What is a clinical research study?

Clinical research studies (also known as clinical trials) are medical research studies conducted with volunteers and play an integral part in the development of new therapies for diseases and health-related conditions. All potential therapies, both devices and medications, must go through intensive testing. The process usually begins when a research company discovers a new compound or device. These research organizations, also known as sponsors, primarily include pharmaceutical and biotech companies.

Long before a new candidate drug or device ever enters a clinical trial, it is studied extensively in the laboratory setting. This phase typically can take several years. Only a few promising candidates make it through this phase and are allowed into the next phase of development which is comprised of pre-clinical, or animal, trials. Any candidate showing significant toxicity is eliminated from further study. Only a few are ultimately selected by the sponsor for a clinical trial, but only if sanctioned by the Food and Drug Administration (FDA). The sponsor then chooses a clinical trial site, like MedPharmics, to actually conduct the study. During this clinical trial phase, safety and effectiveness must be demonstrated. All new drugs and medical devices must be first approved by the FDA before being released into the public market. Understandably, in order to receive such FDA approval, the sponsors must present data that demonstrate safety and effectiveness.

What steps are taken to ensure my safety?

There are no “guinea pigs” in clinical research. Every person considering a clinical trial must completely understand the important aspects of the study. Such information includes the following: 1) Is there a placebo? 2) How long does the trial last? 3) Will blood samples be drawn? 4) How many visits are needed? 5) Is there any compensation? 6) What are the risks? 7) What are the benefits? 8) How is personal information protected? All of this information is included in the informed consent which the participant will sign if he/she decides to volunteer for the study. If anyone is unable, for whatever reason, to understand the information presented in the informed consent, that person cannot be allowed into the study.

This medical research is carefully controlled at every step. The sponsor provides the research site very detailed guidelines, referred to as the protocol, which dictates how the study will be conducted. Before a study can be initiated, the FDA as well as a second independent group, called the Independent Review Board (IRB), must review and approve the protocol. The person responsible for the conduct of the trial at any specific research site is called the principal investigator (PI), who is usually a physician.

The PI’s most important role in the study is to ensure the safety of the participants. Before the study even starts, the sponsor sends all existing information on the drug or device to the PI who reviews this material. If the PI feels the study is lacking in any way, he is free to decline the study.

Every protocol has both inclusion and exclusion criteria. Each participant is carefully questioned to make certain that all of the necessary characteristics are present (i.e. the inclusion criteria) and that none of the disallowed characteristics (i.e. the exclusion criteria) are present. Strict adherence to these criteria is one of the main ways of ensuring participant safety.

Why should I participate?

Every hopeful cure, every advance in medicine couldn’t happen without the participation of volunteers for clinical trials. No matter how exciting a scientific discovery may be, it cannot reach people who might benefit from a new therapy, until it has been thoroughly tested. Clinical trials can also lead to better ways to detect illness, to prevent it, and to improvements in quality of life for the millions of people who live with chronic illness. And new innovations cannot be tested without the help of people like you.

People who enroll in a clinical trials typically decide to do so for a few important reasons:

  • The desire to make a difference
  • To help improve the lives of others
  • To help improve their own condition or gain better access to treatment
  • Getting paid for medical research
  • To receive a no-cost health exam

I’ve decided to enroll. What should I expect?

Taking part in a clinical trial involves:

  • No cost to you – You may receive compensation for time and travel.
  • Medical Care – You can gain access to quality medical care, at no cost.
  • Satisfaction – You know that you are helping to improve the health of millions of people.
  • A right to privacy – Learn more about how we protect your information.

Process in summary

Pre-screening – A MedPharmics patient care specialist contacts you, reviews the inclusion and exclusion criteria, and determines eligibility.

Signing of the Informed Consent – As previously explained, this form explains your rights and responsibilities, as a participant in a study.

Screening – The PI or one of his qualified assistants performs an initial physical examination including vital signs, reviews your medical records, collects test samples (such as blood or urine), and performs indicated procedures (such as an EKG).

Enrollment and Randomization – You are given the study-related treatment, which could be a placebo. You may not know if you have been given a placebo, if participating in a “blinded study”. You may be given a diary, to report how you feel during the study. A study may require followup visits or phone calls