Brad Hightower, CEO, Hightower Clinical

Craig Mooney, VP, Scientific eTech-Enabled Services, Calyx

In an earlier blog, we addressed the questions sponsors should ask before embarking on a Direct to Patient (DtP) drug shipment strategy as a component of decentralized clinical trials (DCTs).

Here, Craig Mooney interviews Brad Hightower to understand the investigative site’s perspective on implementing a DtP approach to clinical trial supply shipping.

Craig: What is a site’s perspective on IRT, in general?

Brad: At the site level, IRT is one of the most overlooked aspects of a trial, and that’s a good thing (compared to other solutions like eCOA, EDC, etc. that can cause pain points). I press a button, it gives me numbers, then I grab the assigned drug. I don’t know what’s happening in the background that makes it work.

Craig: That’s the idea with IRT – to make it as easy in / easy out for the site as possible. It’s easy to over engineer and I think sites want simplicity. Building on this, what do you think that looks like for DtP shipping?

Brad: It depends on several factors. For example, will patients now be expected to bear some of the burden that sites normally incur, in terms of IMP accountability, logging shipments and temperatures, etc.? If so, that’s not a patient benefit. If we keep the same paradigm, but just change the method in which we do it, it’s not necessarily a win for anybody.

Understandably, a DtP approach might sometimes eliminate an investigative site trip for a patient, but ultimately, how much is that moving the needle in terms of trial efficiency, subject retention, or drug adherence? I don’t know that those things are clear yet. Personally, I don’t know that I see a great advantage.

“If sponsors and IRT vendors keep having conversations about DtP with sites, we’ll see evolution at a much quicker pace.”

– Brad Hightower, CEO Hightower Clinical

Craig: In one decentralized approach, sites would need to become logistics organizations to get product to patients. Did you notice this during COVID? How much expertise did the sites in your network have with shipping to patients?

Brad: Depending on the site model, the logistics can be easy or difficult. But it’s important to consider the landscape of sites right now. In a lot of ways, we’re moving away from huge institutional sites toward more community partnerships, smaller networks that can reach underserved areas. A lot of these places won’t necessarily have the built-in infrastructure to manage logistics.

Also, there’s some wariness from sites regarding who’s responsible if something goes awry. We all know shipments get delayed, delivered incorrectly, or even stolen from porches. When that occurs, who bears the responsibility? These are the kinds of things that must be considered.

Craig: Another approach is where a courier delivers study medication directly to patients. Have you seen this in practice?

Brad: I’ve not seen that personally. But obviously a third-party courier approach raises other questions regarding PI oversight. In this scenario, it’s completely out of our hands because we never touch the drug and can’t ensure that the patient receives the right package. Sites get anxious when things shift away from our control. And we all want to help increase access to get more patients involved, but where’s the middle ground?

Craig: You mentioned the possibility of fewer site visits. Do you think that really is a benefit to most patients?

Brad: I think some patients appreciate not having to lose half a day to come into a site, sometimes just for drug. But I think a lot of patients like coming to the site and that shouldn’t necessarily be overlooked.

Craig: Agreed. If we’re running DCTs to be more patient-centric and to expand access to more patients, then we need to be flexible to meet the individual patient’s wants for each visit. And the IRT system would need to accommodate that type of flexibility. Do you agree?

Brad: I think that’s probably the ideal, but it depends on the study design. If the patient is only coming in for IMP (no blood draw or physical exam needed), then yes, let’s shift that visit away from the site. I’m just not confident that there are systems that can account for this level of flexibility today.

“If we’re running DCTs to be more patient-centric, we need to be flexible to meet the patient’s wants for each visit.”

– Craig Mooney, VP, Scientific eTech-Enabled Services, Calyx

Craig: Let’s turn to data protection. Consider the model where the order from the IRT to the depot is patient-specific and to be sent directly to their home. They receive the order, package it, and arrange the delivery. In this situation, third parties now have access to PII they haven’t had in the past. How will patients feel about their PII being given to another organization?

Brad: I’d say that while some are worried, others might not be concerned. We cover a lot of this throughout the consent process and there are questions like where is my data going? Who’s going to know I’m in this trial? Those are legitimate questions that must be addressed to remove patient concerns.

And when you’re talking about their medical data it could get very uncomfortable. That is certainly a legitimate concern that could turn patients against the DtP option or even the trial all together.

Craig: What are your thoughts on the use of RV/mobile units for site visits, especially for delivery of investigational drug?

Brad: I love the idea if the model shifts toward sites offering this, as opposed to a third-party provider. That way, it’s my staff, the same staff the PI and the patient knows. And in that case, I think it makes perfect sense for investigational drug delivery to be a part of that offering. Although, in fairness, not every site is going to be able to do this.

Craig: What is the biggest challenge in this space?

Brad: The biggest limitation with DtP and decentralized trials in general is that we lose some touch points with the patients. Coordinators appreciate having multiple interactions because that’s what keeps patients engaged and compliant, whether that be filling out a diary or taking their medication every day.

Craig: Any final advice on the subject?

Brad: I encourage sponsors and vendors to talk to sites, not make assumptions about what they want or how they operate. And I’d suggest educating sites about how the IRT works, because it’s not always clear to us. Keep having those conversations and I think we’ll start to see evolution at a much quicker pace.

Expertise in medical imaging, IRT, and EDC solution delivery to benefit ProTrials’ worldwide customers

Nottingham, England and Morrisville, NC – March 21, 2022 Calyx, the eClinical and Regulatory solutions and services provider relied on for solving complex data challenges in clinical research, today announced it has been named an approved partner by ProTrials Research, Inc., a mid-sized full-service clinical research organization (CRO) specializing in delivering clinical operations services to the pharmaceutical, biotechnology, and medical device industries.

“We’re pleased to partner with Calyx and are confident that our customers will benefit from the scientific, medical, and clinical expertise they have honed during their 30 years of delivering reliable eClinical solutions to the clinical development industry,” said Christy Meyer, Director, Quality Assurance, ProTrials.

The partnership enables Calyx to extend its proven medical imaging, interactive response technology (IRT) and electronic data capture (EDC) solutions and services to help ProTrials’ worldwide customers achieve their clinical development objectives. ProTrials’ clients will leverage Calyx’s innovative technology to improve the reliability of clinical trial outcomes data, ultimately enabling them to deliver safe and effective medical treatments to patients in need.

“We look forward to delivering the important imaging and eClinical data ProTrials’ customers rely on as they evaluate the safety and efficacy of often life-saving medical treatments,” said Elizabeth Dalton, Vice President, Technical Solutions, Calyx. “We’re honored that ProTrials selected Calyx to support them as they deliver on their commitment to improve the health and extend the lives of patients worldwide.”

Click here for more information on how CROs – and their clients – benefit from partnering with Calyx.

About Calyx

Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and 30 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day.

Medical Imaging | IRT | CTMS | EDC | RIM

Take your trials further with intelligent insights at Calyx.ai or at LinkedIn, Twitter, or Facebook.

About ProTrials Research, Inc.

ProTrials Research, Inc., is a mid-sized full-service clinical research organization (CRO) headquartered in Los Gatos, CA, with clinical operations personnel located throughout North America and across the world. Since our launch in 1996 as a woman-owned business, we have been driven by a shared commitment to provide outstanding service to the clinical research industry. To this day, that commitment remains our guiding principle and is reflected in our high-repeat business rate. ProTrials works with sponsors in the pharmaceutical, biotechnology and medical device industries to deliver high-quality clinical operations services such as study management, investigative site monitoring, grant services, project and program management, biometrics including biostatistics, pharmacovigilance, and associated clinical development services. Our operations support expands into Europe, Asia-Pacific, and Latin American countries. To learn how ProTrials Research, Inc., can help advance your clinical trial success, please visit us at www.protrials.com or call 650.386.7712.

Contact:

Christine Tobin | [email protected] | +1 412-628-8598

Depth and diversity of Calyx scientific and technical teams’ experience extended to ClinChoice’s worldwide clients

Nottingham, England and Morrisville, NC – March 7, 2022 – Calyx, the eClinical and Regulatory solutions and services provider relied on for solving complex data challenges in clinical research, today announced it has been named a preferred provider of medical imaging and eClinical solutions by ClinChoice, a leading full-service clinical research organization (CRO).

“We chose to partner with Calyx due to their tenured scientific, medical, and technical teams who possess a depth and diversity of experience in providing reliable data outcomes,” said Tiepu Liu – President, Global Biometrics, ClinChoice. “We’re pleased to name Calyx a preferred partner and know our customers will benefit from their proven approach to optimizing clinical research.”

ClinChoice is committed to providing deep domain experience through reliable partnerships in support of clinical research trials around the world. As part of this partnership, ClinChoice will offer Calyx’s Medical Imaging and eClinical solutions to their pharmaceutical, biotechnology, medical device, and consumer product clients.

“We’re honored that ClinChoice chose to partner with Calyx,” said John Blakeley, Chief Commercial Officer of Calyx. “We look forward to a long relationship and to delivering the high-quality solutions and reliable services their worldwide customers have come to expect from this leading CRO.”

Click here for more information on how CROs – and their clients – benefit from partnering with Calyx.

About Calyx

Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and 30 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day.

Medical Imaging | IRT | CTMS | EDC | RIM

Take your trials further with intelligent insights at Calyx.ai or at LinkedIn, Twitter, or Facebook.

Contact:

Christine Tobin | [email protected] | +1 412-628-8598

We have talked on many occasions about how IRT can help sponsors reduce the cost of drug management, by applying clever settings that reduce the amount of drug shipped to sites. One of those advanced IRT settings enables the management of pooled medication across trials that use the same compound(s).

Medication pooling is possible when more than one protocol operating at the same depot and/or clinical sites uses the same medication. Not only is it a good way to reduce medication wastage, but it is also an effective solution to address availability (scarcity) concerns or other restrictions that affect the supply of medication. When considering sharing medication across trials, sponsors have the option to apply medication pooling at depot level or at site level.

Sylvain Berthelot - Increase your Chance of Diverse Clinical Trial Enrollment through IRT

“Medication pooling is a good way to reduce medication wastage and to address availability concerns that affect the supply of medication.”

— Sylvain Berthelot, Technical Solutions Director, Calyx

Depot vs site level pooling

Depot and site-level pooling have different supply chain and IRT setup considerations. The level where the pooling takes place will impact on kit labelling, depot supply management, and site supply management. Both levels also provide different savings potentials, site pooling offering the highest medication savings.

In simple terms, depot medication pooling consists of managing medication across trials at the depot but having protocol-specific medication at the site (even if the kit types are identical). On the other hand, site medication pooling results in managing medication across trials both at depot and site levels. The latter solution is always felt to be the best approach, however determining the size of the one pooled stock for all events in the group of studies could be complex.

How does IRT help?

Considering that it controls what medication is shipped from depot to sites, IRT plays a crucial part in the setup of medication pooling. In fact, IRT is one of the key enablers of medication pooling: it allows the use of the same medication across multiple trials, and it ensures each single trial “sees” the same pooled stock quantities, statuses, and locations. Maintaining those records accurately and in real-time is crucial to avoiding conflicting information and orders between trials. As such, IRT is a safeguard preventing issues in a medication pooling context.

Clinical supply managers will be wondering how supply strategies are managed in IRT. It will depend on the type of pooling applied for the program:

Depot-level pooling


When the IRT generates a new shipment request for a certain site, the medication selected to fulfil that shipment request is not pooled anymore, it becomes protocol-specific. This means that site supply strategies are applied at each trial independently and the IRT does not consider if the site already has medication of the same type that may have been shipped for another trial.

Site-level pooling


Shipment requests from depot to site take into account the needs across all the trials for which medication is pooled, so supply strategies should be built with this concept in mind. Supply strategies do not need to be identical across trials, although it may be useful to define the same strategy that works across the program. Our recommendation is to consult with an IRT expert to define the right strategy depending on the trial and/or program needs. With site-level pooling, adding a trial to the pooled program may require amending existing strategies for other trials in the program depending on how they have been setup.

In both scenarios, the resupply algorithm can still include patient-focused predictive supply to cover the needs of ongoing patients across the program.

The definition of supply strategies becomes more complex if protocols include both pooled medication and protocol-specific kit types, or if the sourcing strategy varies between kit types, with some medication being locally sourced, and others sourced centrally. Thanks to their extensive experience in clinical inventory management, Calyx supply management experts understand and apply the best practices that help sponsors adapt to any requirements.

Conclusion

Both depot level and site level pooling options can help reduce drug wastage and study-specific supply management oversight, the site level solution being the most effective. These solutions will not apply to all programs, as there is a need to have sufficient overlap in same kit type requirements across protocols for it to be beneficial.

Sponsors also need to consider the impact on labeling and should refer to regulations in force across all countries included in each trial to make sure they follow the right recommendations. Having multiple labels on kits can become confusing to depots and sites, specific labeling solutions are likely to be required to reduce both confusion and risk of error.

Looking to the future, solutions such as e-labeling should help support medication pooling strategies, as an integration between IRT and the e-label could automatically update the protocol at the right time, reducing depot and site burden, and increasing compliance.

2021 brought with it many healthcare advances – the most monumental being the availability of numerous COVID vaccines to bring an end to the global pandemic. The year also brought many other advances, and opportunities for life science professionals to stay up to date on the research, technologies, and processes that are driving change in how new medical treatments are developed and ultimately approved for worldwide use.

So here, in case you missed them, are the ten most downloaded articles, white papers, webinars and more produced by Calyx scientific, technical, and regulatory experts last year. Each provides direction and perspective on optimizing and accelerating the clinical development and approval of medical treatments. We hope you find them as insightful and valuable to you now as they were the first time around.

Behind the Breakthrough

When breakthrough therapy designation is granted, the challenges of clinical trial imaging increase. This white paper presents an insider’s view of what happens when the stakes, scrutiny, and demands of clinical trial imaging are sky-high, to help you get medical imaging done right in your accelerated trial.

While Direct-to-Patient (DtP)shipping offers potential advantages in improving clinical trial patient engagement, this approach is not as simple as it sounds. This article from International Clinical Trials outlines the pros, cons, and factors to consider when designing decentralized or hybrid clinical trials that include a DtP approach.

Focusing on the use of PET and addressing key problem areas in response assessment seen frequently in clinical trial settings, this virtual panel of IMWG 2016 authors and imaging experts answered questions about optimizing imaging-related assessments in multiple myeloma trials and shared their expertise in imaging as well as the clinical parameters in myeloma response assessment for running successful myeloma trials.

Listen in and learn how clinical trial management systems can adapt to support positive industry changes, including advances in user interfaces, integrations, and the ability to use CTMS as a data hub to better surface clinical trial risks.

Calyx’s Craig Mooney reflects on recent changes in the regulatory landscape that emphasize the investigative site’s ownership of IRT data collected during clinical trials, and considerations for making progress toward this goal.

Regulatory publishing is the backbone of any pharmaceutical, biotech, or medical device business. Do you know what needs to be considered as you bring publishing activities in-house? This guide outlines everything you need to know.

What biomarker to target? Is Blinded Independent Central Review necessary? Should we ‘Collect & Hold’? In this live panel, Calyx medical imaging experts answered questions about how to succeed in early phase oncology.

You won’t want to miss this episode of the Calyx Cafe where our host explains how AI can benefit randomization and trial supply management processes. You’ll never believe who’s asking the questions!

Learn how to prevent data variability and potential clinical trial delays by normalizing local labs data with advanced EDC systems.

Understand the various factors that drive drug wastage in clinical trials and the different IRT approaches that can be used to reduce each in this ultimate guide.

This article is taken from © Multimedia Pharma Sciences, LLC. Reprinted from AppliedClinicalTrialsOnline.com December 2021.

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