Palm Beach Research

Vegetarian Diet Linked to Longer Life, Less CVD Mortality

David Scott — Wed, 12 Jun 2013 18:45:38 +0000

LOMA LINDA, California — In a large observational study of generally middle-aged American Seventh-day Adventists, the vegetarians in the group–ranging from vegans to those who ate meat once a week–were 12% less likely to die within six years than their meat-eating peers [1]. Men who ate a vegetarian diet were significantly less likely to die from ischemic heart disease or CVD. Does this mean everyone should forgo eating meat? Not so fast, experts caution, pointing to study limitations. But it does add support for following a “heart-healthy” diet.

According to lead author Dr Michael J Orlich (Loma Linda University, CA), “This research gives more support to the idea that certain vegetarian dietary patterns may be associated with reduced mortality and increased longevity” and can be used to guide food choices.

However, in an accompanying editorial [2], Dr Robert B Baron (University of California, San Francisco) points out since it was an observational study, cause-and-effect conclusions cannot be drawn from it, and it was based on a one-time questionnaire. He urges clinicians counseling patients to be less focused on a vegetarian vs nonvegetarian diet and rather to look to the broader goal of improving the diet.

Asked to comment, Dr Robert H Eckel (University of Colorado Anschutz Medical Campus, Aurora) concurs. “We need to put this study into perspective. Is a vegetarian diet heart healthy? Probably yes. Should people convert to a vegetarian diet based on this study? Absolutely not. I think they need to look at their overall diet and make sure it is consistent with what we know about diet and heart disease,” he told heartwire .

Cut Out Meat and Live Longer?

Previous studies found that eating nuts, fruit, salads, fiber, and polyunsaturated fats or following a “healthy” or vegetarian or Mediterranean diet was linked with longer life, whereas eating red or processed meat upped mortality, the authors report. The first Adventist Health Study of about 30 000 Seventh-day Adventists living in California in the 1970s found a link between vegetarianism and lower all-cause mortality. But the European Prospective Investigation into Cancer and Nutrition-Oxford (EPIC-Oxford) cohort study did not find this association.

To investigate this, the researchers examined data from 73 308 Seventh-day Adventist men and women over age 25 who were living in the US from 2002 to 2007. The study participants had a mean age of around 57 years, and about 66% were women.

Based on their replies to questions about their consumption of 200 foods over the past year, the participants were classed into the following dietary patterns:

Vegan: Ate eggs, dairy products, fish, and meat less than once a month (n=5548; 7.6%).
Lacto-ovo–vegetarian: Ate eggs and dairy products once a month or more; ate fish and meat less often (n=21 177; 28.9%).
Pescovegetarian: Ate fish once a month or more; ate meat less often (n=7194; 9.8%).
Semivegetarians: Ate meat once a month or more; ate fish or meat no more than once a week (n=4031; 5.5%).
Nonvegetarians: Ate fish or meat more than once a week (35 359; 48.2%).

Over a follow-up of a mean of 5.79 years, 2570 participants died.

Compared with nonvegetarians, the hazard ratio (HR) for all-cause mortality for all vegetarians combined was significant: 0.88 (95% CI 0.80–0.97). The HR for all-cause mortality ranged from 0.81 to 0.92 in the different vegetarian types and was significant only for lacto-ovo-vegetarians and pescovegetarians.

Some vegetarian diets were significantly associated with lower mortality from CVD, ischemic heart disease, renal disease, and endocrine disease (diabetes), but not from cancer. The associations were larger and more likely to be significant in men than in women.

In men, following any type of vegetarian diet was associated with a significant lower risk of dying from CVD or ischemic heart disease, but in women, this type of diet was linked with a nonsignificant lower risk of these outcomes. Men who were vegetarians had a nonsignificant lower risk dying from stroke, but among women, this type of diet appeared to increase the odds of dying from stroke.

Hazard Ratio (95% CI) for Death,* Vegetarian Diet vs Nonvegetarian Diet

Cause of death	Men and women (n=73 398)	Men (n=25 105)	Women (n=48 203)
Ischemic heart disease	0.81 (0.64–1.02)	0.71 (0.51–1.00)	0.88 (0.65–1.20)
CVD	0.87 (0.75–1.01)	0.71 (0.57–0.90)	0.99 (0.83–1.18)
Stroke	1.10 (0.82–1.47)	0.83 (0.52–1.31)	1.27 (0.89–1.80)

*Adjusted for multiple demographic variables

The effect of a vegetarian diet in this study was “pretty modest,” Eckel said. The more extreme diet–the vegan diet–did not appear to add additional benefits.

Information from Industry

Most nutritional experts “agree that diets should limit added sugars and sugary drinks, refined grains, and large amounts of saturated and trans fats, [and healthy diets should include] substantial amounts of fruits and vegetables [and] whole grains, legumes, and nuts,” Baron writes. “Achieving these goals trumps the more narrow goals of whether to include moderate amounts of dairy, eggs, fish, or even meat.”

Eckel agrees. “We need to get away from this ‘good food/bad food’ ” concept, he said. The overall diet is what is important. “Is some red meat or saturated fat in a diet appropriate? I think so. It’s just a matter of how much.”

Low Back Pain Linked to Bacterial Infection

David Scott — Fri, 10 May 2013 18:08:47 +0000

New research suggests that some 40% of chronic lower back pain (CLBP) could be caused by bacteria, and that a significant percentage of people with lower back pain following a herniated disc and swelling in the spine could find relief by taking an antibiotic.

Investigators from the Research Department of the Spine Center of Southern Denmark, University of Southern Denmark, Odense, led by Hanne B. Albert, PhD, conclude that antibiotics may be considered as a treatment option for patients with chronic low back pain, but with caution.

The authors suggest that long-term antibiotics should not be prescribed “without due consideration.” Low back pain is so common in the community that there could be hazards if used indiscriminately, they write.

“However, as many patients, as in this trial, are on sick leave at risk of losing their jobs and have a high analgesic intake, we suggest that antibiotics, when applied along the lines of this MAST [Modic antibiotic spine therapy] protocol may be appropriate in this subgroup, i.e., CLBP with Modic type 1 changes. We do not support the proposition that all patients with lumbar pain should have a trial course of antibiotics.”

Their findings, published in 2 papers, 1 a randomized trial of antibiotics for low back pain, are published in the April issue of the European Spine Journal.

Positive Cultures

An estimated 80% of Americans have low back pain at some point in their life, the authors write, and back pain is the most common reason for workplace absence.

The first of 2 studies shows that patients with an anaerobic infected disc are more likely to develop Modic change (MC) (bone edema) in the adjacent vertebrae after disc herniation, suggesting a role of bacteria in developing Modic changes.

The study included 61 adults (mean age, 46.4 years; 27% female) who had MRI-confirmed lumbar disc herniation and were undergoing surgery. All patients were immunocompetent. No patient had received a previous epidural steroid injection or had previous back surgery.

Using stringent antiseptic sterile protocols, researchers collected 5 tissue samples from each patient. In total, microbiological cultures were positive in 46% of the patients. Anaerobic cultures were positive in 43% of patients, and of these, 7% had dual microbial infections, containing 1 aerobic and 1 anaerobic culture. No tissue specimens had more than 2 types of bacteria.

The anaerobic microorganism Propionibacterium acnes was found in 40% of the total cohort and in 86% of those with positive microbiology. These bacteria typically live in human skin and hair follicles and gums.

The results showed that in the discs with a nucleus with anaerobic bacteria, 80% developed new MC in the vertebrae adjacent to the previous disc herniation. In contrast, none of the patients with aerobic bacteria and only 44% of those with negative cultures developed new MC.

The association between an anaerobic culture and new MCs was highly statistically significant (P = .0038), with an odds ratio of 5.60 (95% confidence interval, 1.51 – 21.95).

The authors said that the detected bacteria are unlikely the result of intraoperative skin contamination. They pointed out that the procedures were conducted under the strictest of sterile conditions. As well, if skin contamination was the cause of the infection, a pattern of multiple skin bacteria cultures would be observed, which was not the case.

Why would some patients develop MC when no microorganisms are present in their herniated nuclear tissue? The authors speculate this could be due to a biochemical effect reflecting edema secondary to microfractures and subsequent inflammation, or the result of an inflammatory process from proinflammatory chemicals penetrating through the microfractures from the nucleus pulposus.

Antibiotic Randomized Trial

The second study, a double-blind, randomized trial, showed that an antibiotic protocol was significantly more effective than placebo in reducing pain and disability. This study included 162 adults who had chronic lower back pain that had developed after a previous disc herniation and had lasted more than 6 months.

These patients also had bone edema, as shown by Modic type 1 changes in the vertebrae adjacent to the previous herniation. Such changes in the vertebrae are present in 6% of the general population and 35% to 40% of those with low back pain.

The patients were randomly assigned to amoxicillin-clavulanate (500 mg/125 mg; Bioclavid) or identical placebo 3 times daily for 100 days and were blindly evaluated at baseline, end of treatment, and 1 year.

The analysis included 144 patients who completed the 1-year follow-up. The antibiotic group improved on all primary outcome measures, including disease-specific score on Roland Morris Disability Questionnaire (RMDQ), and lumbar pain. The improvement continued from the 100-day follow-up until the 1-year follow up.

The improvements in the antibiotic group were highly statistically significant on all outcomes measured, including secondary outcomes of leg pain, number of hours with pain in the last 4 weeks, global perceived health, and days with sick leave, among others.

For example, at baseline, 100 days, and 1 year, the disease-specific disability-RMDQ scores for the antibiotic group were 15.0, 11.5, and 7.0, and for placebo they were 15.0, 14.0, and 14.0 (P = .0001 for the difference between placebo and antibiotic group at 1 year follow up). For back pain, the figures for the antibiotic group were 6.7, 5.0, and 3.7 and for placebo they were 6.3, 6.3, and 6.3. (P = .0001 for difference).

For low back pain, which was experienced by all patients at the beginning of the study, 67.5% of the antibiotic group reported this pain after 1 year compared with 94.0% of the placebo group (P = .0001 for difference). The percentage of those with constant pain was reduced from 73.5% to 19.5% in the antibiotic group and from 73.1% to 67.2% in the placebo group (P = .0001 for difference).

There was a trend toward a dose-response relationship, with double-dose antibiotics being more effective; however, this was not statistically significant because the study was not powered for this comparison.

Adverse events were more common in the antibiotic group (65% of participants) than in the placebo group (23%).

Surgical Setting

In an editorial accompanying the publication, Max Aebi, MD, from the MEM Research Center for Orthopaedic Surgery, Institute for Evaluative Research in Orthopedic Surgery, University of Berne, Switzerland, and editor-in-chief of the European Spine Journal, points out that previous studies have shown that MC I occurs 6 times more frequently in the low back pain population than the general population. The relationship may be mechanical, he writes, “but under certain circumstances, low virulent infections may play a key role.”

These new papers not only demonstrate that patients infected with herniated nucleus material by anaerobic bacteria in lumbar disc herniation develop new MC I in adjacent vertebrae but also that patients with low back pain and MC I after lumbar disc herniation improved significantly with an antibiotic protocol, Dr. Aebi writes.

“This strongly suggests one cause of low back pain in combination of MC I to be of low-grade infectious nature in case of previous disc herniation,” he said.

However, he cautions that it is ethically impossible to take biopsy samples from all of these patients; this could be done only those who have surgery subsequent to disc herniation. The authors ask “the obvious key question” of whether the bacteria found in the nuclear material results from infection or could be due to intraoperative contamination, he writes, and then provide a “plausible” answer as to why such contamination is “highly improbable.”

Information from Industry

“Nevertheless,” Dr. Aebi writes, “further research is necessary to show what exactly happens in patients with disc herniation who develop MC I and low back pain and who have not been operated on. How could we show that in this fraction of patients there could be the same number of anaerobic infections of the nucleus material? By markers of the anaerobic bacteria or of specific infectious tissue, which could be made visible in imaging? By fine needle biopsy?”

Knowing these answers would make the current study results “even more explosive” in terms of better understanding low back pain and corresponding MRI changes, said Dr. Aebi. “We are keen to wait for further innovative research in this field.”

The authors have disclosed no relevant financial relationships.

Eur Spine J. 2013;22:690-696, 697-707, 689. Abstract Abstract Editorial

Health Fair 2

David Scott — Wed, 08 May 2013 15:07:24 +0000

Palm Beach Research Center Innovates Clinical Research with ePRO

David Scott — Thu, 02 May 2013 15:48:28 +0000

By Carolyn Peterson, PHT Corporation
April 29, 2013 | Guest Commentary | “It’s easier for patients and it makes us more efficient.” Laurie Jassenoff, Vice President of Clinical Affairs at Palm Beach Research Center, is talking about the benefits of electronic patient reported outcome (ePRO) systems for collecting data from clinical research patients.
Headquartered in West Palm Beach, Florida, the Palm Beach Research Center’s therapeutic expertise includes arthritis, asthma, back pain, constipation, diabetes, diabetic gastroparesis, IBS, knee pain research, osteoarthritis, and psoriasis.
The majority of new trials use ePRO systems to improve patient data quality, and protocol and regulatory compliance. Jassenoff estimates ePRO systems save patients and staff between 25 and 40% of the time it takes to conduct paper-based clinical studies. And, they increase patient compliance about 33%.
Paper is Painful
Patients give too little or too much information with paper diaries. For example, paper questionnaires for a knee pain study asked participants if it hurt to run up and down stairs. One patient wrote that he lived on the first floor, so he didn’t know what he should write. Patients must complete ePRO questionnaires accurately and in the correct order. They can’t add unrequested information.
When Jassenoff’s staff is working on a study that uses paper diaries, data lock—the time and date the sponsor agrees they will not submit any more patient data to support their New Drug Application (NDA)—is less likely to be on schedule. “A lot of time is lost when coordinators have to enter patient information into the eCRF,” she says. “We don’t know if a subject is being compliant with a paper diary,” Jassenoff said. “Why would a sponsor or CRO want to enter data manually when it can be seamlessly integrated through electronic devices?”

Without real-time access to accurate patient data, study coordinators also can become concerned about the safety of the patient and their ability to participate in a study.
And, paper diaries are more likely to be misplaced, lost or destroyed. “With paper diaries I’ve actually heard ‘my dog ate it,’” Jassenoff laughed.
The Patient’s Choice
Patients of all ages find eDiaries easy to understand and use. Coordinators find that patients enjoy reviewing their completed questionnaires during follow-up visits, which can be up to an hour shorter than paper visits.
If patients have an iPhone or a mobile device they can complete their questionnaires anywhere. Patients complete questionnaires through their device or a study-specific software app. The ePRO System automatically loads the data to an online reporting portal and transfers it, sending custom reports and metrics to the sponsor or CRO.
Because data is integrated into EDC systems and can be reported immediately, coordinators are more likely to know if a patient is qualified. Palm Beach Research Center uses its enrollment metrics to track patients in real time. With ePRO Systems, Jassenoff gets emails alerts only for patients who aren’t completing their diaries on time. She forwards the emails to the study coordinator, who contacts the patient.
Even for pediatric studies of infants when you can’t get first-hand PROs, Jassenoff points out that you can collect good observational PRO data by recording parents’ or caregivers’ observations of a child’s reactions to a new drug.
In addition to the handheld eDiaries, the Palm Beach Research Center uses other devices like PEF meters for Asthma and COPD studies, and Glucometers for Diabetes. These devices patients take home relieve the pressure of “White Coat Syndrome.” Patients can become anxious visiting a site, or they might have had coffee or other caffeinated beverages before their site visit. These portable devices enable 24 hour monitoring so coordinators can see what’s happening with the patient after they leave the site.
A Boost for Site Efficiency
Laurie Jassenoff says using ePRO Systems also improve Palm Beach Research Center’s operations. They eliminate duplication because the team enters the data once. They can review data, enrollment, and compliance and send custom reports to the sponsor quickly. When they do QA for studies, it’s easier to enter data.
With mobile reporting, study coordinators aren’t tied to their computers. They can walk around with their mobile devices and get instant metrics to see if patients are compliant, and if they aren’t their site visits can be rescheduled.
The Future of ePRO
The Palm Beach Research Center staff is enthusiastic about enabling patients to use the web to participate in clinical research programs. Jassenoff explained, “The cost savings is incredible when you think about a patient who doesn’t have a phone line at home and needs a wireless device. Patients like going wireless. And sponsors and CROs don’t have to pay for devices or telecommunications costs.”
The world is moving to faster and better technology based devices are available. “Personally I find it fantastic that as a clinical researcher I’m able to use electronic methods to collect patient outcomes,” Jassenoff said.
About the Author: Carolyn Peterson is Marketing Manager at PHT Corporation, provider of products for collecting patient-driven eData in clinical research programs. She can be reached at cpeterson@phtcorp.com

Green Tea and Coffee mean no stroke?

David Scott — Thu, 04 Apr 2013 17:43:10 +0000

Green tea and coffee consumption may help protect against stroke, according to a large Japanese population-based study.

The study showed that people who drank green tea or coffee regularly had about a 20% lower risk for stroke than their peers who seldom drank these beverages.

“This is the first large-scale study to examine the combined effects of both green tea and coffee on stroke risks,” Yoshihiro Kokubo, MD, PhD, head of the Department of Preventive Cardiology, National Cerebral and Cardiovascular Center in Osaka, said in a statement.

Their findings were published online March 14 in Stroke.

Inverse Link

The study involved 82,369 Japanese adults aged 45 to 65 years without cardiovascular disease or cancer at baseline who were followed for a mean of 13 years. “Green tea and coffee consumption was assessed by self-administered food-frequency questionnaire at baseline,” Dr. Kokubo toldMedscape Medical News.

During more than 1 million person-years of follow-up, the researchers documented 3425 strokes (1964 cerebral infarctions, 1001 intracerebral hemorrhages, and 460 subarachnoid hemorrhages) and 910 coronary heart disease (CHD) events (489 definite myocardial infarctions and 28 sudden cardiac deaths).

In multivariate analysis, higher coffee and green tea consumption were inversely associated with risk for cardiovascular disease (CVD) and stroke.

For example, people who drank at least 1 cup of coffee daily had a 20% lower risk for any stroke (adjusted hazard ratio [aHR], 0.80; 95% confidence interval [CI], 0.72 – 0.90) compared with those who seldom drank coffee.

People who drank 2 to 3 cups of green tea daily had a 14% lower risk for any stroke (aHR, 0.86; 95% CI, 0.78 – 0.95), and those who consumed at least 4 cups had a 20% lower risk (aHR, 0.80; 95% CI, 0.73 – 0.89), compared with those who seldom drank green tea.

The risk reduction for intracerebral hemorrhage was 17% (aHR, 0.83; 95% CI, 0.68 – 1.02) with consumption of at least 1 cup of coffee daily and 23% (aHR, 0.77; 95% CI, 0.63 – 0.92) for 2 cups of green tea daily compared with rare consumption of either beverage.

There was no significant association between coffee and tea consumption and CHD, largely mirroring findings from other studies.

Experts Weigh In

Victoria J. Burley, PhD, senior lecturer in nutritional epidemiology, School of Food Science and Nutrition, University of Leeds, United Kingdom, who wasn’t involved in the study, called it “very interesting.”

She noted that “both high-fiber foods and these particular beverages may have anti-inflammatory properties. Whole grains, fruit and vegetables, and these beverages are all rich in polyphenols, which appear to have multiple potential actions on markers of CVD risk: blood pressure, glucose homeostasis, lipid metabolism, and so on.”

“This appears to be a well-conducted study,” Dr. Burley said, “with good power (plenty of cases), with long follow-up and a respectable method of assessing green tea and coffee intake (for these dietary aspects I think an FFQ [food-frequency questionnaire] is likely the best approach).”

She cautioned, however, that the intakes of green tea in this Japanese cohort “far exceed” usual consumption in western populations and that, conversely, intakes of coffee may generally be somewhat lower in Japan.

“The highest coffee intake category was 2-3 cups per day, which is not particularly high. Other studies (eg, conducted in Sweden) have reported elevated CVD risk in people with much higher intakes ( > 7 cups per day), so in setting their highest category this low these study authors may not have been able to pick up evidence of increased CVD risk with greater intakes,” Dr. Burley said.

“Overall, it’s encouraging data that suggest people who incorporate coffee and green tea in their diet may experience lower CVD risk in later life,” she added.

Information from Industry

Dose reduction is not always an option when trying to meet individual patient needs in relapsing MS

Read about dosing flexibility

Commenting on the coffee findings, Susanna C. Larsson, PhD, from the Unit of Nutritional Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden, found it “interesting that such a small amount as 1 cup of coffee per day reduces the risk of stroke by 20% (quite a large reduction in risk).”

“Otherwise, this Japanese study confirms results from studies conducted in the US and Europe showing an inverse association between coffee consumption and stroke risk. This study adds further support that moderate coffee consumption may lower the risk of stroke,” said Dr. Larsson, who was not involved in the study.

The study was supported by Grants-in-Aid for Cancer Research and the Third-Term Comprehensive Ten-Year Strategy for Cancer Control from the Ministry of Health, Labor and Welfare of Japan. The authors, Dr. Burley, and Dr. Larsson have disclosed no relevant financial relationships.

Stroke. Published online March 14, 2013

Toxin in bee venom kills HIV virus

David Scott — Mon, 11 Mar 2013 15:03:13 +0000

Melittin, the toxic component of bee venom, penetrates HIV and other viruses, essentially killing the pathogens, say researchers at Washington University School of Medicine in St. Louis. They hitched melittin to nanoparticles with molecular stopgaps that prevent damage to healthy cells. Used in a vaginal gel, the toxin could prevent HIV transmission, and researchers hope the findings could be used to treat other infections. ~ Washington University in St. Louis

Diet Sodas, as Well as Regular Ones, Raise Diabetes Risk

David Scott — Mon, 18 Feb 2013 18:08:44 +0000

A new study from France suggests that women who drink large amounts of diet soda are at increased risk for type 2 diabetes. The findings also support the previously documented association between high intake of regular sugar-sweetened beverages and the condition, report Guy Fagherazzi, from the Center for Research in Epidemiology and Population Health, Villejuif, France, and colleagues in a study published online January 30 in the American Journal of Clinical Nutrition.

Prior research into the relationship between diet soda (artificially sweetened beverages) and type 2 diabetes has produced conflicting results, and while the current study does not necessarily imply causation, there are some biologically plausible mechanisms, the researchers suggest.

And given that diet sodas are “considered — and marketed — as healthier than sugar-sweetened beverages,” the findings require further investigation, they say. In the meantime, the authors advise that “a precautionary principle could be applied to the promotion of [artificially sweetened beverages].”

Highest Intake of Diet Soda More Than Doubles Diabetes Risk

The data come from a large prospective cohort study of 66,118 women in France investigating links between diet and cancer. There were 1369 new cases of type 2 diabetes diagnosed during the follow-up period from 1993 to 2007.

Based on self-reported dietary consumption, the average intake of regular sodas was 328 mL/week, while for diet sodas it was higher, at 568 mL/week.

The risk for type 2 diabetes was elevated among the women in the highest quartiles for both sugar-sweetened beverages (>359 mL/week) and artificially sweetened beverages (>603 mL/week) compared with women who did not consume those beverages, with hazard ratios of 1.34 and 2.21, respectively, after multivariate adjustment for a variety of covariates (other than body mass index [BMI]).

Strong positive trends in type 2 diabetes risk were observed across quartiles of consumption for both types of beverage (P = .0088 and P < .0001, respectively). Adjustment for BMI did modify the results somewhat, although the associations remained significant for both sugar-sweetened beverages and artificially sweetened beverages.

The authors also conducted sensitivity analyses to test the hypothesis that people who are at risk for type 2 diabetes by virtue of obesity may preferentially drink artificially sweetened beverages, but the results suggest that such a “reverse causation” mechanism is “unlikely,” they note.

“Our results — in accordance with a recent joint scientific statement of the AHA and ADA — strongly suggest the need to conduct randomized trials that evaluate metabolic consequences of [artificially sweetened beverage] components, such as artificial sweeteners, to prove a causal link between [artificially sweetened beverage] consumption and type 2 diabetes,” the study authors conclude.

The authors have disclosed no relevant financial relationships.

Am J Clin Nutr . Published online January 30, 2013.

Marijuana may raise risk of stroke

David Scott — Thu, 14 Feb 2013 17:23:06 +0000

Dr. Alan Barber of the University of Auckland discusses the surprising potential link between cannabis use and stroke revealed by a new case-control study of stroke patients. And he outlines the potential implications for physicians prescribing medical marijuana to their patients.

Clinical Trial Management Software

David Scott — Fri, 01 Feb 2013 01:37:18 +0000

There are a number of common adages that float around the clinical trial industry, which are usually based in some form of truth:

Access to patients is the number one problem in clinical research.
Eighty percent of patients come from 20% of sites, but sponsors keep going back to 100% of sites.
Monitoring hours are one of the highest costs in a clinical trial.

Laurie Jassenoff, Vice President, Palm Beach Research Center
These phrases, while sounding cliché, do highlight some of the most frequent and cost-heavy challenges in clinical research and relate in one way or another to effective clinical trial management. But the questions remain: How do organizations proactively manage the many different moving pieces and parts of a trial? How can sponsors and CROs alike harvest and institutionalize information on how to run trials effectively? How can operational managers see useful information across dozens of trials to keep programs on track and identify potential problems before they happen?
These are the types of problems a clinical trial management system (CTMS) can address. However, it is not always a smooth and seamless process.

When web-based EDC and automated randomization systems emerged over a dozen years ago it seemed that some of these new systems might eliminate the need for standalone CTMSs. That has not proven to be the case. The need for CTMS is still important for sponsors, CROs, and sites.

Many technology systems are touted to include “business intelligence” or digital dashboards and compatibility with other systems. It’s also become common to include compatibility and integration with other data management systems as a core capability of eClinical systems, but it’s more difficult to implement in ways that are meaningful and beneficial to end users.

This was the case with Palm Beach Research Center, an investigation site that conducts Phase I-IV clinical programs. Laurie Jassenoff, MBA, Vice President of Palm Beach explains, “Today, to get any kind of information on a clinical research program we have to query a particular database. If we want to look at studies, that’s one database. If we want to look at studies with patients, that’s a different database. It takes a lot of extra time and effort. When I log into my bank account I can view all my accounts at once. It would be great if as a researcher I could sign on to one integrated database with the same kind of front page to access all the information I need.”

And while many systems can integrate with other systems, providing compliance and industry standards capabilities, there are cost and time considerations to integration that must be accounted for. Because integration can be difficult, many organizations can end up using different data sources during trial conduct and go through the process of merging data at the end. Jassenoff says, “for example, it would be a huge time saver if we can enter our source data and it merges with the eCRF.”

Palm Beach Research Center is rolling out a CTMS in 2013. “Our goal is for the CTMS to become a huge patient database that will be able to show cross references of studies and patients, and patients in studies, in addition to having budget information integrated to show what we are invoicing and what is outstanding.” Jassenoff said, “Ideally I’d like to be able to review this integrated data on my iPad anywhere, any time.”

CTMS integrations make a great deal of business sense. The combined data streams provide real-time trial information that may come from ePRO, IVRS, and EDC systems that roll directly into CTMSs and roll up into a real time view of a trial.

How will CTMS look 10 years from now? That’s what vendors and organizations alike are contemplating.

The likelihood seems strong that cloud-based computing will make it easier to provide meaningful dashboards from data across trials. The resulting information should flow more easily across systems into data warehouses and reporting servers that provide that actionable knowledge to a variety of stakeholders about the way trials are run.

—Sheila Rocchio, Vice President of PHT Corporation

Why sticking to a treatment plan is important for people with Psoriasis

David Scott — Wed, 30 Jan 2013 20:42:00 +0000

Pills, lotions, syringes and infusions. Caring for psoriasis and psoriatic arthritis can seem like a chore at best, which makes it all that much harder to stick to a treatment plan.

Dr. Steven Feldman, a dermatologist with Wake Forest University, said his office recently tracked the compliance rate of seven patients using adalimumab (Humira) and found that only one of the seven used the drug exactly as directed.

Stopping a drug, administering it incorrectly or reducing the dosage without a physician’s advice can results in flare-ups or cause the medicine to stop working, Feldman said. And increasing the dosage without a doctor’s guidance can result in very serious consequences — even death.

Still, there are many reasons why people with psoriasis and psoriatic arthritis have trouble following a treatment plan. Here are some of most common reasons — and how to overcome them:

They fear side effects.
Patients hear the word “steroid” — a common ingredient in topical creams and ointments — and picture balding men and beefy women, Feldman said. But the steroid used in most creams is cortisone, which is the same hormone the human body naturally creates. It’s common for people to be wary of systemic drugs, such as methotrexate or a biologic. Feldman said he urges patients to weigh the real risk of a side effect, such as the extremely small risk of developing lymphoma from a biologic, with the potential for relief from psoriasis or psoriatic arthritis. If the risk of side effects is too much, patients should work with their doctor on an alternative treatment plan.

Treatment is messy/inconvenient/uncomfortable.
For people with mild to moderate psoriasis, treatment often consists of an ointment or cream. However, topical ointments can be messy or inconvenient to apply to certain parts of the body, such as the scalp. Patients and doctors need to agree on a treatment that the patient is willing to use as directed, Feldman said.

Confused by or forget dosing instructions.
It’s human nature to forget the details, which is why Feldman makes a point of writing down dosage instructions for his patients. “If you don’t give it in writing, it’s almost as if you didn’t tell the person.” If you can’t remember if you should take a drug once a week, or daily for a week, don’t guess. Taking too much of a medicine can result in serious consequences. Taking too little could trigger a flare or make the drug less effective. Call the doctor’s office and get the correct information, Feldman said.

Treatment is too expensive.
It may be tempting to cut back or stop taking a medicine when costs go up or when your insurance status changes, but don’t. Low-income people and those without insurance usually can contact the drug companies for help, Feldman said. Those who don’t qualify for help should work with their doctor to find a less-expensive treatment.