Health Care providers have to find new ways to find revenue, paying close attention to reimbursement rates and contracts, managing patient safety and patient satisfaction.
One of the new areas of finding new revenue is to participate in some way in clinical trials. This is from a large insurance company with whom we work: “Allianz”, sharing ideas and information about the ‘industry’ and risk management, insurance.
Clinical Trial Research is a growth industry for physicians and medical practices: this is, as is the case in many growth industries: because of increased demand. Some are concerned in our country that we are close to another pandemic/epidemic of illness and disease outbreak.
The pharmaceutical industry is well aware of this threat and puts a lot of effort into the development of new drugs to help prevent such threats or cure existing or new diseases. Drug research follows where the money flows, big pharmaceuticals are protected to make a profit when they make the right medical breakthrough.
As a result, the industry’s research and development costs have been steadily increasing in the past years. "At the same time, however," explains AGCS liability underwriter Dr. Andreas Schaer, "it's getting harder and harder for companies to find completely new treatments. Generally speaking, most innovations today are improvements on existing medication."
The long road of R&D Clinical research can take place on a global scale. This challenge is inherently complex because of the obvious reasons. there are many sites, cultures, and legislations involved; and… there is a lot of pressure to fast track the development of new drugs.
The drug development process is difficult, complicated and time-consuming,…and, of course, it is expensive.
There are a number of risks involved with the process: With safety being of utmost importance in pharmaceutical development, there are very strict protocols that need to be observed before a new medication can be approved. This is part of the reason why there are four phases to drug studies on humans.
As the phases show signs of success, the approval process becomes more of a reality, and the drug moves closer.
Each phase involves more people and more elaborate examination of population segments such as age, gender, and race in order to determine the full effects of the new treatment.
Dr. Johannes Klose, AGCS scientific advisor for pharmaceuticals says that a clinical development program typically starts with a Phase 1 trial, on healthy volunteers, so if there are side effects, they will show up!
Later, the other phases: II and III investigate safety as well as the effectiveness of the drug. As you progress from phase to phase and include more and more people, the likelihood increases that a rare side effect will also turn up. Therefore, each stage in clinical development has its own unique risks.
The trials take place at many locations often,at the same time: Phase III trials designed to investigate safety and efficacy in large patient populations so, they involve significant investment in people.
Since this is a website that offers insurance solutions, naturally, we’ll mention that our agency specializes in helping people assess what they need in order to pay just the right amount in order to protect the organization as it moves through the phases.
Trial sponsors are required to carry clinical trials liability coverage in the event of trial-related injuries to trial participants. There are literally tens of thousands of clinical trials taking place around the world today. There are some organizations that predict a 10 % growth for the next five years.
Controlling the risk we have specialized for years in medical malpractice insurance; and, as you’re aware, healthcare has changed significantly, and so with it, changes our insurance agency.
Many of our physicians are covered (written into their medical malpractice polices for no additional premium) for their participation as investigators for clinical trials, and there are some precautions to take if you become further immersed into this industry.
One of the key areas of concern is speed: Clinical trials can take a great deal of time to design and for health authorities to approve. This can mean that the trial is ready to start just days before its actual launch date. It is in that small time window that the sponsor and the insurer must work together to develop the right cover because without it the study cannot begin.
This is where The Doctors’ Insurance Agency and our professional markets can help. We understand the process and the urgency, obtaining coverage is essential, and we are able to respond to their needs to produce an insurance certificate within a couple of days.
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