INSIGHT BLOG
Adopting Direct-to-Patient Methods in Clinical Trials: What to Expect Before You Start
A Direct-to-Patient (DtP) method in clinical supply management is a patient-centric approach in which the supplies are prepared, packaged, labelled, and then shipped directly to the patient's or caregiver's home. Read on for an in-depth exploration of the key considerations when adopting this model.
WHY DIRECT-TO-PATIENT?
This innovative method enables sponsors to avoid shipping to, and storing supplies at, clinical sites. It allows sponsors to:
- Decrease timelines
- Improve quality
- Reduce costs
- Enrol and retain more patients
- By shipping directly to patients, the DtP platform enables sponsors to conduct trials that would be all but impossible with traditional clinical supply chains. DtP is thus ideal for a trial involving a rare disease, orphan indication, or dispersed patient population.
Nonetheless, business leaders who propose changing to a DtP method for running clinical trials can expect resistance. This resistance may have one or more sources. Read on to learn how to be prepared.
WILL DTP CHANGE THE RELATIONSHIP BETWEEN GMP AND GCP?
Timelines and the costs of clinical trials are lowered through reducing the physical distance between patient and medication. In the past, the clinical site was performing both manufacturing (GMP) and distribution (GDP) services, even though it is not properly trained in these services.
Now with DtP, a service provider such as Clinigen Clinical Supplies Management (serving as the GMP expert) can work with couriers (serving as the GDP expert) as the direct link to delivering medication to the patient, greatly reducing time and even costs.
The sponsor is still the responsible party for packaging, labelling, and distribution, and the investigator is still the responsible party for control of the drug during investigation and for maintaining adequate records. Only the location of the handoff has changed. Instead of a receiving department or a site, the handoff now takes place at the home of a patient or caregiver.
HOW WILL DTP AFFECT PATIENT CONFIDENTIALITY?
Confidentiality can become an issue if the service provider and the couriers aren’t familiar with the duties, guidelines and regulations set out under Good Clinical Practices (GCP). Clinigen is is committed to stringent quality standards. While almost all of the communication goes through clinical personnel, it is the service provider’s responsibility to ensure the courier adheres to the delivery protocol as well. For GMP and GDP, it is only about having a patient’s name and address, and possibly a patient or caregiver’s phone number.
The important issue with confidentiality is privacy, which is more than a GXP issue. Many regulations are being implemented to address personal privacy, especially as it pertains to information available about a patient on the Internet of Things. Everyone involved with using the internet and personal information must abide by these regulations. A patient name is represented by the patient number to remove the personal aspect of said patient. Details about a patient or a caregiver’s name is limited to team members that require the details to carry out the function of providing the product.
HOW WILL DTP AFFECT OVERSIGHT OF THE INVESTIGATOR?
GCP requires the investigator to have oversight of their patients, including the receipt, disposition and dispensing of medication. DtP does not change that requirement. The investigator will still be involved and have oversight, but with DtP, the GMP and GDP experts get more involved.
Obliging patients to visit the clinical site for diagnosis, labs and data collection is a challenge for most patients. With this pivot towards a more patient-centric approach, investigators are looking to make it easier for patients to participate using technology and services such as DtP.
Read about the benefits of the Direct-to-Patient model for the patient and learn how it helps to improve patient engagement for your trial.
HOW DOES DTP FIT INTO THE CURRENT REGULATORY ENVIRONMENT?
Regulations are usually the last thing to change. Presently, few regulations specifically address DtP for investigational drugs. The key is ensuring that laws are not violated when providing DtP services, and interpreting and using the existing laws with the patient’s safety and needs in mind.
ADDRESSING FEAR OF CHANGE
An obstacle every company faces is the fear of both internal and external change.
Internal change refers to the need to change learned habits within the company. Decision-makers become accustomed to certain budgets, practices, and timelines.
Changing these can be stressful, because any lack of success is likely to be blamed on that change, whether or not it was the cause. Overcoming this fear requires decision-makers to first recognise it, and then find the courage to see failure as a stepping-stone to success.
External change involves disruptions that decision-makers fear will bring an end to their financial security. For example, while a camera company might have been excited by the opportunities of the digital era, film companies were not. It is the same in the pharmaceutical industry.
Many stakeholders are invested in maintaining the current system of clinical trials. They will fight tooth and nail against change, thinking it easier to maintain current practices than to adapt to new ones.
But this fear, this resistance, is why, despite all of the technological progress in the last 30 years, timelines have not been reduced, drug approval rates have not increased, and the same questions about increasing development costs continue to be asked but not answered.
Sponsors must learn to distinguish between companies that argue against change because of legitimate patient safety concerns, and those that argue merely to protect their own interests.
INCREASED FLEXIBILITY AND EFFICIENCY THROUGH DIRECT-TO-PATIENT
Although DtP methods have not been used extensively in clinical research, they have become standard in commercial settings. Millions of prescriptions are shipped directly to the homes of patients every year. Comparing these commercial practices to clinical research practices yields several opportunities for clinical trial sponsors.
Direct-to-Patient shipping is an effective and cost-efficient method of managing clinical supplies. In addition, combining Direct-to-Patient shipping with On-Demand packaging can radically streamline the supply chain for clinical trials. No matter the size or scope of your trial, it can benefit from the new level of flexibility that the DtP method offers.