Achieve cost-efficiencies and speed data delivery by combining bioanalytical and central laboratory services for clinical trials.
With most sponsors utilizing an outsourcing model of some kind, the biggest opportunity might still lie ahead. As the industry adapts to be more budget minded and efficient, the quest for innovation remains. So, what does meaningful innovation look like for the clinical trial industry?
Typically Clinical Research Organizations (CROs) involvement in the clinical trial process has centered on site management in terms of identifying potential sites and managing patient recruitment. They also offer services related to activities such as protocol development, data management, laboratory services, and toxicology analysis amongst others. Managing clinical supplies has always been seen as a backroom activity, one which sponsors tended to keep a firm hold on, perhaps highlighting their importance to the sponsor in terms of meeting First Patient In (FPI) deadlines.
Historically, scientific innovation alone in the absence of any significant pricing pressures was sufficient to maintain return on investment (ROI) and deliver on unmet medical needs.
CTI Clinical Trial & Consulting Services, a full-service global contract research organization (CRO) specializing in complex therapeutic areas, adopted the Medidata Clinical Cloud® as its preferred platform of clinical trial technology to efficiently run the operations of its rapidly growing global business. The company has been using Medidata’s cloud-based platform for over three years.
The Infectious Disease Division of a world-renowned nonprofit research organization in the Pacific Northwest is the world’s largest clinical trials network for the development and testing of an HIV vaccine. The group conducts all phases of clinical trials, from evaluating experimental vaccines for safety and their ability to stimulate immune responses to testing vaccine efficacy. Due to the nature of their work, researchers at the center frequently need to modify protocols during their clinical trials, either by changing the timing of scheduling windows or by inserting new steps into the protocol, such as adding vaccines or changing dosage, which may require collecting additional consent forms from research subjects.
Every quarter, Synergy Research Group, a full-service CRO headquartered in Moscow, Russia, issues its Orange Paper. The report, which looks at the state of clinical trials in Russia, is comprised of research done by combing through data from the country’s Ministry of Health. The Orange Paper offers a concise snapshot of clinical trials in the region.
The Q2, 2014 Synergy Orange Paper was just released. One of the more significant findings is that the gap between previous years’ trials and the current period is closing. In the first quarter of 2014, there were 18 percent fewer trials than in the same quarter in 2013. In the second quarter, there was a gap of only three percent.
In a recent news report[i] Bayer AG was asked to obtain “more data about the quality of life for patients” who use its expensive “new cancer medicine Stivarga” (regorafenib). The request came “from a German panel that makes coverage decisions for public insurers.” The Federal Joint Committee “voted to give the company 18 months to provide the new data, which could come in the form of a clinical trial,” and unveiled a “temporary ruling today that Stivarga offers patients a slight added benefit compared to existing therapy that costs less than a quarter as much.”[ii]
It seems both sensible and practical that evidence for efficacy and effectiveness should be accompanied with a measurement of QoL benefit. Even if QoL results cannot reach the level of content validity required by FDA for a claim, payers and formularies want to know how patients would benefit if they cover the costs of a newly approved medication.
As we slipped into the booth at the local diner, it occurred to me that the last time I had spoken to Glen was at this same venue. “Yeah, that was two years ago,” he said with a tinge of nostalgia. Two years ago? Time had flown by for me but I know it was not the case for him. Glen still had not found a new full-time position.
A Ph.D. scientist (organic chemistry) with solid people skills and senior management experience, I was surprised when he got down-sized. I was just as sure he would end up in a good place in the long-run. Unfortunately, the long-run never came. After pursuing “more than 100 legitimate job leads and conversations throughout the pharmaceutical industry,” Glen is still looking for a new job. And just like that, I found myself sitting face-to-face with the long-term unemployment epidemic that is afflicting many individuals in the U.S., as well as scientists and pharmaceutical employees from around the world.
With the rationale of making Europe a better environment for clinical research, the European Union is taking steps towards greater transparency of clinical trial data. In this article, CROS NT highlights the connection between traceability and transparency, and makes recommendations on how to satisfy the regulatory authorities and be prepared for future clinical data transparency obligations.
A recent initiative (April 2014) by the European Medicine Agency (EMA) on data transparency was ﬁnally passed into draft law by the European Union, requiring that detailed summaries of clinical trials are published in a publicly accessible database once marketing authorization is granted. Sponsors could face strict ﬁnes for not complying. Also, in March 2014, the EMA published the ﬁrst summary of a risk management plan (RMP) for a newly authorized medicine, stating “the Agency will pilot the publishing of RMP summaries for all newly centrally authorized medicines during 2014 and at a later stage will start producing RMP summaries for previously authorized medicines”. The RMP will be a publicly available document that describes all that is known and unknown about a drug’s safety and what actions will be taken to monitor the drug on the market and mitigate any risks.