Clinical Trial Logistics: Preventing Delays and High Costs

Clinical Trial Logistics

In today’s tough clinical trial landscape, speed is key to getting a drug from discovery to market. Everything that speeds up the process (without sacrificing safety and quality) should be a priority to today’s drug developers. In an article for PharmaTech, Patricia Van Arnum explains that “the key problem relates to the increased globalization of clinical trials and the resulting problems in rest-of-world distribution management that cause delays in receiving CTM on time.” The implication: unless pharma can start to reduce logistical costs delays, ROI will eventually fall to levels that threaten the sector’s viability. Below are four areas where pharma can refine their practices to cut down on costs.

1. Patient recruitment and retention
One of the main causes of delays in clinical trials is patient recruitment and retention. The specific types of patients needed for trials in foreign countries force sponsors and CROs to look for treatment-naïve patients, patients with a rare disease, or patients of a certain nationality. Unfortunately, many trial sponsors are ill equipped to handle the logistics of the regions where they need to conduct their trials. Access to broader patient populations can significantly increase recruitment and retention, but working in emerging markets can be a logistical nightmare. One solution to these concerns is to collaborate with partners who have logistical expertise in these regions. Working this way would ensure that patients are equipped from the start with the best data collection devices and that protocols will fit the region rather than working from something designed for a trial in the developed world.

2. Varying government regulations
The expansion of trials into more remote regions opens the difficulties of dealing with different government regulations. Each country has its own regulatory requirements and sometimes a single trial is so large that it’s conducted in multiple countries. As there is no central hub to determine clinical regulations, each country determines their own and these regulations are often changing, sometimes just to keep up with advancing technologies. A sponsor or CRO entering these markets will have to adhere to the regulations, and failing to do so can severely derail timelines and budgets. When trials are conducted across multiple markets, navigating each region’s rules of logistical compliance can be daunting.

3. Partnering with logistical experts
Conducting more trials and studies across more geographies gives strong incentive for coordinators to look for partners. Of course, it’s crucial for them to evaluate potential partners in terms of quality, efficiency, and added value. The ability to source devices globally and having storage in relevant areas are important qualities to have in a partner, but trust in your choice of partner is vital. It’s important to ask if the partner has experience working in emerging markets, expertise with local policies, and a successful track record of on-time deliveries. “Does the partner have flexibility to onboard new projects quickly enough to match the manufacturer’s needs? Does the partner offer the level of consistency and quality across multiple locations to create value out of a preferred vendor strategy versus best-of-breed strategy?” – Sam Herbert, COO at World Courier. A partner with global ties and resources can open the door to hassle-free distribution of clinical trial supplies. Choosing the right partner can simplify the entire process.

4. Increasing ROI
If a trial is abandoned, the amount of time and money lost can be devastating to study coordinators and sponsors. The primary reasons for failed trials are losing patients or failing to recruit enough at the start of the trial. To combat this issue, many trials are adopting a patient centric approach. The idea is to design trials to fit in easily with the patient’s daily life, rather than disrupting it with constant tests and site visits. Of course, catering to the patient can increase the burden on the coordinators. The good news is that every day new technological advances are opening the doors to conducting automated trials. Study coordinators can use their study sites as a central hub with devices that are directly connected to the mobile devices in the hands of their patients. It’s important to note that many help desk issues can occur when trying to coordinate several hundred devices. Because of this, uniformity in the type of device is the best way to simplify any IT concerns and streamline the trial process. A dedicated distribution partner is ideal for this situation as devices can be delivered directly to patients. This direct-to-patient formula designed to ease the burden on the patient correlates to an increase in enrolled patients and a decrease in those who drop out before the trial is over. The execution of this decentralized process can of course be challenging but working with the right distribution partner can simplify the process and increase ROI. Mobile technologies allow for accurate monitoring and tracking of products, whether they are at the manufacturer’s facility, a clinical depot, a traditional clinical trial site, or a patient’s home. At the same time, partnerships between clinical-trial management companies and specialty logistics providers are opening new possibilities for where, how, and how quickly clinical trials can occur.” – Sam Herbert, COO at World Courier.

Every year drug approvals are declining. Patent expirations are leading to a reduction in revenue. Biopharmaceutical companies face increasing pressure to reduce the time required to develop new drugs. That is why it is more important than ever for biopharmaceutical companies to find new ways to reduce timelines and costs of clinical trials without affecting the quality.