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

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.