Transformation of the clinical trial landscape
Many of the drug candidates advancing through the clinic, such as next-generation antibodies, cell and gene therapies, and other specialized and targeted therapies, are very different from drugs developed even a decade ago. In 2018, nearly 40% of drugs in the pharmaceutical industry pipeline were biologics,¹ most of which require storage and transport at low temperatures. A much greater proportion treat rare diseases that affect small patient populations; many are developed by small or emerging pharma and biotech firms. The result of these trends is significantly larger numbers of clinical trials, often with less centralized with sites located in multiple countries.
Efficiently and effectively managing the supply of specialty clinical materials and patient samples used in international trials has become more challenging. Navigating the varying and rapidly evolving complex and stringent regulations in each country requires detailed knowledge. Compliance with data protection laws, which are also rapidly changing and vary among regions, is complicated, as is ensuring data security and protection against digital attacks. Access to advanced packaging solutions that provide active temperature management combined with real-time tracking capabilities has become essential.
The two biggest challenges are patient recruitment and retention. A 2012 study estimated that more than 60% of trials fail to fully enroll their intended participants,² and approximately 30% of patients drop out of studies.³
The consequences are significant. Nearly 80% of clinical trials do not finish on time, with 20% delayed for six months or more.⁴ For a blockbuster drug, each day a trial is delayed causes a loss in revenue of about $8 million. For orphan and other specialized therapies, the loss in revenue opportunity is approximately $600,000 per day of delay.
Benefits of direct-to-patient solutions and movement toward decentralized/virtual trials
Patient centricity has thus moved to the forefront, with trial protocols focused on patient convenience and incorporating patient input. It is also driving the adoption of direct-to-patient (DTP) services in virtual clinical trials.
DTP services include delivery and administration of clinical trial drugs to participants in their homes, as well as pickup of patient samples, so patients can avoid travel and widely dispersed patient populations can participate in a single trial. DTP services are ideal for trials enrolling patients in remote locations or with mobility issues.
For sponsors, DTP services can boost participation and retention and potentially lower trial costs. The ability to access real-time data from remote monitoring devices enables trending and more rapid identification of potential safety issues.
These benefits have been confirmed in various studies. For instance, one survey found that over half of patients indicated they would be more likely to participate in a clinical trial if they could receive care at home.⁵ Another study found that the use of DTP services increased patient retention rates — with rates above 95% in some cases.³
Despite the limitations of virtual or decentralized trials, such as varying international regulations or the need for nursing assistance, approximately 24% of clinical studies conducted in 2017 included DTP services.⁶ A total of 30% of respondents in a 2017 study indicated that their companies were considering the incorporation of DTP services in trials over the next 12–18 months.⁷ The FDA, meanwhile, recently published draft guidance on the use of electronic media to facilitate the informed consent process for clinical trials⁷ and has endorsed DTP services and virtual clinical trials.
Leveraging a solution-based approach
Partnering with a clinical logistics provider that has an established, global network of depots, demonstrated knowledge of the regulations in these regions, centralized management, and tracking systems and a highly trained workforce is a key to success for virtual clinical trials and DTP studies.
Yourway BioPharma Services offers — in addition to our comprehensive transport capabilities — comparator drug sourcing, primary and secondary pharmaceutical packaging services, warehousing and distribution support, unused product return services and assistance with logistics project management for all types of clinical trials, including decentralized studies that rely heavily on DTP services.
As the only truly integrated premium courier and clinical packager in the market, Yourway is uniquely positioned to support DTP clinical trials. The ability to access packaging services and courier/shipping services from a single provider creates unique opportunities to find solutions that will protect the integrity of the drug products and increase the efficiency of the trials.
Understanding the full scope of a client's needs allows us to apply a solutions management approach to eliminate the inefficiencies that can result from a complicated supply chain involving multiple discrete service providers. Integrating packaging and shipping services at Yourway means that decisions about packaging design — from primary and secondary packaging through temperature-controlled shippers and beyond — are made with a comprehensive understanding of the conditions that the shipment will encounter on the way to the patient. Likewise, routing, shipping, and temperature-control decisions are made with a unique, complete understanding of the capabilities of the clinical packaging.
Furthermore, because the relevant drug products and related materials remain in our hands from the initial packaging steps in our temperature-controlled packaging facilities all the way through the last mile to patients, we can ensure an unbroken temperature-controlled chain. We maximize the use of supplies and minimize waste and shipping costs while ensuring that products stay within specifications (e.g., temperature, pressure, vibration), creating efficient and effective solutions for even the most complex supply chains. Additionally, since no handoffs are required between packaging and shipping, we can eliminate lags and enhance the efficiency of the entire trial, critical given that all lost time can cause loss of profit.
Unlike the few big players in the clinical trial logistics space, Yourway offers highly personalized services that can only be found with small to mid-sized companies. We have the bandwidth of a large firm but are responsive to our customers' individual needs in a way that only small companies can be. We offer true one-on-one customer service that ensures high-quality, responsive, tailored support from start to finish.
1. Ian Lloyd and Alexandra Shimming, "Pharma R&D Annual Review 2018," Pharma Intelligence presentation, May 16, 2018. https://pharmaintelligence.informa.com/resources/product-content/sitecore/shell//~/media/informa-shop-window/pharma/files/pdfs/pharma-rd-annual-review-webinar-2018-slides.pdf
2. U.S. Department of Health and Human Services. "Examination of Clinical Trial Costs and Barriers for Drug Development." July 25, 2014. https://aspe.hhs.gov/pdf-report/examination-clinical-trial-costs-and-barriers-drug-development.
3. Aidan Nuttall "Considerations for Improving Patient Recruitment Into Clinical Trials." Clinical Leader, March 23, 2012. http://vertassets.blob.core.windows.net/download/64c39d7e/64c39d7e-c643-457b-aec2-9ff7b65b3ad2/rdprecruitmentwhitepaper.pdf.
4. Praxis "The real cost of clinical trials," Blog, July 25, 2017. https://www.gopraxis.com/real-cost-clinical-trials/.
5. Travis Amengual, Heather Adams, Jonathan Mink and Erika Augustine. "Rare Disease Clinical Research: Caregivers' Perspectives on Barriers and Solutions for Clinical Research Participation." April 05, 2016; 86 (16 Supplement) https://n.neurology.org/content/86/16_Supplement/S20.002.
6. Clinical Trials Arena. "Arena International Survey reveals Current and Future Trends in the Clinical Trial Supplies market." Press Release. March 8, 2017. https://www.clinicaltrialsarena.com/news/arena-international-survey-reveals-current-and-future-trends-in-the-clinical-trial-supplies-market-5758435-2/.
7. FDA, "Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers," Guidance Document, August 28, 2018. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-electronic-informed-consent-clinical-investigations-questions-and-answers.