About Clinical Research
The Department of Clinical Research at the Palo Alto Medical Foundation (PAMF) provides the bridge between medical research and patient care. The Department conducts trials of new therapies conducted by PAMF physicians. Experienced research nurses shepherd studies through a required safety approval by PAMF's Institutional Review Board, recruit patients to participate, monitor patients throughout the study, and ensure compliance with privacy regulations and other rules.
This coordination, along with PAMF's large base of patients and physicians, attracts pharmaceutical and biotechnology companies and other collaborators. Patients, however, may derive benefit from clinical trials by gaining early access to new treatments. Most, however, have altruistic motives and participate in order to further the understanding or treatment of particular diseases.
Clinical research has been conducted at PAMF for approximately 20 years. This has allowed patients to benefit from early advances in treatment for chronic illnesses.
Trials managed by the Department of Clinical Research are usually proposed by a PAMF doctor or an outside organization. The trials may aim to test an experimental medication or medical device, find new uses for old therapies or analyze innovative strategies for doctor-patient interaction.
From there, the study must receive approval from PAMF's Institutional Review Board (IRB). The IRB ensures that all research meets federal standards, protects the rights and safety of human subjects, and meets PAMF's own quality criteria. The average time from proposal to IRB approval is about one month.
The study is then assigned an experienced research nurse or coordinator from the Department of Clinical Research. Working with the lead physician investigator, the nurse/coordinator identifies and contacts patients who might be willing to participate. Patient recruitment and monitoring is made easier with PAMF's electronic health records (EHRs). The department places high priority on patient privacy and accesses patients' EHRs only after receiving permission from potential participants.
Trials may run weeks, months or years depending on what is being studied. Throughout the study, research nurses or coordinators stay closely involved with participants, providing treatments, monitoring progress, and ensuring that patients' rights and privacy remain protected.
Physicians have reported that participating in clinical trials is both intellectually challenging and professionally rewarding. Many believe that the research process makes physicians better patient caregivers. By working in both clinical care and research, doctors become attuned to what treatments are up to date and learn to think more creatively.
Patients who join clinical trials receive access to new treatments and the dedicated attention from physicians, research nurses and coordinators. Many participants are also motivated by helping future patients, as many studies may not influence treatment for years.
Much of PAMF's strength in research comes from its patient population. People in our community understand the significance of clinical studies, and our participants are dedicated. It puts us in an optimal position to do innovative work.
Back to top
Research Study for Pregnant Women Before Amniocentesis or CVS
This study will consist of a blood test which, in the future, might replace current prenatal screening tests and potentially reduce the need for more invasive procedures such as amniocentesis and CVS.