There were numerous articles in August 2016 that covered a wide range of topical issues. Here are five of the best stories you might have missed... (click the headline to finish reading the story)
Over the past 20 years since the Human Genome Project was initiated, precision medicine has come to prominence in the clinical trials space. In the early 90s, genomics came to the fore as a discipline, and served as a precursor to the shift towards pharmcogenomics in the late 90s/early 00s.
In recent times, there has been a clamour towards personalised medicine, “a form of medicine that uses information about a person’s genes, proteins, and environment to prevent, diagnose, and treat disease” (NCI). Even the term ‘personalized medicine’ has taken many guises in the form of targeted medicine, stratified medicine, before evolving into what is now commonly termed precision medicine.
As the stock in precision medicine continues to grow, questions have been raised over its potential to transform drug development.
“The key question to be asked over the last 20 years is: Are the innovators – the pharma companies – prepared to embrace this trend?” said Sean Hu, senior VP & head of consulting, GlobalData.
A few emerging themes have been at the forefront of discussions surrounding study feasibility assessments. Despite technological improvements and real-time access to data, we continue to be plagued by some common mistakes often overlooked in our feasibility steps. For example, most sponsors and CROs continue to provide very limited information and time to sites to respond to protocol feasibility. A two-page synopsis excluding inclusion or exclusion criteria (IC/EC) and sample size is simply not enough information for sites to adequately respond to patients that may be eligible for a trial.
As an industry, we continue to underestimate the use of site feasibility questionnaires. Sites frequently tell sponsors what they want to hear and this is often in response to the types of questions being asked. Instead of asking how many patients can be enrolled in a certain study, we should ask how many patients with this particular IC/EC will be enrolled in one month, six months, or beyond. Insights into the future of feasibility and steps we can take to improve our methodology are presented in this article.
Africa is one of the world’s fastest-growing economic regions. What’s more, the continent is emerging as an important target for clinical research, although developing countries are usually under-represented due to the lack of commercial viability and trained researchers. With the descent of traditional pharmaceutical markets, Africa is one such destination which has developed interest for most pharmaceutical companies of all sizes.
One of the regions in Africa that is making remarkable progress with investments in institutions, integration, and infrastructure is the East African Community (EAC). The EAC is a regional intergovernmental organisation of the Republics of Kenya, Uganda, Tanzania, Burundi and Rwanda with its headquarters in Arusha, Tanzania. Kenya is considered the reference standard being the largest economy in the region and is much more dynamic than those of other member countries. This makes Kenya the most sought after destination for generating data in the African population as far as ease and standards of conducting clinical research are concerned.
In 2008, the CRO market counted for 20 Million USD in the US alone, which was approximately 30 percent of the overall development budget spent by pharmaceutical companies in the same year. Additionally, since the origins of Clinical Trials, the industry has witnessed an immense growth of partnerships and preferred service provider relationships between many CROs and their Pharma-clients.
In spite of these impressive numbers pharmaceutical companies and their CRO partners fail to reach the benefits expected by such partnerships. Development timelines have been increasing an average of 20 percent in respect to 5-10 years ago and similarly costs have reached more than 2 Billion USD per each new drug developed in a medium complexity situation. Also, it has been estimated that more than 80percent of partnerships fail to deliver more than 90percent of their expected value (e.g. savings, efficiencies, higher quality and shorter cycle times).
If you’re a start-up pharma or medical device company, acquiring the funds to get off the ground can in many ways be half the battle. While some companies outsource large parts of their clinical trial to various CROs, others partner with academic institutions to help conduct the study from start to finish.
Sorin Popa is the founder of Stent Tek Ltd., a start-up medical device company, which is developing a stent implant device in collaboration with Imperial College London. In this compelling interview, Sorin explains the pros and cons of academic partnerships.