Pharma Tips

Introduction of Clinical Research & Clinical Trial

By: Pharma Tips | Views: 3371 | Date: 01-Oct-2012

Introduction about Professional Clinical ResearchIntroduction about Clinical TrialClinical Trials: Where to Find Them & Are They Appropriate for You?What drug studies are available for patient involvement?What are the benefits and risks of participating in a clinical trial?Who can participate in a clinical trial?

Introduction about Professional Clinical Research

Professional Clinical Research

Professional Clinical Research (PCR) is dedicated to providing quality data and compliant patients. We have been conducting clinical trials in Northern Michigan for eight years. Our mission is to provide our community with opportunities to participate in cutting edge medicine right here in their own back yard. We participate in a broad range of studies in multiple medical specialties. Our professional staff of qualified clinical research coordinators is committed to providing their patients with the best possible research experience.

PCR is a group of research clinics. Each Clinic is its own entity with support from the Site Managers (Marilyn Wilmot and Laura Jackson) and our expert research staff. We strive to provide quality regulatory and study specific paperwork for each study. Our dedicated staff is trained to recruit, screen and follow patients throughout their participation in each clinical trial.

Patient safety is our first and foremost concern. We are committed to strictly complying with sponsor protocols as well as 'Good Clinical Practices' and FDA safety guidelines. PCR's purpose is to find and disperse appropriate research studies to our clinical sites and provide a qualified and learned research coordinator (CRC) for each clinic. The benefits of clinical trials are limitless for both subjects and investigators participating in research.


Introduction about Clinical Trial
A clinical trial is a research study designed to answer specific question about new drugs, medical devices, or new ways of using known treatments. Clinical trials are used to determine whether the new drug or treatment is safe, and whether it works.

Clinical trials consist of four phases: Phase I tests a new treatment on a small group, and concentrates on safety; Phase II deals with safety and efficacy, and expands the study to a larger group of people (several hundred); Phase III expands the study to an even larger group of people (thousands), and is designed to determine conclusively whether or not the treatment is effective; Phase IV takes place after the drug has been licensed, to monitor the drug for long-term effects.

The randomized, double-blind, placebo-controlled (or active-comparator-controlled) trial offers the strongest evidence that a treatment is effective. The number of participants also considerably effects how reliably the trial can determine the effects of a treatment.

Clinical trial must be consistent with good clinical practice (GCP), a rigorous*** detailed set of guidelines designed to protect the participants' safety and the integrity of the trial data. The FDA requires pharmaceutical companies and the contract research organizations (CROs) to conduct rigorous clinical trials verifying the safety and efficacy of the new drugs before granting approval for marketing.

The trial objectives and design are usually documented in clinical trial protocols. Once the objectives are determined,
case report forms must be carefully designed to gather complete, unambiguous data from the trial.

During the trial, data management team must continually monitor and verify the data to ensure that they are accurate and consistent. Any missing or inconsistent data must be investigated and corrected.

Professional Clinical Research (PCR) adheres to the above information consistently and commitment. We have been successful because of passion and dedication to this process.

Clinical Trials: Where to Find Them & Are They Appropriate for You?


When patients saw the preliminary results from the testing phase of Kalydeco, many couldn’t wait to start the medication.  And soon different age groups will be tested with the drug to determine if it is just as effective and safe for younger generations.  Those patients and their parents are doing what they can to be a part of the new set of clinical trials for Kalydeco.

But how is a patient supposed to know when/where a clinical trial is taking place?  And more importantly, how is he supposed to know if that trial is appropriate for his current situation?

We’ve researched and found information that could be helpful for patients:

What drug studies are available for patient involvement?

A great resource for patients to find ongoing clinical trials is www.clinicaltrials.gov. This website, which is part of the National Institute of Health, allows individuals to choose to search by either drug or disease state.  Additionally, patients can filter the results by those which are and are not seeking volunteers.

Each study listed has its own detailed page that includes such information as the purpose of the study, eligibility requirements, and study centers.

There are currently at least 114 cystic fibrosis studies recruiting or preparing to recruit patients, and over 60 of these are studying drug therapy.

Patients can also go to the Cystic Fibrosis Foundation website (www.cff.org) and by clicking on “Find a Clinical Trial” on the left-hand side, search for trials in a similar fashion.  Furthermore, an advanced search allows patients to find studies based on FEV1%, Pseudomonas status, B. cepacia status, and state of residence. The results will be grouped by recruitment status if no filters are chosen.

However, always make sure your lifestyle and treatments are a good fit before signing up for a clinical trial.  Here are some things to keep in mind:

What are the benefits and risks of participating in a clinical trial?

Benefits
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

  • Play an active role in their own health care.
  • Gain access to new research treatments before they are widely available.
  • Obtain expert medical care at leading health care facilities during the trial.
  • Help others by contributing to medical research.

Risks
There are risks to clinical trials.

  • There may be unpleasant, serious or even life-threatening side effects to      experimental treatment.
  • The experimental treatment may not be effective for the participant.
  • The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.



Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria”. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.



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