Today, clinical trials are widely regarded as the most reliable and trustworthy means of conducting evidence-based medical research. Their potential to improve patient outcomes makes them a promising healthcare option, especially in the field of oncology. By shedding light on the mechanisms behind cancer development, cancer trials hold the potential to alleviate the financial strain of treatment for patients while simultaneously advancing our understanding of the disease. In this next installment of Vial CRO’s Oncology Trial Management series, we discuss how sponsors can increase their chances of success when running an adrenal gland tumor clinical trial.
1 | Understanding Adrenal Gland Tumors
The adrenal gland is a key organ in the human body that functions to produce important hormones, such as cortisol, aldosterone, and adrenal androgens [1]. Most adrenal gland tumors will occur in the outer layer, known as the adrenal cortex, and form as either adenomas or carcinomas, depending on whether the cancer is benign or malignant, respectively. Tumors growing in the inner medulla layer are classified either as pheochromocytomas or neuroblastomas. Typically, the treatment options patients can consider will depend on whether the tumor is a benign adenoma, which are the most common [2], if hormone regulation has been disrupted, and whether a single or both adrenal glands are cancerous. These treatments can include surgical adrenalectomy, laparoscopic surgery, hormone therapy, chemotherapy, radiation therapy, or a combination therapy [3].
2 | Leveraging Technology to Optimize Speed, Savings, and Success in Cancer Trials
Like other oncology studies, adrenal gland cancer trials often have complex data to collect and interpret. Traditionally, clinical researchers have had to choose between speed, cost, and success at the expense of the other two, but when digital technology is wielded properly, sponsors can optimize all three areas simultaneously.
Let’s compare the data entry process for three different sites:
- Site 1 relies on paper-based source documents and patient-reported outcome (PRO) questionnaires, then manually transcribes this information a second time into a separate EDC system.
- Site 2 has implemented electronic source (eSource) data collection and dispenses patient e-PRO devices, but still has to re-enter everything into the electronic case report form (eCRF) at a later time.
- Site 3 not only uses eSource and ePRO platforms to collect patient data, but these are also integrated into the same digital ecosystem as a central EDC accessible to sponsors. This advanced type of EDC software is automatically able to pull corresponding visit data from other platforms in real-time.
When a sponsor favors more outdated technology or source documentation methods, they will lose valuable time and money to inefficient and redundant data management processes. Unlike the first two sites, Site 3 is able to leverage modern clinical trial systems to divert their time from duplicate data entry to refining performance elsewhere, such as recruitment or study assessments. Sponsors can streamline their cancer trial’s data collection timeline by taking advantage of newer digital resources, whether it is their own or a tech-enabled CRO’s innovative products. Vial CRO’s real-time eSource, EDC, and ePRO integrated workflow remove the burden of inefficiency and redundancy during data collection while easing the communication gap between sites and study teams.
3 | Using Clinical Trial Readiness to Mitigate Risk
When approaching a new study, any number of issues can arise because clinical trials are complex, with multiple moving parts for a sponsor to oversee. Part of minimizing the risk of unexpected study delays after startup is proactively ensuring all parties are properly trained to handle the nuances of each project. This is otherwise known as clinical trial readiness [4]. Project leaders must be aware of exactly where their team and the project is in terms of strengths and weaknesses. Sponsors can develop mitigation strategies by determining the following:
- Which clinical sites are more expected to succeed, and which may struggle?
- What key components of the sponsor’s study objectives are still poorly understood and may lead to recurring protocol deviations?
- Can the study staff’s experiences be distributed strategically to maximize efficiency and minimize risk in specific areas of clinical trial project management?
Achieving Success for Your Adrenal Gland Tumor Trial
Although the majority of adrenal gland tumors tend to be benign, patients diagnosed with more aggressive adrenocortical carcinomas can face grim 5-year survival rates, particularly when it reaches the advanced stage [5]. For patients who fail to respond to first-line therapies, clinical trials are a significant source of hope. It’s no small challenge for sponsors to carry their drug to market, but taking the opportunity to adopt advanced digital technology and ensure every team member involved in their project is ready to handle trial activities can go a long way in improving their chances of success.
Visit https://vial.com/cro/oncology/ to learn how Vial CRO’s next-generation digital products and clinical trial services are revolutionizing the way cancer clinical trials are conducted. By leveraging cutting-edge technologies, Vial CRO can help streamline your next clinical trial, reducing costs and accelerating timelines. With Vial CRO, you can expect a seamless and efficient clinical trial experience that delivers high-quality results. If you’re planning your next cancer clinical trial, consider partnering with Vial Oncology CRO. Connect with a team member today!
