Lancaster Urology has been involved with clinical trials for over 10 years. We have participated in clinical trials for prostate cancer, erectile dysfunction, benign prostatic hypertrophy, overactive bladder, stress incontinence, prostatitis, premature ejaculation, renal cell cancer, and high grade prostatic intraepithelial neoplasia (PIN).
Clinical trails are research studies that test new drugs and treatments for safety and effectiveness in human beings. The results of clinical trials help determine if a particular treatment should be approved and made available for use to improve the overall standard of care.
Lancaster Urology has participated in clinical trials leading up to the approval of such drugs as Viagra, Ditropan, Ditropan XL, Detrol, Detrol LA, Oxytrol patch, Vesicare and Sanctura.
- It is important to understand the clinical trial process, as well as the features of the particular trial you are considering, before you agree to become a participant
- For further information, the website: www.clinicaltrials.gov includes a list of questions to ask about trial participation, and links to additional resources'
- Remember that you should discuss trial participation with your healthcare provider, as well as with your loved ones.
- Clinical trials are sponsored by government agencies, biotechnology, pharmaceutical and medical device companies
- Before any drug, device or treatment is tested in humans, it is tested in animals; this is done to ensure the basic safety of the treatment; once the treatment is determined to be safe for testing in humans, it goes through 4 phases of study.
- A protocol is written that describes the clinical trial, i.e., why the study is being conducted, the treatment to be studied, the participants requirements.
- Inclusion and exclusion criteria will identify the characteristics that identify whether a patient can or cannot participate
- Before a treatment is administered to patients in a clinical trial, all aspects of the treatment and thoroughly reviewed by a qualified panel of experts called an Institutional Review Board
- When a patient is identified as a candidate to participate in a clinical trial, an informed consent is provided for the patient to review; an informed consent gives extensive information about the trial.
- It is important to know that agreeing to do a clinical trial puts the patient under no obligation to begin or complete the trial process; the patient always has the right to withdraw from the trial at any time without penalty
- Researchers review the clinical trial data after each phase to determine if the next phase should begin
- After phase III has been completed and the treatment judged to be safe, effective, and an improvement upon existing treatments, the treatment is submitted for review by the FDA
- The FDA may then approve the treatment for use in the general public or mandate that additional research be conducted
- You may find that the drug or treatment is not effective for you
- You may not receive the treatment being studied (you may receive a placebo)
- You may experience side effects or adverse reactions to medications or treatments
- You may be required to visit a physician and undergo evaluations more often than you would otherwise
- Clinical trials allow access to new treatments before they become available to the public and allow you to expand our treatment options
- Clinical trials offer the possibility of quality medical care at leading institutions
- Clinical trials provide an opportunity to contribute to science and medical research for future disease prevention and treatment
- Prostate Cancer Studies
Interested in enrolling in one of our trials? Please call 717-431-2285.