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.
You see, after about three months on the farm, lots of people started coming to play with us. That was great fun but, eventually, they would pick up one of my brothers or sisters and walk away. After about a week, all of my siblings were gone, and I was very lonely. Then, one day, a very nice lady came to play with me. She told me that her name was “Tilly,” and she picked me up and put me in her lap. Tilly smelled a lot like those pretty purple flowers in the garden. She scratched my head in just the right spot, gave me a cookie and, then, rubbed my tummy. That felt so good I fell asleep. The next thing I knew, I was riding in the front seat of Tilly’s car listening to her sing. Tilly has a very pretty voice.
Don’t you worry, little guy. We’ll be home in no time. Then, we’ll go to the store and get you a new collar, a leash, lots of toys, a big bag of puppy food, and … some cookies! How’s that sound? We’re going to have so much fun together. You are such a little rascal. Rascal … hmmm … I think I’ll call you Roscoe. Do you like that name?
I wasn’t quite sure what Tilly had said, but it included the word “cookies” so that sounded pretty good! Tilly also took me to visit one of her friends. There were lots of dogs and cats there. Her friend looked in my ears and in my mouth. He stuck me with something a couple of times and squirted some liquid up my nose. Tilly has some strange friends. But he did give me a cookie, so he’s not all bad.
And so began my life with Tilly. She was true to her word: We had lots of fun together … every day. We’d go for a long walk every morning. Then I would take a nap while Tilly went someplace she called “work.” When she came home, we would go for another walk and then we’d both eat dinner. Sometimes, Tilly would give me a little bit of her food. It was very different from mine, but it tasted pretty good. After dinner, I’d take another nap. And then we’d play with my toys until it was time for bed.
One day, Tilly took me with her to “work.” That was loads of fun. There were lots of little people there. They all played with me, and let me sit in their laps while Tilly talked to them. I liked that a lot. Tilly took me to other places with little people and we did the same things. I had a great time!
One day, while chasing a squirrel in our back yard, I tripped over a tree root and fell down. That really hurt. Tilly came over and rubbed my hips, which made the pain go away. Several years later, when I jumped off the back porch after another darn squirrel, I landed funny and hurt my hips again. But Tilly rubbed them and I felt much better. But they still hurt a little whenever I jumped. As I got older, the aching in my hips grew worse. I noticed it most often after a nap because I had trouble getting up. Once I got moving, though, it didn’t hurt so much. Tilly was always close by and she massaged my hips and then gave me a cookie.
I know you love your cookies, but I don’t want you to get fat because that will make your hips hurt more.
I think I understood what she was saying. It was something about being a good boy and getting more cookies. Yum.
The big trouble started a few weeks ago when I jumped off the bed. My legs went in all directions and I landed flat on my tummy. Tilly ran right over, sat down on the floor, and held me in her lap. After a few minutes, she took something out of her pocket and started talking into it. I heard her say my name several times. Then she put the thing back in her pocket and started rubbing my hips.
I just finished talking with Dr Spenser and he has an appointment open this afternoon. I want him to look at your hips to see what we can do so that you’re not in pain. I never want you to hurt. You’re my Roscoe.
I looked up at Tilly. She had water dripping down from her eyes, so I licked her face. Tilly held me tight. That felt very good.
Well, you know the rest of that story. We saw Dr Spenser a few times and I got lots of cookies. He must like me. But my hips still hurt. On one particularly painful day, Tilly took me to see Dr Spenser again. This time, Tilly and Dr Spenser talked for a long time and looked at lots of papers. After a while, Dr Spenser’s helper, Sarah, came in and gave me a cookie that looked and tasted different from the usual cookies. Then, everyone stood around and watched me. I wagged my tail, hoping to get another of those special cookies.
You liked that, didn’t you, Roscoe Boy! Sarah gave me a bag of those special cookies, and I’m going to give you one every morning before our walk. Let’s go home!
“Cookie,” “walk,” and “home.” Three of my favorite words.
The next morning, Tilly gave me one of the special cookies, and then wrote something on a piece of paper. I hoped it was a reminder to buy more of those cookies.
If you drool, throw up, or start scratching, I have to write it down. Then, I have to call Dr Spenser and tell him all about it. I don’t think you’ll do any of that, but I’ll watch you nonetheless. We’ll just sit here on the kitchen floor for a while, and then we’ll go for a walk.
The next day, Tilly gave me another special cookie and we sat together on the kitchen floor. Pretty soon I started feeling sick. I must have made some noises because Tilly jumped up.
Uh, oh. I think we’d better go outside right now.
Just in the nick of time, too. It reminded me of when I ate that dead mouse and it came right back up. Yuk!
Dr Spenser? You told me to call you if anything unusual happened with Roscoe. Well, just now, about five minutes after I gave him the study medicine, he threw it up. What’s that? You want me to wait 30 minutes and give him another one? Are you sure? I don’t want him to throw up again. OK. I’ll call you back if he has another problem.
Tilly gave me another special cookie and, this time, I felt fine. We went for our morning walk and then I took a nap.
A few days later, Tilly took me to see Sarah. As soon as we walked through the door, I smelled Lucy, Dr Spenser’s Labrador. I really like Lucy. She and I used to have lots of fun running around the yard behind Dr Spenser’s clinic. Now that my hips don’t hurt, maybe we could do that again today. I kept looking for Lucy. All of us went into a small room and Tilly gave Sarah the piece of paper she always wrote on after giving me my special cookie. Sarah seemed very interested in that piece of paper.
You are very thorough, Tilly. Your diary is perfect. You even recorded the exact time that Roscoe regurgitated his dose. I’ll take a blood sample and check Roscoe’s temperature. Then Dr Spenser will come in to check Roscoe and do a lameness evaluation.
Sarah gave me a hug and told me to be a good boy for Dr Spenser. She told Tilly that she’d be back in a little while. Then Dr Spenser came in and stood in front of a small TV on the counter.
Good morning, Tilly. Hi, Roscoe. I’m going to pull up your study record on my computer so I can see how you’re doing.
Just then, there was a lot of excitement in the exam room across from mine. Someone was talking very loudly.
What do you mean, Prudence is out of the study? Just because I went out of town for four days and my house sitter gave Prudence her study medicine? I showed her exactly what to do before I left. I’m sure that she gave Prudence the medicine and just forgot to write it down. What difference does it make anyway? Can’t you just write it down now?
Dr Spenser stopped looking at his TV and told Tilly that he had to step out of the room for a minute. After Dr Spenser left, Tilly rubbed my head, put on her glasses, and picked up a magazine to read. Since Dr Spenser had left the door partly open, I peeked out to see what was going on.
There she was. “Prudence” was a beautiful silver Poodle. I looked to see if Tilly also noticed, but she was busy with her magazine. So, I did what any dog would do. I trotted over to meet Prudence. As I approached, she wagged her tail. That’s always a good sign.
You can’t take Prudence out of the study. She has much more energy now. She’s like a new puppy! If you take her out of the study, what will I do? Her hips were hurting her so much before. She just has to be in the study, especially because she’s getting the real drug instead of a placebo.
All this hubbub left Prudence and me time to get to know each other. Prudence smelled wonderful, and she had very pretty eyes. It tickled when she sniffed my ear. I was falling in love.
Mrs Crosley, as much as I don’t want to, I have to remove Prudence from the study. The protocol allows up to two missed doses, but Prudence missed four. And I know that you think that your house sitter gave Prudence the drug and just forgot to write it in the diary, but you returned four more doses than we expected. In any case, in clinical trials, if dosing isn’t properly documented, it is assumed that it didn’t happen as required. I am very sorry. However, I will give Prudence something else to make sure that she’s not in pain. Now, if you could please excuse me …
Dr Spenser was surprised to see me at his feet. He grabbed my leash and led me back to the room where Tilly was sitting. Dr Spenser and Tilly had just begun talking again when Sarah came in.
Dr Spenser? Colin is here.
Sarah bent down and rubbed my ears. She reached in her pocket and pulled out a cookie. I really like Sarah.
That’s great. I forgot he was going to monitor today. Come with me, Roscoe. Tilly, this will just take a minute.
Sarah, Dr Spenser, and I greeted Colin at the receptionist’s desk. Dr Spenser was the first to speak.
I’m glad you’re here, Colin. We have two study subjects here right now. As a matter of fact, Roscoe is one of them. Say “hello” to Colin, Roscoe.
I wagged my tail. I hoped Colin had one of those special cookies. He bent down and scratched my head. His breath smelled like hamburger. I wondered where he found that.
I didn’t get a chance to find out because Dr Spenser tugged on my leash.
Come on, Roscoe. Let’s go find Tilly so Colin can watch your study visit.
As we entered the exam room, Tilly looked up from her magazine.
Oh, there you are. I was beginning to wonder whether Roscoe had gone exploring. Roscoe loves to explore.
Tilly took my leash from Dr Spenser and rubbed my head.
Tilly, this is Colin Young, from Spritzer Pharmaceuticals, the company that makes the study drug you’ve been giving Roscoe. Do you mind if Colin observes Roscoe’s study visit?
Tilly took off her glasses and looked at Colin.
I guess not. Is there a problem with the drug? I sure hope not because it’s really helping Roscoe.
Colin explained that he was a study monitor and that he visited each study site several times during the study to make sure that each investigator was following the protocol.
I am responsible for ensuring that all study investigators, like Dr Spenser, follow the study protocol exactly, record all required data as soon as it is observed, and account for all study drug. The purpose of my visit today is to confirm that all of the study documents are being maintained properly, that any corrections to the data forms have been made in a satisfactory manner, and that the inventory of study drug is accurate. Would you mind if I observe Dr Spenser while he examines Roscoe and records his findings?
Tilly chewed on her glasses and thought for a minute.
Well, I guess if it’s OK with Dr Spenser, it’s OK with me. What do you think, Roscoe?
Fine, fine. Can I go back to see Prudence?
Dr Spenser checked me all over, just like he does every time he sees me. Then, he put me on the scale.
Good boy. Your weight is right where it should be.
I knew that! Next, we did the part I like the most. Dr Spenser led me into the hallway and threw a ball down to the other end. I ran after it and brought it back. After we did that a few times, I started getting tired and ran a little slower. He threw the ball one more time and I just walked down the hall. As I turned around with the ball in my mouth, I saw Prudence walking out to the front desk. She turned around, saw me, and whined. I dropped the ball and ran up to her.
Roscoe, come back here. We’re not done yet.
I didn’t care. I nuzzled Prudence and stood next to her. Dr Spenser came up behind us, apologised to Mrs Crosley, picked up my leash, and led me back to the exam room. I kept looking back at Prudence, hoping that she was following me. She was wagging her tail but her owner held onto her leash.
Well, Roscoe, you’re doing quite well on this study. And, Tilly, you are doing a great job with the diary. Let me just record my observations in the computer before you leave. Other than that one time when Roscoe regurgitated his study medicine, Tilly, were there any other problems?
Tilly shook her head and patted mine. She also reached into her pocket and gave me one of my favourite treats. I loved all this attention.
You know, Tilly, you are the perfect owner of a study participant. You’ve done exactly what you’re supposed to. What do you think, Colin?
Thank you, Tilly, for doing such a great job. And thank you, Dr Spenser, for producing such good data. You make my job very easy. I did send you a few queries a while back, but you answered them the same day. I wish every investigator were as thorough and responsive as you are. Some of our investigators start off following the protocol but then get a bit sloppy, which shows up in their documentation or, rather, lack of it. Whenever that happens, I realise that I need to do a better job of training. I think I’m done here. Can I see the other subject?
Unfortunately, Colin, I had to remove her from the study because her owner missed four doses. I’ll be glad to show you the data I have so far, but I don’t know whether it will be of any use to you. I’m sorry that the owner wasn’t as diligent as Tilly.
Dr Spenser and Colin talked a little longer, and then we all walked up to the front desk. Sarah was kneeling there with a big smile on her face and her arms way out to her sides. I ran up to her and gave her a big kiss. She gave me a hug and a cookie. Then she and Colin walked back into one of the exam rooms.
I leaned against Tilly’s leg while she scheduled my next appointment. Maybe Prudence will be here when I come back. Now that my hips don’t hurt, we could chase some squirrels together. I feel just like a puppy!
And that is the heart of the matter!