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Corvallis Clinic Health Information Blog

Failure is Not an Option

Dec 05, 06:00 AM

Clinical Research Center

By Julie Carrico, MBA, CCRC

Remember when you were a kid, having a grand time running around, then took a fall and got the wind knocked out of you?  That’s about the only way to describe the feeling we had last week after it was announced that large scale clinical trials for solanezumab (our site is participating in the Expedition 3 clinical trial of solanezumab) are being halted.  According to study sponsor Eli Lilly, the clinical trials are being stopped because “patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo.”

Our next step was to regroup and contact the seven amazing study participants and their study partners to inform them of this development.  Kim, who recently wrote a wonderful article about her work with these patients, made the calls.   We expected emotional responses from the patients/partners when we informed them that the trial was being discontinued.   What we didn’t expect was that each pair expressed concern for Kim: Was she ok? Would she have a job?  After reassuring all the participants that she was fine, Kim explained there are other studies (we are working on two other Alzheimer’s disease studies) and began making arrangements for the final Expedition 3 study visits. 

The results of the Expedition 3 clinical study were disappointing, to say the least.  And although it might be tempting to chalk the experience up as a waste of time, I assure you it was not.  First and foremost, the patients on study received the current standard-of-care treatment and then some.  What I mean by this is that as a result of study participation, these patients received clinic visits for their Alzheimer’s disease much more frequently than is the current norm.  Second, scientists have learned a lot about the disease from the clinical trial data for solanezumab, and all of this knowledge will be applied as other treatments are developed. 

As one phone call to an Expedition 3 patient drew to a close, Kim asked the patient if she had any other questions and the patient said “Thank you for taking care of me”.   When Kim relayed this story to us, we took a moment to wipe our eyes, and then made our silent pledges to continue the fight to end Alzheimer’s disease.  You see, failure is not an option.

The Clinical Research Center is currently seeking volunteer patients in two studies for those with mild Alzheimer’s disease, several Type 2 diabetes studies, and one study for those with very high triglyceride levels. 

If you are interested in learning more about clinical trials, contact the Clinical Research Center at 541-766-2163, or send an email to research@corvallisclinic.com or fill out our Research Study Information Request form. And, don’t forget to follow us on Facebook at https://www.facebook.com/corvallisclinicresearch.

- Julie Carrico, a Certified Clincal Research Coordinator, is Associate Coordinator of The Corvallis Clinic Clinical Research Center 


How the wonderful world of clinical research became personal

Nov 18, 01:57 PM

Clinical Research Center

By Pat Eshelman, RN, BSN, CCRC

I have worked in the health care field for 42 years, the last 36 years as an RN, the past 18 in clinical research. It has been a most interesting journey. When I started in health care, stomach ulcers were believed to be caused by stress, few drugs were available to treat those having a heart attack, and cancer was believed to be a death sentence.

Through research we learned that we can treat the infection that causes stomach ulcers and cure them. We are able to intervene when someone is having a heart attack and prevent heart damage. Many cancers are either cured or treated as chronic diseases.

Have we solved all the mysteries of the human body?  Of course not! However, we are making slow but steady progress toward treatment and cure of common diseases.

During my career in research I have been privileged to help bring many new drugs to market. Some of these drugs were first in class. They treated conditions by new and often better pathways.

I didn’t enter research thinking that I would be improving the life of my family members, but that is how my career choice turned out.

Many new drugs to better treat diabetes have been developed with the help of The Corvallis Clinic Clinical Research Center physicians and staff. Recently, a relative of mine was diagnosed with diabetes and is benefitting from those discoveries.

In the 1990s the research department worked on Pradaxa, a first-in-class direct thrombin inhibitor agent. Revolutionary at the time, Pradaxa was the first drug other than warfarin to prevent blood clots in those with atrial fibrillation. When a relative was no longer well controlled on warfarin he started on Pradaxa.

It is very gratifying to be able to improve the lives of those that I care most about.

A huge thank you to the hundreds of patients who have helped The Corvallis Clinic’s Clinical Research Center to bring these and many other drugs to market. You are the medical heroes of our age.

If you are interested in learning more about clinical trials, contact the Clinical Research Center at 541-766-2163, or send an email to research@corvallisclinic.com or fill out our Research Study Information Request form. And, don’t forget to follow us on Facebook at https://www.facebook.com/corvallisclinicresearch.

-  Pat Eshleman, RN, BSN, CCRC, is the Manager of The Corvallis Clinic Clinical Research Center and a Certified Clinical Research Coordinator.

 

 


Placebos work!

Nov 03, 11:29 AM

Clinical Research Center

By Julie Carrico, MBA, CCRC

In the office recently we were discussing newly published results of a study suggesting that placebo treatments can in some cases be effective treatments, even when patients know they are receiving placebo treatment.  A placebo, in case you don’t know the term, is a sham treatment that looks exactly like the active treatment – a sugar pill, if you will.  This apparent power of the placebo is intriguing.   

Although our site has never done a study where patients knowing received placebo treatment, we do have a lot of experience with studies where some portion of the patients will receive placebo treatment as part of the study design.   These patients receive the investigational treatment in addition to the current standard of care for the medical condition.  So while there is a chance the investigational treatment is a placebo, all volunteers receive the usual treatment and some might be receiving additional treatment via the investigational product. 

In our experience, we’ve found that patients feel good about participating in studies, even if they know there is a chance of placebo treatment.   The study provides an opportunity to educate all patients – those receiving active treatment or placebo - on the disease being studied.   Many of our patients look forward to their visits and appreciate the extra time and attention our staff can provide.  Given the close monitoring and the education research patients receive while on a study, it makes sense that patients on a study have better health outcomes.

One of our staff members put it perfectly when she described a meeting with a potential patient to discuss participation in a diabetes clinical trial.  She told the patient: “I can’t guarantee the study treatment will improve upon the treatment you’re currently receiving, but I can guarantee you will learn a lot about your diabetes and how to manage it.”  

The Clinical Research Center is currently seeking volunteer patients in studies for Alzheimer’s disease, Type 2 diabetes, and those with very high triglyceride levels. 

If you are interested in learning more about clinical trials, contact the Clinical Research Center at 541-766-2163, or send an email to research@corvallisclinic.com or fill out our Research Study Information Request  form. And, don’t forget to follow us on Facebook at https://www.facebook.com/corvallisclinicresearch.

- Julie Carrico is Associate Coordinator of The Corvallis Clinic Clinical Research Center 


What to expect when preparing for a research visit

Oct 27, 08:40 AM

Clinical Research Center

By Josh Borunda, PBT

Let’s say you volunteered for a clinical study, have signed the Informed Consent and are scheduled to come in for the first study visit.  Basic procedures to assess your health will be done at this visit.

Key instructions patients will hear for this and later visits throughout the study include:

  • Arrive fasting, if asked to do so
  • Hydrate by drinking plenty of water
  • Bring back study supplies, such as medication, diaries, and glucometers
  • Wear appropriate attire

Fasting is defined as no food or drink 8-12 hours before the visit. Patients sometimes think they cannot have water during this time frame. However, water is encouraged prior to study visits because blood samples are much easier to obtain when patients are well hydrated.  Suggested appropriate attire includes wearing a button-down shirt so that a 12-lead ECG (electrocardiogram) can be obtained, so you won’t have to change into a clinic gown.

To illustrate the importance of the visit reminders, let’s meet “Dan.” Dan has diabetes and has recently enrolled in a clinical study for a new diabetes medication.   At Dan’s first visit he was given a glucometer and a paper diary to document his blood glucose levels during the week.  Prior to Dan’s next visit, the research staff will call to remind Dan that he should arrive fasting.  He is also reminded to bring all study materials (glucometer, completed diary and study medications) and to dress in a button-down shirt.  

Dan has been empowered with the responsibility of being prepared for the study visit.  The doctor/coordinator can more effectively assess Dan’s health in relation to the study medication because Dan was ready for the visit.

These suggestions are not inclusive for all clinical studies, but it does shed light on the expectations for patients. Patients who follow directions can be assured of getting the most out of their research experience.

The Clinical Research Center is currently seeking volunteer patients in studies for Alzheimer’s disease, Type 2 diabetes, and those with very high triglyceride levels. 

If you are interested in learning more about clinical trials, contact the Clinical Research Center at 541-766-2163, or send an email to research@corvallisclinic.com or fill out our Research Study Information Request form. And, don’t forget to follow us on Facebook at https://www.facebook.com/corvallisclinicresearch.

Josh Borunda is a Certified Phlebotomy Technician in The Corvallis Clinic Clinical Research Department.


Alzheimer's disease research takes a village

Oct 12, 03:17 PM

Clinical Research Center

By Julie Carrico, MBA, CCRC

Alzheimer’s disease clinical research is a frequent topic of this blog and for good reason.  At this time, our group is involved with three different Alzheimer’s disease studies, two of which are actively looking for volunteer participants. 


Three years ago, our team committed to advancing medicines and treatment for Alzheimer’s disease but it has been a complex process to align our resources for these studies.  For example, until recently each clinical study required the involvement of one study coordinator in addition to specialist support for lab draws, EKGs, etc. This simple resource allocation is not remotely adequate for Alzheimer’s disease studies.


To begin with, the process to determine volunteer eligibility for the typical Alzheimer’s disease study is the most complex I’ve encountered in my career. As potential participants step through the eligibility screening process, they will meet with at least three study coordinators who will work with the volunteer to complete a battery of standardized questionnaires. Additionally, each potential patient volunteer is accompanied by a study partner who must also be guided through a series of questionnaires.


Volunteers demonstrating eligibility after the questionnaires will go on to receive an MRI and a PET scan at Good Samaritan Regional Medical Center, who is collaborating with the Clinical Research Center on this part of the study.  Volunteers will have blood work, an EKG, and a physical exam with neurologist Dr. Alex Wang. In addition, eligible volunteers may also need dermatology and eye exams prior to study enrollment.  Whew!  These studies do take a village!


The good news for volunteer patients and their study partners is that the flurry of activity to arrange the eligibility assessments is largely invisible - the study team makes all the arrangements.  If you or a loved one are concerned about memory loss issues, give us a call – our village would be happy to speak with you!


The Clinical Research Center is currently seeking volunteer patients in studies for Alzheimer’s disease, Type 2 diabetes, and those with very high triglyceride levels.


If you are interested in learning more about clinical trials, contact the Clinical Research Center at 541-766-2163, or send an email to research@corvallisclinic.com or fill out our Research Study Information Request form. And, don’t forget to follow us on Facebook at https://www.facebook.com/corvallisclinicresearch. 


- Julie Carrico is Associate Coordinator of The Corvallis Clinic Clinical Research Center