Survivor Story: Jo Ann Sebastiano

The Other Side of Research:  The Face Behind the Trial
By: Jo-Ann C. Sebastiano

Properly designed protocols, streamlined case report forms, sound biomedical ethical principles, as well as validated randomization techniques are all typical concepts for researchers conducting clinical trials. These routine practices and tools can be administered without any personal connections to the actual recipient’s psyche   But what does go on in the mind and body of the randomized patient behind the trial? What are the fears, expectations, and questions?  Recounting my own experiences as a research professional participating in a clinical trial this article not only addresses how some of these routine tools and practices take on a personal perspective, but also serves as an acknowledgement of the much-appreciated advances in medical mindsets and treatments in the realm of clinical research.

Having been a research-based employee within the pharmaceutical industry for over 25 years, I experienced clinical research from a data analysis and training point of view.  I was very aware of all the tools, templates, and training needs for those involved in conducting trials but was not at all aware of what it would be like to actually experience clinical research as a patient nor did I grasp the emotional component of being a trial subject.

Being diagnosed with Stage II Colon cancer, I immediately researched what the expectations were for treatment after colon resection surgery.  The typical standard of care was to not have chemotherapy. Considering a large university hospital for treatment, an option did exist to become part of a clinical trial.  Never before did I think I’d be a patient participating in clinical research let alone for cancer. In my mind, I was too young and too healthy for this to happen.  In the past when I read protocols and received clinical trial data, I felt so much remorse for these patients and how they were in essence, at the mercy of our company’s research.  I felt so distant from them in the sense that I was looking at their data and not realizing the human being behind that data.  Now, agreeing to be part of a trial as a patient has exposed me to a different perspective on the clinical research community. I once viewed the investigators and study coordinators as supporting our company’s research, needing to follow our procedures, and. in essence as becoming tools for completing our company’s research effectively.  Now I viewed them as experts in their research, procedures and practices, as well as true patient advocates and my link to better health. This has strengthened my faith in the clinical trial process as a whole in ensuring patient are treated ethically and holistically.

Ethical considerations are of utmost importance when we select and manage clinical trials at our company.  I was very pleased to experience this firsthand with the oncology clinical research team I chose to manage my condition.  They carefully followed the protocol guidelines and criteria to ensure data integrity.  They fully explained all of the procedures, spent time with me during the consent process and continued to ensure my understanding of what was happening to me throughout the trial.  Even when I tried to persuade the staff to lower my dosage based on a symptoms (which I did at every visit), they carefully checked the study criteria prior to making any medication adjustments. I truly felt like a respected person and not a sacrificial laboratory animal being dosed unnecessarily for the benefit of science.

Being an educated patient and my own advocate of health proved to be a critical component of my healthcare. No one has a more vested interest in every blood test or scan result as the actual patient. Having taken advantage of the medical websites that are available and keeping my own personal files of my medical records, as well as asking the staff questions, has helped me to make connections between my medical condition and my treatments.  The trial coordinators, nurses and physicians I worked with really appreciated my attempt at being a well-educated patient whom they can provide guidance to on specific questions.

Through my trial experiences, I realized that the clinical research community has become very progressive in their approach to managing diseases and accepting a holistic approach in gaining back health.  Taking care of your physical body is critical but it is equally important to make the mind /body connections and treat both at the same time.  Massage therapy can relieve stressful muscles, and nutritional counseling can answer questions on what natural supplements can decrease symptoms from the disease and/or treatment.  It is amazing that the medical community recognizes the need for this approach and supports it by offering programs to their patients. The old stereotype belief that all physicians only support scientific studies has been changed in my experience.  I am grateful to have these offerings made available to me to supplement my medical treatment.

Another realization I made was that investigators are not only interested in obtaining data on their patients to support the trial but are truly interested in the needs of the patient when considering treatment options.  When I declined the second phase of my participation in the trial, I was treated with respect and compliance.

I am grateful not only to the investigators, but to the nursing coordinator staff at both the hospitals as well as through the care connects programs at my corporation.  They have provided invaluable services and expertise to me in choosing a surgeon, understanding drug therapies and their side effects, as well as discussing my overall mental well being.

In addition to gaining more appreciation of the medical staff, I have broadened my appreciation for the overall mission of pharmaceutical companies in researching and producing products that will minimize the symptoms associated with surgery and adjuvant therapy.  In my opinion, the money spent to conduct research is well worth the benefits that they are providing to patients on a global basis.  Additionally my oncology team was all very aware of the most advanced pharmaceutical therapies to provide relief for the typical side effects. Having been prescribed a drug from one of our company’s biggest competitors, which had such a tremendous impact on my quality of life during chemotherapy, has made me rethink that these competitors are really inter-company partners working together in the race towards a cure.

My experience as a pharmaceutical industry professional participating in a clinical trial has motivated me to rethink how we develop the tools, templates, and training that we offer to clinical research professionals.  I have now experienced both sides of the business and learned valuable perspectives in both arenas.  I feel that the bar has been raised in terms of expectations and trust of the clinical research community and the clinical research trial process.  I think this is especially critical in these political times of healthcare reforms and concerns.

I hope I can impart some of my insights and words of encouragement to both the pharmaceutical companies, as well as the clinical research communities in a quest to bring life saving drugs and treatment options to patients. After all, you never know when you may become the next face behind a clinical trial.

Appeared in The Monitor (Vol 22, Issue 5 Sept 2008) issued by the Association of Clinical Research Professionals.