Palm Beach Research Center

Relishing in Cranberry Biology

admin — Thu, 01 Dec 2011 18:13:06 +0000

Twenty years ago, the cranberry was considered a luxury crop in contrast to grain, wheat, and corn. While researchers have come to understand that it has some benefit to human health since then, today it is still regarded as a specialty crop. But Nicholi Vorsa believes that the cranberry has an un-harvested potential to improve human health, so he’s developing new varieties to provide a stable supply of cranberries for our consumption.

At the Rutgers School of Environmental and Biological Sciences, Vorsa is the director of the Blueberry and Cranberry Research and Extension Center. To develop new varieties that are resistant to environmental pressures, his team is sequencing and annotating the cranberry genome. For this research, New Jersey is the perfect place.

The annotated cranberry genome will provide a map of the locations of desirable and undesirable genes on the plant’s 24 chromosomes.Source: Wikimedia Commons, Muffet

“From the standpoint of breeding better varieties, it’s the best place because we can select the varieties under the pressures that you’re looking for, such as disease and heat stress,” says Vorsa.

In the end, the annotated cranberry genome will provide a map of the locations of desirable and undesirable genes on the plant’s 24 chromosomes. The major challenge is that often desirable and undesirable genes share the same real estate in the genome, making it difficult to isolate these linked genes.

“We’ll have an understanding how to break those linkages better to keep the qualities that we’re interested in, such as high yield, high color, and high quality,” says Vorsa.

Furthermore, the genome will provide insight into the molecular mechanisms behind its positive effects on human biology. For example, Vorsa and colleagues have recently analyzed the different effects of the cranberry metabolite called flavonoid in normal and obese mice. In a paper published last month in PLoS One, the group reported that obese mice fed a flavonoid-rich diet had not only improved insulin resistance and plasma lipid profiles but also lost internal fat mass (1). In the normal mice, the same diet reduced the plasma atherogenic cholesterol. In conclusion, flavonoid affects different pathways in mice with different metabolic states.

In cancer research, a specific class of these cranberry flavonoids called proanthocyanidins holds a particular promise for future treatments. In a paper published in the International Journal of Oncology, Vorsa and colleagues at Brown University reported that cranberry proanthocyanidins not only make ovarian cancer cells more susceptible to treatment but also deactivate pathways that help these cells avoid apoptosis (2). While researchers have developed drugs that are initially effective against ovarian cancer, the cancer eventually becomes resistant.

“The hope is that we can use a combination therapy with the therapeutic drug along with some how these cranberry proanthocyanidins to thwart the cancer’s ability to resist treatment,” says Vorsa.

References

Insights into the molecular mechanisms of the anti-atherogenic actions of flavonoids in normal and obese mice. Shabrova EV, Tarnopolsky O, Singh AP, Plutzky J, Vorsa N, Quadro L. PLoS One. 2011;6(10):e24634. Epub 2011 Oct 10.

Int J Oncol. 2012 Jan;40(1):227-35. doi: 10.3892/ijo.2011.1198. Epub 2011 Sep 12. Anti-angiogenic activity of cranberry proanthocyanidins and cytotoxic properties in ovarian cancer cells. Kim KK, Singh AP, Singh RK, Demartino A, Brard L, Vorsa N, Lange TS, Moore RG.

Written by Andrew S. Wiecek for BioTechniques.com

Optimizing clinical research site performance through additive patient enrollment

admin — Mon, 14 Nov 2011 22:27:43 +0000

Twenty years ago, research sites alone would provide their total enrollment quota simply by reaching into their own database of patients. But in the last two decades, the clinical trial landscape has changed and the ripple effect has meant that sites need to go outside their practice for patients.

Increases in clinical studies and protocol complexity are putting a strain on sites and their ability to recruit solely within their own walls. Competition for the patients has increased, while fewer patients in a practice are qualifying for contracted studies. Today, sponsors are responding to this challenge by routinely using additive recruitment services to provide 30-50% of randomized subjects. Additive patient recruitment is defined as the process of sourcing patients who are not indigenous to a site’s practice, via the services of a third party provider.

These additive patients optimize site enrollment performance and help ensure that a sponsor’s investment in sites produces the required number of patients in the prescribed timeframe, even when sites have run out of their own patients. Therefore, additive patient recruitment is no longer a nice to have or a rescue solution — it is very often a critical part of the study plan.

For some sponsors, however, the temptation to forgo additive patient recruitment in favor of what appear to be safer or more cost-effective options is still prevalent. These traditional options have significant shortcomings in the new world order of clinical trial complexity and competition.

Financial Implications

Once a study team agrees that sites alone will not meet their enrollment in time, there are generally a limited number of choices available to fill the patient gap. These options all have budgetary implications, and it is critical to analyze the financial and value impact of each. The analysis should answer the question: “What is the most cost effective manner to obtain the patients we need, within the timeframe we need, and at the lowest risk of failure?”

Successful evaluation requires a clinical study team to compare the current cost of obtaining patients through additive recruitment versus the cost to continue trying to add more patients via the same site-based approaches.

To benchmark the latter scenario, let us consider for the purposes of illustration that a sponsor needs 300 patients for a phase III study. The study team concludes that 50 sites will be required to enroll the 300 total patients (six patients per site). Once we know the average number of patients per site, cost per patient can be calculated.

For some sponsors, however, the temptation to forgo additive patient recruitment in favor ofwhat appear to be safer or more cost-effective options is still prevalent.

The process of vetting, hiring, maintaining and winding down sites requires time and cost, driven by activities such as:

Site identification
Site negotiation and contracting
Training site staff on the study design, data capture systems, filing requirements, etc. (may include investigator meeting attendance costs)
Supplying site with study related materials, drug supply, and equipment
Performing a site initiation visit
Site monitoring

These items reflect sunk costs incurred whether the site ever enrolls one, three, or the desired six patients. Numerous clinical trial costing tools such as ClearTrial and a wide variety of publicly available research estimates that total sunk costs range from $20,000- $75,000 per site. Such a range largely reflects the costs of training the site depending on study complexity, the costs of supplying the site depending on study procedures, and whether or not the sponsor is performing the work themselves or outsourcing to a CRO.

Going back to our example, we will assume a site cost average of $30,000 and estimate that each site will contribute an average of five patients. Divide those two numbers and the average cost per patient is $6,000 (and the study team will still be 50 patients short of the enrollment goal).

Through this simple analysis, we have successfully benchmarked the current cost for each internally “recruited” patient. Now the study team is prepared to evaluate options to compensate for the enrollment shortfall.

Limited options for fixing enrollment issues The most common options study teams consider are:

Add more sites

Do nothing and wait

Give sites money for local advertising

Hire a patient recruitment company

Let us examine each of these options and assess their typical impact on time, budget and enrollment effectiveness.

Add more sites

When the top sites fall short on their numbers, there is little chance that adding second or third tier sites will match or do better than those sites with higher expectations or more robust patient populations. Moreover, it takes months and the aforementioned expense ($20,000 to $75,000) for the study team or CRO to locate, evaluate and initiate more sites.

Existing sites are ready to process patients right now – but do not have enough qualified candidates within their ranks. When sites have run of their own patients, they are akin to empty processing facilities, waiting to receive the raw materials needed to produce enrolled patients. Study teams, under pressure, simply do not have the time to source and initiate new sites, but could easily increase the production capacity of existing ones through additive recruitment – providing existing sites with new influx of patients to raise their enrollment contributions.

Waiting to see if sites can fix the problem

Sites are small businesses – sponsors have hired them to provide the study with patients, for which sites are paid per a negotiated contract. This is revenue sites need to pay their own expenses and realize a profit, so they are not holding back when it comes to enrolling patients. If they are not able to source patients now, they are not likely to suddenly discover patients in a few weeks. And as the study team waits for patients to magically to appear, the budget continues to be spent – sites still need to be monitored, IVRS is still running, drug supply is expiring, etc. Doing nothing has a substantial cost.

Provide money for local advertising

Some sites do a good job spending their advertising stipends efficiently, but many do not, and will be the first to admit it. Moreover, there is limited or no tracking of how the sites spend these dollars and what resulted from the effort. How do study teams know that all the money allocated was specifically spent on their study, versus used on a competitive study? Do they know how many enrolled/randomized patients they received for the stipend?

Generally speaking, most study teams would not accept such a lack of accountability in any other area of study management or organization. Individual study sites are not experts in advertising or media buying. They are experts in patient care. Providing $2,500- $5,000 to each site for local advertising is a long-standing practice, if not tradition. Yet, with ineffective patient recruitment still a pervasive issue, the efficacy of providing local advertising stipends to sites remains in question.

The increasingly popular option

Hiring a specialty vendor to design and manage an additive recruitment campaign, focused on enhancing individual site enrollment, is the option that is increasingly making sense from a time, risk, and financial standpoint. However, the call to action is not to simply hire a company that specializes in patient recruitment advertising. Patient recruitment is not advertising. Advertising is advertising. True patient recruitment is a set of proven processes that manage recruitment from the moment a patient responds to an advertisement through their initial eligibility pre-screening, first visit to the site, review of consent, and ultimate enrollment in the study. This is central management designed to optimize the enrollment performance of every site. These processes use the raw material created by many different forms of advertising to ensure that, with the help of each site, potential patients are managed and enrolled in the most timely and cost-efficient manner. A central recruitment campaign should ensure participating sites always have a steady, well-paced supply of additive, suitable patients to screen — patients these sites would not have otherwise enrolled in the study because they are not part of the sites’ existing databases.

In other words, the recruitment effort must provide high quality raw material for clinical research processing centers (sites) to be running at peak efficiency until the patient quota is met. So the question is: How do clinical study teams select the recruitment partner who can consistently and reliably produce results?

Selecting a recruitment partner…choose wisely

The primary mission of a patient recruitment partner is to design and implement a plan that provides a discrete number of patients to fill the gap sites cannot fill on their own. That is the basic premise and function of this unique business we know as patient recruitment. The primary mission of the patient recruitment partner is not to develop great advertising campaigns. The capability to create effective patient recruitment advertising is a given, not a differentiator. Therefore, the fundamental selection criteria for the study team is to find a partner that can — in contractual not anecdotal terms — contribute a predictable number of additive patients over a specific period of time.

That partner should also be able to offer a fee structure based on the delivery of enrolled/randomized patients depending on the therapeutic area, and that per-patient fee can often include all the set up, project management, and pass through fees. In other words, a partner confident in its assessment of the enrollment challenge will contractually put the vast majority of its fees on the delivery of patients into the study.

Clearly those patients should not be ones the sponsor would have otherwise received from the sites’ own activities. This also requires a symbiotic relationship where the selected recruitment partner has access to independent, blinded controls (e.g., IVRS-data matching) to verify which patients enrolled in the study as a result of their work.

Budget accordingly…and confidently

It is not unusual for there to be a 50 to 1 ratio of people who respond to a specific study advertisement for every one patient who enrolls/randomizes.

If it costs $60 to generate a respondent, then that hypothetical recruitment campaign would cost the sponsor $3,000 per randomized subject, not including any program fees (e.g., project management, call center, site support fees). For the uninitiated, $3,000 may appear expensive. However, as presented earlier in the benchmarking exercise, it is not unusual for a sponsor to already be technically paying $5,000, $10,000, even $20,000 per patient (for the hardest studies) based upon the average number of patients enrolled per site and the total cost of hiring the site.

If an additive recruitment campaign results in a sponsor avoiding a three-month enrollment delay and/or prevents it from adding 10 second- or third-tier sites at an average cost of $30,000 per site, there is a high likelihood that the campaign will either be cost neutral or cost positive. And, importantly, the study will enroll on time.

Looked at another way, additive patient recruitment does not mean additive budget, especially when selecting a partner with a results-based philosophy and contracting approach. Sponsors should not be afraid to ask for both. Study teams should also not be surprised when the CRO, despite having its own patient recruitment department, will hedge on offering this type of results-based contract. Expedited enrollment, in fact, reduces the overall earning capacity of CRO projects which are driven by time, materials, and the number of participating sites. The more sites and time involved, the more a CRO makes, especially on change orders when enrollment stalls.

Moving forward

Proactively budgeting for additive patient recruitment services is, with the help of the right partner, a fairly straight-forward exercise that is appropriately vetted through the sourcing and procurement departments of most sponsors. Study teams should ask their outsourcing representatives to source multiple proposals and look for the company that offers detail on the process, and not just the advertising. Moreover, they should look for the company that puts its own funding at a payment milestone that is truly meaningful and truly results based, like enrolled or randomized patients.

With the right partner, patient recruitment is a predictable, repeatable process that optimizes site performance and prevents budget overruns caused by adding sites, adding time, and paying for CRO change orders.

Courtesy 2011 Acurian, Inc. White Papers

Depression Can Lead to Heart Disease

admin — Mon, 14 Nov 2011 22:26:42 +0000

Depression may have more far-reaching consequences than previously believed. Recent data suggests that individuals who suffer from a mood disorder could be twice as likely to have a heart attack compared to individuals who are not depressed. This process has been poorly understood — until now. A new study led by Concordia University has found that depressed individuals have a slower recovery time after exercise compared to those who are non-depressed.

These findings suggest that a dysfunctional biological stress system is at play among depressed individuals. Published in the journal Psychophysiology, the research warns of the importance of testing for cardiovascular disease among people suffering from major depression.

“There have been two competing theories as to why depression is linked to cardiovascular disease,” says first author Jennifer Gordon, who is a PhD candidate at McGill University. “Depressed people may have poorer health behaviors, which may in turn lead to heart problems. The other possibility is physiological: a problem with the stress system known as the fight or flight response. Our study was the first to examine the role of a dysfunctional fight or flight response in depression in a large population.”

Heart rate recovery is a powerful diagnostic tool

A total of 886 participants, who were on average 60 years old, took part in the study conducted by Concordia in association with the Montreal Heart Institute, McGill University, the Hôpital Sacré-Coeur de Montréal, the Université du Québec à Montréal and the University of Calgary.

Approximately five per cent of participants were diagnosed with a major depressive disorder. All individuals were asked to undergo a stress test after which their heart rate and blood pressure were recorded. Recovery heart rates and blood pressure levels were compared between depressed and non-depressed individuals.

“We found that it took longer for the heart rate of depressed individuals to return to normal,” says senior author, Simon Bacon, a professor in the Concordia University Department of Exercise Science and a researcher at the Montreal Heart Institute. “Heart rate recovery from exercise is one way to measure the fight or flight stress response. The delayed ability to establish a normal heart rate in the depressed individuals indicates a dysfunctional stress response. We believe that this dysfunction, can contribute to their increased risk for heart disease.”

“The take-home message of this study is that health care professionals should not only address the mental disorder, but also the potential for heart disease in patients who are suffering from major depression,” adds Bacon. “Both of these health issues should be treated to minimize risk of severe consequences.”

Source: Concordia University

Big Apple Genomics

admin — Mon, 14 Nov 2011 22:25:12 +0000

A new genome research center is scheduled to open next year between the upscale boutiques on Madison Avenue, creating about 500 new research positions in New York.

In the fall of 2012, the new genomics research center is scheduled to open on Madison Avenue in New York City.

The New York Genome Center (NYGC) will centralize data storage and other resources for 11 local research institutions to improve collaboration in personalized medicine. The center is expected to create about 500 new research jobs and generate economic growth for the city by tapping into the $7.4 billion genomics industry.

In the fall of 2012, the new genomics research center is scheduled to open on Madison Avenue in New York City. Source: New York Genome Center

“When we were approached about the NYGC, we were happy to join,” said Bruce Stillman, president of Cold Spring Harbor Laboratory (CSHL), one of the participating institutes. “Some [of the NYGC partners] are hospitals, and we have a lot of opportunity in integrating technology, which we’re already doing a little bit but hope to do more,” said Stillman.

Each institution brings its unique experience and resources to the collaboration. For example, CSHL will focus on molecular biology, genetics, and cancer research. Since establishing its first Genome Research Center in 1998, the principal strength of the lab has been its clinical applications in diagnostics.

The other participating institutions include Columbia University, Cornell University, The Jackson Laboratory, Memorial Sloan-Kettering Cancer Center, Mount Sinai School of Medicine, New York-Presbyterian Hospital, New York University, North Shore-Long Island Jewish Health System, The Rockefeller University, and Stony Brook University.

For many of these institutions, it won’t be the first time they have worked together. For instance, CSHL has collaborated with Memorial Sloan-Kettering Cancer Center, Columbia University, North Shore-Long Island Jewish Health Systems, and Cornell University on previous research projects. Currently, its collaboration with the New York Presbyterian Hospital involves clinical trials using software algorithms developed by Columbia University researchers to personally identify cancer progressing mutations (1).

Data sharing within this new alliance has the ability to integrate research in DNA diagnosis and find drugs that can treat patients, improve bioanalysis, and promote advancements. The new center will also provide a large high-throughput genome sequencing facility featuring Illumina sequencers for participating institutions, develop new products for hospitals to improve healthcare, and establish new collaborations with pharmaceutical companies.

The $125 million facility was funded by several groups including the Simons Foundation, Carson Family Charitable Trust, and Bloomberg Philanthropies.

Operations will be finalized once the leaders create a strategic plan for the center and enroll a science director in charge of the internal research department.

References

1. Akavia, U.D., Litvin O., Kim J., Sanchez-Garcia F., Kotliar D., Causton H.C., Pochanard P., Mozes E, Garraway L.A., Pe’er D. An Integrated Approach to Uncover Drivers of Cancer. 2010. Cell. 143:1005-1017.

Fearless & Successful

davidscott — Mon, 14 Nov 2011 19:18:31 +0000

A successful stand-alone investigator site—one not affiliated with an academic institution, a hospital or any other sites—is a rarity in clinical research. Most sites that try independence find that they can’t find a steady flow of studies.

Palm Beach Research Center is an exception. The 15-year-old, 25-employee investigator site chugs along with many Phase II and III studies from large pharma and big contract research organization (CRO) partners. It’s one of Quintiles top sites. Palm Beach Research is paying overtime to process all the volunteers coming in to be screened for possible participation in studies.

Standalone Center

Being around for a decade and a half is part of its success, says president and co-owner David Scott. Word of mouth—among sponsors and also among study participants—has been pivotal. But there are more tricks to the trade, he says. The primary care physician and general surgeon who launched the center in 1994 had independence in mind from day one. “The smartest thing they did was to locate the site in a separate office, not sticking it in the back of one of their practices and asking a nurse to do clinical trials as well as regular duties,” Scott says.

The two doctors started with chronic pulmonary obstructive disorder (COPD) and smoking cessation studies, and were able to successfully recruit from their own patient base. Family members managed the site “so there was always a high level of trust,” says Scott. After a few years, one of the doctors moved to Kentucky and the other moved to a different part of Palm Beach County. Scott and a nurse psychologist bought out the founders.

Numbers Driven

All along, Scott says, the site had a laser-sharp emphasis on getting fair payment. “This kind of business will only be strong if you continually focus on getting paid for what you did,” says Scott. “Otherwise, you will grind to a halt.”

This is trickier than it sounds. Scott shares a common scenario: Say a study contract was negotiated two years ago. Since then, there have been multiple protocol amendments rendering the study more complicated and time-consuming. Maybe what began as a one-infusion-per-day study has turned into two infusions spaced three hours apart. But the contract was not amended to provide additional payment. “Some of these things happen faster than we can realize,” says Scott. He’s not shy about understanding that research is a business.

Next step? A conversation with the sponsor. “We’ll say, ‘Look you added an extra IV infusion with no extra payments for the nurse who now has to wait three hours between infusions,’ ” says Scott. “We need more money.”

Careful organization of all this is possible due to the site’s home-grown time-tracking system. The site’s study monitors and coordinators use it to log in their time spent on each study.

Cash Helps

Having the center’s VP of clinical affairs act as the primary coordinator on all studies has been pivotal, too. This streamlines things, says Scott, who explains that, with other less-organized sites, when the sponsor asks who the primary coordinator will be, “sometimes there’s a rush to figure out who it is.” This can cause stress and waste time.

His site pays research subjects in cash. “The easiest way to do it is to let them finish the study, then mail a check. But we started to realize that when we switched [to cash], compliance went up,” says Scott. Patients are paid $50 at the end of each visit and there’s a receipt associated with the cash, which is entered into the site’s patient tracker. There’s a clear record of it.

The company has one location, in the heart of West Palm Beach, at the entrance to a major highway. Management dabbled in running multiple locations at one point, but decided it wasn’t for them.

Single Location

“The weakness of that model is if you think of the headquarters as ground zero, and you try to see everything that’s happening [with other sites], the further away you get from that office, the less you hear and the less you know,” says Scott. “Eventually, financially, you’ll have a drain. We found we were spending so much time running around and maintaining those sites that they were only semi-profitable—not as strong and rich as we know clinical research can be.”

Palm Beach Research also has had loose affiliations with a few hospitals, but discontinued those, too. The red-tape interfered with the site’s agility, says Scott.

“I can tell a sponsor on the phone all they need to know when they call up: how long enrollment will take, how many coordinators you’ll have to have and how much time it will take,” he says, adding that when hospitals were also in the mix, many phone calls had to be made to multiple parties, which made obtaining even the smallest bit of information take weeks. Scott would rather work faster, leaner, and be able to turn around a budget approval in two days.

Patient Surplus

Palm Beach Research has worked on approximately 325 studies, with an average number of 20 patients per study. Phase II and III is the site’s forte. The center can do Phase I, though its size—just three extended-care rooms—really doesn’t support that. Not yet, anyway. The center expanded into an adjacent office in January of 2009 and now occupies 8,500 square feet.

Palm Beach Research doesn’t do anything revolutionary to get the word out to prospective patients. It sends postcards to previous study participants, as well as placing ads on TV and in newspapers. It also has an active refer-a-friend program. And the place is overrun with volunteers, apparently due to the economy. “Five years ago, you could walk into our lobby and be screened and seen for a study right away. Today? No chance. There’s probably a two-week wait,” says Scott.

—by Suz Redfearn

Published January 05, 2010

Trial gives participant insights into diabetes

admin — Fri, 08 Jul 2011 17:58:05 +0000

When her endocrinologist suggested she consider a clinical trial involving newly diagnosed Type 1 diabetics, Markee Flint’s head nearly split in half.

“It’s very difficult emotionally when you’re first diagnosed,” says the 27-year-old Durham, N.C., resident. “You’re grieving for your health and trying to work this new chronic illness into your life. Trying to decide whether to participate in a clinical trial on top of that is hard.”

The University of North Carolina was conducting a two-year Phase 3 trial of a drug that researchers hoped would preserve beta cell function in newly diagnosed Type 1 diabetics, but Markee was nervous about the risks and concerned because she’d have to miss six days of work. What’s more, researchers advised participants against becoming pregnant during the trial and Markee and her boyfriend were talking about getting married and starting a family.

Markee read the trial information carefully and sought input from both loved ones and professionals. In the end, she says, “I felt like if I didn’t do it I’d regret it for the rest of my life.”

Markee joined the double-blind study, which called for participants to be infused with either a placebo – also known as a “dummy drug” — or the investigational drug for eight consecutive days. Over the next two years researchers would evaluate her condition using blood draws, meal tolerance tests, clinic visits, and information she entered in a personal digital assistant.

Markee admits the eight days spent lying in a hospital bed while she received her infusion treatments were painfully boring. Still, she says, other than an excruciating headache during one of her last treatments, for which the research staff gave her Tylenol with codeine, she didn’t suffer any other side effects. As her two-year participation comes to an end, Markee says the most oppressive aspect of the research has been the mundane task of tracking her meal, insulin and blood sugar data.

But if Markee has been surprised by the tedious nature of the trial’s downside, she’s been even more surprised by the inspirational nature of the upside.

“When I was diagnosed, I’d never met anyone with Type 1 diabetes,” Markee says. “I was really lonely because I felt no one really understood what I was going through. My coordinator at UNC helped me connect with the diabetes community and that helped me.”

Those new friendships have helped change her perspective on clinical trials as well, Markee says.

“When I joined the trial I just wanted to help myself. I didn’t really care about trying to help society or serving the greater good. But as you meet more people who have the same condition as you, you start to hope. Even if you didn’t get the drug, you hope you’re doing your small part because all of a sudden it means so much more.”

What are Clinical Trials?

admin — Thu, 07 Jul 2011 18:57:38 +0000

What are clinical trials?
• A research study involving human volunteers to answer specific health questions.
• Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people and new ways to improve health.
• Clinical trials are conducted according to a plan called a protocol.
• A protocol describes what types of patients may enter the study; schedules of tests and procedures, drugs, dosages, and length of study, as well as outcomes that will be measured.
• Each person participating in the study must agree to follow the protocol.

Why are clinical trials conducted?
• To see if a new drug or device is safe and effective for people to use.
• To compare existing treatments to determine which is better.
• To study different ways to use standard (approved) treatments, so they will be more effective, easier to use, and/or decrease side effects.
• To learn how to best use the treatment in a different population, such as children, in whom the treatment was not previously tested.

What are some of the possible benefits of my participation?
• Gain access to potentially new research treatments.
• Receive expert medical care for the condition being studied, since investigators are often specialists in the disease area being studied.
• Help others by contributing to medical research and treatment advances.
What are some of the possible risks of my participation?

• There may be unpleasant, serious, or even life threatening side effects resulting from the treatment.
• The treatment may not be effective.
• Participation in the trial may be demanding and time consuming.

Research Trial Success Story

admin — Fri, 17 Jun 2011 10:15:35 +0000

Jenna Korb: Back from the Brink

Happy dreams of a promising future can vanish in an instant.

That’s what Jenna Korb, then a bright, lively college student from Montana, learned when she went to the school nurse for a check-up.

It was 1993 and the 19-year-old had been feeling exhausted and lightheaded. She decided to drop by the college nurse for a spur-of-the-moment exam.

“I thought I’d get a quick slap on the hand for not getting more sleep and not eating better,” says Jenna. But the nurse told her she looked terrible. “When she pricked my finger for a drop of blood, it didn’t even look normal,” recalls Jenna, now the executive director for the Leukemia & Lymphoma Society San Diego/ Hawaii Chapter.

Jenna was rushed to the local hospital and soon transferred to the Fred Hutchinson Cancer Research Center in Seattle. There she was diagnosed with myelodysplastic syndrome, a condition in which blood cells that develop in the bone marrow are defective and die off.

The prognosis was dire. Jenna underwent chemotherapy and lost her hair, but she needed a bone marrow transplant to survive. Prior to the transplant, Jenna’s doctors approached her about taking part in clinical trials.

She decided to participate in two trials. “One was a medication for rejection that would allow me to take one pill after the transplant rather than 10 or 15,” she says. “The other was a clinical trial for a drug I could take during treatment that would help relieve nausea.”

The clinical trials at Fred Hutchinson were well organized, Jenna recalls. “Everything they did was centralized. My responsibility was taking the pills and they recorded everything”

After the bone marrow transplant, Jenna spent 40 days in a Laminar air flow room, which keeps the air free of any impurities or pathogens that could lead to infection. At one point she became overwhelmed with the amount of medication she had to take.

“I started to skip taking the pills,” Jenna says. “The researchers came in and said ‘We can’t effectively track your response to all these drugs because you’re not taking everything we want you to take.’ They monitored me very closely.”

Jenna’s body tried to reject the bone marrow: She wound up in intensive care several times and at one point had to be put into a drug-induced coma. Gradually, however, her condition improved. Seven years after the transplant, Jenna’s doctors declared her disease free.

Today Jenna is “100% healthy” and her treatments and tests are in the past. Through her work with the Leukemia & Lymphoma Society she’s met people who have received the drug she helped test and is gratified to know that “it’s still out there working and helping with rejection to bone marrow transplants.”