Direct-to-Patient (DtP) is the trending clinical supply technique with a promising future, revolutionizing the pharma world. DtP is based on an integrated supply chain system that allows, among other things, clinical trials to be conducted directly at the participant's site. Read more to find out how you can capitalize on the new technique.
Evolution of Clinical Trials
Clinical trials for drug development have seen tremendous changes in the past decade. Currently, DtP clinical trials are the norm. However, this was not the case several years back. Various factors have contributed to the evolution of clinical trials. The main causative factor is the transition from single-arm (which there is only one treatment group and no control group), single-country trials to robust, multinational drug development programs. As a result, the manual techniques that worked effectively for localized trials can no longer handle the new and complex landscape.
Moreover, these robust clinical trials have come with multifaceted challenges ranging from increased need for flexibility, minimal waste emission, and patient-centered treatments. In addition, trial drugs are susceptible even to minute temperature fluctuations, have a short shelf life, and are expensive to manufacture.
That is why manufacturers are striving for the flexibility and cost-effectiveness of Direct-to-Patient clinical trials.
Another factor, though not the least among the causative reasons, is the rapid growth in personalized medicine.
Direct-to-Patient Clinical Trials Are Here to Stay
DtP clinical trials are the future of pharma and drug development research. Modern clinical trials by far outweigh the abilities of traditional supply techniques and thereby render them ineffective. Consequently, this paves the way for the growth of newer supply models such as DtP. With the current increase of biological medicinal products, DtP is the only method able to manage the growing need for cost and quality control effectively.
Another reason that indicates the trend is here to stay is its support from modern technological advancements.
Wearable electronics are making the remote monitoring of patients enrolled in trials easy, cost-effective, and convenient.
In addition, advanced communication systems facilitate telemedicine and real-time monitoring and have eliminated the need for patients to visit clinical trial sites. With benefits for both participants and sponsors, the expectation is that clinical trials will continue to flourish and to harness more from DtP strategies.
Regulators continue to impose more stringent measures to ensure quality maintenance from production and throughout the distribution cycle. With such binding regulations, players in the pharma sector must rely on innovative supply chains to remain relevant and competitive. Projections indicate that DtP trials are the future, and the question is whether or not you will join the bandwagon and reap the benefits.
Disadvantages of Direct-to-Patient Clinical Trials
Despite the benefits that DtP clinical trials bring to the healthcare industry, there are several ensuing challenges. One such problem is the variation in regulatory requirements from one country to another. The roles of medical practitioners vary according to regional dynamics, so it can be challenging to launch an effective multinational clinical trial via the DtP strategy.
Additionally, different countries have varying healthcare capacities. For example, more developed nations may have the financial muscle to handle home-based care. At the same time, other regions suffering from inadequate healthcare personnel and insufficient healthcare budgets will find it difficult to incorporate DtP clinical trials.
DtP clinical trials require you to work within rigid confines of time. To preserve product quality and safety, the drug must be shipped to the participant on time and in good condition. Late delivery or damaged trial drugs can have far-reaching consequences. The user may suffer from the use of a damaged product, they could be disqualified from the study for missing a dose, and the study results could be compromised.
Finally, replacements are costly for the producer.
The Direct-to-Patient Approach
DtP clinical trials place the patient at the center, giving them power, control, and more influence on their health. The trial drug can be delivered directly to the participant’s home, and trial samples can be collected. Depending on the complexity of the procedures, there may be the inclusion of a trained medical practitioner to administer the therapy or collect samples and vitals. Here are the main categories under the DtP supply procedure:
Depot-to-Patient refers to the supply chain model where the intervention drug can be delivered from a centralized pharmacy or depot directly to the participant's location. The model eliminates the need to first deliver to a clinical site and incur additional storage and logistics costs before shipping to the participant's home. However, centralized depot shipments are more likely to cross borders. Therefore, border control regulations should be considered to prevent late deliveries.
An advantage of the Depot-to-Patient supply model is increased inventory control. The model tracks how much product goes out in a day so you can precisely stock the inventory. Other distributors may have to be involved if the central depot serves a large area. Also, top-notch logistics are necessary to manage distributions effectively without delays and deliveries to wrong addresses.
Site-to-Patient involves transporting a trial drug from a pharmacy or depot within the study site to the user's home. Since the depot is within the study area, cross-border deliveries are unlikely. Some instances may require delivery to a caregiver instead of directly to a participant.
Reasons for Using Direct-to-Patient Clinical Trials
The following are the three main reasons to use the DtP clinical trials:
Improved Patient Retention. DtP clinical trials improve patient retention, which is one of the biggest challenges for clinical trials. With the classical approach, patients must travel to the site pharmacy for consultations, drug collection, and sample deposit. Consequently, many patients are reluctant to join the trial, and most of those who join the trial drop out along the way. This is a time burden as well as a financial burden. It also makes it difficult for participants with chronic illnesses who cannot make the journey. These challenges make DtP the most logical and beneficial methodology.
Ability to Reach a Dispersed Population. Using the traditional approach to clinical trials, participants can only be reached close to the distribution center. However, with DtP clinical trials, you can enroll patients in other countries. They can be reached through the Depot-to-Patient supply method.
Improved Communications. Thanks to modern technology, participants can have better and more frequent communication with the administrator from the comfort of their homes. DtP facilitates face-to-face engagement that enhances communication. Instead of waiting for participants to visit the pharmacy or site to take their vitals, participants can wear sensors that provide continuous updates on their health conditions. Additionally, the instant feedback allows researchers to identify data trends and the trial drug’s effect on the user in a timely fashion.
Overcoming the Challenges of the Direct-to-Patient Technique
One main challenge of DtP clinical trials is the possibility of compromised patient confidentiality. The best way to ensure patient privacy is to have a caregiver collect the prescription on behalf of the participant. That means the trial drug is shipped under the name of a registered caregiver whose responsibility is to administer it to the participant. That way, the patient's name never appears in any documentation that falls outside the jurisdiction of the trial administrator.
Another challenge of DtP is the possibility of late deliveries. To avoid late deliveries, a good practice is to formulate delivery protocols. These protocols should ensure there is adequate stock and that each delivery leaves on time.
DtP clinical trials will continue to shape the pharma world. They offer better flexibility and cost control, which allows you to thrive in the current competitive landscape of clinical trials. Also, more patients will enroll and stay throughout the trial because they no longer have to travel to study sites.