The Association of Clinical Research Professionals plans to release a report today that says Americans are turning their backs on opportunities to participate in clinical trials following negative portrayals of such research in the media. The bad press comes at a particularly bad time for the drug industry, the report says. To test the safety and effectiveness of new medications, drug companies need an ever-increasing pool of volunteers. Without them, the report says, a growing number of clinical studies may not be able to go forward and medical progress may be endangered.
Regulators require such studies before approving new drugs for use.
Contrary to the media portrayals, the group says, examples of investigator fraud, financial conflicts, or other ethical lapses in clinical trials are isolated and rare. The product is meant to reduce relapses in patients who receive back their own stem cells after chemotherapy. The stem cells are often contaminated with the patients' own malignant cells, and studies have shown that purging the malignant cells before restoring the stem cells increases survival. Eligix's HDM technology coats heavy particles with monoclonal antibodies that seek out and attach to the malignant B-cells. Once the monoclonal antibodies bind to the malignant cells, the weight of the particles drags them to the bottom of a solution, where they are easily filtered out.