Achieving approval of a new pharmacologic agent or device on a worldwide basis is a significant challenge. The guidelines
and requirements that steer our efforts at enhancing and extending life around the world are tedious and, fortunately, comprehensive.
In spite of relatively few setbacks, perhaps in no other category than pharmaceutical development are the advantages of these
guidelines more evident.
As expensive and time-consuming as research and development currently are, drugs developed in the last few decades have allowed
people to live longer and delay or prevent serious complications of a number of diseases. The standards by which medications
are brought to market are second to none, and they are in no small part the reason that people in many parts of the world
enjoy a high quality of life.
The European Union is developing a harmonized approach to drug and device development that will alleviate some of the obstacles
encountered by pharmaceutical and biotech companies as they bring their products to market. Once these regulations are put
into place, development will improve as companies continue to collaborate and compete.
Regardless of the system, clinical trials that provide crucial information on the safety and efficacy of potential medications
are the cornerstone of the drug or device development process. A well- implemented clinical trial can mean faster approval,
a smooth transition to market, and substantial cost savings; a poorly implemented trial results in an unnecessary expense,
and most importantly, a delay in regulatory approval.
Clinical Research Organizations (CROs) are the backbone of successfully implemented clinical trials. Partnering with the drug
or device developer, CROs ensure that all participating study sites are properly monitored, all data entered for evaluation
is accurate, and all safety concerns are addressed. In short, CROs carefully monitor each component of the study trial, making
sure that all appropriate measures are taken to ensure legitimate, scientifically valid, and corroborated results. Mistakes
made during the development process can mean the failure of any drug or device for regulatory approval and thus, market availability.
There are times when the desire for marketability of treatments may overlook small but potentially grave safety concerns.
While CROs cannot influence the efficacy of a drug or device, they may, however, work with the developer to detect potentially
grave safety concerns earlier — possibly saving lives, money, time, and the client's reputation.
Before approving any drug, regulatory bodies such as the US Food and Drug Administration (FDA) rely heavily on scientific
valid data to attest positively that the medication meets the utmost safety parameters with respect to the population for
which it is intended. A trial must be conscientiously planned, flawlessly executed, and comprehensively reviewed.
Despite a wealth of new developments in treatment of cardiovascular disease, heart disease is one of the leading causes of
death in the US and Europe. Furthermore, the disparities across ethnic groups have become apparent more recently with respect
to heart disease. Congestive heart failure (end-stage heart disease) came to the forefront of the medical community's attention
last year as a disease that disproportionately affected subjects of African descent, as a new medication emerged indicated
for that specific population. It was clear that new and better treatments were needed both to reduce the overall incidence
of the disease as well as to reduce the heart disease ethnic disparity gap.
CROs that are able to ensure patient safety and efficacy by carefully following clinical trial requirements, will lead the
medical community in the quest to increasingly advanced and targeted medicines. A CRO that does its job well ensures data
collected from the research study is accurate, reliable, and allows life-enhancing therapies to reach the patients who need
them most as quickly as possible.
Bruce Garrett, chief medical officer, Medifacts International, 2101 Gaither Road,Suite 400, Rockville,MD 20850, 301 296-4731