Have you ever wondered why we made so much progress in technology and still do not know how to cure cancer? In this edition of Newsweek (double issue from May 24 and 31,2010), we read that medical research is not making progress rapidly enough and that scientific discoveries of new molecules are often getting stagnant in the process of development and its multiple administrative loops. Many of us do not even know how it is that new medication makes it to the pharmacy and how we know it is safe and helpful.
Developing new medication is called clinical research study or trial and it starts in the scientific lab working on, so called, pre-clinical experiments in applying new molecules to animals’ studies. Once those turn out positively promising, phase I of clinical research introduces the new drug to healthy volunteers who try it and escalate the dose of it in order to establish safety levels. Phase I studies are usually done in close outpatient or inpatient facilities, allowing for a high level of monitoring of the participating volunteers, their vital signs and blood testing. If the study is successful in phase I, pharmaceutical sponsors begin working on protocols for phase II. The drug is introduced to a small (100-200) group of patients with an actual medical condition, meeting all the criteria of participating from the safety perspective. For instance, a person with on-going chronic and untreated hypertension should not be a patient in a study due to unstable blood pressure and possible side effects related more to that unstable condition than the drug they are trying. Data from phase II studies is strictly monitored and constitutes a background to initiate phase III.
During phase III trials, the drug is usually introduced to a larger group of patients (500-600) and criteria of participation may be less restrictive. Usually, it is already known how patients accepted the new drug in phase II, and phase III serves as an efficacy study.
All phases of clinical research is conducted under control of FDA, Federal Drug Administration, a government institution responsible for the safety of all pharmaceutical products and devices distributed in the United States. Not too many of us participate in clinical research. Not too many doctors conduct trials. Running phase II or phase III studies requires a lot of time, training, and dedication to a detailed medical investigation. However, we all can help to make the process of developing new drugs easier and quicker. Finding patients qualifying for the studies can take months. By participating in clinical research, patients can speed up the processes of gathering data necessary to move to the next phase. They receive free medical examinations and treatment for their particular conditions according to the protocols of the trials.
They can also first-hand observe and witness potential efficacy of the drug. Some pharmaceutical sponsors pay for the patients’ time and travel in a form of a stipend.
If you want to learn more about clinical research or would like to participate in studies related to skin conditions, please call Altman Dermatology Associates. Dr. Bukhalo and his research team study new medical solutions for psoriasis, eczema, acne, actinic keratosis, sun damage, and more. You can get more information about particular studies after you sign a consent prepared for a given study. The staff will provide you with general information how you can help and how you can be helped. Please, call 847-392-5440 and ask for any of our research team members.
Dr. Michael Bukhalo
Elizabeth Szalko, PA-C
Autumn Hunt PA-C
Courtney Knoebber PA-C
Research and record keeping are extremely important in our clinical studies.