Successful Recruitment for More Specialized StudiesWed, 09/06/2017 - 10:23
Q: What advances has RM Pharma made in its operations over the past year?
A: Our main achievement over the last year was the establishment of an alliance with Bio Clinica, an American company, which enabled us to be part of a global network of research sites focused on making clinical trials a success and to diversify our activities in different therapeutic areas
This year, we will launch a protocol for dyslipidemia that could help prevent heart attacks, based on a new model to reach a large number of participating patients. We are also starting to work with children for a local allergic rhinitis study and with an international study on pediatric psoriasis.
Q: How has the new pharmacovigilance NOM impacted RM Pharma?
A: We are focused on pharmacovigilance follow-ups and we report side-effects and serious adverse events and submit real-time reports. We provide training to our doctoral staff on the norm’s updates so they can be aware of patient progress and report any changes to COFEPRIS.
However, we will need at least another year to completely integrate the norm, because we have to invest more in educating patients so they know there is a line they can call if they have an unusual reaction and we need to train first-contact doctors and laboratory staff to register all the important data when patients call.
Q: What strategy does RM Pharma employ to recruit volunteers and how difficult is it to find the ideal patient for studies?
A: Our database grows mainly through references from existing patients. To keep them engaged we provide free check-ups. A specialist evaluates them and creates a patient profile, so when we start a new protocol we check the profiles to see who has the best potential for the study and we call them. We also advertise in newspapers and we hold talks with first-contact doctors to provide them with information on new molecules and to see if they are interested in participating or in referring patients. For pediatric studies, most of the recruitment is achieved by referral from specialists so we distribute brochures among pediatric associations, explaining the type of conditions we are looking for. It is hard to find the ideal patient for every study, which is why we have to work every day to expand our database.
Today, inclusion criteria is increasingly complicated, so when we need samples of 10 patients with certain characteristics, we need to contact at least 300 patients from our database because there will be criteria most of them do not meet. However, we always keep those patients in the database and continue to perform followups because we know that at some point they may be the patients we need for a study.
Q: What added value does RM Pharma bring to the health industry over other companies?
A: Based on our client feedback, one of our values is the high quality of data we provide to the industry, rapid recruitment and our high rates of patient retention in studies, which is around 93 percent. Some of our studies have lasted four years and the patients are still participating. This is achieved through the quality of the medical service we provide and the experience of our doctors.
Q: What are your goals for 2017 and how will you reach them?
A: Our goal is to start providing more CRO services, such as monitoring of clinical studies, capturing electronic databases and protocol reporting. We will start reaching out to national labs that require more local studies, especially with the new pharmacovigilance norm. We have plans to open operations in Queretaro next year, a region that is growing rapidly due to the automotive and aerospace industries and we know there will be a need for more studies because national and international hospitals are settling there.