Clinical trial supply and logistics: what has been and what’s to come.

Global market changes

The shift to high-value therapies for rare and orphan diseases in the drug development pipeline has arguably driven the biggest changes in the industry over recent decades.

These therapies mean that trials are invariably getting smaller, products more expensive and manufactured in lower volumes, and they often unique supply chain challenges.

To give a rudimentary example, trial sponsors would traditionally overstock product by about 20% on overage to allow for flexibility in enrolment, retention and supply demand and just throw a lot of product in the bin when it wasn’t used. Now we’re talking about cell-based and biologic therapies with $10,000+ vials so enrolment and forecasting has to be better and so does the supply chain.

The FDA is also trying to offer more flexibility and reduce the amount of time it takes to get rare and orphan disease products to market.

Contract services providers in turn have had to become faster and more agile in our response to study demands to create and adopt new approaches and technologies. Automating trial supply through Interactive Response Technology (IRT), creating genuine patient-centric trial practices and adopting more flexible supply chain processes like Just in Time (JIT) labeling are just a few of the things we’re doing to drive innovation and continue improving our services.

Interactive response technology (IRT) and automating trial supply

The proliferation and adoption of technology has had a huge impact on clinical trials. 20 years ago, data gathering was done manually, using a lot of paper, spreadsheets and time – the introduction of solutions such as interactive response technology (IRT) has radically changed that.

Computer-controlled supply systems can now automate drug dispensing and manage site inventories a practice is becoming more common. It reduces waste within the supply chain and gives companies a tighter handle on the amount of drug used – making significant savings long the way.

Looking ahead, the clinical trials consumables market is set to grow at 5% per year between 2017-2021, and this will coincide with further evolution as trial managers seek to further improve efficiencies in trial processes by automating clinical trial supply.

The complexity of clinical trials increases exponentially when conducted across multiple sites. An increasingly proactive approach to managing clinical trial ancillaries has become a key driver for cost-saving in trials, and continues the trend toward automation.

Patient centricity

At the other end of the supply chain, we see the rise of patient-centricity. Through the internet, patients are now able to draw on the increasing influence of patient groups to become more involved in all aspects of their treatment and in clinical trials.

They’re forming support groups to discuss their disease with other patients and to share available treatment options. These support groups will very often continue long after the trial has been concluded.

The concept of patient-centric clinical trials – where the participants are active collaborators in the trial – is nothing new. Pharma and Biotech companies are leveraging mobile platforms and messaging to drive patient recruitment for them trials and then also to keep patients on track during the trial. Continuing to promote patient centricity, finding new and innovative ways to engage and inform patients, will improve the trial outcome for sponsors.

However, truly patient-centric trial practice is now really taking a step forward.

This can offer cost savings, improve recruitment and support patient adherence as mobile apps remind them about appointments when to take drugs and even provide personalized guidance.

Virtual pharma and clinical trials

We’re seeing virtual pharma start-ups being used to supplement the R&D programs of large pharma. Virtual companies are supported up by private equity and venture capital in the early phases of discovery development and even phase I trial with large pharma often stepping in when there are positive early results.

Clinical contract partners have had to become more consultative in their approach to support these virtual companies that often have no experience in developing and delivering clinical trials.

The downsizing of R&D departments in big pharma has also contributed to a proliferation of consultants in our industry. These independent consultants are highly sought after by smaller virtual start-ups, for their experience, connections and knowledge.

The push for patient-centricity is also forcing change in the virtual space. ‘Virtual clinical trials’ where patients are managed remotely using digital platforms mandate for direct to patient (DTP) trials and this poses a challenge to logistics providers. It’s becoming more common for nurses to visit patients in their homes and for them to use technology (smartphones) to record diaries and perform check-ins (Skype). Increasingly patients use their own devices – such as smartphones – to keep detailed diaries of their trial participation.

If the industry wants to move towards virtual trials as standard then the use of wearable and mHealth technologies will need more widespread acceptance. In recognition of this demand, significant steps have been taken as legislators focus on tackling the current lack of regulatory guidance for their use.

In July 2017, the FDA’s Centre for Devices and Radiologic Health released its Digital Health Innovation Action Plan committing it to developing and implementing regulatory strategies and policies for digital health technologies. It follows from the European Commission’s Smart Wearables paper that discusses similar issues.  It’s only a matter of time before they start to be used but a more thorough understanding of their use and value among sponsors is needed if their potential is to be realized.

This trend will only grow and CROs, CDMOs and the like must accelerate the development of partnerships with patient services providers to ensure they can offer the more comprehensive services required.