Article: 6 Learnings From our State of the Patient-Centric Landscape Seminar 

By Mike Sweeney; Jaime Sanchez; Kelly Frend; Matimba Swana; Sharon Schnieder |

Recent changes to traditional clinical trial models are having a significant and positive impact for patients. This ultimately includes access to more treatment options for those in need. These shifts are substantial for both patients as well as clinical trial sponsors that are seeking to measure the effectiveness of new treatments as efficiently as practical.

In our recent seminar we discussed the state of the patient-centric landscape from an operational, quality and regulatory perspective, our team of experts - who presented at the seminar - have put together a summary of the key 6 learnings that were discussed with the attendees.

 

1. Patient Centricity

 

  • Patient needs should always come first and foremost.

  • Direct-to-Patient can make life easier for patients and their loved ones by accommodating flexible visits to ensure their schedules remain largely uninterrupted, making everyday lifestyles easier to maintain.

  • Patient welfare is always at the heart of everything that we do, underpinned by our high standards, dedicated resources and depth of experience.

 

2. Early Planning

 

  • Understand the key requirements of the protocol before establishing the basis of your strategy.

  • Choose the right partner(s) for your specific needs.

  • Keep in mind that there is no "one size fits all" service.

  • Reach out to different providers to execute different parts of the trial, if needed, such as one for kits and ancillaries, another one for the temperature and time critical IMP or commercial product. 
 
 

 

3. Constant Training

  • Choose a partner with a robust and continuous training program.

  • It is key to implement Standard Operating Procedures, train and continuously retrain everyone involved in your trial. 

 

4. Communication and Transparency

 

  • Communication is essential at all steps of the process, before, during and after the trial. It is important to keep all the stakeholders involved up to date, whether it is the patient, the site, the logistics providers, the pharmacy, the nurse, the sponsor, the CRO or the lab.

  • Transparent communication is the foundation that will tie all the different elements, stakeholders and suppliers together. Assign clear roles and responsibilities from the set up phase and ensure you align and work closely with all the parties involved. This will benefit the patient, and ultimately all the other stakeholders. 

 

5. Regulatory Compliance and Good Practices

 

  • Patient confidentiality is the cornerstone of ethical healthcare. Countries worldwide embrace and adhere to patient privacy laws similar to HIPAA or the EU's General Data Protection Regulation (GDPR).

  • Knowledge of all local patient privacy requirements and your partner's ability to suitably support their adherence are of paramount importance within Direct-to-Patient.

 

6. Cost Efficiency

 

  • Direct-to-Patient reduces the burden on traditional healthcare. by shifting outpatient procedures from hospital to home, healthcare resources can be redeployed, ensuring a better site performance.

  • This approach requires less travel, less expenses and a limited impact on the patient's lifestyle, as daily schedules remain largely uninterrupted.

  • Direct-to-Patient helps reduce high dropout rates, maintaining the retention rate at 95% or more, and improve enrolment by at least 60%.
 

 

Direct-to-Patient services represent a collaborative approach to the delivery of care that can bring great benefit to patients, sponsors, CROs and manufacturers alike.

Not all studies or commercial therapies are a good fit for this model though. If the approach is deemed a good fit for your study and the proper due diligence is undertaken, a patient-centric model such as Direct-to-Patient can be an incredibly effective strategy for a more successful clinical trial.

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About the Authors

Portrait of Mike Sweeney

Mike Sweeney

Senior Director, Patient Centric Logistics
World Courier
Mike is responsible for the development and product management of World Courier’s specialty service offerings across 140 company-owned offices in 50+ countries, with focus on patient-centric areas such as Direct-to-Patient services. Since joining World Courier in 1992, Mike assumed a number of positions within US operations, customer service, training, compliance, marketing, sales and clinical trials management. He progressed to senior roles, including director of US customer service/operations, director of new service development and director of regional accounts, prior to transitioning into a global IT leadership position and most recently into his current role in 2015.
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Jaime Sanchez

Sales Manager
World Courier
Jaime is Sales Manager for World Courier Spain. With more than 30 years of experience in international transport, Jaime fully understands the logistics and supply chain industry. Before joining World Courier, he worked at El Corte Inglés as a Sales Promoter, Industrial Division, for 5 years, followed by 6 years as a Sales Manager at TNT Express. Having been responsible for the Iberian Peninsula area at World Courier for 4 years, Jaime now focuses his work on supporting pharmaceutical and biotech companies, based in Spain, with the most adapted specialty logistics solutions.
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Kelly Frend

Specialty Services Manager
World Courier
Kelly is Specialty Services Manager and Subject Matter Expert for Direct-to-Patient and Cell and Gene Therapy at World Courier. Kelly has nearly 14 years of experience within the specialty transport and logistics industry. At World Courier, Kelly is a subject matter expert in temperature-controlled logistics, with a deep knowledge of Direct-to-Patient and Cell and Gene Therapy supply chains. She is responsible for leading the WEMEA region by overseeing all specialty service offerings within this area. She maintains a thorough understanding of the regulatory landscape and drives improvement initiatives that ensure all customers receive the highest level of service at all times.
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Matimba Swana

Senior Business Development Executive
Medical Research Network 
Matimba is Senior Business Development Executive at Medical Research Network. Matimba has 9 years’ experience working across both the Academic and Clinical Trials industries, with a wealth of knowledge in Immunology, Stem Cell Research and Home Clinical Trials. Matimba joined Medical Research Network 4 years ago and has co-authored An Economic Evaluation of Clinical Homecare for Applied Clinical Trials (21 Feb 2017 [Peer-Reviewed]) - focusing on Home Trial Support and Direct-to-Patient. She has met and presented to vendors, partners, regulators (including the Ministry of Health), sponsors and CROs in 12 countries across Europe, Africa and South America to discuss how they can help develop and utilise the community-based clinical trial model globally.
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Sharon Schnieder

Regional Quality Manager EMEA
World Courier
Sharon is Regional Quality Manager EMEA at World Courier. Prior to joining World Courier, Sharon had more than 10 years experience in civil aviation. He was interested in combining the operational knowledge he gained, with quality assurance in the transportation business. Currently, Sharon is based in Berlin, Germany, and together with his colleague from France, he is responsible for the Quality Management in more than 30 countries across Europe and beyond.
In 2018, he has been certified by the ASQ (American Society for Quality) as CQIA (certified Quality internal auditor) and gained experience in client as well as internal audits globally.
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