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PATIENTS

 – It all starts with you!

Clinical research is the gateway to a healthier future.

Did you know that all medicines and medical devices on the market today have been tested in clinical trials? Each year millions of people participate in research studies that aim to improve lives. If you want to get involved, this site will help you to get started. Here you will find all the answers you may have about clinical trial participation.

WHAT IS A CLINICAL TRIAL?

 

A clinical trial is a carefully designed and executed medical research study for people who volunteer to receive an experimental drug or medical device under controlled circumstances for a specific period of time. The purpose of a clinical trial is to find solutions for the prevention and treatment of various medical conditions. Some trials accept volunteers who exhibit symptoms of a disease that is being studied, while other trials accept healthy volunteers. Clinical trials are usually sponsored by leading international pharmaceutical and biotechnology companies and executed by clinical research organisations like VX Pharma.

REASONS FOR JOINING A TRIAL

Clinical trials assist pharmaceutical and biotech companies to improve medical knowledge and develop new therapies that bring better health to the world. All medicines, from aspirin that treats a headache to prescription drugs that treat serious diseases like cancer and diabetes, have had to go through medical research before being made available for public use. Not only does your participation help the advancement of healthcare but taking part in a medical research study can benefit you directly in many ways.

TYPES OF CLINICAL TRAILS

There are six main types of clinical trials:
Bioequivalence Trials
To compare two drugs from different suppliers to verify that they work in the body in identical ways and have equal activity. Generic drugs are more affordable copies of original drugs and are all required to undergo this type of trial to demonstrate that they work in the same way and have the same effect as the original drug (i.e. bioequivalent). These trials are conducted in healthy volunteers only.
Diagnostic Trials

To evaluate new tests that could identify a disease in its early stages; usually, people must show symptoms to qualify for participation.

Treatment Trials
To gather information about the efficacy and risks of experimental drugs or medical devices, or to compare experimental therapies with existing ones to decide which is the best treatment for a particular condition.
Prevention Trials
To determine if positive lifestyle changes, like a more nutritional diet, or vitamins and vaccines could reduce the risk of illness or prevent the recurrence of a disease.
Screening Trials
To use imaging, laboratory or genetic tests to identify a disease before symptoms occur.
Quality of Life Trials
To find ways of improving life for sufferers of chronic health problems or life-threatening diseases.

CLINICAL TRIAL PHASES

During a clinical trial a new drug or medical device can go through the following four distinct phases:

Evaluated in a small group of healthy people (20 to 80) to check safety, side effects and associated dosage of the new drug.

Evaluated in a larger group of people (100 to 300) over a longer time period to primarily check if it is effective but also to continue monitoring safety.
Evaluated in a large group of people (up to 3,000) over an even longer period of time to check almost exclusively for efficacy. At this point, the product is evaluated by regulatory bodies such as the U.S. Food and Drug Administration (FDA).
Takes place after market launch to monitor ongoing safety and efficacy in patients treated by the product.

Typical participants

Whether you have a common acute or chronic condition or are suffering from a rare or serious disease and may benefit from new improved therapies, you may qualify to participate in an appropriate clinical trial. However, you do not need to be sick to volunteer for participation –  healthy people are suitable for bioequivalence studies that seek to compare a medication produced by two different companies. While there might be no direct health advantage of this type of participation, you will be remunerated, and you help to get new quality medicines to the market.

BENEFITS OF PARTICIPATION

  • Free access to medication and treatments that may be available only through trial participation.
  • Depending on the trial protocol, free physical examinations, blood tests, scans, surgery and disease management you may need but might not otherwise be able to afford.
  • If required by the research study, you will get free access to specialist care.
    Whether suffering from a chronic disorder or serious disease, you end up with better insight into your condition and how to treat it.
  • Your involvement in one of our trials will not cost you anything as VX Pharma undertakes to cover all costs associated with trial visits, including refreshments and travel.
  • You can expect appropriate remuneration when overnight inpatient stays are required.

CURRENT TRIALS OPEN TO ENROLLMENT

View current trials here
SYSTEM  DISEASE   CANDIDATE CRITERIA                                                           CLICK BUTTON IF INTERESTED
ENDOCRINE  Diabetes Teenagers (10-17 yrs) with Type 2 Diabetes
  Diabetes Type 2 Diabetes  with Cardiovascular Risk.
CARDIOVASCULAR 

 

Hypercholesterolaemia  (raised cholesterol)

Adults intolerant to standard cholesterol treatment

 

  Hypercholesterolaemia  (raised cholesterol) Teenagers (10-17 yrs) with Hypercholesterolemia
RESPIRATORY Asthma Adult (18 yrs and above) with moderate to server Asthma
  Asthma Children (6-12 yrs) with Uncontrolled Asthma
  RSV (Respiratory Syncytial Virus)

(i) Healthy infants entering their 1st RSV season
(ii) Children with Chronic Lung Disease (CLD) or Congenital Heart Disease entering their 1st and 2nd RSV season
(iii) Children (3 – 6 yrs) with acute RSV
(iv) Healthy Adults (60 – 85 yrs)

 INFECTIOUS DISEASE  HIV (Human Immunodeficiency Virus)

HIV positive, treatment exposed both adults and children 

  HSV (Herpes Simplex Virus) Post-herpetic neuralgia 
  Influenza Healthy volunteers patients (12-64 yrs) with two unvaccinated household contacts

FAQ’s

What are clinical trials?
  • Clinical trials are studies designed to determine whether a treatment, medical strategy or device is safe for use by humans.
  • Clinical trials help us build on, and advance medical knowledge and provide reliable data to assist in health care decision-making and guidelines.
What are the different types of clinical trials?

All clinical trials have specific goals. Some of the most common reasons for conducting clinical trials are:

  • Treatment: Testing new treatments, new drug combinations, or new approaches to surgery or therapy.
  • Diagnostic: Researching new techniques and procedures for diagnosing diseases and conditions.
  • Screening: Improving the systems used for identifying certain diseases or health conditions.
Who can participate?

Depending on the nature of the research being conducted, possible inclusion criteria may be:

  • Specific illness or condition.
  • People with no health conditions i.e. healthy volunteers.

Exclusion criteria can include age, gender, a specific type or stage of a disease, previous treatment history and other medical conditions.

How long do trials last?

Some trials last days, while others continue for years, this is all dependant on the type of research being conducted. Before enrolling in a trial, participants will be told how long it is expected to last and will be supported throughout.

Possible benefits and risks

Medical research benefits all humans. For individuals taking part in clinical trials, the benefits and risks should be carefully considered.

Possible benefits:

  • Access to new treatments that could potentially be life changing and/or saving.
  • Participants who don’t receive a new treatment may receive the standard treatment for the particular condition, which may be as good or better than the new approach.
  • Health is closely monitored and supported by a team of qualified health providers.

Possible risks include:

  • Due to the nature of clinical trials, results may vary from person to person, and in some cases prove to be unsuccessful in treating diseases and conditions.
  • Unexpected or unforeseen side effects are always a risk that patients have to consider, especially in phase 1 and phase 2 trials.
How are participants protected?

The Good Clinical Practice (GCP) guidelines were initially set out in 1947 to protect the rights, safety, and welfare of participants:

GCP aims to:

  • Provide guidelines and standards for the conduct of clinical research.
  • Guarantee that data collected is reliable and is of an appropriate quality.
  • Make clear the rights of patients participating in clinical research by ensuring that patients understand the concept of voluntary participation and informed consent.
Clinical Trial Process
  • At the outset, you have to be identified as a suitable candidate for a specific trial by matching the ‘inclusion criteria:’ factors such as age, gender, the type and stage of a disease, previous treatment history and other medical conditions are usually considered.
  • A screening visit is booked, either by your GP or a member of our clinical staff, for a medical examination in order to record your health at the start of the investigation process.
  • Your next visit will be with a study coordinator to discuss the trial protocol and receive an informed consent document: an outline of the key facts about the trial that helps you to decide whether or not to participate. You have time to review the document and schedule a return visit for more questions, before giving your permission to be signed on to the trial.
  • Inpatient or outpatient status is decided by the type of trial: early phase studies (phase 1 and 2) may require that you stay overnight for periods ranging from 2 to 14 days, whereas late phase studies (phase 3 and 4) may require you to only come in for weekly or monthly appointments.
  • Please know that you can expect ethical and professional conduct from both our operations and clinical staff throughout the trial. You will not be rushed to sign on, and you are at liberty to withdraw from a trial at any time.
  • Once your application has been approved by our ethics committee, your GP will be informed that you are participating in the trial.
  • If you are participating in an outpatient trial, every visit will be booked in advance. You can expect each visit to last about 1 to 2 hours. Our staff will always try to accommodate your needs and availability, provided these fall within the parameters of the trial protocol.
  • If you are participating in an inpatient trial, you will need to stay overnight for a few nights. Once you have been discharged, some follow-up visits may be needed, depending on the requirements of the study.
  • Transport to and from our facility is covered by VX Pharma. Refreshments are usually provided, and if your treatment results in a missed meal, you will be compensated for this as well.
  • In the event of required overnight inpatient stay, an appropriate stipend will compensate for any inconvenience and possible loss of income.

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