We are not surprised that clinical research is a regulated industry. Sponsors undertake to report the results of the study for ethical reasons. Geolocation researchers, on the other hand, are delighted with the idea of publishing research data. Institutions and industries can use the Accelerated Clinical Trial Agreement for multi-site studies initiated by sponsors. This streamlined process will allow sites to participate earlier in clinical trials without undue delay in contract negotiations. However, the Clinical and Translational Science Award (CTSA) working group recently developed a possible solution: the Clinical Trials Agreement (ACAC). ACTA provides a standardized model for contracts between site researchers and study sponsors, a model that has the potential to accelerate contracting and improve the efficiency of the start-up process for clinical trials. On the other hand, sponsors and CROs are required to inform the IRB/EC directly of any infringements that may affect the safety and well-being of the subjects. In the United States, the Sunshine Act strengthens control over payments to health organizations and health care professionals. The project description contains the necessary information on the nature of the agreement.
Kunal Sampat, senior manager, Clinical Research, Abbott, explains the essential elements of a clinical study site may realize that there is more work involved in a study than they had anticipated. Or sponsors decide to revise the protocol, which affects the CTA`s milestone payment schedule. When a signed ATC is agreed, sponsors are entitled to receive data collected prior to the termination of the contract and sites receive compensation for testing activities carried out by research staff. Websites want to be paid for their search results. In the case of a multi-year clinical trial, sponsors and CROs intend to manage their budget and cost estimates for current and future years. One of the persistent problems of the clinical research enterprise is the difficulty of negotiating the contractual terms in which clinical trials are conducted at individual clinical research sites. For many research centres, the process is complex and time-consuming and can often lead to significant delays in launching studies. Use this article as a guide if you are reviewing or issuing your next clinical trial agreement. However, you should always seek advice from a qualified lawyer on all conditions within the CTA. In this contribution, I share nine key components of a Clinical Trials Agreement (ATC).
You will know what the purpose of these components is and how they can protect you in the event of conflict or disagreement. Contract negotiations are a complex process and are often identified as a major obstacle to effective study opening. Data from a 2010 CTSA Contracts Processing study described an average trading time of 103 days, which was reduced to 73 days when a “mastery contract” was used. To overcome this obstacle, the CTSA Master Contracts Working Group, Comprised of legal experts from 25 CTSA institutions, collaborated with industry and the university industry demonstration partnership to develop a standardized clinical trial agreement – a unique agreement that will be used (voluntarily) by each participating institution and each sponsor to reduce contract negotiations for industry-sponsored multi-site trials, particularly for Phase 2b and 3 clinical trials.