By Howard Johnson, head of practice, CRO & Vendor Services at RBW Consulting
From concept to clearance, clinical trials are typically long, complex, and expensive, and they’re only getting more so. From 2015 to 2020, the number of registered clinical trials nearly doubled from 181,000 to 326,000. With this increase in volume came an increase in cost – the EMA estimates that the average cost of bringing a drug to market doubled from 2010 to 2018.
The complexity of clinical trials has also increased, with one study pointing to lower patient recruitment, longer study durations, and high error rates drawing out trials.
The triple threat of complexity, frequency, and cost means that the big challenge for life sciences companies is finding a solution to make trials cheaper and more efficient, while maintaining high standards of patient safety. The life sciences industry’s digital transformation has provided the tools to overcome many of the industry’s problems and has unlocked new avenues for the role of tech in clinical trials. Going forward, clinical execs can use tech in a multitude of ways to power clinical trials.
Go Remote For Your Clinical Trial
The bulk of clinical research has traditionally been rooted in face-to-face interactions between physicians and patients. Ensuring patient satisfaction and retention in the trial has typically been a task for patient-facing clinical execs. However, conducting trials remotely, either entirely or through a decentralized hybrid model, can bring major benefits through cost, efficiency, and convenience, while maintaining patient engagement levels.
But maintaining patient engagement isn’t enough on its own; engaged patients still drop out of trials. The real benefit of decentralizing your trial with a remote element is the flexibility for the patient. Major factors in trial complexity are dropout and retention rates, of which the financial impact on the patient was a notable influence. Trial participation can often be expensive due to time off work, unexpected side effects, and travel time. In turn, this can lead to patients dropping out and leaving incomplete data sets.
Through remote site access and virtual communications platforms, clinical execs can avoid these pitfalls. Patients are empowered to participate in trials on their own terms, without sacrificing the efficiency of the trial – patients can fill out evaluations and maintain a video connection with their HCP on a flexible basis. Through all of this, remote site access can ensure the sponsor, CRO, and research site are fully connected.
On top of this, remote trials allow participation from some of the most vulnerable patients. In particular, this includes people with low mobility or with chronic illnesses, who would previously struggle to travel to a research site. By bringing this comfort and accessibility to patients, sponsors and CROs are able to offer a better experience with minimal disruption when looking to recruit patients, potentially increasing enrollment rates.
Switching to a fully remote clinical trial can be a costly affair, and CROs will need to be trained in new processes, systems, and engagement models before they make the switch. But offering a form of hybrid, a decentralized trial can allow teams to be flexible with their patients, while still gaining the benefits through engagement and patient comfort.
Stamp Down On Non-Adherence
Medication non-adherence is a costly problem in the life sciences industry, both in terms of finances and the potential impact it has on patients. From poor communication between the clinical exec and the patient, to forgetfulness and cognitive conditions, there are a variety of reasons why patients don’t take their medication.
Non-adherence is less of a concern in controlled medical settings such as hospitals, due to the proximity of a doctor. Tech can help bridge this gap to replicate it in decentralized trials. This doesn’t have to be complex: One study showed that a simple text message can double the odds of medication adherence.
Naturally, a text message doesn’t quite count as "cutting edge" anymore, but recent advancements in med tech have brought new opportunities. Through wearable medical devices, patients with cognitive impairments can receive regular updates reminding them to take their medication and track when it’s done. Additionally, informal care givers can be provided a greater role in the conversation. As often the most trusted point of contact for the patient, their involvement can encourage medication adherence.
Clinical execs and physicians can also use virtual engagement platforms and flexible consultation forms to maintain a strong dialogue with their patients. One of the major concerns of decentralized trials is that the patient may feel detached from the process. Virtual engagement platforms can bridge this gap and build trust throughout the process.
Streamline Data Practices Across Research Sites
With remote clinical trials comes the need for increased efficiency in data practices. Streamlining the way data is collected, stored, and shared will be at the forefront of the move away from on-site trials.
The challenge for research sites spread across multiple locations is to have an electronic data management strategy that gives CROs and sponsors access to a fully integrated set of data in real time. Typically, this is done manually and as a result is time-intensive, complex, and open to human error. Sponsors looking to improve this further will have their eye on new research into cloud-based data integration platforms that can process data from multiple sources. The aim is an interactive solution that provides easy access to data sets for sponsors and CROs, allowing them to make actionable insights into the clinical management process.
This doesn’t mean trial teams will be able to pay for software and have the job done. But instead of more laborious forms of data collection, they can now focus their time on compliance and analysis of the data.
CROs are constantly adapting to overcome the disruption of the last year or so. This has led to a rise in vendors offering decentralized trials and specialist e-clinical vendors coming to the forefront of trial innovation. With new advancements in remote monitoring, data practices, and remote trials, sponsor companies and CROs have an increasing wealth of tools at their disposal to make trials safer, more cost effective, and more suited to the clinical landscape of 2021.
About The Author:
Howard Johnson is head of practice, CRO & Vendor Services at RBW Consulting, specialist search consultants in the life sciences space. Throughout his time at RBW, the CRO world has exploded with service producers coming to the forefront of the pharmaceutical industry, making them hugely important to the clinical development process. Recognizing this importance, Johnson has now grown a practice whose primary goal is to service the global CRO and vendor services market.