Portal of clinical trials of the Americas

Discussion questions:

1. How can this problem be solved? Whose job is it to ensure coordination among trials? 
2. Is it necessary to set research priorities at the regional level to advance regional clinical trials? 
3. What specifically is preventing the launch of large-scale regional trials? How can these hurdles (regulatory, logistical, organizational, etc.) be overcome?  
4. Is the establishment of a regional clinical trial network necessary? What would this network look like? Who should be part of it? 

There are limited local research capacities. Researchers from the region who obtain high-level training often establish themselves abroad.

Discussion questions:  

1. How can we enhance the capacities to conduct robust, high-impact clinical trials? What skills and areas of specialization are needed for each relevant role associated to the conduct of clinical trials? What has been successful in terms of bolstering individual skills, leadership, infrastructure, and available resources?
2. How can we augment capacities to secure funding, handle logistics, and ensure long-term viability?
3. How can we address the challenges of recruiting and retaining talent in the region?
4. Which incentives should be adopted to increase the number of local researchers? Which strategies have proven effective to attract local researchers who were trained abroad?
5. In order to enhance capacity to conduct clinical trials in all phases, is it necessary to develop capacity to conduct a prior type of research (e.g., basic research, animal research)? What strategies to transfer knowledge to local researchers are feasible and effective?
6. How can we ensure that clinical trial capacities are responsive to emergencies?
    

The establishment of networks and collaboration could facilitate the conduct of larger, high-impact clinical trials, as well as increasing local research capacity.

Discussion questions:

1. Are clinical trial networks needed to foster collaboration? If so, what would they look like? Who should be part of them? Should they be specific to a disease or type of treatment?
2. Which strategies are necessary to ensure sustainable regional networks?
3. What other strategies should be adopted to strengthen collaborative clinical trials? Who should lead them?
4. Which mechanisms should be devised to increase opportunities for collaboration among different stakeholders?
5. What role should funders play in encouraging collaboration? What role should PAHO play?
6. How can we address barriers to cooperation and collaboration among countries of the region?

In some cases, national regulatory authorities (NRAs) do not exist or have a limited scope of work. In others, their requirements and procedures for the authorization and control of clinical trials do not adhere to international standards and become practical obstacles. These hurdles are even more complex when a trial must comply with regulations of different NRAs at different maturity levels, and there are no adequate channels of communication and coordination between the NRA and the investigators, RECs, or other authorities involved in conducting clinical trials.

Several research ethics committees (RECs) must review the same trial. Numerous reviews by different RECs within the same jurisdiction (i.e., country, state) are often necessary, which delays the processes to launch trials without necessarily strengthening them from an ethics perspective. Additional reviews are further needed from different jurisdictions where trials are being conducted.

Discussion questions:

1. What is the best strategy to ensure rigorous yet efficient ethics review of clinical trials in the region, i.e., within specific jurisdictions and across Latin American and Caribbean countries?
2. A “single IRB” policy has been implemented recently in the US. Can a similar policy be developed for the needs of Latin American and Caribbean countries, and implemented successfully, considering the lessons learned in the US and prior experience centralizing ethics review processes in Latin America?
3. Are there other strategies that should be explored to avoid repetitive ethics review processes, e.g., adopting novel mechanisms for review that have been used in Argentina during COVID or establishing an extra-territorial ethics review committee, at least in certain jurisdictions like the Caribbean?