It is well known that patient recruitment into early phase oncology trials remains a challenge. There are several reasons for that:
1) Investigators’ lack of experience and trainings in early stage trials;
2) Study complexity, intensity of the phase I protocol schedule and requirements to perform the study at in-patient departments;
3) Safety and toxicity issues;
4) Intense PK and PD;
5) Challenges with blood processing procedures;
6) Requirements for samples storage at -85° С;
7) Patients’ motivation.
«BioEq» tried to overcome most of the challenges associated with early stage clinical trials.
1) «BioEq» has an experienced team of Principal investigators and oncologists who are capable of performing early stage trials with tight adherence to protocol requirements.
2) «BioEq» has a trained team of oncologists who are trained in most complex procedures. «BioEq» infrastructure allows to hospitalize patients to perform all needed procedures 24/7.
3) «BioEq» team provides careful monitoring of patient safety during the trials. «BioEq» has a team of emergency care doctors who are experienced in first-in-human trials and a fully equipped intensive care department (24/7).
4) «BioEq» has a dedicated team of nurses who are responsible for most complex PK and PD sampling.
5) «BioEq» has a dedicated laboratory staff who is responsible for samples processing and storage.
6) «BioEq» has fridges and freezers with different temperatures for samples storage. «BioEq» has separate fridges and freezers for back-up samples. The freezers have:
Visual / acoustic alarm
Adjustable high/low temp. alarm
Power failure alarm
Contact for remote alarm
7) «BioEq» has a dedicated department for subjects enrollment, which works with the leading oncology sites referring into clinical trials those patients who failed standard treatment. «BioEq» has a mechanism to adequately compensate physicians for referring patients to clinical trials. In addition to that, our oncologists speak with patients very carefully discussing all the risks (adverse reactions, low chance of therapeutic benefit) and benefits (attention, quality of care, better infrastructure, possible financial compensation for taxi etc) to recruit the right patients into the right trials.
In conclusion, we would like to state that site selection for early stage trials in oncology should begin with sites that are both competent and capable of enrolling appropriate patients, have good clinical practice facilities and procedures, and employ sufficient and available qualified staff.