Clinical Supply Issues Challenge Sponsors and Patients

The International Society for Pharmaceutical Engineers (ISPE) examined issues involving supply and production of investigational medical products.at its annual meeting in November.

A new ISPE survey (www.ispe.org/) on patient experiences with clinical trial materials examines how upstream decisions on the packaging and labeling of clinical supplies can influence the success of a clinical study. Clinical supplies that are easy to use, have clear labeling and directions can improve patient satisfaction with participating in a study and enhance compliance, according to responses from 1,400 study participants. Also, there's strong interest in direct-to-patient refill and resupply options, especially when clinic visits are difficult.

One concern, noted Ken Getz, Director of the Center for Information and Study on Clinical Research Participation, which conducted the study for ISPE, is that a strong minority of patients say they keep unused clinical trial medicines for later use. Analysts cited the need for clearer policies and instructions on unused medicines, for investigators and patients.

Clinical supply delivery also is important for direct-to-patient studies, which have gained more attention as an option for remote trials. While such studies may reduce burdens on clinical sites, they raise logistical challenges for sponsors in maintaining blinding, scheduling timely delivery of test products, and ensuring that patients understand directions.

ISPE members noted tensions within pharmaceutical companies about providing comparators to other firms, particularly for newly approved therapies. More streamlined drug manufacturing systems that reduce excess production have tightened up supplies available for comparators, driving up prices. This has created "a perfect storm for counterfeits" to enter the clinical supply system and compromise patient safety, observed Terry Walsh of GlaxoSmithKline.

Walsh and others have established the Clinical Trial Comparator Network under the TransCelerate BioPharma initiative to support reliable and efficient distribution of comparator drugs to clinical sites. The aim is to replace two-company comparator supply arrangements, which can take months to negotiate, with a network that adopts standard legal agreements for participating manufacturers to supply other network members with products needed for legitimate research purposes. Price negotiation will be left to individual companies.