Conducting a clinical trial requires the involvement of a sponsor, which can be a person, institution, company, or organization. The sponsor is responsible for initiating the trial and acts as a coordinating center, selecting qualified researchers at other sites that are suitable for the trial. Sponsors also ensure that research is carried out according to the protocol and manage the exemption of any new investigational drug or device. In industry-sponsored clinical trials, sponsors often work with contract research organizations (CROs) that act as representatives of the company.
When the University of Alabama at Birmingham (UAB) is chosen as a venue for a clinical trial, the sponsor will provide a clinical trial agreement (CTA). If the trial is conducted under a project master agreement (PMA) with the sponsor, then the agreement provided will be a simple work order. CROs are hired by sponsors to plan, coordinate, execute and manage the clinical trial lifecycle. They act as the primary contact between the sponsor and other interested parties throughout the trial and provide information and training to researchers to properly carry out their IIT.
Choosing a good CRO is essential for the success of your trial as they offer a wide variety of services related to carrying out the study from start to finish. Clarity about the acceptable scope of roles of sponsors and researchers in the context of a clinical trial would help mitigate some of the current confusion and uncertainty present in these areas. Active clinical monitoring can help predict potential challenges or identify problems early so that they can be addressed before they cause delays, increase costs, or derail the trial. The Office of Sponsored Programs at UAB has master clinical trial agreements with many pharmaceutical and medical device companies that conduct clinical trial research.
Once an investigator requests an IND, the clinical trial cannot begin for 30 days to ensure that the FDA has sufficient time to review it. The budget for a clinical trial will be per patient or per visit, with additional items such as start-up costs and fees for industry-funded trials billed separately. Sponsoring investigators assume responsibility as sponsors of the clinical study and also carry out or oversee it. Working with a CRO can offer innovative tools that can increase efficiency and reduce time and costs.
MED Institute is an example of a full-service CRO with more than 35 years of experience designing and executing clinical trials.