The biotech and medical industries have come a long way. While many marvels have been created – such as vaccines, treatments and prosthetics – some of the research could pose dangers to the public, if it is not used correctly or if the initial findings from early experimentation are wrong. It is for these reasons that the FDA requires proper clinical testing (or clinical trials) to be performed, before they are eligible for public use. We would like to explore what exactly a clinical trial is, the data they collect and how a clinical trial moves on to the next phase:
What is a Clinical Trial?
A clinical trial is a medical study of volunteers, in the exploration of a new, experimental drug, treatment method, screening, or other proposed medical actions. Trials are carried out according to the planned protocol that dictates the “types of patients [who] may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured” (Source: FDA). For an example of some of this information, please see our clinical trials page for our Phase II trial treating Merkel cell carcinoma.
These trials are meant to find out if the proposed science is valid, safe for human use and beneficial for to the public. For each new drug, treatment or screening method you see, many did not make it out of clinical trials. FDA authorities meet with researchers and inspect the facilities, data and participants, in order to maintain safety and the integrity of the clinical trials. While the media often exaggerates the effectiveness of some clinical trials, the FDA takes a scientific and in-depth approach to their investigations.
Different trial phases seek to collect different data surrounding safety, methods for administering treatment, dosages, effectiveness, side effects, comparisons with existing methods, and more. For clinical trials pertaining to cancer treatment, the response rate is of utmost importance. Response rates explain the number of patients that responded to treatment, to what extent, and how long the results latest. For more information on response rates, please see our “Importance of Durable Response Rates for Cancer Treatment Trials” post.
While some results show parts of the trial that are working, others exemplify where there can be improvement or aspects that simply may not have worked. Steps are also put in place, in order to remove bias, by randomizing participants within trials; “masking” or “blinding” participants, so they do not know which treatment they are receiving (Source: NHLBI). This creates more accurate results, within some types of clinical trials.
Moving Trials to the Next Stage
With many factors impacting the outcome of clinical trials, separate phases are created, in order to effectively test as many avenues as possible. Traditionally, there are three different phases of clinical trials. However, some drug and treatment types may not require all phases and the amount of time each phase takes varies wildly, from case to case. There are also several different distinctions that can help a new drug, treatment or screening be approved by the FDA, depending on the nature of the illness being treated and the results of initial clinical trials.
Significant positive results are necessary, before a clinical trial can move from one phase to another. Without it, there is no chance for approval. With new drugs costing an average of $1.3 billion (and as much as $11 billion, for large corporations), you can see just how costly clinical trials can be (Source: Forbes). However, it is all to protect the common good and to insure on the best medical options become available to the public.
For the most recent (July 22nd, 2013) response data presented from our Phase II clinical trial for metastatic melanoma, please see our press release. A list of our ongoing clinical trials is also available, including our immunotherapy research regarding Merkel cell carcinoma, cutaneous T-cell lymphoma, and metastatic melanoma. If you would like to join OncoSec’s online community, please visit us on Facebook and Twitter.