Clinical Trials Basics

Know your options when considering participation in a pharmaceutical clinical trial
By Paula Papp Pharmaceutical clinical trials help physicians research better ways to improve healthcare outcomes by providing scientific data to help diagnose, prevent and treat many different types of medical conditions. Pharmaceutical clinical trial companies set up specific research protocols and guidelines and standardize patient recruitment processes.
 

Pharmaceutical clinical trial services are funded/sponsored by different types of organizations such as medical-related institutions, groups or foundations as well as pharmaceutical clinical research companies and take place in many locations, such as physician offices and large tertiary care hospitals. They all have expertise in pharmaceutical clinical trial basics, management and regulatory standards.

Pharmaceutical clinical research involves testing of new medications for the treatment of targeted medical conditions. During clinical monitoring, experts evaluate participants for side effects and physiological responses. Prior to participating in any type of pharmaceutical trial:

1. Consider the potential side effects and benefits that may result from participating in the pharmaceutical clinical trial services offered for the medical condition you have.

2. Know where, when and how the pharmaceutical clinical trial management and monitoring will happen.

3. Assess the level and type of health care services provided if enrolled in the program.

Know the basics of pharmaceutical clinical trials

Clinical trial programs are developed for different conditions and reasons. Some programs monitor the effectiveness of specific medications while others monitor the amount of the medication (doses) that is safe to give. Medicines, treatments and diagnostic processes all need clinical trial monitoring before they receive approval for widespread use.
Try: The National Cancer Institute has a free clinical trials matching service, which helps patients find the most appropriate clinical trial available to them based on the their medical condition. Another source of information regarding clinical trials for pharmaceuticals is MedlinePlus.

Know the purpose of the pharmaceutical clinical research/study prior to participating

It is imperative to know what the researchers hope to learn from the clinical trial. Many pharmaceutical clinical studies focus on medications and the reactions associated with them while others monitor the impact of different treatment modalities.
Try: The University of Michigan's Comprehensive Cancer Center has a full list of the various types of clinical and pharmaceutical trials and their focus points which can help to educate patients and their families in becoming informed consumers regarding their choices of clinical trial programs. Another source of referrals for pharmaceutical clinical trials is at CenterWatch, which has many thousands of trials available.

Inquire about services included in the clinical monitoring program

It is very important to find out what medical services will be provided by the clinical monitoring program and if there is a cost. Many insurance companies will pay a portion of the costs of a trail, but in most cases, these services must be prior authorized in order for payment approval.
Try: Finding out what each individual state's insurance laws are very important when considering participating in a pharmaceutical clinical trial. The American Cancer Society gives a clear outline of these laws, as does the National Conference of State Legislatures forums.

• Knowing clinical trial basics requires a degree of research into the programs available, goals of the programs, type of monitoring and potential results.