It’s nearly impossible to overstate the importance of clinical research, especially as we dig our way out of a global pandemic—a feat we’re accomplishing, in large part, thanks to clinical trials involving tens of thousands of participants. Whether they’re designed to uncover the next blockbuster drug, test new ways to diagnose a disease early or shed light on existing therapies, these trials play an invaluable role in spearheading medical breakthroughs, and ultimately, saving lives.
Despite their significance, clinical trial practices haven’t exactly kept up with the times. While the coronavirus has accelerated the pace of change, the real challenge facing life sciences companies will be sustaining this momentum and future-proofing their methods in the long term. Although COVID-19 was the spark that seemingly lit the match, there are other catalysts that fueled the fire long before terms like “social distancing” and “PPE” became part of our popular lexicon.
A lack of diversity among trial participants, for one, is a major driving force behind the need for change—specifically, changes in how and where trials are conducted and how both patient-centric and commercial supply chains are structured to support them. As things like personalized medicine and decentralized (aka remote or site-less) clinical trials rise in popularity, so does the need for direct-to-patient (DtP) distribution. The commercialization of cell and gene therapies is also making an impact on drug development, production, distribution, and consumption. Based on the current pipeline of cell therapies, it’s likely that approximately 10-20 advanced therapies will be approved by the Food and Drug Administration (FDA) each year until 2025. The commercial success of advanced cell and gene therapies is sure to test drug developers’ abilities to sustain the supply chain while mitigating risks.
Another driver for this patient-centric approach is the shift many companies are making from B2B to B2C. This is a growing trend in the medical device industry, where everything from genetic tests and heart-rhythm monitors to hearing aids and diabetes test strips can be produced and shipped directly to patients in need. These advancements undoubtedly make life easier for patients and participants, who can access care and partake in clinical research from the safety of their own homes. But what does it mean for the wide swath of care providers, biopharmaceutical firms, contract research organizations (CROs), manufacturers, distributors, investigators, and funders and sponsors of trials? For many, if not all of them, it means adopting a whole new way of working.
Before you charge ahead and start restructuring your operating model or R&D supply chain, it’s important to consider what the transition to a patient-centric model will look like for your organization and who should be involved in the process—if you haven’t already guessed, this shift requires quite a bit of input and effort from a lot of stakeholders. We’ll help you begin to wrap your mind around the nuances, big and small, that you should consider when making the move toward a more patient-centric approach.
Stakeholder Collaboration and Coordination
In the wide world of clinical research, everyone’s got a different role to play. It truly takes a village to get a trial up and running, which is part of the reason the process has remained sluggish despite advancements in clinical science and technology.
Collaborating to drive change, proactively identify obstacles, and encourage adoption is a must, and it’s a necessary common goal for anyone directly involved in the clinical trial process. Understanding each key player’s top priorities will help establish how to coordinate these efforts.
Keep in mind that each member of the clinical trial community and commercial supply chain is responsible for serving different segments of the customer population, whether that’s pharma companies, drug manufacturers, or trial participants. Once roles are defined, it’s a matter of getting everyone in the same room to hash out which parties are accountable for each part of the process and who takes on what risk. What data matters to each of these key players? Who is responsible for sharing this data? Who will handle issue mitigation? An external partner can bring all of these stakeholders together to lead design strategies prior to launching new processes.
This will require a bit of experimentation on a small scale—through piloting one specific trial or type of trial—before making major modifications to your R&D supply chain. Ideating with different partners, prototyping, and testing things first will help to secure small wins that can then be replicated elsewhere.
Overcoming the Digital Divide
Regardless of a given clinical trial’s specific goal, participants should be the central focus, especially when it comes to patient-centric models. Historically, the onus has been on participants to spend time and money traveling to research sites. This might not seem like a big deal on the surface, but logistical issues make a noticeable difference: Nearly 70% of patients express interest in participating in clinical research; however, only 10% actually enroll—and 1 in 3 of those who do enroll drop out before studies end, citing the burden of time and travel.
Decentralized trials remove that barrier by allowing patients to participate from home, boosting trial participation and retention rates. This is good news for research institutions and patients alike, but it also adds a layer of complexity to an already intricate supply chain.
Not all clinical studies are as simple as taking a pill and monitoring symptoms, of course, and that’s where things tend to get tricky. The advanced cell and gene therapy supply chain is more complex than the traditional pharma supply chain, which has generated a need for technological solutions. Many patients aren’t used to managing the technology necessary to complete certain trials, some of which require sophisticated equipment, setup, and education on proper usage techniques. Nurses may need to make house calls, or telemedicine could be leveraged for instructions and support that can be provided via phone or video chat. Whatever the case may be, this new approach to conducting trials calls for crystal-clear communications and a robust change management effort.
Some organizations are better primed for change than others. Perhaps your company is in high growth mode, or maybe you’ve attempted to implement change initiatives in the past without much luck and unresolved, deep-seated organizational issues are showing up as resistance to change. If any of this sounds familiar, chances are you need to formulate a process for building change expertise internally to ensure your shift to a patient-centric approach is successful.
Providing Data Transparency for Patients
While the DtP distribution model makes life easier for patients, it also comes with a new set of challenges. For example, participants who are given a 48-hour window to return a blood sample may have anxiety about meeting these requirements. Will their sample arrive in time? How can they track progress and ensure they’re hitting key milestones? Access to an online portal can go a long way in alleviating these anxieties by allowing researchers to set expectations and enable patient engagement.
Data transparency has a positive impact on business outcomes, too. When you have the ability to track patient progress, you’ll gain access to better quality data. Supporting participants, designing patient-friendly systems, and giving them the tools they need to record their activity gives patients the transparency they’re looking for, and it gives research organizations insight into accurate data that produces results. A strategic partner with technology enablement expertise can help you design digital tools that accomplish this goal.
Preventing Operational Inefficiencies
Moving from a centralized to a decentralized supply chain often comes with some growing pains. Adding patients’ homes to the supply chain increases the complexity of getting product, equipment, and patient samples to and from the participant, creating risk around product or equipment loss and tracking transparency. The goal of DtP services is to reduce costs and increase patient access, but without the proper structure in place, inefficiencies can lead to cost overages and turmoil for patients and distributors.
That’s why it is essential to make your supply chain as resilient and agile as possible. To achieve this, your organization needs to have visibility into the supply chain to quickly mitigate issues and eliminate inefficiencies. Establishing a risk mitigation center, for instance, can help you tackle issues head-on before they cause capital losses or cost overages. It will also allow you to attain more accurate data from your supply networks while driving patient value.
Many organizations have already started harnessing the momentum prompted by the pandemic to make changes and improve their supply chains and operating models in support of patient-centricity. Decentralized clinical trials and advanced therapy options benefit each and every stakeholder, because when businesses are able to get their products and services to market faster, everybody wins—including trial participants and future patients. If your organization needs help getting started or accelerating progress, we’re here to help.