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.