Thermo Fisher Scientific Supports Direct-to-Patient Clinical Trials

October 29, 2020 - Thermo Fisher Scientific recently expanded its direct-to-patient clinical trial service offerings to support decentralized clinical trials, minimize length and costs, and increase patient enrollment and participation rates. 

Through the direct-to-patient solution, Thermo Fisher Scientific supports ancillary sourcing, blinding, patient kit production, clinical supply optimization, and decentralized clinical trial setups.

Additionally, the service also offers end-to-end cold chain management and traceability, as well as centralized storage of clinical trial material. This reduces waste and minimizes the storage space needed at clinical sites. 

"Decentralized clinical trials have been on the rise even before the COVID-19 pandemic due to the location of study centers and the amount of time required for study visits being barriers to patient enrollment and ongoing participation," Chris Armstrong, president of clinical trials business at Thermo Fisher Scientific, said in the announcement.

"As patients increasingly reach out to clinical trials sponsors to request receiving medication at home, it's critical to have a solution that delivers patients' medications safely and on time, without compromising trial quality and speed."

The company’s offering now includes clinical site-to-patient, pharmacy-to-patient, and depot-to-patient services, which will  allow for clinical trial medication delivery directly to patients’ homes. 

Pharmacy-to-patient and depot-to-patient services will also enable centralized control and simplify supply chain planning in managing high-value or limited supply products in all US states, the company said.

Additionally, investigational medicinal products (IMP) and non-IMP drugs will be shipped directly to patients' homes from either a pharmacy or central depot site. 

Meanwhile, clinical site-to-patient services will leverage Thermo Fisher Scientific’s total transportation management capabilities to choose the best option for delivering medications to homes or study sites.

This allows for maximum patient compliance, according to the announcement. 

The company stated that its expanded direct-to-patient services build on its global clinical site-to-patient program that launched in early 2020. The program ensures patients have uninterrupted access to life-saving drug shipments without the hassle of visiting a clinic. 

Additionally, the program supports any trial phase and other variables, such as response technology systems, blinded/unblinded trials, and home nursing providers, Thermo Fisher Scientific noted. 

So far, clinical site-to-patient services are available in 47 countries and have supported 1,500 shipments to patients worldwide to help treat over 25 different indications.

The company also noted that it provides additional services, such as coordination with home nurses, for patients participating in hybrid or virtual trials.

Overall, a direct-to-patient platform is a patient-focused approach that benefits both the patient and the sponsor.

Specifically, patients can receive their prepared, packaged, and labeled medications right to their front step, and sponsors can decrease timelines, improve quality, reduce costs, and enroll and retain more patients via direct-to-patient approaches. 

But experts voiced concerns with this approach in a 2017 report.  

One major concern patient confidentiality, which may be an issue since the provider and couriers are not familiar with good clinical practices. It is the service provider’s responsibility to ensure the courier follows the delivery protocol. 

Policymakers have implemented regulations to address personal privacy, but everyone who can access this information must abide by regulations. 

Another issue is that many clinical research companies still implement quality-by-inspection, rather than quality-by-design. While quality-by-inspection is important, it can hinder innovation in clinical research because it requires planned deviations when something new occurs.

Regulations are extremely important in a clinical trial setting, but only few regulations specifically address direct-to-patient strategies for investigational drugs. Therefore, sponsors must ensure that laws are not violated when providing these services while keeping patient safety in mind.