients/volunteers/ study participants without any physical human intervention.

How far is Decentralized Clinical Trial Successful?

The trial sponsors are continually and consistently on a treadmill to make clinical trials faster and result-oriented. Many traditionally executed clinical trials have gone astray due to the time lag or lack of one-on-one with the recruited patient. Decentralization is a tool to increase the physician-patient experience quotient and to do away with the abovementioned issue. With this methodology, the entire algorithm of the trial is brought to the patient site rather than displacing the patient and bringing him to the trial site. 

The Covid-19 pandemic worked as a catalyst to fast-track the maturation of this tool in the therapeutic industry. It was enthusiastically and widely adopted as clinical trials increased manifold. The number of clinical trials and their activities could be conveniently carried out remotely and in the participants’ home premises. As health systems and the availability of healthcare workers are stretched thin by a leaping demand for Covid-19 related care, norms for social distancing put a hard stop to traveling. This, in turn, reduced patients’ presence at the trial sites by 80%. Data on the number of monthly trials start to show a decline of 50% between January 2020 to April 2020. In the face of such a big shutdown of clinical trials and investigations, a yawning gap would have disrupted the continuity of care, and data integrity had they not brought in remote consent and patient monitoring, videoconference assessments, and at-home phlebotomy. 

In 2020, Clinical registry protocols revealed that 673 intervention drug trials used decentralized and virtual components.  In 2021, the number jumped to 1011. This is expected to increase further by the end of this year, 2022. Some 1300 interventional trials were to have begun this year using decentralized and virtual components. That is a whopping 93% hike in numbers taking 2020 as the base year.

One can no longer be in doubt about the sure-shot success of Decentralized clinical trials.

Objectives of Decentralized Clinical Trial Software

The software and the virtual components are integrated to fulfill certain objectives of the clinical trials. Besides the pressure of delivering new treatments to the market against stringent timelines, things must be considered and brought together to complete the above successfully. 

  1. Accelerate Patient Recruitment - Global data and analysis are needed to identify and connect with the exemplary volunteers.
  1. Strengthen Patient Engagement - Patients can participate from wherever due to the concierge-digital experience. This reduces his burden and ensures the patient’s happy engagement. There are text reminders and alerts, live chats, and 24/7 support to help the patient with his queries. Lastly, a scheduling tool is in place for scheduling or rescheduling assessment conferences.
  2. Data Protection and Patient Safety: There has to be adherence to GDPR or General Data Protection Act. The Patient’s data cannot be leaked, and his medical records and responses are classified and can only be accessed by an authorized person.
  3. Reduction in Complexity and Trial Timelines: It has been proven, undeniably, that digitally enabled workflow process management and engagement platforms draw quicker results and reduce complexity in the clinical trial processes. They minimize turnaround time and ensure a lean timeframe.

5 Key Factors for Designing your Decentralized Clinical Trials

Decentralized Clinical trials are a pivot that swings a very agile model for developing therapies.  It should be lighter on the patients and more result-oriented for biopharmaceutical investors. However, incorporating this technology and its methodology is not a cakewalk, it is about adding another layer to an already complex process of clinical trials. There cannot be a plug-and-play model here, and some tools and devices need to be seamlessly integrated to ensure the success of the whole exercise. So to ensure and assure the successful completion of objectives, sponsors need to consider several key considerations before designing and conducting decentralized clinical trials.

  1. Importance of Simplification of the Process: A very robust Operating System is needed to conduct activities on-or-off premises. This should be able to maintain two-way access both for patients as well as providers. Expectations, objectives, and matrices should be clearly cited before an Operating System is quoted in the strategy formulation.
  1. Maximising Trial Efficiency:  A very proactive approach is needed to increase patient engagement and experience. Garnering and gathering patient input during the development process and using patient-reported outcomes would result in the effective closure of the trial.
  1. Requirement for an agile and flexible design: Decentralized clinical trials are more than just a one-size-fits-all approach. It is not a package that has to be implemented in its entirety. The sponsors should review what elements of the trial should be decentralized and which elements would be more fitted for site visits. A trial might have two arms to it. One would be using telemedicine to monitor and manage remote patients, while there would be site visits for advanced imaging to do an in-person review.
  1. Being Patient-centric: Being patient-centric means maintaining an unbroken dialogue with the volunteer, their personal and trial experiences, their preferences, any specific challenges that they might be facing, and most importantly, they are agreeable to using devices and apps, or they would be happier seeing a physician. So one has to determine the level of patient centricity.
  1. Configuration of technologies and networks: It is understood that each trial requires a unique configuration of technological and virtual components. Strategy and design would be necessary to tap the complete potential of DCTs. Biopharma companies conducting these trials would require technical expertise navigating components and regulatory frameworks.

8 Trends to develop and design your DCT strategy

When a trial fails, it results in inefficient drug development. In other words, fewer new drugs reach the market despite millions spent on researching and developing drugs and cures.  A major cause of this could be suboptimal patient recruitment. Along with this is the inability of the sponsor to coach and manage/monitor the patient effectively.  To help overcome these failures, a copper-bound design should be adopted. Trends to follow are:

1. Artificial Intelligence (AI):

Here, a machine simulates the human brain processes that include learning, reasoning, self-check, and rectification. It provides diagnostic decision support with the help of corroborating medical data and electronic medical records. A proof-of-concept of AI can be seen in its successful imaging for detecting diabetic retinopathy and skin cancer. It uses data Electronic Health Record Data to predict disease onset and even mortality. Conversational AI is currently used for sentiment analysis of the patient. The system decodes and understands the patient's spoken words and helps understand the patient’s feelings. This is being used in treating mental ailments.

2. Association rule mining:

These are ML algorithms for unearthing relations and connections between variables in large databases. Here it mimics the capability of the human brain to retrieve abstract associations amongst free unlabelled data. 

3. Brain-machine interface or BMI:

This is a direct, unhindered pathway between an external device and a wired brain. Also referred to as a brain-computer interface, a mind-machine interface, or a direct-neural interface.

4. Deep learning or DL:

It refers to the multiple layers that have to be transcended before data can be transformed and interpreted. It apes the human mind in its function to read and categorize raw input.

Deep reinforcement learning or DRL: This is used to build software that can take action when prompted by a particular environment.

5. Human-machine interface:

When a pathway is created for direct communication between a human and a device. It is a developed system capable of understanding and responding to human language-written or spoken.

6. Natural Language Processing (NLP):

This is used through conversational artificial intelligence in DCTs, and it picks up data from the patient during the trial. 

7. Internet of Medical Things or IoMT:

These will integrate multiple platforms. For example, an ECG device connected to a weighing scale, a blood sugar monitor, and a blood pressure machine are all on one platform. The patient's vitals will be monitored on one platform, which is extremely helpful in reaching a conclusion about the patient’s health and way forward. 

8. Preventive and Predictive Technology:

The former uses home tracking devices that alert the doctor about any abnormality in the patient’s vitals. The latter collects and collates the patient's medical history, producing the bigger picture. This is in terms of their risk quotient, precision medicine, reaction to a particular drug, or chemical composition. These predictions are powered by Artificial Intelligence and facilitate prevention rather than being solely curative. 

Final Thoughts

Modern technology has enabled the health industry to provide a more personalized treatment plan to patients, along with offering continuous monitoring and precision in the diagnosis. Your strategy for Decentralized Clinical Trials is incomplete without adding the aforementioned modern technological trends to your must-have list. 

Mahalo Health is here to supervise you, in planning and executing your Decentralized Clinical Trial strategies with the most user-friendly medical-grade digital health platform. From developing a companion app to personalizing patient care - our services can help you out with anything and everything digital health! 

Experience Mahalo's transformative platform. Book a demo today!

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