Certified Clinical Research

What is a Clinical Trial? Clinical trials utilize human volunteers to test investigational medications for safety, effectiveness, and appropriate dosage. Once a volunteer meets the criteria to enter a study, there may be physical exams, laboratory work, or other medical procedures required. The information from all of these will be documented and submitted to the pharmaceutical company for review and analysis. Trials may last from just a few days to years in length.

How are drugs approved? Investigational medications are required to go through several phases of clinical trials which may take several years to complete. If preliminary analysis of the data suggests that a new drug is safe and effective, the pharmaceutical company will submit a New Drug Application (NDA) to the FDA for market approval. Once all of the clinical trial data has been reviewed by the FDA and meets its strict criteria, it is eligible for approval. If there are any questions or concerns, the FDA may require additional clinical trials with specific parameters or it may deny the application altogether.

Why should I volunteer? Human volunteers are imperative in clinical trials and key to the advancement of healthcare. This may be one of the reasons why some individuals volunteer for clinical trials. Some may volunteer due to having a medical condition that is not well controlled with current treatment available and hope that the investigational drug will provide them with the control they seek. Whatever the reason for participation may be the reality is that no new drug would make it to market without human volunteers. They are essential to the approval process and their contribution to the future of healthcare and the benefit to mankind cannot be understated.

How is my medical information protected? The Health Insurance Portability and Accountability of 1996 (HIPPA) went into effect in April 2003. This federal regulation was passed to protect the privacy of an individual’s medical information. Certified Clinical Research shares the same concerns regarding your medical information and is in complete compliance with this act.

Who looks out for my interests? Safety is the number one concern for human volunteers in clinical trials. As such, there are strict federal regulations (FDA) and international guidelines in place to assure this. Each research site is also overseen by an Institutional Review Board (IRB) to ensure that the study is being conducted according to the protocol and that the safety and rights of the volunteer are being protected. In addition, throughout the trial the sponsor pharmaceutical company assigns a representative to monitor the study at each trial site. If at any point during the study the investigation medication proves to be unsafe or ineffective the study may be terminated.

Who do I call with questions? We have only addressed a few of the many questions you might have about clinical research, but it is of paramount importance to Certified Clinical Research that you are knowledgeable and completely comfortable about your decision to participate in a drug study. We welcome any additional questions you may have to help you decide if participating in a clinical trial is right for you. Please feel free to contact us by e-mail (webmaster@certifiedclinicalresearch.net) or by telephone (916-638-3874) with any questions you may have.