Disruptive Innovations – Boston
Last week, Dr. Jules T. Mitchel (standing) updated the participants at the meeting on Disruptive Innovations in Boston. The presentation was an update of Target Health’s progress on its approaches to eSource and risk-based monitoring in an ongoing Phase 3 program. After the presentation, a detailed interview occurred with Craig Lipset (seated left), Head of Clinical Innovation, Development Operations within Worldwide Research & Development at Pfizer and Dr. John Orloff (seated right), Chief Medical Officer and Senior Vice President, Global Development at Novartis. Craig and John were chairpersons of the conference together with Dr. Andreas Koester, Head, Clinical Trial Innovation / External Alliances, at Janssen.
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website, and if you like the weekly newsletter, ON TARGET, you’ll love the Blog.
Stages of Cervical Cancer: Stage 0 describes cancer cells found only on the surface of the cervix. More invasive cancers are separated into four stages. Stage I is when the cancer has not spread beyond the cervix. Stage II means the tumor has spread to the upper part of the vagina. A Stage III tumor extends to the lower part of the vagina and may block urine flow. In Stage IV, the tumor has reached the bladder or rectum, or cancer cells have spread to other parts of the body and formed new tumors.
Worldwide, cervical cancer is second most common and the fifth deadliest cancer in women. It affects about 16 per 100,000 women per year and kills about 9 per 100,000 per year. Approximately 80% of cervical cancers occur in developing countries Worldwide, in 2008, it was estimated that there were 473,000 cases of cervical cancer, and 253,500 1) ___ per year.
TODAY, NO WOMAN SHOULD DIE OF CERVICAL CANCER.
Young people should be given the HPV vaccine before they become sexually active. Regular PAP smears will reveal pre-cancerous changes in plenty of time to prevent cancer.
Cervical cancer is a malignant neoplasm arising from cells originating in the cervix uteri. One of the most common symptoms of cervical cancer is abnormal vaginal bleeding, but in some cases there may be no obvious 2) ___ until the cancer has progressed to an advanced stage. Treatment usually consists of surgery (including local excision) in early stages, and chemotherapy and/or radiotherapy in more advanced stages of the disease. Cancer screening using the Pap 3) ___can identify precancerous and potentially precancerous changes in cervical cells and tissue. Treatment of high-grade changes can prevent the development of cancer in many victims. In developed countries, the widespread use of cervical screening programs has dramatically reduced the incidence of invasive cervical cancer.
HPV or 4) ___ ___ ___ infection appears to be a necessary factor in the development of almost all cases (90+%) of cervical cancer. HPV vaccines effective against the two strains of this large family of viruses that currently cause approximately 70% of cases of cervical cancer have been licensed in the U.S, Canada, Australia, and the EU. Since the vaccines only cover some of the cancer-causing (“high-risk”) types of HPV, women should seek regular Pap smear screening, even after vaccination.
The cervix is the narrow portion of the 5) ___. Most cervical cancers are squamous cell carcinomas, arising in the squamous (flattened) epithelial cells that line the cervix. Adenocarcinoma, arising in glandular epithelial cells is the second most common type. Very rarely, cancer can arise in other types of cells in the cervix. The early stages of cervical cancer may be completely asymptomatic. Vaginal 6) ___, contact bleeding, or (rarely) a vaginal mass may indicate the presence of malignancy. Also, moderate pain during intercourse and vaginal discharge are symptoms of cervical cancer. In advanced disease, metastases may be present in the abdomen, lungs or elsewhere. Symptoms of advanced cervical cancer may include: loss of 7) ___, weight loss, fatigue, pelvic pain, back pain, leg pain, swollen legs, heavy bleeding, bone fractures, and/or (rarely) leakage of urine or feces (rarely). Infection with some types of human papilloma virus (HPV) is the greatest risk factor for cervical 8) ___, followed by smoking. Other risk factors include human immunodeficiency virus. Not all of the causes of cervical cancer are known, however, and several other contributing factors have been implicated.
Cervical cancer occurs when abnormal 9) ___ on the cervix grow out of control. Cervical cancer can often be successfully treated when it’s found early. It is usually found at a very early stage through a Pap test. Most cervical cancer is caused by a virus called human papillomavirus, or HPV. You can get HPV by having sexual contact with someone who has it. There are many types of the HPV virus. Not all types of HPV cause cervical cancer. Some of them cause genital 10) ___, but other types may not cause any symptoms. Human papillomavirus is the cause of 70% of cervical cancer globally.
You can have HPV for years and not know it. It stays in your 11) ___ and can lead to cervical cancer years after you were infected. This is why it is important for you to have regular Pap tests. A Pap test can find changes in cervical cells before they turn into cancer. If you treat these cell changes, you may prevent cervical cancer. Abnormal cervical cell changes rarely cause symptoms. But you may have symptoms if those cell changes grow into cervical cancer. Symptoms of cervical cancer may include:
- Bleeding from the vagina that is not normal, or a change in your menstrual cycle that you can’t explain.
- Bleeding when something comes in contact with your cervix, such as during sex or when you put in a diaphragm.
- Pain during intercourse.
- Vaginal discharge that is tinged with blood.
As part of a regular pelvic 12) ___, one should have a Pap test. During a Pap test, the doctor scrapes a small sample of cells from the surface of the cervix to look for cell changes. If a Pap test shows abnormal cell changes, your doctor may do other tests to look for precancerous or cancer cells on your cervix. Your doctor may also do a Pap test and take a sample of tissue (biopsy) if you have symptoms of cervical cancer, such as bleeding after intercourse. While the pap smear is an effective screening test, confirmation of the diagnosis of cervical cancer or pre-cancer requires a biopsy of the cervix.
The widespread introduction of 13) ___ screening by the Pap test or Pap smear for cervical cancer has been credited with dramatically reducing the incidence and mortality of cervical cancer in developed countries. Pap smear screening every 3-5 years with appropriate follow-up can reduce cervical cancer incidence by up to 80%. Abnormal results may suggest the presence of pre-cancerous changes allowing examination and possible preventive treatment. If precancerous disease or cervical cancer is detected early, it can be monitored or treated relatively noninvasively, with little impairment of fertility.
Cervical cancer screening is typically recommended starting at age 21. Recommendations for how often a Pap smear should be done vary from once a year to once every five years, in the absence of abnormal results. Guidelines vary on how long to continue screening, but well screened women who have not had abnormal smears can stop screening about age 60 to 70. The treatment for most stages of cervical cancer includes:
- Surgery, such as a hysterectomy and removal of pelvic lymph nodes with or without removal of both ovaries and fallopian tubes.
- Radiation therapy.
Depending on how much the cancer has grown, you may have one or more treatments. And you may have a combination of treatments. If you have a hysterectomy, you won’t be able to have children. But a 14) ___ isn’t always needed, especially when cancer is found very early.
The Pap test is the best way to find cervical cell changes that can lead to cervical cancer. Regular Pap tests almost always show these cell changes before they turn into cancer. It’s important to follow up with your doctor after any abnormal 15) ___ test result so you can treat abnormal cell changes. This may help prevent cervical cancer. If you are age 26 or younger, you can get the HPV vaccine, which protects against two types of HPV that cause cervical cancer. There are two HPV vaccines (Gardasil and Cervarix) which reduce the risk of cancerous or precancerous changes of the cervix and perineum by about 93%. HPV vaccines are typically given to women age 9 to 26 as the vaccine is only effective if given before infection occurs. The vaccines have been shown to be effective for at least 4 to 6 years, and it is believed they will be effective for longer; however, the duration of effectiveness and whether a booster will be needed is unknown. The high cost of this vaccine has been a cause for concern. Several countries have considered (or are considering) programs to fund HPV vaccination.
ANSWERS: 1) deaths; 2) symptoms; 3) smear; 4) Human papilloma virus; 5) uterus; 6) bleeding; 7) appetite; 8) cancer; 9) cells; 10) warts; 11) body; 12) exam; 13) cervical; 14) hysterectomy; 15) Pap
María Eva Duarte de Peron (May 7, 1919 – July 26, 1952) was an Argentine political leader, the second wife of President Juan Peron (1895 – 1974) and served as the First Lady of Argentina from 1946 until her death in 1952. She is usually referred to as Eva Peron, or by the affectionate Spanish language diminutive Evita. The nature of Peron’s illness was initially shrouded in silence. Her doctors diagnosed advanced cervical cancer in August 1951, but as was common at the time, the patient was told only that she had a uterine problem. According to the biographers Nicholas Fraser and Marysa Navarro, secrecy was so paramount that an American specialist, Dr. George Pack, performed Peron’s cancer operation without her or the public ever knowing. He entered the operating suite after she was under anesthesia.
Despite surgery, radiation and chemotherapy, Peron gradually worsened, dying in late July 1952 at age 33. Only then was it revealed that she had died of cervical cancer, although details of her treatment, including Dr. Pack’s involvement, remained concealed.
Peron’s first wife also died of cervical cancer, a venereal disease almost always caused by the Human Papilloma Wart Virus (HPV). Probably not a coincidence that both wives died of cervical cancer. Most likely, they both received the virus (HPV) that causes almost all cases of cervical cancer, from Juan Peron. In a 1972 biography, Erminda Duarte, Peron’s sister, claimed she had suffered intense pain and distress.
Eva Peron addresses the Peronists on 17 October 1951. By this point she was too weak to stand without Juan Peron’s aid.
By 1951, it became evident that Evita’s health was rapidly deteriorating. On January 9, 1950, she fainted in public and underwent surgery three days later. Although it was reported that she had undergone an appendectomy, she had actually developed advanced cervical cancer. Fainting continued through 1951, with extreme weakness and severe vaginal bleeding. Although her diagnosis was withheld from her by Juan Peron, she knew she was not well, and a bid for the vice-presidency was not practical in light of her condition. Only a few months after “the Renouncement,” Evita underwent a secret radical hysterectomy in an attempt to eradicate her advanced cervical cancer. In 2011 a Yale neurosurgeon studied Evita’s skull x-rays and photographic evidence and stated that Peron was possibly given a prefrontal lobotomy in the last months of her life in order “to relieve the pain, agitation and anxiety she suffered in the final months of her illness”. When used for psychiatric illness, lobotomy was once seen as a huge advance. Dr. Egas Moniz, a Portuguese neurologist who developed the procedure in the 1930s, was awarded the Nobel Prize in Physiology or Medicine in 1949.
Lobotomies for mental illness fell out of favor in the 1960s because of the development of effective antipsychotic medications, misuse of the procedure and a growing unease among doctors with the confusion and stupor that resulted from the operation. But the earliest practitioners of lobotomy saw another potential benefit: relief from severe and resistant pain. Lobotomy, the New York neurosurgeon Dr. Sidney W. Gross wrote in 1953, was a “valuable and humane” procedure that reduced pain by blunting patients’ emotional reactions to it. Even advocates acknowledged it could make patients “childish, dull, apathetic, with little capacity for any emotional experiences.” They simply believed such a state was preferable to constant pain.
In 2005, the Hungarian-born neurosurgeon Dr. George Udvarhelyi, who claimed to have assisted in Peron’s care in the 1950s and later moved to the Johns Hopkins School of Medicine, publicly discussed for the first time a lobotomy he said Peron received for intractable cancer pain a few months before her death. But it wasn’t until a Yale neurosurgeon, Dr. Daniel E. Nijensohn, himself an Argentine, began to research Dr. Udvarhelyi’s assertion that evidence began to accumulate. Dr. Nijensohn’s research, published in the journal World Neurosurgery and posted online, turned up several pieces of suggestive evidence. He confirmed details of Dr. Udvarhelyi’s story and found other contemporaries of Peron who had said she had had surgery for her pain. Dr. Nijensohn also unearthed information indicating that Dr. James L. Poppen, a neurosurgeon at the Lahey Clinic in Boston and an international expert on the use of lobotomy for intractable pain, had been summoned to operate on Peron in the summer of 1952. X-rays of Peron’s skull, Dr. Nijensohn found, showed indentations in the areas where lobotomies were usually performed. Dr. Nijensohn believes that a lobotomy was performed in May or June of 1952, meaning that Peron may have already had the procedure at the time of her last public appearance, riding in a limousine at her husband’s second inaugural.
If Peron indeed had a lobotomy, was she aware of what the doctors – with the permission of her husband, President Juan Domingo Peron – planned to do? Perhaps not, given the efforts to conceal her fatal diagnosis in general. And could a lobotomy actually have helped ease Peron’s suffering? Dr. Nijensohn is not sure. But many patients who were lobotomized in those days reported relief. “After the operations,” Dr. Frank J. Otenasek, a neurosurgeon at Johns Hopkins, told The Baltimore Sun in 1947, “patients either said they were not suffering or that the pain did not bother them.”
One of the ironies of Dr. Nijensohn’s story, if true, is that another method already existed for treating Peron’s pain: aggressive use of opiates like morphine. Doctors of the era, however, so feared that their cancer patients would become addicted to these drugs that they saw lobotomy as a suitable alternative. Today, our understanding of cancer pain has certainly changed. The liberal use of narcotics, accompanied by other medications to treat side effects, is seen as appropriate, not indicative of untoward behavior by patients. One of the most successful innovations in pain treatment, the morphine pump, allows patients to give themselves enough medication to dull the pain but to remain alert.
On 4 June 1952, Evita rode with Juan Peron in a parade through Buenos Aires in celebration of his re-election as President of Argentina. Evita was by this point so ill that she was unable to stand without support. Underneath her oversized fur coat was a frame made of plaster and wire that allowed her to stand. She took a triple dose of pain medication before the parade, and took another two doses when she returned home. In a ceremony a few days after Juan Peron’s second inauguration, Evita was given the official title of “Spiritual Leader of the Nation.” She died one month later. In 1971, Evita’s body was exhumed and flown to Spain, where Juan Peron maintained the corpse in his home. Juan and his third wife, Isabel, decided to keep the corpse in their dining room on a platform near the table. In 1973, Juan Peron came out of exile and returned to Argentina, where he became president for the third time. Peron died in office in 1974. His third wife, Isabel Peron, whom he had married on 15 November 1961, and who had been elected vice-president, succeeded him, thus becoming the first female president in the Western Hemisphere. It was Isabel who had Evita’s body returned to Argentina and (briefly) displayed beside Juan Peron’s. The body was later buried in the Duarte family tomb in La Recoleta Cemetery, Buenos Aires.
On July 26, 2012, to commemorate the sixtieth anniversary of Evita’s death, there began to be issued publicly tickets with a value of 100 pesos, in which the controversial effigy of Julio Argentino Roca is replaced by that of Eva Duarte, making the first real woman that appears on the coins of Argentina. The image in the notes is based on the design of 1952, whose sketch was found in the Mint, made by the engraver Sergio Pilosio with artist Roger Pfund settings. The emission totals 20 million tickets and is not yet clear whether it will fully replace the notes with the images of Roca and the Desert Campaign. Sources: The New York Times, by Barron H. Lerner MD; Dr. Barron H. Lerner, professor of medicine and public health at Columbia University Medical Center, is the author, most recently, of “One for the Road: Drunk Driving Since 1900;” Wikipedia
Rare Cancers Yield Potential Source of Tumor Growth
According to an article published in the New England Journal of Medicine (2012; 367:922-930), a genetic mutation has been discovered that appears to increase production of red blood cells in tumors. The discovery, based on analysis of tissue from rare endocrine tumors, may help clarify how some tumors generate a new blood supply to sustain their growth. According to the authors, the finding could lead to information on how to hinder the growth of tumors and treat cancers associated with excessive production of red blood cells.
The study analyzed tumors from two patients with a rare type of tumor, known as a paraganglioma,. which forms from chromaffin cells outside the adrenal glands, near blood vessels and nerves. Chromafin cells produce the hormone norepinephrine (adrenaline.) One patient also had a rare tumor of the duodenum known as a somatostatinoma. Since birth, both patients had polycythemia, a rare disease in which the body produces too many red blood cells.
Results showed that the tumor tissue contained an alteration in one of the family of genes called hypoxia-inducible factors (HIFs). HIFs have been implicated in the development of tumors and the progression of cancers. HIFs are made of two subunits, termed alpha and beta, and those subunits have been found to play a role in cancers. In the current study, it was found that the altered HIF2A gene generated proteins that were broken down more slowly than the typical form of the gene. In the presence of these proteins, there was also a documented increased levels of a hormone that stimulates the production of red blood cells.
HIF genes are most active in conditions of low oxygen, such as in tumor tissue. In previous studies it was observed that a patient’s polycythemia disappeared after a paraganglioma or pheochromocytoma (chromaffin cell tumors arising in the adrenal gland) was removed.
Protein Linked to Increased Risk of Heart Failure and Death
Heart failure occurs when the heart cannot fill with enough blood and/or pump enough blood to meet the body’s needs. Galactin-3 has recently been associated with cardiac fibrosis, a condition in which scar tissue replaces heart muscle, and cardiac fibrosis plays an important role in the development of heart failure. Heart failure carries enormous risk for death or a lifetime of disability and often there are few warning signs of impending heart failure.
This research is based on work from the Framingham Heart Study, which began in 1948 and has been the leading source of research findings about heart disease risk factors.
According to an article published online in the Journal of the American College of Cardiology (29 August 2012), a protein known as galectin-3 can identify people at higher risk of heart failure who could possibly benefit from treatments to prevent debilitating heart failure and death. Early identification of predisposed individuals would allow treatment to begin long before heart failure develops and could help people at high risk for heart failure to live longer, more active lives.
For the study, galectin-3 levels were measured in 1996-1998 as part of a routine examination of 3,353 participants enrolled in the Offspring Cohort of the Framingham Heart Study. At the time of measurement the average age of the participants was 59 years old. During an average follow-up of 11 years, 166 participants (5.1%) had a first heart failure event. Among the 25% of people with the highest galectin-3 levels (ranging from 15.4 to 52.1 ng/mL) the annual rate of heart failure was 12 per 1,000 people compared with 3 per 1,000 people for the 25% of participants with the lowest galectin-3 levels (ranging from 3.9 to 12 ng/mL). Fifty-three percent of participants were women.
Spironolactone and other related drugs believed to counteract cardiac fibrosis have been shown to improve outcomes in heart failure patients. According to the authors, future research will be needed to determine whether treatment with these or other drugs can benefit healthy patients with elevated galectin-3 levels.
Gastric Bypass Surgery Can Work
Extreme obesity is associated with health and cardiovascular disease risks. Although gastric bypass surgery induces rapid weight loss and ameliorates many of these risks in the short term, long-term outcomes are uncertain. As a result, a study published in the Journal of the American Medical Association (2012;308:1122-1131), was performed to examine the association of Roux-en-Y gastric bypass (RYGB) surgery with weight loss, diabetes mellitus, and other health risks 6 years after surgery.
The investigation was a prospective study conducted in Utah between July 2000 and June 2011. The study included 1,156 severely obese (BMI > 35) participants aged 18 to 72 years (82% women; mean BMI, 45.9) who:
- sought and received RYGB surgery (n=418)
- sought but did not have surgery (n = 417; control group 1)
- who were randomly selected from a population-based sample not seeking weight loss surgery (n = 321; control group 2).
The main outcome measures were weight loss, diabetes, hypertension, dyslipidemia, and health-related quality of life were compared between participants having RYGB surgery and control participants.
Results showed that 6 years after surgery, patients who received RYGB surgery (with 92.6% follow-up) lost 27.7% of their initial body weight compared with 0.2% gain in control group 1 and 0% in control group 2. Weight loss maintenance was superior in patients who received RYGB surgery, with 94% and 76% of patients receiving RYGB surgery maintaining at least 20% weight loss 2 and 6 years after surgery, respectively.
Diabetes remission rates 6 years after surgery were 62% in the RYGB surgery group, 8% in control group 1, and 6% in control group 2, with remission odds ratios (ORs) of 16.5; P < .001) vs. control group 1 and 21.5; P < .001) vs. control group 2. The incidence of diabetes throughout the course of the study was reduced after RYGB surgery. The numbers of participants with bariatric surgery-related hospitalizations were 33 (7.9%), 13 (3.9%), and 6 (2.0%) for the RYGB surgery group and 2 control groups, respectively.
According to the authors, among severely obese patients, compared with nonsurgical control patients, the use of RYGB surgery was associated with higher rates of diabetes remission and lower risk of cardiovascular and other health outcomes over 6 years.
TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area.
FDA Approves Aubagio as a New Multiple Sclerosis Treatment
The FDA has approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS).
MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs at least twice as frequently in women as in men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery periods may be incomplete, leading to progressive decline.
The most common side effects of Aubagio experienced by patients in clinical trials include diarrhea, abnormal liver tests, nausea, and hair loss.
The drug contains a Boxed Warning to alert prescribers and patients to the risk of liver problems, including death, and a risk of birth defects. Physicians should do blood tests to check liver function before a patient starts taking Aubagio and periodically during treatment. Also included in the Boxed Warning is an alert noting that, based on animal studies, the drug may cause fetal harm. For this reason, Aubagio is labeled as Pregnancy Category X, which means women of childbearing age must have a negative pregnancy test before starting the drug and use effective birth control during treatment.
Aubagio will be dispensed with a patient Medication Guide that provides important instructions on its use and drug safety information. Aubagio is made by Bridgewater, N.J.-based Sanofi Aventis.
For more information about MS, go to National Institute of Neurological Disorders and Stroke: Multiple Sclerosis Information Page
To Avoid Heartburn, Don’t Eat in Stressful Situations
Eighty years ago this month, workers putting up “The Rock” at Rockefeller Center in Manhattan, posed as they ate their lunch on a beam 69 stories up.
Sea Scallops With Figs and Butternut Squash Sauce
When I heard about a luscious scallop dish my husband had during his business trip this week in DC, I got a little jealous and decided to compete by creating a recipe for him to try upon returning home.
Figs are still in season, at a local farmer’s market, and today the scallops were sold (Dean & Deluca) within 24 hours of being caught (harvested?) and couldn’t be fresher. I decided to combine seafood and fresh fruit and here, below, is what I came up with. Serve these delicious flavors with an icy white Bordeaux (we get most of our wines from Sherry-Lehmann here in Manhattan) served in chilled glasses and lovely warm French bread to sop up any juices left on the plate. Enjoy!
Warm French baguette
8 Fresh Figs
2 teaspoons or more sugar-free apricot jam
1 Tablespoon Sugar-free maple syrup
1 Butternut Squash
1 pound Sea scallops
½ cup almond flour
Pinch Salt and pepper (or no salt)
Very fine balsamic vinegar
2 teaspoons extra-virgin olive oil
1 cup arugula
Annie Chun roasted seaweed for garnish
- Peel and roast the butternut squash. Then puree it in food processer and add the sugar-free maple syrup and pepper to your taste. Salt if you wish. Keep warm and set aside
- Wash figs, remove stems, and halve lengthwise. Dip the cut side of the figs in the sugar-free apricot jam and set aside.
- Wash arugula very well and drain. Then dry on paper towel. Put in small bowl and toss with about 1 Tablespoons of olive oil and a few drops of the balsamic.
- Heat a skillet over medium heat and add 1 tablespoon of olive oil, so the surface is lightly coated. Add a little sugar-free apricot jam and on it, put the figs cut side down until lightly caramelized.
- Flip figs and cook for an additional 30 seconds, remove from pan, and reserve. Add one drop (we keep a regular medicine dropper in the kitchen) of balsamic to each fig half and put them aside, trying to keep them warm
- Wash scallops and dry with paper towel. Cut each Sea scallop in half and lightly coat with the almond flour.
- Season scallops lightly with black pepper and salt, if you wish.
- Use the same pan, with oil and jam left in it. If you need more olive oil, add it lightly and mix it with the remaining jam.
- Add scallops and cook for 1 to 3 minutes (until a golden color). Turn the heat up, but be sure to constantly swirl the pan so that the scallops are rolling around and don’t get tough or burnt.
- Get ready to serve. Put the arugula on each plate. Now place half of the scallops on the arugula and then a fig half on top of the scallop.
- To the pan juice, add the butternut squash puree, heat and stir it with all the pan juices until nice and warm. If the squash is not the consistency of a sauce, slowly add some chicken broth until there is the desired thinner sauce. Now spoon this butternut squash sauce over the scallops and figs. Crush the seaweed and sprinkle it over the sauce and serve.
- One option: At the last stage, when you’re stirring the butternut squash with the pan juices, consider adding 1 or 2 Tablespoons of cream sherry. Do this slowly so you can taste before adding a second Tablespoon.
- Another option: If you’re pressed for time, consider using a frozen package of Birds Eye Southland frozen butternut squash. Thaw and warm it up, taste, and consider adding sugar-free maple syrup or cream sherry. If not, use as is to pour over the scallops and figs. Crush the seaweed and sprinkle over the scallop/figs.
Update of Phase 3 Clinical Trial Using eSource (Target e*CTR)
A phase 3 clinical trial started in August this year is using Target e*CTR™ (eClinical Trial Record), fully integrated with Target e*CRF, in lieu of paper source documents. Subject data are being entered at the time of the office visit in real team, thus the name eClinical Trial Record. Clearly, being alerted in real time when a subject signs informed consent, seeing data in real time, and being able to query almost immediately after entry, has revolutionized the way we now monitor our clinical trials. We met with FDA and shared our approach at a Type C Meeting under an IND. Interestingly, the sites are making very few errors. The majority of the database changes have to do with modifications of form properties based on requests from the sites, changes of online edit check specifications, and yes, “over-zealous” monitoring. Once we modified the Target e*CRF EDC application and retrained the monitors, query rates dropped.
Here are some metrics:
A. Query Rates
- At the time when 2,291 forms were entered the query rate was 8.3%. A week later, when 3,432 forms were entered, the query rate dropped to 7.6%.
- When there were 190 queries, 62% came from just 2 forms. A week later when there were 260 queries, those 2 forms represented 59% of total queries (sites retrained, EDC tweaked)
- Just 29 online edit checks fired from 2291 entered pages (forms) for a rate of 1.3%. This rate has stayed stable (1.4% a week later)
- Of the 29 edit checks, 15 were from one edit check which was modified. A week later when the edit check was modified, of the 49 edit check firing, there were still 15 from that edit check indicating that the problem was solved
B. Form Review: From the time of the office visit, of the entered forms:
- 1. 50% were reviewed in 4 hours
- 2. 75% were reviewed in 23 hours (<1 day)
- 3. 90% were reviewed in 45 hours (<2 days)
- 4. 95% were reviewed in 66 hours (<3 days)
Goodbye Paper: Time to go to the shredder
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at www.targethealth.com