One reason why you should participate in an oncology clinical research organization is that it can allow you to transfer your skills between therapy areas. For example, skills you acquire in oncology can be applied in cardiology since the protocols are similar. Another benefit of working for a CRO is that they often recognize hardworking employees and invest in their personal development. In contrast, pharmaceutical companies are less likely to invest in their employees’ development because they focus on one or a few specific therapy areas.
They delegate tasks and obligations relating to clinical trials
Participating in an oncology CRO involves delegating tasks and obligations related to clinical trials to an outside organization. These obligations apply oversight of clinical trials and non-interventional studies. Clinical trials are intended to test new drugs, while non-interventional studies track participants’ health outcomes by taking established therapies.
A CRO typically assigns a CRA to conduct the study during a clinical trial. CRAs provide oversight at trusted research sites and monitor patient safety, quality control, and other aspects of the problem. They may also evaluate prospective research sites before the study starts.
The FDA’s guidance on CRO oversight notes that sponsors must ensure appropriate management of their subcontractors and retain evidence that their oversight measures are being met. While the guideline requires sponsors to maintain the proof of ongoing oversight, many sponsors take different approaches. Some choose a hands-off approach, while others micromanage. The key is to strike a balance between the two.
CRAs are the most critical contact for oncology CROs
A large CRO may be the best option for specific trials, but it’s also risky. They may be able to mobilize a team quickly, but it’s unlikely that the same team will be working on your trial from start to finish. A boutique CRO will ensure that your problem is staffed with the same people throughout the trial.
A seasoned CRA has years of experience in the field and is a valuable resource for oncology CROs. They will be able to provide excellent quality onsite monitoring and remote monitoring. A seasoned CRA will also have experience in managing multiple studies.
They can mobilize a team quickly
The number of patients per site per month continues to decline, with an average of 0.38 per site per month across all Phase I-III trials. Meanwhile, the total cost of oncology medicines in the U.S. has increased from $42.1 billion in 2012 to $49.8 billion in 2018. With growing regulatory hurdles for market entry, biopharma companies are looking for ways to cut costs and increase efficiency.
Smaller CROs often have lower turnover and can identify the exact people needed to conduct the trial. Oncology trials require a high degree of expertise at all team levels. While many large CROs may have highly experienced CRAs and PMs, not all have extensive oncology experience. Small CROs focus on the specific needs of biopharma sponsors. These firms are responsive and keep pace with the latest technologies and tools. They can customize solutions for sponsors and patients.