Cancer research has evolved exponentially over the last two centuries. The first time radiation was used to cure cancer happened in 1903. Less than 100 years later, cancer preventatives were receiving approval. However, rare disease is more involved. In our last article, we looked at rare cancer research in detail. In this article, we will discuss rare oncology research today and moving forward.

Rare Cancer Research in Practice

The year 2020 saw many changes and breaking news stories, but one that may have missed your radar is the Pan-Cancer Analysis of Whole Genomes study. It was a consortium that analyzed over 2,600 genomes covering nearly…


COVID-19 has presented a variety of challenges. The way people live their lives and conduct their work has been disrupted. There are restrictions that limit where they can go and what they can do, but those limitations are not confined to home life or office settings. COVID-19 has had important implications for clinical research and patient management in particular. In this article, we will review our top strategies for navigating clinical studies during COVID-19.

1. Modify Existing Protocols for Safety

Many studies were put on-hold but as the pandemic rages on and escalates, finding a way back to active trials makes sense. Modifying existing protocols for…


Risk assessments are often an afterthought. A company is required to be audited, and the auditor finds gaps or holes in its processes. That company then scrambles to make corrections. The auditor, as an objective third-party, may see things that the company misses or have seen more cohesive operations elsewhere — but his or her recommendations often come after the damage is done. Risk management resolves this issue by making risk assessments proactively and continuously.

Consequences of Poor Risk Management

When companies practice poor risk management, they aren’t just risking failing an audit. They are putting their time, costs, and quality at risk. Many end…


Medicine is continually advancing. New bodily mechanisms are uncovered and understood as analytical platforms improve. It happens almost by a zeitgeist, with several locations around the world happening upon similar discoveries and subsequent researchers leveraging those findings to prompt an evolution of those understandings. The transformation manifests by a sudden influx of publications describing the phenomenon, but this change is evident in the volume of work surrounding the discovery. It also becomes apparent in the vocabulary used to describe elements of the mechanism.

Lately, microbial communities have received increased attention and a relative explosion in study volume, but there are…


Ventilator-Associated Pneumonia (VAP) is a common complication of mechanical ventilation. Overall, the percentage of VAP or cases of pneumonia associated with mechanical ventilation compared to the sum of nosocomial pneumonia cases is greater than 50%, with the highest incidence occurring in the ICU, where approximately 90% of pneumonia cases are ventilator-associated. Roughly 15% of people on mechanically-assisted breathing will develop the condition — although some estimates put that figure as high as 27% — and, of those, roughly half will die. …


Rare disease drug development varies from the pathways seen in more established indications. The sample sizes are often extremely small, and establishing a good base of clinical data can be difficult. Natural history studies help bridge the gap.

Per the FDA, the natural history of a disease can be defined as “the natural course of a disease from the time immediately prior to its inception, progressing through its presymptomatic phase and different clinical stages to the point where it has ended, and the patient is either cured, chronically disabled or dead without external intervention.” …


Personal data privacy has taken another evolutionary step with the release of the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons, the General Data Protection Regulation (GDPR). If you work for an organization that is not based in the EU, you may or may not be aware of the GDPR. The GDPR came into effect on May 25, 2018.

In this article, we will discuss the GDPR, whether it’s applicable to your clinical trial and if it is, what are the five considerations of which non-EU-based sponsors…


Clinical trials monitoring

Clinical research continues to evolve. At the same time, the methodologies used to protect patient safety are changing. The techniques and strategies used in our field evolve with new technologies. New regulations and other challenges also have an impact.

In 2020, the biggest influence on the way our industry operates has been COVID-19. The pandemic has limited access to investigative sites and prohibited onsite monitoring. COVID has also spurred on the adoption of virtual monitoring.

The 3 Types of Clinical Trial Monitoring

The concept of monitoring subjects is not new to a veteran researcher like yourself. Yet, the types of clinical trial monitoring techniques can sometimes get…


Rescue Study Transition

Clinical trials are large complex projects, and occasionally a sponsor may need to make a change to bring an underperforming project back on schedule. This type of change is not taken lightly by sponsors. Making such a transition takes time and a large investment in coordination and additional money. In this post, we will take you through a general scenario for a full-service contract research organization (CRO) transition. Our example will show when a sponsor fully transitions from the CRO currently running their study to a new CRO taking over and finishing it off. You may be wondering, “how long…


Cohort Management

Cohort management is part and parcel of conducting dose-escalation studies, but not all teams effectively manage it. Pharm-Olam is focused on expediting our sponsors’ early phase cycle time in Oncology to enable rapid delivery of a mean tolerated dose (MTD)/recommended Phase 2 dose (RP2D). Thus, tightly orchestrated cohort management strategies that both protect the safety of trial participants and support the capture of the quality data that sponsors need to move to the next stage of development are equally important.

At Pharm-Olam, we use a series of cohort management tactics as part of our best practices. Here is an outline…

Renee A Butler

Marketing Content Manager at Pharm-Olam. Dedicated to telling stories and writing content that converts. Passionate about books, adventure, and classical music.

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