Research
Highland Clinic’s Clinical Research Department has been actively involved in clinical research (or trials) for over twenty years. Studying the possibilities of new treatment and potential benefits has provided hope and new methods of treatment for its patients. Innovative medications and devices provide safer or more efficient methods of treatment. The Clinic is actively involved in over 20 trials with great potential for participants.
Conducting the highest quality research involves three partners: the patient, the physician and a staff dedicated to patient care and ethical research. Communication between these partners is vital to keep information flow and answer queries. Asking questions overcomes the patient-physician barrier and helps patients take an active role in their healthcare. Some questions she commonly encounters are:
How does a medication or drug get to the market?
Before a drug or medication is launched in the market, extensive laboratory testing or preclinical research is done. This type of testing typically involves animals and human cells in the laboratory. If successful in this stage, the drug and all its treatment benefits are presented to the United States Food and Drug Administration (FDA) for approval to begin research in clinical settings. This is called an application for an Investigational New Drug (IND).
What are clinical research/trials for treatment?
Simply put, it involves the study of a new drug or device. There are three phases to testing a new medication:
Phase One: This involves testing the drug in small numbers of patients, some being healthy subjects (usually under a 100 people). The purpose of this Phase is to determine the safety of the drug, dosage and side effects. The pharmaceutical company and the FDA monitor all the results.
Phase Two: This next stage tests the drug for its efficacy in the condition it is intended to treat. This phase lasts much longer than the first one, usually involving several hundred people in different centers nationwide. Most of these trials are ‘randomized’ i.e. involve two groups, one taking the investigational drug and the other taking a ‘placebo’ (sugar pill) or the standard treatment. Usually the patient is ‘blinded’ to which drug they receive, to avoid any type of bias. Sometimes the treating physician is not aware of which drug the patient is taking i.e. they are ‘double blinded’ in the study. This helps the physicians and patients have an unbiased treatment plan with impartial selection. Patient care being the number one priority, this blinding can be removed for the treating physician in the event of an emergency. Usually a developed ‘protocol’ or method of treatment is followed at all the centers, so you could be getting the same cutting edge treatment that someone in a different state gets! It is estimated that only about 1/3rd of the drugs make it through Phase 1 and 2 trials.
Phase Three: Once the drug’s preliminary evidence is gathered from the last phases, it undergoes this large scale testing in several hundred to thousand patients. Most of these studies last many years and aim to deepen the knowledge of the drug’s benefits, efficacy and range of side effects. Once this phase is successful, the FDA may approve marketing of the drug.
Late Phase Three and Phase Four: This final phase usually compares the drug to others on the market in terms of long-term safety, cost, efficacy and effects on quality of life.
Studies are funded by drug companies or by Federal funds through the National Institutes of Health (NIH). Physicians are aware of the treatment, research plan and patient visits. Any care that is outside one’s standard (such as special lab work for drug levels in the blood) or follow-up care is usually paid for by the drug company.
How did we identify you?
Your doctors, nurses and medical staff may recommend you to the Research Staff as a potential candidate for a trial. You may also approach, call or write/e-mail us at any time if you view our television or print advertisements.
Why do you need me to participate?
You, the patient, are the reason Highland Clinic exists. By choosing to participate in a clinical trial, one gains access (at no added cost) to drugs that might be promising in treatment before they are available in the pharmacy, continue to receive care from your experienced physician and from the Research Team at Highland. Your participation is voluntary, takes little extra time and may pass on benefits to fellow humans who share your condition and concerns.
I want to sign up, what is the process?
Once you have been identified by the physician or Research Team as showing interest in participating in a trial, you will be presented with an ‘informed consent’ form, which will describe the study, how long your involvement will be, contact people, risks and benefits.
What about my treatment and my rights?
Your treatment and excellent care by Highland doctors will not change at any time with or without your involvement in a trial. Due to our respect and value for our patients, along with our compliance with federal laws we do not release any of your identifying information. An independent Institutional Review Board (IRB) looks at every trial with a view to protect patient rights to safety, privacy and right to make an informed decision. A trial cannot proceed until the IRB approves it. Your regular physician monitors all your blood tests, scans etc. and the Research Staff is also available to answer any questions or concerns related to your drug and treatment. Any side effects are monitored and treated by your doctor and reported to the Research Staff.
Who is the Research Staff at Highland?
Our Research Staff are dedicated to excellent and ethical research keeping the patient’s needs as the highest priority. Our Research Team looks forward to getting to know and serving your needs through our trials. They can be contacted via phone (318)798-4630 and e-mail research@highlandclinic.com or in person on Highland Clinic’s third floor.
Dermatology: For psoriasis, this study focuses on patients with lesions on two extremities. Five treatment options -- four creams and one placebo -- are involved in this study. Patients are assigned two tubes of medicine, one for each of their arms. To assure equal compliance, boxes are labeled for each arm and each tube is weighed after a certain amount of time to ensure the same amount was used.
Internal Medicine: This five-year study for women older than 60 years of age and men older than 55 years of age who are healthy, with no heart disease, will test a cholesterol-lowering medication to reduce the risk of future heart disease. Rather than curing an illness, this study may find a preventative medication for future cardiac conditions.
Oncology: Since the FDA has already approved this drug for cancer patients on chemotherapy who also have anemia, this study focuses on patients who have active cancer and anemia but are not taking chemotherapy.
Ophthamology: Patients with conjunctivitis (pink eye) test a new antibiotic.
Eye, Ear, Nose, and Throat: This new eardrop for acute otitis media, or middle ear problems, is tested on children who already have tubes in their ears but still develop infections and visible drainage from their tubes.
For more information, please call 318-798-4630 or 318-798-4629.