Bioequivalence Studies

While typical bioequivalence studies (BE) using healthy volunteers are relatively straightforward to design and manage, bioequivalence studies in oncology present special challenges, and are best managed by a CRO with experience in both oncology and bioequivalence studies.

The Nuances of Oncology Bioequivalence Studies

In an oncology BE study, the patients are generally already receiving treatment with the drug under study, and find little to no benefit to the patient to participate in the BE trial.

Identifying sites for oncology BE studies can also be a challenge.  Sites are typically most interested in promising treatments that employ novel therapies. They may also be more likely to participate in larger studies that last longer. The “thought leaders” in the area are often far too busy and even if they do agree to participate, the BE study may be placed at the bottom of their priority list.

BE studies also require precise laboratory procedures. Even though the typical efficacy study may include PK sampling, the importance of having every sample collected, processed and analyzed becomes much more crucial in a BE study. If a few samples can not be analyzed in a typical efficacy study, it’s disappointing but will probably not have major implications. If these samples can not be analyzed in a BE study, it may mean enrolling more patients and extending the timeline since the PK data are the basis for establishing the bioequivalence.

This creates a burden on sponsors to select sites that have the expertise and attention to detail to properly collect, process, store and ship the samples. And it’s important to have the CRO coordination with the bioanalytical laboratory to ensure communication of sample shipments and coordination of analysis runs. In an oncology BE study, a proactive approach is imperative.

Documentation in BE studies is also critically important. The drug storage, drug preparation, drug administration, blood draws, PK sample processing, PK sample storage and PK sample shipment must all be carefully documented by the sites. Site training must also be carefully documented.

Medelis’ Experience with Bioequivalence Studies

Medelis understands these challenges because we’ve dealt with them first hand. We have the experience and skill set to oversee oncology BE studies requiring both the specified target population and the site’s technical ability to conduct the specified PK sampling.

We understand the challenges of investigator selection and work to select sites that meet the various criteria we have found important for this type of study. The patient investigator relationship is key in BE studies. If the PI is enthusiastic, then the patient is more likely to consider the study. If the PI is not enthusiastic, the patients will be much less likely to participate.

Medelis also understands the importance of training at the site and in monitoring sites to ensure that the PK collection and processing are conducted correctly. The first visit at a site is conducted within approximately 2 weeks of cycle 1 day 1 with particular attention paid to the dosing and the PK collection and processing. If any problems are found, these can be identified early so that they are not repeated.

We are also adept at coordinating the various vendor activities to ensure that sites have the needed materials to dose patients and process the samples. As the patients are so difficult to obtain, we want to make sure that we do not lose a potential patient for logistical reasons.

If you’d like to talk in more detail about our experience in bioequivalence studies, contact us.