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Facilitating complex clinical trial logistics for rare diseases

Doctor looking at lab specimen

Developing drugs to treat diseases creates opportunities to simultaneously address the urgent unmet medical needs of patients and access new markets.

This challenging clinical trials landscape for drugs continues to achieve new efficiencies due, in part, to streamlined regulatory processes, decentralized models and next-generation technologies — all supported by a flexible and evolving supply chain.

Putting rare diseases in context

Though individual orphan diseases are rare by definition, the 7,000 identified diseases collectively affect an estimated 25 million people in the United States and 30 million people in Europe.

The market impact of rare diseases and their available treatments becomes clear when considering return rates. Between 2000 and 2012, orphan drug companies had a 9.6 percent higher return on investment than non-orphan drug producers.

Orphan drugs can yield dramatic results and may provide a faster road to approval.

“There’s an opportunity to generate convincing clinical safety and efficacy data with very limited patient populations,” says James Wilson, director of the University of Pennsylvania Orphan Disease Center, “which means the cost of development would be a fraction of what it could be for more common diseases.”

Shift toward patient centricity

In general, the industry is driving toward more patient-centric clinical trials, with more options for patients.

"Between 2000 and 2012, orphan drug companies had a 9.6% higher return on investment than non-orphan producers."

Traditional trials, however, can present intrinsic logistical challenges, including small or geographically dispersed patient populations, which has led the clinical trials landscape to shift toward site-less trials or hybrid trials.

Marken’s direct-to-patient (DTP) clinical drug delivery and direct-from patient (DFP) sample pickup, combined with Home Health Care (HHC) services by a global network of licensed providers, facilitates these patient-centric trials.

Next-generation, patient-specific treatments and precision medicines are taking center stage, with DTP services offered as an option in many clinical trials occurring worldwide. These new models facilitate drug investigations and support more populations, but they impose new demands on the logistics of the underlying supply chains.

While all clinical trials pose challenges surrounding enrollment and retention of patients throughout the trial, recruitment is typically the most time-consuming phase of any given trial, with almost 80 percent of trials failing to meet initial targets.

Even once enrollment has reached its goals, 30 percent of traditional clinical trial participants drop out, nearly 20 percent of trials end before completion because of participation shortfalls and many trials take two or three times as long to complete as anticipated.

 Partnering with supply chain experts

Unlike traditional clinical trials, which require frequent patient visits to a central investigational site, remote clinical trials run using a virtual/hybrid model based in the patient’s home. This enables patients with mobility issues — such as the elderly or disabled — or patients who live in remote areas with limited transportation options to participate in the trial.

Virtual and hybrid trials using a DTP approach can make conducting clinical trials more cost effective. Implementing mobile technologies to support DTP trials can potentially reduce costs: 8 percent for phase I, 12 percent for phase II, 12 percent for phase III and 13 percent for phase IV.

Pharma companies are taking advantage of this new efficiency model, with DTP trials predicted to increase from 24 percent of all clinical trials in 2017 to 33 percent in coming months.

To truly facilitate such complex clinical trials, pharma companies and CROs must partner with supply chain organizations that manage intelligent, flexible networks that continually provide agile and adaptive solutions.

Enhanced technologies

As clinical trials and tracking software become more sophisticated, so has the support infrastructure for documentation, processing, randomization, communication and supply management fundamental to decentralized clinical trials. Notable innovations include wearables, mobile apps, Interactive Response Technology (IRT) and e-Clinical Outcome Assessments (eCOAs).

"Remote clinical trials run using a virtual/hybrid model based in the patient’s home."

One clear benefit of these technologies is improved patient adherence. Companies are focused on bringing the lab into the real world with a host of mobile tracking products.

Sensing technologies are now capable of tracking bioparameters regularly monitored in trials such as heart rate, glucose levels and blood pressure — any unusual activity or metabolism changes are then flagged by artificial intelligence.

Mobile platforms can track adherence through facial recognition algorithms. After patients submit a video of themselves swallowing a pill, artificial intelligence can validate that the correct patient has taken their prescribed drug.

Incorporating mobile technologies into trial design can also boost retention of clinical trial participants. According to decentralized technology provider Science37, known for its strategic alliance with Novartis, the firm’s virtual trials boast an impressive 97 percent retention rate and are completed 30 faster than traditional trials.

The promise of personalized medicine

In the age of personalized medicine, the Marken network is designed for patient-centric trials.

The complexities of a global DTP/DFP program — particularly in the last mile — require a supply chain solutions provider with the ability to anticipate potential points of risk.

"Marken works closely with global partners to provide full chain of custody and identity for every trial."

Marken is a leading provider of DTP/DFP services, managing a large portfolio of 360 DTP trials over the past 24 months, including global trials with more than 20,000 patients. Marken is experiencing continued growth of client requests for DTP/DFP and HHC components for new clinical trials.

Next to home-based trials, the industry’s other major focus is cell and gene therapy trials. In response, Marken has expanded our cryogenic (liquid nitrogen) service locations to nine facilities globally. We are the chosen provider for the past five years for global cell and gene trials and work closely with global partners to provide full chain of custody and identity for every trial.

To read the complete article, click here.

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