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.

Action Steps
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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.

I recommend: 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.

I recommend: 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.

I recommend: 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.

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Helpful advice for making the most of this Guide

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

Almost half of all Americans take a prescription medication, according the U.S. Department of Health and Human Services. With prescription drug use on the rise, the demand for pharmaceutical clinical research continues to increase.

To keep up with the growing research needs, members of the pharmaceutical industry often outsource pharmaceutical clinical trial services to clinical research companies.

If your company chooses to obtain the services of a pharmaceutical clinical trial company, evaluate the following:

1. What services does the clinical research company provide?
2. How experienced is the company in pharmaceutical clinical trials?
3. How does the pharmaceutical clinical research company measure quality performance?

Action Steps
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Evaluate the ability of the pharmaceutical clinical trial services company to meet your needs

Clinical research companies offer a wide range of services including pharmaceutical clinical trial management, laboratory processing, data management and marketing. Make sure your research firm specializes in services to meet your company's particular needs.

I recommend: Coastal Carolina Research Center is a pharmaceutical clinical trial services facility primarily focused on conducting clinical trials on behalf of pharmaceutical companies. They offer two equipped pharmaceutical clinical research sites and a staff of investigators, coordinators, management and support personnel. SeqWright’s clinical trial services focus on custom molecular biology services. BioClin Health Research, Inc. specializes in pharmaceutical clinical trial management, clinical trial coordination and clinical trial financial services.

Examine the pharmaceutical research company's experience with medications and industry organizations

Experience is important when it comes to pharmaceutical clinical trials. Find out how much experience each clinical trial management company brings to the table, not just in years of experience but also in the number of pharmaceutical clinical trials. Ask for a listing of pharmaceutical companies the clinical monitoring company worked with, research studies completed and number of patients enrolled.

I recommend: Coastal Carolina Research Center’s 7 study coordinators possess a total of 80 years of research experience. The clinical trial services company provides a list of studies on their website. Jacksonville Center for Clinical Research offers a listing of their clinical trials sponsors, contract research organizations and therapeutic areas of expertise. Pinnacle Research Group also lists their pharmaceutical clinical research experience online. Pharmaceutical Research Organization cites working with 63 pharmaceutical companies, 36 contract research organizations and 45 independent and private-practice investigators to conduct 250 research studies with more than 7,600 patients.

Research pharmaceutical clinical trial companies to assess performance quality

Your company strives to develop safe and effective ways to treat and prevent disease. Make sure your pharmaceutical clinical trial management firm is committed to patient safety and ethical standards throughout the research process. Ask about their quality control standards.

I recommend: Coastal Carolina Research Center offers a comprehensive online standard operating procedures guide and a section of their website dedicated to previous audits. SeqWright developed a Quality Assurance Program to support its pharmaceutical clients and now hosts monthly audits. Pinnacle Research Group received positive audits without citations from institutional review boards, sponsors and the Food and Drug Administration.

Tips & Tactics

Helpful advice for making the most of this Guide

• •  When outsourcing pharmaceutical clinical trial services, many different departments will be involved based on the services rendered. Ask for one primary contact to provide consistent information in a timely manner.

There are many options to consider when evaluating participating in any type of pharmaceutical clinical research program. These programs follow specific types of protocols, including observational or interventional studies. Interventional studies depend on outcomes from various types of interventions or treatments. Observational studies measure patient outcomes by directly observing the reactions of patients to the research protocol.

Pharmaceutical clinical trial companies focus a trial based on guidelines using types of criteria such as age, disease stage and past treatments received. There are many types of trials-each with a particular focus. These are:

1. Treatment trials, which use new ways to do surgery or radiation therapy.

2. Prevention trials that help prevent different types of medical conditions in people who have the condition, but hadn’t yet found it.

3. Randomized pharmaceutical trials where people receive the study medication or a form of sugar pill known as a placebo.

4. Trials performed to find better procedures for treatment or interventions, called diagnostic trials.

Action Steps
The best contacts and resources to help you get it done

Understand the goals and options of any type of pharmaceutical clinical trial services provided

Pharmaceutical clinical trials have many different types of goals based on the medical condition being treated. Knowing the goals of treatment and the options available enable patients to be their own health care advocate.

I recommend: Knowing where to find the right information in regards to the clinical trial chosen is imperative. Clinicaltrials.gov has a huge database of all clinical trials available along with criteria and inclusion data to help those investigating clinical trials as a treatment option. The American Cancer Society also has detailed information on specific types of trials available as well as the expectations for treatment of each trial.

Become knowledgeable of all pharmaceutical clinical trial management activities

Clinical trials for pharmaceuticals are usually monitored by clinical research companies affiliated with the medication under study. The activities require clinical monitoring activities that adhere to guidelines established by the sponsor or clinical trial company. It is important to understand the types of expected activities when participating in a study.

I recommend: There are many providers for clinical monitoring services, which can assist with the programs associated with research studies. Organizations like Contract Clinical and SeqWright follow strict guidelines when administering a clinical monitoring program.

Develop an expertise in pharmaceutical clinical trial key terms to be your own health care advocate

Knowing the basics of any clinical or pharmaceutical trial will allow the patient to know what to expect when choosing to participate in a clinical trial program. Knowing key terms used for and in any clinical monitoring program will allow you to make the best health care decision when considering participation.

I recommend: Clinical trials allow patients to have another option for health care. In considering these options, it is very important to become aware of all the usual terms utilized by the professionals involved in the research programs. Good reference sources to assist in obtaining this knowledge are at the Huntington Study Group organization and The CenterWatch Clinical Trials Listing Service, both of which have extensive information on the process of clinical trials and their management.

Tips & Tactics

Helpful advice for making the most of this Guide

• •  Becoming knowledgeable of the process of pharmaceutical clinical trials will enable people to make the most informed health care decisions when faced with possible life altering medical conditions.