The ongoing pandemic has altered the face of human clinical trial execution, stimulating the adoption of decentralized/virtual trials. Here's how to ensure success with your trial.
According to the Office of the Assistant Secretary for Planning and Evaluation (US. Department of health & Human Services), approximately $2.28 billion is spent by pharmaceutical and other companies recruiting patients, but there has been a staggering rate of failure to finish on time (nearly 80%), or to retain the number of patients through conclusion (85%).
And this is before the pandemic created severe impairments and hurdles in the clinical trial process. Pre-COVID, for every day that a trial was delayed, it would puncture the bottom line by devouring hundreds of thousands of dollars – and of course on the other end, potential lost revenue of the product not being on the market.
For years, the industry has been gradually transitioning into decentralized/virtual clinical trial models. These create a more patient-centric experience, which has been reported to help increase patient retention, protocol compliance and data quality.
During (and post) COVID-19, this model has and will become more dominant by necessity.
Yourway, through strategic alliances and a culture of proaction, quality, compliance and patient-centricity has helped numerous direct-to-patient trials conclude successfully, within budget and time frame.
Paramount to Yourway's operational resiliency during this unprecedented pandemic is its robust global network, experience with domestic and international logistics, strict adherence to Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP), including detailed business continuity programs, and its extensive experience in the clinical trial space. In uncertain times, clients need to be certain of the quality and safety of clinical materials through the entire supply chain journey. Yourway is continuously developing solutions to address the unique challenges of today's clinical supply chain. With primary and secondary packaging services provided in-house, Yourway helps add efficiency, reduce the cost, the vulnerabilities and the hassle of projects that would otherwise depend on multiple providers.
Despite all the disruptions that COVID-19 has created, Yourway has been able to maintain its operations by navigating to overcome all challenges globally. In addition to the strict GMP and GDP cleaning requirements already in place, which govern facilities, vehicles, equipment and personal hygiene of employees, Yourway, a global service provider has taken internal measures to further augment these procedures. Its team of experts proactively monitor the situation and implement solutions during the changing conditions brought forth by COVID-19. All of these measures have allowed Yourway to continue to efficiently support several ongoing global clinical trials, while protecting the integrity of intellectual property (IP) and ancillary products being stored and transported. As an example, with current travel and social distancing restrictions in effect, Yourway offers virtual audits to protect the health and safety of employees, clients and stakeholders, allowing auditors the ability to conduct full audits with real-time access to Yourway's facilities and documents from anywhere they are located.
The COVID-19 pandemic is far from over. India and Brazil have now moved to one of the top nations experiencing rapidly growing cases of infection and mortality, while Italy, China, Spain and the US are in a downward trend.
Still, trials are continuing in the new norm – decentralization. Yourway is the global specialist in providing true direct-to-patient (DTP) and direct-from-patient services (DFP) for decentralized/virtual trials. Yourway has configured operations to focus on the smooth implementation of DTP/DFP protocols to support sponsors seeking to transition from traditional centralized/virtual clinical trial models to decentralized/virtual models, allowing subjects, including the immunocompromised, to remain at home but still receive therapy.
The long-enduring "shelter-in-place" mandates have galvanized the necessity for trials to expedite DTP/DFP protocols. Several centralized studies currently in place have been and are being converted into decentralized/virtual studies to afford patients the ability to continue to receive treatment at home. This brings forth several key new challenges for many sponsors that have little experience in this area.
Challenges vary and can heavily impact a trial, even causing it to halt. For example, if study material is transported in a way that compromises its integrity, patient becomes non-compliant, or regulations are not checked resulting in non-compliance. Or the materials, methods and goal of the trial itself are not understood clearly.
Now more than ever, the following Yourway capabilities are needed in the growing area of decentralized clinical trials:
- Procurement of comparator drugs and ancillary supplies
- Primary and secondary clinical packaging
- Translation services
- Label and booklet printing
- Qualified Person (QP) releases
- Importer of Record (IOR) and customs brokerage services
- Specialized temperature-controlled transportation and storage for all temperature ranges from minus 180 degrees Celsius to controlled 15 to 25 degrees Celsius.
- Temperature-controlled storage at one of Yourway's 21 global GMP depots strategically located in all continents
- Integrated in-home healthcare services
- Returns and destruction services with full accountability
Yourway speaks the language of human clinical trial research and has an extensive global network that understands study protocols, logistics, patient privacy, international regulations, and, equally as important, the human element – ensuring patients and their families/caregivers are respected and comfortable, minimizing disruption.
Yourway assigns a project management team including a project manager to each study; the team works closely with clients to analyze and understand the complexities and unique needs of the study protocol. The team creates solutions based on the needs of the patients, of the sponsors and of the healthcare professionals performing in-home care. As a result, the DTP solutions Yourway implements are always based on patient-centricity, while offering safety, protocol and regulatory compliance, cost-efficiency and operational excellence.
The faster rate of adoption of decentralized clinical trials will, if executed correctly, create a higher rate of retention, and of compliance through the conclusion of the trial. The current experience should increase the number of sponsors who will embrace the decentralized/virtual model for their studies and incentivize faster adoption of the same model for more studies moving forward.