CRAs Must Evolve Alongside Oncology Therapeutics

By Christina S.T. Wilhoit, inSeption Group

Many new CRAs enter the field with only a master’s in clinical research and an expectation they will learn medical concepts on the job. Beginning the role with so little knowledge in the medical field can make it difficult to be an effective monitor that produces high-quality data.

In oncology in particular, this problem has been compounded by recent high turnover rates, which force many clinical research organizations (CROs) to place CRAs with no oncology experience into oncology monitoring roles. However, the knowledge required to monitor oncology studies differs greatly from the knowledge necessary to monitor non-oncology studies, leading to sub-par monitoring performance by some CRAs in these situations.

The onus is on sponsors and CROs to implement hiring and training processes that identify and rectify shortcomings in medical knowledge. Some strong monitors and/or those with medical backgrounds may not require additional training, but programs should be established to serve those who do require additional education — ensuring all CRAs on a study have the ability to understand and critically analyze what is recorded within the medical record.