Direct-to-Patient Clinical Trials: Benefits & Challenges

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.

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.

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

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.