Welcome to the fourth installment of this series! The goal of each article in this series is to improve the quality of all clinical trials by reminding you, the reader, of another important step that will increase the likelihood that your next study will be completed on time, within budget, and with a minimum of complications.

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Welcome to the second installment of my new series! The goal of each article in this series is to improve the quality of all clinical trials by reminding you, the reader, of another important step that will increase the likelihood that your next study will be completed on time, within budget, and with a minimum of complications.

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Almost ten years ago, I ran across a very disturbing statistic: 90% of all clinical trials experience significant delay! At first, I deemed it the exaggerated wailing of a disgruntled researcher. However, as I spoke with research directors and project managers across our industry, I came to understand that it was unfortunately true. But why?

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Welcome back for Part 2 of Extraordinarily Successful Leaders! As I explained in my introduction to Part 1, I had long wondered why certain companies in our industry were very successful while others were not. Over time, I uncovered a host of reasons. However, a common factor that appeared in almost every case was effective senior leadership. So, I set about interviewing as many of those leaders as I could to learn what skills and practices made them and their companies so successful. I uncovered ten key traits. In this article, I explore emotions, leadership traits, self-doubt, inspiration, and authenticity. Then, as an added bonus, I share some life lessons that these executives learned from their pets! So, let’s get started.

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A recent focus of inquiry has been why certain companies are very successful while others are less so. As you might expect, the answer is a combination of factors, some common across the field while others are more specific to individual companies. However, a key determinant, evident in almost every case, is effective leadership at the top.

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Trust Me

In “Gaga Over Clinical Research” (June 3, 2001), I noted that, while all investigators are good veterinarians, not all veterinarians make good investigators. Some have practices that are too small. Others are too busy. A few would participate in clinical trials for the money but, otherwise, don’t care. Some like the idea but can’t seem to follow the protocol. And then there are those who have participated in several clinical trials and, therefore, “know it all.”

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In the February issue’s article, Riding the Veterinary Learning Curve, I noted the influence of study training on investigator performance and explored the connection between investigator learning styles and study training effectiveness. I also summarised the comments of eleven current and former veterinary school professors (who had been recommended by thirteen practising veterinarians I had interviewed) regarding their teaching strategies. As I promised at the end of that article, I will share my suggestions for more effective study training sessions based on what I learned from those two surveys, as well as from my own experience over the last 30 years.

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A Query Named Matilda

Good Clinical Practice guidelines (VICH GL9) Section 8.3.1 requires that all raw study data, “whether handwritten or electronic, be attributable, original, accurate, contemporaneous, and legible.”

“Original and accurate means the raw data are the firsthand observations.”

“Contemporaneous means the raw data are recorded at the time of observation.”

“Legible means the raw data are readable and recorded in a permanent medium , e.g., ink for written records or electronic records that are unalterable.”

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Hi! I’m Roscoe! I’m the Golden Retriever you might remember from a previous article, “Roscoe’s Remedy” (Volume 2, Issue 4). I’m 13 now … which makes me pretty old in human years. I live in the city in a nice house with a big back yard. The back yard reminds me of the farm where I was born, the third pup in a litter of ten. Oh, what a grand time I had playing with all of my siblings! I wish I knew where they all went.

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Data Dilettantes

The success or failure of a clinical trial turns on the integrity of the data, i.e. whether it is complete, accurate, and contemporaneously-recorded. The integrity of the data depends on the diligence of those collecting and recording it. And that is where many clinical trials run into trouble.

Most investigators and other site personnel participating in clinical trials start out with the best of intentions. However, good intentions alone will not result in high quality data. They must be supplemented with comprehensive protocol training and frequent follow-ups to prevent the normal daily demands of a busy clinic from distracting the investigator and other site personnel from their important study responsibilities .

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Roscoe’s Renewal

“But, honey, I just don’t know what to do.” During Tilly’s weekly calls, it was usually her daughter who was looking for advice. “This morning, Roscoe stood at the edge of the bed for quite a while, just staring at the floor, before finally jumping down. As soon as his front paws hit the carpet, he yelped. His old legs are so stiff that any sudden movement or impact hurts a lot. I guess that I’m going to have to take him in to Dr Spenser again but, honestly, nothing he does seems to help much. But I know one thing. If he tells me it’s time, I’m walking right out of there. I’m not putting Roscoe to sleep, even if I have to carry him in my arms.” The thought of losing Roscoe upset Tilly, so she ended the call.

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Ask a study monitor why they do what they do, and they’ll quickly tell you that they love being involved in clinical research. Then, they’ll usually add that they were lured by the money, the flexibility, and the variety. While one or more of these reasons may prompt someone to become a monitor, their success in the field depends on an entirely different set of factors. Some of the necessary skills can be learned in school, especially if the course of study was in one of the physical sciences. Other skills can be taught as part of the new monitor’s onboarding and at individual study training sessions. However, of equal and perhaps greater importance are the individual’s personal commitment to excellence and the amount of actual field experience. Those are the factors that distinguish great monitors from all of the rest.

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I love Halloween … the pumpkins, the corn stalks, the hay rides, the hot apple cider and, of course, the trick-or-treaters.

From walking my two dogs, I have come to know most of the kids in my neighborhood. So, I enjoy matching each child to the character they have chosen to portray. Usually it’s fairly easy. Although, as I get older, I find that I am increasingly out of touch with current film and TV heroes.

However, at least once each Halloween, someone comes with a costume so elaborate or a mask so life-like that their identity is totally obscured. Most eventually tell me who they are but a few leave me wondering for the rest of the night. This year, there was one ghastly, ghostly, grim reaper who had me totally stumped. I still am unsure whether it was a boy or a girl behind that very scary mask with the articulating jaw.

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Band-Aids and Vaccines

My July 2015 article, “How to Cut Study Delays-Revisited;’ generated quite a bit of interesting feedback. However, since research has shown that 90% of all clinical trials experience significant delay, I was not surprised. Some people shared their version of one of the problems I had cited. Others called to recount their tales of clinical trials gone bad. A few offered solutions or strategies that I had not considered. What did surprise me was the concentration of troubled scenarios around one of two causes: incomplete protocol development or slow enrollment.

All clinical trials have a timeline, some more aggressive than others. However, I have yet to see one that did not increase the stress level of one or more members of the project team. When the inevitable problems occur, there is rarely enough time to pause all activities while the team determines the root cause. More often than not, a looming deadline reinforces the natural inclination to apply a Band-Aid and keep moving forward. The intention always is to revisit the situation at a later, less rushed date to develop a permanent solution — a vaccine, if you will — so that particular problem does not recur in future trials. Finding the time for that extra step in today’s pressured development environment is difficult.

The future dividends, though, make the effort a worthy investment. To further illustrate this point, I selected seven scenarios from those I received, together with the corresponding Band-Aid and my recommended vaccine.

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The Right Investigators

While every investigator is a veterinarian, not every veterinarian makes a good investigator. Good investigators are not a homogeneous group, but they do share certain characteristics, like organizations, perseverance, and integrity.

Finding Study Investigators
There are multiple ways to recruit investigators. Some sponsors compile a database of veterinarians to whom they mail or fax study invitations. This method may often generate a high number of responses, but selecting from such a pool can be time-consuming and relatively risky. Even veterinarians who appear to satisfy all of the requirements may falter under the burdens of protocols and regulatory standards.

That may be why certain sponsors rely on a roster of trusted investigators to whom they return for every study. Even if one of these investigators is not interested in participating in a particular trial, they often can refer the sponsor to one of their colleagues. Reliance on familiar investigators can yield more predictable results but, over time, may also lead to complacency. When the sponsor-investigator relationship gets too cozy, data quality usually suffers. It should never be blindly assumed that an investigator who performed well during one study will automatically deliver the same results in a subsequent trial.

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As I sat down to compose my next article for Animaf Pharm, I decided to reread some of my past articles for inspiration. I suddenly realized that I have been writing these articles for nearly five years. This prompted me to reflect on all of the topics I have addressed and I began to wonder whether things have changed in any significant way over the last half-decade.

In my very first article in July 2010, ‘Cutting Delay in Clinical Trials; I cited the shocking statistic that 90% of all clinical trials experience significant delay.

I then listed the four principal causes of study delay: slow subject enrollment; poor data quality; lax test article control; and weak project team communications. From my experience, I would say that these problems still exist, in one form or another, in most studies. However, I would now reclassify these causes of delay under two main categories: study planning and study execution.

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Hand in hand with her new husband, Jill Casey was walking the beach at sunset when a bumpy landing woke her from her honeymoon daydream. “Back to reality;’ she thought as she collected her things from the seat pocket. A few days earlier, she had received an email from Dr. Silver telling her about a call from ‘By Mo’. After explaining what Bioresearch Monitoring program (BIMO) was and what the inspector might want to see, Jill promised the anxious veterinarian that she would help the clinic get ready.

Jill arrived at Dr. Silver’s clinic right after they opened and was greeted by Melanie, the receptionist. “I’m so glad you’re here, Jill. Everyone is frantic! Go right into the lunch room and I’ll let Dr. Silver and the others know you’ve arrived:’ Jill went to the lunch room and made herself some coffee as the staff trickled in.

After everyone had grabbed a chair, but before Jill could say a word, Dr. Silver exclaimed: “I remember you telling us that we could get audited at any time but I didn’t register that it could be by the FDA! Why would they pick our clinic?”
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I recently traveled to meet with the president of a fledgling biotech firm. They have a promising new veterinary product and want to get FDA approval so they can start selling and paying back their investors. My visit was both exciting and frustrating. Seeing their initial clinical results was the exciting part. If these results are confirmed by more extensive testing, the new product has tremendous potential. If they can get it approved before a competitor hits the market with a similar therapy.

The frustrating part was trying to get them to focus on the many important and specific steps they will have to take to get their marketing approval. I did my best to explain the approval process, suggested a few regulatory consultants who could help them with their New Animal Drug Application, and offered to help them write their protocol and prepare for their clinical trial. I even spoke with several of their advisors in an attempt to get everyone headed in the same direction. How much of my advice they take remains to be seen.
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Oh, No…a call from BIMO!

“I just got a message from someone at the FDA. He said he works for By Mo and wants to schedule an audit. I don’t know what By Mo is, so I thought I’d better contact you first:’

Jill Casey had just returned from her honeymoon and was trying to catch up on email. Jill chuckled at Dr. Silver’s spelling of BIMO but, as the study monitor for Dr. Silver’s site, she knew that the auditor’s call was no laughing matter. She picked up the phone and called Dr. Silver.

“Hi, Dr. Silver. This is Jill. I just read your email. What else can you tell me?”

“Welcome back. My email is all I know. Some guy named Thompson left his name and number and said to call as soon as possible to schedule the audit. What should I do?”
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Trials and Errors

The investigator meeting was over and the entire sponsor team, Abigail, Drew, Mike, and Tammy, thought that it had gone very well. To celebrate, they decided to have lunch at a local barbeque joint. The place was packed. When the waitress finally appeared, she brought a pitcher of beer on the house, and apologized for the wait. As everyone placed their order, Mike poured the beer. Read More

Vowel Avowal

Natalie Salerno had loved her job as a field monitor  for a large international human CRO. However, after ten years of constant travel, she welcomed her promotion to Vice President, Global Monitoring Management. Read More

Do Clinical Trials Work?

As college professors, Alana and Morton Prescott could schedule their time around a daily ride in the countryside on their Draught horses, Cadillac and Caydence. Read More

Any discussion of individual learning styles invariably conjures the age-old argument of nature versus nurture. I did not set out to solve that debate. Instead, I wanted to investigate the various teaching styles that a select group of practising veterinarians experienced during their years in veterinary school and how those styles shaped their thinking and, in some cases, influenced their career choices after graduation. That exercise gave me valuable insights applicable to the training of today’s investigators.

My starting point was a survey of 27 veterinarians currently employed in animal health companies, academic institutions, private veterinary clinics, governmental agencies, law firms, and industry groups. I was quite pleased that 13 of these 27 busy professionals responded and, collectively, mentioned 11 veterinary school professors. I next contacted those 11 professors (eight of whom are still teaching) and asked each of them a series of questions in hopes of discovering why they had made such a profound and lasting impression on their former students.
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Are You Going to the Guidance?

The FDA’s Center for Veterinary Medicine (CVM) recently published its list of “Guidances Under Development for 2014.” When I read descriptions of the 32 pending guidances, I wondered how CVM decided when a new guidance was needed. I then realized that, although I had been following FDA guidances for 30+ years, first on the human and now on the veterinary side, I knew little about the FDA’s history, the development of its regulations, or what prompts the issuance of a new guidance. Dr. Susanne Junod’s 2013 publication, “FDA and Clinical Drug Trials: A Short History” was very helpful. Read More

Musings from Margaritaville

Henry, drink in hand, settled into his chaise on the beach. Waves lapped the sandy shore and a gentle off-shore breeze tempered the tropical heat. Henry closed his eyes and drifted off, smiling at the thought of seven stress-less, unscheduled days of a badly-needed vacation. As he dozed, vignettes from the last six months scrolled through his mind. Henry’s tranquil visage gradually morphed into a grimace. He awoke with a start, spilling half of his drink. “Too darn fast,” he muttered as he downed what was left of his drink and signaled for the cabana boy to bring him another. Read More

Center stage to stage left

An experimental therapeutic undergoes many years of development and testing to confirm its safety, efficacy, and dose range. However, once it is ready for field trials, the focus shifts to other activities. Finding qualified and interested investigators, planning and conducting study training, site initiations, and subject enrollment all take their turn in the limelight, while test article accountability often slips into the shadows. Allowing this to happen can set the stage for future problems.

Here are just a few of the things that can go wrong:

  1. Test article is shipped by the sponsor but not received by one or more study sites;
  2. The amount oftest article received by the site does not match the shipping record;
  3. Test article arrives opened, damaged, or leaking;
  4. The wrong test article is shipped and received;
  5. A study subject is randomized to the wrong treatment group;
  6. A study subject receives the wrong dose (too much or too little); and
  7. Study site inventories of test article cannot be reconciled.

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At the end of the study’s protocol training, everyone agreed that the meeting had been very successful. Most of the sessions were quite interactive, lively in fact, and all of the attendees were eager to get started. Read More

Hang on Snoopy!

My experience in clinical research began many years ago in human trials, first as a nurse and later as an administrator. Though I now work exclusively on the veterinary side, lessons learned during those human trials have shaped my approach to managing animal studies. Read More

Jack Hoselton is an experienced monitor, having reviewed data forms at nearly 200 animal hospitals for more than 50 clinical trials. Jack always looks forward to the training meeting for each new trial because he gets to finetune his understanding of the protocol and meet his assigned investigators before the study starts. Last February, Jack was thrilled that the meeting for his latest trial would be in Florida, giving him a break from the harsh winter in Massachusetts. Read More

Bake a Perfect Batch

The principal purpose of most clinical trials is the collection of data to prove the study hypothesis. Whether the data are collected on paper case report forms or entered directly into an electronic data capture (EDC) system, every data point must be checked for accuracy, consistency, and legibility. With paper data forms, this review is time-consuming and labor-intensive. It also is conducted retrospectively, i.e., after the study visit has occurred. This can mean that data forms are reviewed later during the same day, days or weeks later, during the next monitoring visit, or as individual cases are closed out at the end of the study. Whenever the review occurs, each form is inspected, either on-site by a study monitor or remotely by the sponsor’s project manager.

A major advantage of EDC systems is their ability to identify data errors and other entries requiring further documentation before the investigator has sent the data form…and usually while the study subject is still present in the clinic. This real-time data cleaning saves most of the time lost in paper data form review and error correction. It also permits transmission of data directly to the study database. This allows the biostatisticians to set up their tables, listings, and figures and the medical writers to draft the report shell as cases move through their study visits versus waiting until after the last subject’s last visit. We have found that EDC shaves two to four weeks from these downstream activities.
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All The World’s A Stage

I’ve often thought of clinical trials as theater. As director, I know the playwright and the producer. Having read the script, I know the plot. All that I need for a box office bonanza is a killer cast.

While each role contributes to the story, the choice of protagonist can make or break an entire production…just as the choice of investigators can spell success or failure for a clinical trial. What would you be looking for during auditions?

Some companies prefer to conduct their clinical trials in-house using a select group of veterinarians as their investigators. This practice eliminates much of the uncertainty inherent in different groups of investigators but it could reduce the level of investigator objectivity. Other companies outsource some or all of their studies, but insist on investigators with previous trial experience. Such investigators might be easier to train, but may come with preconceived notions of proper trial conduct and other bad habits. Still other sponsors recruit investigators through broadcast-fax casting calls and hope to find a few stars.
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“But, Officer…”

The FDA’s Code of Federal Regulations (21 CFR 312.53 and 812.43) requires that anyone involved in clinical research be properly trained to perform their research activities. For clinical field trials, this requirement would apply to sponsor project leaders, study investigators, site coordinators, field monitors, and others directly involved in the conduct of the study. Training certainly would include a detailed review of the protocol and related case report forms, discussion of the inclusion/exclusion criteria and required laboratory tests, development of subject enrollment strategies, and agreement on deliverables and study timelines. Another key component of any study training should be a thorough review of VICH GL9 (Good Clinical Practice) guidelines or, as they are more commonly called, GCPs.

Some people think that GCP training is a once-in-a-lifetime exercise because, like riding a bicycle, you never really forget what to do. Others disagree and suggest that GCP training should be repeated with some regularity to keep its tenets in sharp focus. This disparity of opinion prompted me to contact a selection of industry colleagues to pose the question: “When, and how often, should GCP training be conducted?” It was most gratifying to receive responses from 41 of the 48 colleagues I contacted (30 from pharmaceutical/nutraceutical companies, 7 from CROs, and 4 industry consultants).
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Pharma for Fat City?

My first dog was a Springer Spaniel named Bonzo. When we picked him up from the breeder, he was a chubby 10-week-old ball of energy. Once home, Bonzo bounded around the kitchen as we poured a 40-pound bag of puppy chow into a 30-gallon container, snapped on the lid, and pushed it into a corner. We then played with Bonzo until he dropped from exhaustion. Sensing our opportunity, we quietly closed the kitchen door, and left to go shopping for more “pet stuff” before Bonzo’s first veterinary exam that afternoon.

We arrived home, tip-toed into the house and slowly opened the kitchen door, expecting to see our new baby still snoozing. Instead, we saw a very full Bonzo atop a mound of puppy chow. He somehow had managed to topple the container, pry the lid off, and gorge himself on its contents. Hysterical with laughter, we grabbed Bonzo and rushed to the clinic.

“What a belly!” exclaimed Dr Williams, as he petted Bonzo. Dr Williams told us that, recent feasting aside, Bonzo was fat. He explained that, while chubby puppies are cute, they too often grow up to be overweight dogs. Once fat, they suffer many of the same ailments that afflict overweight humans, like arthritis and diabetes. Carrying those excess pounds can shorten a dog’s lifespan by as much as two years.
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Compliance of Complacency

At ten minutes after noon, Maggie McGuire rushed into the clinic, pulling her Pug, Sydney, behind her. “I’m sorry I’m late, she said breathlessly. “Time just got away from me this morning. Can Tom still do Sydney’s study visit?” The receptionist checked the study coordinator’s schedule and saw that Tom did not have another study visit until later in the afternoon. “Of course. Did you bring your diary? Tom likes to review them before each visit.”

After searching her purse, Maggie remembered that she had thrown the diary in the back seat of her car after Sydney’s last visit. “Darn, I must have left it in the car. We’ll be right back.” Scooping Sydney up under one arm, Maggie ran out the door and back into the clinic’s parking lot.
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Risky business

When the US Food and Drug Administration (FDA) issued its draft guidance for industry “Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring” in August 2011, the response ranged from enthusiastic acceptance to wary skepticism.

The last time the FDA had issued a guidance document related to study monitoring was in January 1988 (“Guideline for the Monitoring of Clinical Investigations”). Prior to that time, most data forms were mailed back and forth between study sites and the sponsor or CRO, or they were collected and delivered by the field monitor at each site visit. As technology evolved, faxing of data forms became the prevalent method, which significantly shortened the review and error correction cycle. Eventually, scanning technology improved to the point where real-time data form review and error correction was possible. This made remote monitoring feasible, resulting in shorter timelines and more cost efficient trials.
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Gimme Shelter!

Everyone in Bart Harvey’s young family was distraught when Cisco, their 13- year-old Lab-Shepherd mix, was diagnosed with lymphosarcoma and died a few months later. Cisco had been Bart’s dog when he met his future wife, Jill, but he quickly became “our” dog, and then a guardian and playmate to Bart and Jill’s two daughters, Emily and Casey. After several lonely weeks without Cisco, Jill suggested adopting a new dog from the local shelter.

So, one Saturday, Bart, Jill, Emily, and Casey spent much of the morning on the floor of the shelter, playing with all of the dogs and trying to decide which one to adopt. Eventually, Bart and Jill noticed that one small puff of a dog kept jumping between Emily and Casey, making them laugh and squeal with delight. “Cotton” had chosen them.

After filling out all of the paperwork and making a donation to the shelter, Cotton and her new family drove off to meet Dr Chase, the veterinarian who always had cared for Cisco. “You got a good one,“ Dr Chase said after examining Cotton. “How old is she?” asked Emily. “I’m not quite sure, Dr Chase responded. “However, from her teeth, coat, eyes, and overall condition, I’d guess somewhere between six months and two years. In any case, you and Casey have a new friend for a long time!” Casey smiled at that thought and said, “Let’s make today Cotton’s birthday!”
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Dave Berger has been running since college. Now in his mid-50s, Dave has slowed his pace to accommodate his aching knees. He’s noticed that Barkley, his 12-year-old Retriever, also has slowed, rarely tugging on his leash like he used to. In fact, Barkley now seems to limp a little as they walk up the driveway. Dave has thought about leaving Barkley home, but he knows that Barkley would sit by the kitchen window, barking until he returned.

One recent morning, after he and Barkley finished their run, Dave grabbed a cup of coffee and went to his study to check email. Barkley headed for his pillow next to Dave’s desk. One message was from a pharmaceutical company announcing a clinical trial for a new osteoarthritis drug. “Just what I need,” mumbled Dave. Barkley sighed in agreement. As Dave read further, he discovered that the solicitation was for a virtual clinical trial. Dave’s only experience with clinical trials had been with Barkley several years earlier, in a skin allergy study. He had visited their veterinarian seeking relief for Barkley’s incessant scratching. The study provided free treatment… plus a nice honorarium… but, since Barkley was assigned a placebo, not much relief. A diet change and some lotion prescribed by their veterinarian finally cured the problem. However, the frequent trips to the clinic over three months soured Dave on clinical trials.
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The recent Kentucky Derby set me thinking about horses. Not just race horses, although some of them are unforgettable: Alydar, Secretariat, Seattle Slew, Seabiscuit, Man O’War, and (alas) Barbaro. Read More

Debbie had scheduled Rex, her one-year old Vizsla, for his annual check-up in early spring. As she and Rex entered Dr. Jenson’s office, Debbie guided Rex to the floor scale so Tina, one of Dr. Jenson’s technicians, could check his weight. “Fiftyfour point eight.” Tina recorded Rex’s weight on his chart. “You’re getting to be a big boy now, “ Debbie cooed as she scratched Rex’s ears and then followed Tina into one of the exam rooms. Read More

The alarm buzzed at 4am. I hit the “off” button and tried to go back to sleep. Then I remembered that it was my turn to watch the new calves that had been born the day before. Hurriedly, I brushed my hair with one hand and washed my face with the other. Still groggy, I ran into the barn and found my charges snoring lightly on a bed of hay. Seeing that all was well, I plopped down in the corner of the stall. Read More

Push the envelope!

“It’s just the squirrels, playing on the roof again,” I told myself as I folded laundry in front of the television. But then something banged into the kitchen table. Startled, I ran into the kitchen. There, I saw Smudge, the youngest of my three Springer Spaniels, convulsing. As an emergency room nurse, I had cared for human patients with epilepsy, but I had never seen an animal seizure. Heart racing, I called my veterinarian. “My dog is having a seizure! What do I do?” I blurted as the receptionist answered. Read More

The conduct of a clinical trial involves many players: the sponsor’s project team, investigators, lab technicians, field monitors, data managers, biostatisticians, medical writers, and others. The extent to which these participants follow the study protocol in fulfilling their responsibilities will determine the overall success of the trial. In the past, some sponsors felt more in control of their study’s outcome if most of the trial participants were company employees (except for investigators, who must be independent). Read More

Not long ago, I read that a colleague had been promoted to director of research at a large pharmaceutical company. So, when I ran into him at a recent industry conference, I was eager to congratulate him. He thanked me for my sentiments, but muttered something about “good news, bad news.” When I asked what he meant, he told me that his management had decided to run a pivotal study using their newly developed project management system. Read More

Maintaining Balance

We all struggle with balance. Splurge today vs. save for tomorrow, enjoyment vs. discipline, rest vs. exercise, career advancement vs. life enhancement…an endless series of choices that define our lives. For those of us in the pharmaceutical industry, there is another kind of balance: the objective, unbiased outlook of the ideal clinical investigator. We even have a name for this special kind of balance: equipoise.

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Recently, I received a call from a veterinarian who wanted to be an investigator for an upcoming study. When I asked about his clinical trials experience, he told me, “I’ve got many studies under my belt.” As I probed further, it became clear that he had indeed worked on quite a few trials for several different sponsors.

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Determining whether a particular occurrence during a clinical trial constitutes an adverse event can lead to honest differences of opinion. There are those who feel that too many unexpected, yet very ordinary, occurrences are reported as adverse events, adding to the paperwork burden and driving up the cost of studies. Others contend that any unexpected or unintended occurrence should be classified as an adverse event and quickly reported. Who’s right?

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A Clinical Conundrum

Time. Cost. Quality. Three important parameters of any clinical trial. Ideally, you’d want the highest quality data, collected at the lowest possible cost, delivered in the shortest period of time. Unfortunately, in some studies, one or more of these parameters is sorely stressed. The severity of the stress, together with your response to it, will determine the ultimate success of your trial as well as the long-term viability of the test article in the marketplace.

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Eat your vegetables

Many people think of clinical research as a relatively modern development. However, scientific comparisons of competing theories have been conducted for centuries. For example, one of the earliest recorded trials was conducted in 530 BC.

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What Makes You Happy?

In many companion animal clinical trials, the subject’s owner is asked to keep a diary. Among the daily entries that each owner will make is their assessment of the effectiveness of the test article on their pet.

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As a young nursing student, I was taught that, unless an activity was documented, it did not happen. Nursing notes had to be signed, dated, and time-referenced. Once I graduated and started working in a hospital, I saw other nurses get reprimanded for not satisfying this rule. Those receiving multiple reprimands were enrolled in remedial training.

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In a previous article, I shared the results of a survey that we conducted following the conclusion of a recent multisite, double-blinded trial. We found that 82% of the owners had enrolled their pet to improve its health and/or well-being. Encouraged by that positive statistic, we then wondered how each subject owner evaluated their pet’s reaction to the study treatment. Was it purely subjective judgment, or did they employ some sort of metric? And could there be a “placebo effect?”

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Almost 90% of all clinical trials experience significant delays. There are four main causes of study delay (please see Animal Pharm 690, p 11) but, by far, the most significant is slow enrollment. Sometimes, enrollment lags because the investigator forgets about (or loses interest in) the study. Sometimes, the investigator overestimated his/her available population of potential study subjects. Other times, the study’s inclusion/ exclusion criteria present formidable challenges to successful enrollment.

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Even if you are already satisfied with the results of your current clinical trials, there’s always room for improvement. And the investment you make now in improving your study management processes will pay big dividends as every future trail delivers cleaner data, in less time, and at lower cost. So, how do you tune up your study machine? Here are some tips from the trenches.

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Everyone expects their clinical trial to be completed successfully, on time, and within budget. Unfortunately, the vast majority of trials fall short of those expectations (up to 90%, according to industry research). However, there are 10 simple steps that, if followed, will virtually guarantee a successful outcome. They are:

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The inaugural article in this series of articles (Animal Pharm 690, p 11). “Cutting Delay in Veterinary Clinical Trials,” cited the disturbing statistic that 90% of all clinical trials experience significant delays. Even more disturbing is the economic cost of those delays to the companies that suffer them. The article then described the four main causes of study delay, why these occur, and what can be done to avoid them. In this article, I’d like to be more proactive and suggest ten steps to make your next trial a rousing success.

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Recently, while reading back issues of Applied Clinical Trials, I came across a shocking statistic: 90% of all clinical trials experience substantial delays. I almost didn’t believe my eyes, so I read that sentence again. 90%…9 out of every 10… almost every study takes much longer than expected. As I pondered those numbers, the economic impact of such a percentage struck me. While there are different causes for study delay, the results are always the same: lost revenues and diminished market share.

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