Insights on Clinical Trial

Goals

To understand the key differences between a diagnostic clinical trial and a clinical trial for pharmaceutical drugs, specifically from the standpoint of the U.S. Food and Drug Administration (FDA).

Early Findings

Clinical Trials

  • According to the FDA document titled ‘FDA and Clinical Drug Trials: A Short History’, the purpose of a controlled clinical trial is to separate the relative handful of discoveries which prove to be true advances in therapy from the numerous false leads and unverifiable clinical impressions.
  • It is also to note that the purpose of a controlled clinical trial is not the "discovery" of a new drug or therapy.
  • Clinical trials are designed to answer specific research questions related to a medical product following a specific study plan, called a protocol.
  • According to the FDA guidelines, clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies.
  • FDA requires these three phases of clinical trial to determine if the drug can be approved for use.
  • The Phase 1 trial is used to conduct an experimental treatment on a small group of often healthy people (20 to 80) to judge the safety and side effects of the drug and to find the correct dosage for the drug.
  • The Phase 2 trial is conducted on a larger bunch of 100 to 300 people. The purpose of this phase is to gather preliminary data on whether the drug works in people who have a certain disease or condition. It is to note that this phase can continue for several years.
  • Finally, a Phase 3 trial is conducted on a large group of people ranging from several hundred to about 3,000.
  • The purpose of this phase is to gather more information about the safety and effectiveness of the drug.
  • After Phase 3, if the FDA agrees that the trial results are positive, it will approve the experimental drug or device.

Diagnostic Trial

  • Clinical trials can be classified according to their objectives and also the way they are organized.
  • Diagnostic trials are considered as one of the sub-segments of clinical trials. The other segments are interventional trials/treatment trials, prevention trials, observational trials, and therapeutic and non-therapeutic trials.
  • Diagnostic trials are defined as trials that are conducted to find better tests or procedures for diagnosing a particular disease or condition.
  • These tests are conducted on people who have signs or symptoms of the disease or condition being studied.
  • To give an example of diagnostic trial, the Alliance for Clinical Trials in Oncology sponsored a diagnostic trial to study the effectiveness of lymph node mapping and sentinel lymph node lymphadenectomy in patients who were undergoing surgery to remove early-stage cancer of the mouth.
  • The rationale driving this trial was to find out diagnostic procedures to detect cancer cells in sentinel lymph nodes that could help plan effective cancer treatment.
In addition to this public search, we scanned our proprietary research database of over 1 million sources and were unable to find any specific research reports that address your goals.

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