Written by Gerald E. Finken, CSO at CSM
A Direct-to-Patient (DtP) platform is a patient-centric approach to clinical supplies in which the supplies are prepared, packaged, labeled, and then shipped directly to the patient's or caregiver's home.
This innovative method enables sponsors to avoid shipping to, and storing supplies at, clinical sites. This allows sponsors to:
- Decrease timelines
- Improve quality
- Reduce costs
- Enroll and retain more patients
Furthermore, 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.
Business leaders who propose changing to a DtP method for running clinical trials can expect resistance. This resistance may have one or more sources.
Concern that DtP Will 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 CSM (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, labeling, 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.
Confidentiality becomes an issue with DtP, since the service provider and the couriers are not fully trained in good clinical practices (GCP). 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.
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.
It is important to note that DtP is a minor issue with regard to the investigator’s oversight. The real issue is that the industry has conducted clinical studies focused on what the industry needs rather than what the patient needs. Forcing patients to visit the clinical site for diagnosis, labs and data collection is a challenge for most patients.
With the patient-centric movement, investigators are trying to make it easier for patients to participate using technology and services such as DtP. Receiving medication while the patient is at the clinical site is often a secondary concern, especially after the first visit.
Reliance on Outdated Methods of Quality Assurance
Many clinical research companies still implement quality-by-inspection, rather than quality-by-design. While quality-by-inspection is important in the commercial setting, it often inhibits innovation in the realm of clinical research, because it requires planned deviations every time something new occurs.
Companies can preempt this challenge by moving toward a quality-by-design system of quality assurance.
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.
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 recognize 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.
Direct-To-Patient Offers Innovative Opportunities
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 expansion of the Direct-to-Patient platform.
Direct-to-Patient shipping is an exciting, novel method of managing clinical supplies. In addition, combining Direct-to-Patient shipping with On-Demand packaging can radically improve the supply chain for clinical trials. No matter what your study involves, it can benefit from the new level of flexibility that the DtP platform offers.
Want to learn more about the Direct-to-Patient platform? Download CSM’s DtP case study.