Kate McGowan

A few weeks ago I had the opportunity to attend the American Association for Cancer Research conference in San Diego. This year the AACR conference was focused on “Harnessing Breakthroughs, Targeting Cures.” This conference was attend by researchers and staff from all across the cancer research spectrum.  Aside from the beautiful, sunny southern California weather, the conference was a great chance to gain insight about oncology research, especially clinical trials. 

If you were unable to catch the conference this year, or even if you did, I have compiled of the top trends I picked up on at AACR this year. 

Increasing collaboration with research partners across the industry was a trend that couldn’t be missed. On their way to develop novel cures for disease investigators have always worked with partners in other universities and biopharma companies. 18,000 researchers in one building can connect and share ideas. This year it seemed more obvious than ever that bringing new therapies from concept to commercialization will require the combined efforts of many partners. 

Personalized Medicine and Biomarker Driven Studies 

Biomarker-driven studies and personalized medicine are bigger than ever. This poses significant challenges in recruitment for trials because the target patient population is inherently very limited. In order to leverage all possible patients eligible for a biomarker-centered study, the investigators will need to securely maintain a database of eligible patients. 

AACR is a great forum for basic science investigators to connect with downstream researchers that can take their breakthroughs to clinical trials and ultimately medicinal products and treatments. Translational research often requires industry partners to help pre-clinical advancements to become cancer cures. Just by looking at the number of talks and posters focused on translational research it is clear that this step in the development process is critical to the mission of generating cures for cancer. 

Throughout the conference it became clear that in order for researchers to be successful in “Harnessing Breakthroughs, Targeting Cures,” technology needs to support their efforts. Oncology clinical trials are labor intensive, data intensive, and frequently very long. To bring a new therapy to market requires such immense collaboration and effort from all players in the research supply chain. Technology, such as CTMS, needs to make the jobs of investigators and their staff easier. CTMS can deliver efficiencies that will allow the administration of clinical research to proceed more quickly and for less money. Shouldn’t administration of clinical trials be as high-tech as the tools researchers are using to conduct the studies? 

Kate McGowan is a Strategic Marketing Consultant at Bio-Optronics

Articles

This year the AACR conference was focused on "Harnessing Breakthroughs, Targeting Cures."

Observations from AACR 2014

In an effort to reduce costs and improve quality of research, clinical trials are increasingly being offshored. According to 

 the proportion of studies conducted in North America has been steadily decreasing. Moving portions of studies to geographic areas outside of the US can benefit the study in several ways: 

Larger and more diverse pool of patients 

However, there are several concerns that become important when trials are run internationally. 

The right CTMS can help maximize the benefits of offshoring trials while minimizing the negative aspects. The system provides transparency into recruitment and finances in real-time anywhere in the world. Milestones can also to be set and tracked remotely, and all communications can be organized, directly within the CTMS. Ideally, investigative staff in one part of the world can automatically share all relevant information with stakeholders in another, including networks, CROs and sponsors. 

Organizations engaging in global clinical trials can benefit from the enhanced levels of real-time communication that comes from using a collaborative CTMS. Site and enterprise level CTMS features can work together to seamlessly share information anywhere in real time with the right people and organizations. This will help improve oversight, simplify logistics, and lower operating costs; enabling staff to focus on conducting the study. Sponsors and CROs can observe progress in real-time rather than waiting for queries to be returned. These products work seamlessly with other Clinical solutions to help researchers realize the benefits of their global trials. 

In an effort to reduce costs and improve quality of research, clinical trials are increasingly being offshored.

CTMS: Maximizing Your Global Clinical Trials

The analysis of patterns in clinical trials has indicated that studies are becoming increasingly complex. Over time, more and more procedures are included in protocols, and these procedures are increasingly complex. Frequently, amendments are added to protocols, further complicating the implementation of the desired protocol. 

In addition, adaptive trials are predicted to gain traction in the next several years. In fact, many CROs and sites have already expanded their capabilities to accommodate adaptive trials. Adaptive clinical trials are another effort to reduce waste in clinical trials. In this design, protocols can be optimized or changed midstream as data is collected. According to the Journal of the National Cancer Institute, the types of adaptations “can be to drop a treatment arm that isn’t effective, alter dose levels, or increase the trial size if a drug proves less responsive than predicted.” The belief is that many trials fail because the protocol is not optimally designed, making it difficult to tell if an IMP is actually effective. The FDA and industry are pushing for adaptive trials because they are expected to be more efficient that traditional studies.

Adaptive trials are expected to encourage more patients to enroll in studies. In adaptive trials, if a treatment is working with the initial trial participants, later enrollees are more likely to be given the medicine over a placebo. It is proposed that patients will prefer the increased chances of receiving a new treatment and will be more likely to enroll. 

Nevertheless, adaptive trials and otherwise complex trials will require more time and effort by staff be spent on administrative tasks. Ideally, a technology could alleviate the administrative burden of increasingly complex trials, leaving staff to focus on patients. 

The right CTMS can help sites, CROs, AROs, other research networks, and sponsors simplify their workflow and the complex environment around them. The investigative staff should be able to easily add procedures to the protocols, and change them as needed.  A product should provide flexibility that can handle many amendments and will allow the user to determine when each is activated and can apply the changes going forward. 

The analysis of patterns in clinical trials has indicated that studies are becoming increasingly complex.

Kate McGowan

Articles

Observations from AACR 2014

CTMS: Maximizing Your Global Clinical Trials

CTMS Technology Alleviates Pain of Increasingly Complex Trials