Improving the success rate of clinical trials

Clinical trials are costly and time-consuming. Since the Covid-19 pandemic forced many clinical studies to pause, decentralized clinical trials have emerged as a suitable alternative for recruiting patients, allowing participants to receive treatment at home. We take a look at what this approach involves.

According to research by Sanofi, around 70 percent of candidates for clinical trials live more than two hours away from clinical trial sites, posing a major barrier to recruitment. Trials that study children’s medicinal products can be even more challenging due to school absences and parents having to miss work to travel to the sites.

The Covid-19 pandemic, particularly in the first few months, had a particularly damaging impact on clinical studies, as many sites were closed and participants were unable or unwilling to travel due to the risk of infection.

Jennifer Jones-McMeans, Pharma IQ advisory board member and Divisional Vice President of Global Clinical Affairs at Abbott’s vascular business explains: “With many of the diseases that we develop therapies for, patients are challenged with leaving the house because the disease can be very disabling. But with Covid-19 not many patients want to go into the hospital,” she says.

Read the full report: How DtP can improve the success rate of clinical trials

As a result, an increasing number of sponsors began deploying decentralized clinical trials, also known as direct-to-patient trials, to ensure patients were able to receive medication and adhered to it for the duration of the study. Jones-McMeans notes that decentralizing clinical trials is “a game changer. I was at a clinical site recently, where a lot of the patients live in rural communities. They said the home visits have been the biggest selling point because patients don’t have to go back and forth.”

Patient-centric solutions

In 2017, Janssen Pharmaceuticals, part of Johnson & Johnson, began trialing a more patient-centric approach by providing transport to the site of a clinical trial. A year into the study, zero patients had dropped out; by comparison the average drop-out rate of clinical trials is around 30 percent.

Since the success of this pilot, Janssen has launched several direct-to-patient clinical trials to study how autoimmune conditions develop in high-risk individuals, by identifying and recruiting participants online, collecting blood samples from their homes and managing all aspects of the trials via a telemedicine platform.

While decentralized trials have many advantages however, they also present new logistical and regulatory challenges.

Neta Bendelac, Senior Director of Strategy at 4G Clinical, a randomization and trial supply management (RTSM) software provider, explains that in many cases the clinical trial coordinator is responsible for collecting patients’ contact details and passing these on to the courier assigned to ship the medication. “Linking the patient’s private data such as their address and telephone number with the system records would require them to look at a paper form each time. You can imagine how many mistakes can happen” she says.

Data and regulations

This system is neither scalable nor sustainable, as it makes it difficult to manually keep track of each shipment and when a patient’s medication is due. This was especially problematic during the height of the pandemic when demand for deliveries was high. “When there is high demand there is always a shortage of drivers,” Bendelac adds. “At the same time [during Covid-19] flights were limited. It added additional risk of something going wrong.”

Software solutions such as 4G Clinical’s, encrypt patient data and store it in a way that ensures it is only available when needed, to the appropriate people. “This saves sites and couriers a huge amount of time linking the right data together,” Bendelac explains.

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Another key challenge is the ambiguity of standardized regulatory guidance across countries. “That was the main challenge for pharma – how to make sure that all the different requirements are kept, allowing separate processes in different regions and yet are still simple to operate,” Bendelac says. “How do we ensure we are successful at keeping those patients on treatment and delivering drugs so they can keep using them per the protocol?”

There is also the issue of drug safety. While clinical trial sites employ staff who are trained to ensure the drugs they administer are safe and of high quality, the process is different when these are shipped to the participant’s home. Medication needs to be stored in the right conditions and taken in the correct dosage. There are currently discussions among industry groups to decide what is best practice while following new updated guidance.

Decentralized clinical trials require new technologies

The Covid-19 pandemic pushed many areas of the healthcare and pharmaceutical sectors to accelerate the adoption of new technologies. Implementing decentralized trials successfully requires a variety of digital tools including data-capturing apps and/or wearable devices, along with cloud-based platforms to securely store patient and clinical trial data.

Integration between different systems and devices is vital to accurately track patients’ adherence, capture data and help with decision-making should things go wrong. For example, a temperature monitoring system can provide live information relating to the temperature of the shipment before arriving at the patient’s home. If a temperature excursion happens along the way this can be easily detected and managed before the drug reaches the patient and any time is lost. This can also help save costs, particularly when the product is sensitive or has a short shelf life.

While there are still logistical and safety complexities that require smoothing out, digital technologies can provide a robust, patient-centric model for decentralized clinical trials. Improving recruitment and retention of participants will increase the success rates of clinical trials, reducing a major barrier to drug development.

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