A complete guide to Clinical Trials

Clinical trials play a vital role in the discovery, testing, and eventual marketing of new drugs. Over a million individuals participated in clinical trials during 2022/23, involving more than 6,000 studies. Understanding eligibility criteria for clinical trials can help you determine if you can contribute to advancements in the medical field.

A clinical trial is a medical study that tests a pharmaceutical drug, medical device, or other healthcare innovation on human participants. These trials aim to gather data on the safety and efficacy of new treatments compared to existing ones. Human volunteers are essential for these trials, providing valuable data that helps advance drug research and bring more effective treatments to market.

Eligibility for clinical trials varies depending on the study’s specific design. Common factors include age, gender, and the presence of a particular disease or condition. Your medical history is also crucial, as it helps determine whether it is safe for you to participate. Consulting with your doctor before enrolling in a trial is essential to assess your eligibility and potential risks.

Clinical trials require meticulous planning and a team of professionals. A company initiating a study must involve healthcare professionals to oversee the administration of treatments and ensure compliance with regulations. Researchers screen and recruit patients, collect data, and monitor progress throughout the trial. The planning phase includes creating a protocol outlining the study’s objectives, methods, and procedures.

Clinical trials are conducted in phases:

  • Phase 1: Evaluates the safety of a new drug or device in a small group, usually fewer than 100 participants, and determines safe dosage levels.
  • Phase 2: Involves 100 to 300 participants to assess the efficacy and side effects of the drug or device, lasting up to two years.
  • Phase 3: Compares the new intervention against current treatments with thousands of participants.
  • Phase 4: Conducted after the intervention is approved and on the market to gather additional long-term use data.

Before enrolling in a clinical trial, review all provided information, including leaflets and consent forms. Ensure you understand the trial’s purpose, potential risks, and benefits. Speak with trial staff and your healthcare provider to address any questions or concerns.

The clinical trial process begins with a screening interview. If eligible, you will need to provide informed consent, receive the treatment, and attend follow-up visits. Researchers collect data throughout the trial to create reports.

Understanding the trial’s purpose and the safety of the drugs or devices used is crucial. If the trial is in phase two or higher, inquire about any noted side effects. As a participant, you have the right to withdraw and should communicate any concerns or adverse reactions to the staff.

Clinical trials are essential for testing the safety and efficacy of new drugs. It is crucial to fully understand the process, how it works, and what to expect. For more information about enrolling in a clinical trial or questions about clinical trial safety, contact FluCamp.

hVIVO plc (formerly Open Orphan plc), led by Cathal Friel, is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human challenge clinical trials, providing end-to-end early clinical development services for its broad and long-standing client base of biopharma companies.

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