What Is A Clinical Trial?

A clinical trial is the process whereby medical treatments are studied for safety and effectiveness. Trials are absolutely essential in the approval process for new and ground breaking medications along with other interventions prior to widespread use. Clinical trials give researchers a wealth of vital information in the advance of medical science. In addition to new drugs and procedures, existing medications can be studied for use in treating different conditions, or to see how effective they are when combined with other therapies. Clinical trials are also used to study vaccines, dietary choices and supplements, medical devices, and treatment protocols. And the best part is that people like you are vital in the final results.

History Of Trials

Throughout recorded history, mankind has developed new treatments through medical trials. Some come from necessity, as in 1537 when surgeon Ambrose Pare ran out of the oil normally used for treating open wounds and improvised with a mixture of egg yolk, oil of rose, and turpentine. The new superior mixture changed the way wounds were treated for centuries. British physician James Lind, considered by many to be the inventor of the clinical trial, conducted the first survey with a true control group in 1747. Lind separated twelve sailors with scurvy into groups of two and controlled their diet while giving different treatments to each group—including cider, nutmeg, vinegar, or oranges and lemons. Lind discovered the link between citrus and scurvy treatment, documenting it in 1753’s A Treatise on the Scurvy. Placebos, or non-effective medical treatments that serve as a control, were introduced in 1863 by Austin Flint, a US physician who substituted an herbal extract for a known effective rheumatism treatment. In more recent times, various government organisations (such as the United State’s Food and Drug Administration) have refined the clinical trial process necessary for new drug approvals. Over the years, these agencies have defined acceptable trial protocols and helped shape modern effective methods. Today, virtually all new drugs, medications and procedures go through a very thorough process before reaching the market. Each year, thousands of people participate in clinical trials worldwide to ensure safety and efficacy.

Benefits of Clinical Trials

People have different reasons for participating in a clinical trial. Participation includes potential risks and benefits. By being involved in a trial, you’ll receive medical information, and may have access to approved or potential treatments. You’ll also be assisting researchers provide society with the best possible standard of care. Plus, volunteers may benefit from future advice and a better understanding of their own conditions, physical makeup and treatment options. Participants may be able to access the very latest potential medications or devices under development, and clinical trials often come at no monetary cost. Many studies may offer the following benefits:

  • No-cost study-related care from a local doctor and/or specialist for the duration of the study
  • Possible access to new and innovative treatment
  • Treatment right away; no long waiting lists
  • No-cost study-related medications
  • Ongoing medical care
  • No doctor referral required

Safety and Efficacy

Clinical trials are an important component in the development of new medications. In fact, most new drugs and treatments have gone through hundreds if not thousands of trials before they actually reach pharmacy shelves. The top two criteria are always the medication’s safety and efficacy. Safety is vital to clinical trials, since the ultimate goal is to help people live healthier and happier lives. There are set guidelines every clinical study will employ when selecting the participants, starting first and foremost with eligibility. To be considered for volunteering, one must meet certain criteria.

Inclusion:

  • Existence of condition symptoms or a diagnosis of the actual condition
  • Pre-set age requirements
  • Compatibility with elements of the study program such as travel, exams, medications and data records
  • Subjects may be required abstain from certain foods, medications or other activities during the period of the study to ensure accurate data
  • Willingness to comply with all protocol requirements and procedures given by medical team
  • Ability to give consent for the study and be able to provide intelligent feedback during the study
  • In some cases, demographic criteria such as sex and ethnicity may be part of the approval process
  • Subject often needs to reside within a certain geographic distance of the test site

Exclusion:

  • Any additional conditions that may adversely impact the effectiveness of the study drug or the participant’s ability to use the study drug
  • History of medical conditions that may negate study drug results
  • Acute illness within a set period of time before the study
  • Use of certain drugs before the study.
  • Current or anticipated participation with another clinical study
  • Positive diagnosis of serious disease or chronic conditions
  • Family or demographic limitations that could negate someone’s participation in the study.

Regulatory Overview

Some people may shy away from volunteering for clinical trials for fear of the unknown and because of potential risks. Trials are in place to test potential new drugs and treatment options with results that are as of yet uncertain, thus careful consideration of participation is warranted. Clinical trials are heavily regulated and safeguarded with the protection of participant safety and rights as top priorities. Before a clinical trial is even begun, a comprehensive and all-inclusive protocol must first be approved by an Ethics Committee under strict guidelines. A high level of transparency and clarity of purpose has been established wherein participants must have a clear understanding of the associated risks and benefits. Informed Consent is a strict requirement of the clinical trial process in which a volunteer participant is briefed on the specifics of the study. Eligible candidates are thoroughly versed in every aspect of their involvement until it is clear that they understand the information presented. A study will not begin until the IRB (Institutional Review Board) has reviewed and approved the informed consent form. The Ethics Committee is comprised of scientists, doctors and members of the community, and is in charge of scrutinising every aspect of an application for a trial. If a trial is approved, the Ethics Committee is also tasked with monitoring the safety and scientific integrity of the trial, as well as ensuring ethical standards.

 

 

Interested in participating in a clinical trial?

Want to be contacted to participate in a clinical trial? We welcome you to join millions of other people who have registered as a potential trial volunteer. It’s fast, at no cost, and you are never obligated to join a trial, even if you qualify.

 

 

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