The Bay Area is generally considered the world’s capital for biomedical research. On any given day there are hundreds of different pharmaceutical products being developed all around us. Clinical trials are some of the most highly regulated procedures in existence and for the average person this can seem like an overwhelming sea of acronyms and medical jargon.
The first stage of a clinical trial, often called ‘first in man’ studies, start after extensive research on animal models has determined that the drug under review poses no great threat to a human patient. Even though researchers are confident that the medication will not cause any long term damage, Phase I is still considered a safety trial since it uses a very small group of people to look at the side effects of the drug at various dosage levels.
Dr Bettina Steffen MD, Scientific Officer at the California Institute for Regenerative Medicine (CIRM), says that the most noticeable difference about a Phase I is the experience for the patient enrolled in the study. Unlike later phases where patients usually receive a bottle of pills to take home with them, these subjects are monitored closely in a setting similar to an intensive care unit. Every vital sign imaginable is recorded to ensure that no severe adverse effects occur.
The second distinguishing factor of Phase I is that the patients are not usually part of the population targeted for eventual use of the medication. These are young, healthy individuals recruited specifically because they do not have an illness that could skew the results. Oncology studies are one exception to this is given the urgency of the disease. Late stage cancer patients are often very willing to try an experimental drug and can be entered into a clinical trial as early as Phase I.
Once a clear understanding of the side effects has been outlined the study can now expand to the scope of Phase II protocols. Here the sample size will grow to over a hundred patients and this time around they are likely to be ones who have the disease or condition targeted by the medication. The primary goal is to determine the dose amounts that give maximum effectiveness with minimal side effects. Additionally, pharmaceutical companies perfect a way to produce the medication in large quantities since it has only been needed in small batches upto this point.
While the primary goal of Phase II is to find the impacts of different dosage levels, companies also need to be looking at preliminary data on how effective a drug is. Interim Director for Scientific Research at CIRM, Dr Patricia Olson, Ph.D. says that, “No company is going to make an investment in a Phase III unless you have seen some indicators of improvement in patients.”
The third and final stage of a clinical trial takes place several years after the whole study has begun. Now that safety levels have been established (in Phase I) and dosage effects have been outlined (in Phase II) researchers are finally able to measure how effective the drug is at treating the target illness. This is where thousands of patients are needed from every applicable demographic group (age, gender, disease severity etc.). Patients are randomly assigned to either receive treatment or a placebo and neither they nor the clinicians monitoring them know which group they are in (hence the term “double-blind, randomized study”).
One of the misconceptions about clinical trials is that they proceed in a stepwise fashion from the first phase to the third. In reality a stage might be repeated several times or there can be several trials at the same Phase running concurrently. For example, Gilead is currently running two Phase III trials simultaneously for a hypertension drug called Darusentan. One trial has only two groups—a placebo group and a Darusentan group. The second study, with several hundred more patients, includes a placebo group, Darusentan group, and a third group of patients who receive a hypertension drug already on the market. This second arm of the study allows Gilead to see if their drug not only works, but works better than treatments that are currently available.
From an employment perspective Phase III is where the greatest number of staff are brought on board at the pharmaceutical company. According to Paul Hastings, President and CEO of OncoMed, at the Phase I stage only a few people are needed to manage the daily operations and the biggest hire will be a Chief Medical Officer who will oversee the entire study. By the time Phase III is up and running, however, a team of up to a hundred people are needed. At this point the employment opportunities increase considerably since individuals are needed to work on quality assurance, FDA regulatory procedures, manufacturing, extensive statistical analysis of the data and all the administrative support a clinical trial requires.
While the most highly sought after employees are ones with a clinical background or experience in the hard sciences, this doesn’t mean that drug companies are only looking for people at the doctorate level. Someone with a bachelors of science and several years of experience is also an asset to the team since he or she can navigate the medical lingo with ease. The Bay Area is home to the some of the most advanced medical research in the world, and luckily, that means the biomedical employment market is booming.