Dermaceuticals Trial - Part I

To maximize safety and efficacy , dermatology clinical trials are conducted in four separate phases. Phase I trials are initial tests on a small group of human subjects to determine treatment safety, dose range, and potential side effects). Phase II trials are conducted on a larger group of people to determine treatment efficacy Phase III trials involve the randomized and controlled multicenter study of even larger populations to determine and confirm the effectiveness of the treatment or drug in question . Lastly, Phase IV studies typically occur after marketing of the product and assess the long-term adverse events and effects in varying populations.

Clinical trials can be conducted at academic medical centers and in private practice settings. Typically, the study sponsor is a pharmaceutical company that studies a drug, treatment, or device with the goal of marketing the product to the public

Every study team includes a clinician who serves as the principal investigator (PI) who is responsible for the study conduct and oversight of the research activities. First, the PI is approached by a pharmaceutical company to determine the PI's interest in conducting the research and generate an initial contract. Next, the PI signs a confidentiality agreement to assure nondisclosure of any proprietary information that is related to the research. The sponsor of the study will then assess, through a questionnaire and communication with the PI, whether the trial can be conducted at the PI's site. The questionnaire surveys the investigator's experience, information on the site and patient population, and provides the PI with the full study protocol to determine whether the physician can feasibly conduct the study with use of the facility, available resources, and support staff. After this information is collected, sponsor representatives conduct a preliminary onsite visit to confirm that the site is adequate to support a trial, including an onsite review of space for storage of study records and study drug and the study protocol with personnel who are involved in the trial. After selection of the trial site, multiple PIs and coordinators convene during an investigators' meeting to discuss details of the protocol and exchange information about the study .

The next critical step before initiation of the study is approval by an institutional review board (IRB)or independent ethics committee. The study site must submit documents with regard to the study protocol, patient informed consent, drug and/or treatment to be studied, and other relevant details to protect the subjects who will be recruited for the study. IRB approval can present a challenge to research sites that initiate studies because it can significantly delay the start of a trial. The reviewed literature in support of a centralized IRB approval process instead of the common local IRB approval process and found that there are proponents of both procedures. Proponents of the centralized IRB review value consistency among sites and those who prefer the local review process raise concerns about the loss of quality of the review and of the emphasis on the context of the local community

Informed consent documents are also critical to initiate a study and provide study subjects with the information they need to make a well-informed decision about participation in the trial. Once the IRB approval process is satisfactorily completed, the PI will submit multiple regulatory documents and a clinical trial agreement to indicate the sponsor's responsibility to fund the trial. The site initiation visit is the final step before subjects can be enrolled in the study. Study representatives at the site will receive all the necessary equipment and documents from the sponsor and meet with the clinical research associate who will monitor the study throughout the course of the trial. Once a site is fully approved and initiated, enrollment of subjects can begin.

For all trials, one main concern of investigators is subject recruitment, especially at sites that do not have an adequate patient population for the study in question. Some academic centers rely on a patient registry or database to find potential study subjects (Bain, 2005) whereas others use broadcast messaging techniques, flyers, letters, phone calls, and presentations to health care providers. Recruitment is crucial to the success of the study because without patients, there is no trial. If the overall target sample size is not achieved, the study can be “underpowered”, which may potentially jeopardize the validity of the results, so all efforts go for adequate recruitment.

In addition to a clinical trial site with facilities, qualified principal investigators, proper study protocols, and recruitment strategies, the last requirement is to fill the crucial role of study coordinator.  Study coordinators serve as clinical interpreters and patient advocates throughout the course of the trials, and are well versed in all aspects of the study protocol, initiate the recruitment of patients, and ensure the clinical care of all subjects. They also record important data from the study subjects in case report forms, assist investigators with skin assessment records, monitor and report serious adverse events, process tissue specimens for laboratory testing, conduct the informed consent process, and schedule all patient visits that last several hours .Study coordinators manage all dimensions of study trials as well as focus on all aspects of patient care. As noted above, without patients, there would be no trial, and likewise, without coordinators, there would be no study patients. They are an invaluable resource to the clinical trial team.