Marlene Llópiz
CEO
Clínica Responsable Operativa, S.C. (CRO Mexicana)
/
Expert Contributor

Clinical Trial Disruption: Getting Back on Track, Part 1

By Marlene Llópiz | Thu, 11/11/2021 - 12:49

The coronavirus pandemic is having a major impact on initiating, conducting and completing clinical trials. There has been lesser enrollment of patients into ongoing or new studies (not related to the pandemic), while continued treatment and follow-up of patients already in trials have been curtailed or adapted to minimize risk. This may have a significant impact on the timeliness of clinical trial data gathering, as well as potentially introducing risk to the resulting evidence base (for example, lack of statistical power, important missing data or altered outcome measures).

Latin America is no different than the rest of the world when it comes to clinical trials. Over 80 percent of the Latin America market share of pharmaceutical sales and growth is distributed among Mexico, Argentina, and Brazil, in addition to new opportunities in other Latin America countries, such as Chile, Peru, Costa Rica, the Dominican Republic, Ecuador, Guatemala, and Panama.

However, it is important to take into consideration what Latin America has to offer with respect to types of prevalent diseases, a diversity of sites for trials, timelines, availability of resources – researchers, hospitals and patients – or pharmaceutical companies and Contract Research Organizations (CROs) to conduct trials. Latin America is a vast region that includes Mexico, Central America, the Caribbean and South America. The average annual growth rate of trials in Latin America was 20 percent in other topics not related to the pandemic. Nowadays, most clinical trials are directly related to treating COVID-19, finding a cure or winning the race to getting a vaccine on the market.

Latin America provides an attractive environment for conducting clinical trials because it holds an excellent geographical location, a diverse population of over 560 million inhabitants, with massive patient populations with all possible therapeutic indications, a ready and professional supply of research facilities, and contract research organizations offering professional services for partnering solutions in clinical studies.

As a vastly varied and populated region, Latin America provides large drug-naïve patient populations with common and special disease profiles, rapid compliant patient recruitment, motivated and experienced researchers, US and EU equivalent medical standards, and well-prepared and experienced monitoring and project management teams thoroughly trained in the International Conference on Harmonization (ICH) Good Clinical Practices (GCP) guidelines. Placing trials in Latin America provides pharmaceutical companies and CROs an array of countries and races for testing drugs, as well as a reduction in costs with strategic multicenter studies.

The year 2020 took us all by surprise in practically every field, whether in the economic, social or political spheres and, shockingly enough, in the health sector.

Clinical trials are no exception and have been impacted in every aspect. 

The COVID-19 pandemic has had global repercussions but the effect and handling of the situation has been different worldwide. The pandemic has forced all sectors to find other mechanisms and to follow new strategies, in most cases disruptive from “normality,” that require adaptation to the surrounding circumstances.

Contract Research Organizations

The CROs in Mexico, as well as in other countries, slowed down at the start of the pandemic. This hindered any trial from continuing or new studies considered appropriate for Mexico from starting. At the beginning of the outbreak, minimal work was done by the CROs. Ongoing trials were halted and new studies were put on the back burner for the time being. No new sites could be visited to see if they were adequate for trials, hospitals were switched from regular, fully staffed centers to COVID facilities, researchers were not physically visited and if at the hospitals, they were treating COVID patients. Even monitors and staff were kept from having any contact with other important trial participants – most all employees were conducting business from their homes.

Regulatory Agency

A fundamental factor in implementing and developing any clinical study has to do with the local and global regulation. The pandemic caused a paralysis in the system. The regulatory body in Mexico – the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) – halted most services and in some instances stopped working altogether. It placed its attention on everything related to the pandemic, whether treatment schemes or vaccine development. This has considerably slowed down new registrations, paperwork and submissions, as well as the monitoring of those sites that were already working. Processes were severely backed up. Now, it seems to be getting slowly back on track with new digital developments being put in place.

In addition to the above, a restructuring of COFEPRIS is underway by the federal government, which has generated a great deal of uncertainty as to the way in which this institution will be managed in the future while questioning its autonomy.

Both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have offered and provided guidance and advice to sponsors regarding ongoing trials and the initiation of new ones. However, how the new government will handle the overall structure of the health sector is still unknown for many.

Healthcare System

The healthcare system in Mexico encompasses both the public and private hospital sectors. According to the design of most clinical studies, these are carried out mainly in public hospitals, due to the availability of large numbers of patients at these institutions, the feasibility of recruiting them due to their meeting inclusion and exclusion criteria, and the attractiveness of a study where patients are provided all the benefits of participating in a clinical study (access to laboratory tests, treatments, and close medical follow-up).

In Part 2 of this article, we will continue examining each of the factors and parts of a clinical study, including speaking on patients participating in studies that are now limited to being enrolled since the vast majority of the hospitals where the protocols were being carried out were “converted" to sites where patients with COVID -19 are being treated.

Photo by:   Marlene Llópiz