Radio Free Asia (RFA) is reporting that a government investigation in China has revealed fraudulent practice on a massive scale in clinical trials. China's food and drug regulator recently carried out a one-year review of clinical trials, concluding that more than 80 percent of clinical data is "fabricated," state media reported.
The healthcare industry’s transition to value-based care is putting a lot of pressure on pharmaceutical companies in terms of margins and the need to demonstrate improved outcomes at lower costs. In attempting to create breakthrough therapies and “beyond the pill” solutions with fewer resources, companies are demonstrating an increased appetite for outsourcing functions – and Contract Research Organizations (CROs) could be the beneficiaries.
Driven by the steep costs of hosting clinical trials in the United States and Western Europe, pharmaceutical companies have increasingly turned to global markets to conduct trials over the last decade. During that timeframe, Israel has emerged as an attractive market – bolstered by its high-quality medical infrastructure and well-trained physician workforce, diverse patient population and widespread adherence to Good Clinical Practice (GCP) standards.
The core addressable early phase market is USD 11.9 billion growing with a CAGR of 2 – 3 percent. Early-phase trials are outsourced at greater than 60 percent by pharma, as the trials are costly and small in number. The supply market for early phase is comprised by CROs, research centers, and academic institutes. The market size that is comprised by the CROs is estimated to be around USD 8 billion, which is about 67 percent of the early phase market.
Traditionally in the pharmaceutical and biotech industry worlds, a pharma company develops a candidate product and then works with a group of doctors to test that product under careful standards and procedures—very much managed by the pharma company. If the product shows therapeutic value and safety, it becomes available to prescribers to administer to patients.
In clinical trials involving patients with complex medical diseases such as chronic kidney disease or cancer, nursing skills are especially useful. Nurses are trained on how to interact with, evaluate and appropriately care for, patients. They are familiar with complex medical regimes and are comfortable talking with and educating patients.
While many life sciences system vendors espouse the popular promises of Softwareas-a-Service (SaaS) technology, only a rare few can deliver.
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In advising and providing consulting to many different companies in recent years making a switch to risk-based monitoring (RBM) it's become apparent to me that the opportunity to improve patient safety and enhance data quality is the top reason for adoption. Later this year when the revised ICH E6 (R2) guidance goes into effect we will have even more incentive to adopt RBM!
Once a sponsor has completed research and clinical trials and believes enough evidence is available on the safety and effectiveness of the new drug, the final step of the development process is to submit an application to regulatory authorities to gain approval for marketing the product. The application must contain data outlining the technical specifications of the product, as well as statistical analyses demonstrating the safety and efficacy of the new molecular entity as evidence of the acceptable benefit:risk profile.
I recently had the opportunity to attend DIA. While listening to the panelists, I realized TransCelerate companies appear to be the furthest along in their journey of risk-based monitoring (RBM), and even so, RBM is still relatively new for most of them. For the companies presenting at DIA, the main reasons given for implementing RBM were to comply with the impending ICH E6(R2) guidelines, increase the overall quality of their data, provide better oversight of patient safety and target their efforts on the areas of trials that matter most.
CRA turnover is a problem in the industry. Finding qualified CRAs can be a problem for many companies. It then takes time to train and educate them on policy, procedures, and protocols. If that asset then leaves the company, you are back to square one.
I first met Glenn Gormley, M.D., Ph.D., at the 2014 PhRMA’s (Pharmaceutical Research and Manufacturers of America) annual meeting in Washington, D.C. At the time, I was engaged in a conversation with James (Mit) Spears, EVP and general counsel for PhRMA, and so my discussion with Dr. Gormley was brief. However, our encounter reminded me of an idea I once had for doing an article about Daiichi Sankyo. Though the company has a lengthy history, it had little experience in the area of oncology R&D. As Gormley is the senior executive officer and global head of R&D at Daiichi Sankyo Co., Ltd., as well as chairman of the board, executive chairman and president of Daiichi Sankyo, Inc, I thought perhaps he could share some insight on the company’s approach to entering into the field of developing cancer therapeutics. We conducted our formal interview on June 30, 2014. It resulted in the September 2014 Life Science Leader magazine cover feature — How Daiichi Sankyo Is Venturing Into The Unfamiliar Terrain Of Oncology R&D.
As is my custom, I provide interviewees with questions in advance to guide our discussion. After an article is published, it is rare for me to revisit these questions. Further, it is unheard of for me to receive legally approved written responses to my interview questions — especially after an article is complete. But with Glenn Gormley, I have come to expect the unexpected. What follows are the previously unpublished written responses to my interview questions, which serve to shed additional insight into Daiichi Sankyo’s approach to entering the field of oncology drug development.