When it comes to safety, PRA puts its patients and its people first. Clinical trials are meticulous, with many moving pieces and crucial steps. It’s important that each piece of a trial contributes in a meaningful and safe way.
In light of World Patient Safety Day, we spoke with our experts to hear their thoughts on pharmacovigilance, patient safety, and what we can all do to ensure that drug developments remain safe and effective.
As pharmacovigilance and patient safety experts, we ensure patients can benefit from treatment with medicinal products (including devices) while minimizing the risks associated with them.
It starts as early as exposure to medicinal products during clinical trials. It continues post-marketing once a product is approved and until it is withdrawn from the market. Pharmacovigilance and patient safety require resources, processes, and technology to collect and evaluate adverse events. We identify, manage, and minimize safety risks as well as communicate safety information to regulatory authorities, health care professionals, and patients.
Patient safety is at the heart of our day-to-day activities. We have a team of safety experts who can detect safety signals early on, which manages and minimizes risk to patients. We’ve invested in technology to meet the needs of our customers and ultimately to protect patients. Increasing awareness by attending and speaking at conferences, as well as issuing publications, remains one of our goals.
Communication and educational materials targeting both healthcare professionals and patients can help in selecting the right treatment at the right dose. This ensures appropriate monitoring, reducing the number or severity of adverse events, and ultimately minimizing the risks to patients.
Implementation of personalized therapy or personalized medicine could help get these numbers down. Still, the pharmaceutical industry often follows the approach of “one size fits all,” which does not consider individual responses to medication and can cause side effects.
It’s key to have a cross-functional team approach to mitigating and solving complex patient safety issues. Engaging subject matter experts from multiple disciplines enables better decisions that impact patient safety. This requires collaboration from various stakeholders, including pharmacovigilance and patient safety, epidemiology, regulatory, medical, and clinical. Additionally, experts in individual countries need to be consulted for local pharmacovigilance standards, practices, procedures, and regulations. Understanding local nuances allows for customized solutions to ensure the safety of patients.
The CROs, healthcare providers, and pharmaceutical industries, as well as global regulatory authorities, rely on reports from patients and their health care professionals. These reports gather details of emerging safety issues and adverse event trends. Allowing patients to be more involved in safety initiatives can be as simple as reporting an adverse reaction to a medical treatment or as complex as serving as an advisory committee member.
It’s key to have a cross-functional team approach to mitigating and solving complex patient safety issues. Engaging subject matter experts from multiple disciplines enables better decisions that impact patient safety.
Catherine Godefroy, Executive Director, Patient Safety, Pharmacovigilance & Patient Safety
It means identifying the balance of safety and adverse events from drug exposure vs. the benefit of efficacy and treatment. Our bioanalytical teams work every day to assess Pharmacokinetic (PK) end points (what the body is doing to the drug), Pharmacodynamic (including biomarkers) end points, and both the safety and efficacy of the drug (what the drug is doing to the body).
Additionally, we often support drug-drug interaction studies (the understanding of what drugs are), perpetrators, and which drugs are victims of interaction with concomitantly administered therapies. When we do this right—by developing robust, validated-methodologies capable of elucidating this information in each sample—we’re able to create critical data that can be used to make adjustments or assessments that directly affect patient safety.
The biolab can start this as early as pre-clinical development in toxicologically/pharmacologically relevant species, and helping considering safety in dosing human patients. The process continues for us through the stages of drug development, and we do this by providing high-quality, science-driven results back to our sponsors and clinical teams. Finally, we also partner with key clients to oversee continued monitoring on their marketed products through other outsourced vendors.
At the bioanalytical laboratories, we rarely get to see the patients firsthand, but we know the impact of the work we do. Every day, we get to see a piece of the patients in valuable samples that are collected and entrusted to us for analysis. At the labs, we have a statement that defines WHY we do what we do each day, and goes directly to the impact of patient safety.
If we do that right, and with quality and urgency, the data we provide will be delivered in a timely way, with critical information to either support the promising treatment with the drug or to quickly make decisions to go in another direction.
Quality, precision, and new technologies—these three things allow us to see what we couldn’t see before. We also need a holistic understanding of the chemistries, biology, and pathways, as well as administration routes that can impact these outcomes.
We must have a continued ability to access established data and its application, and relevance to current treatments, as well as the continued advancement of open-innovation models that allow industry experts from across academia, pharma, biotechs, and CROs to share and gain knowledge together.
Help increase the awareness of the importance of clinical trials with continued education, involvement of patients, Private Investigators (PIs), and patient advocacy groups. We need to make more aware of the monitoring and outcomes procedures, and encouraging patient involvement in the key factors that can influence study outcomes and patient safety.
Ultimately, we want to encourage better and easier access for patients to be involved in trials and be a part of finding the next treatment. That includes educating on risks and benefits, ease of access, as well as how we monitor and share information for drug safety.
Behind every sample waiting to be analyzed, there is a patient waiting to be treated.
Jason N. Neat, Executive Director – US Lab
Pharmacovigilance and patient safety includes the people, processes, and tools that monitor and improve drug safety through clinical trials and after a drug has been marketed.
Within my own area of technology, there has been an explosion of advancements in the field of robotics and automation. By using this technology, PRA safety personnel can spend more time on value-added tasks and less time on non-value-added activities, such as document filing, translation, etc.
From a technology standpoint, we have the data to predict future trial outcomes and, likely, safety issues. However, we lack sophisticated tools to analyze this data in order to find all of the safety insights.
There has been a huge emphasis on technology (virtual trials, automation, etc.) and cost efficiency in the past several years. Our industry should not lose sight of the “prime fundamental concept” of patient safety: a patient/consumer is the most important commodity in the drug development process.
I think that CROs and pharmaceutical companies can do a much better job of safety awareness campaigns. The public needs to develop trust in CROs and sponsors, and to trust that the safety information provided is genuine rather than a marketing campaign in disguise.
A patient/consumer is the most important commodity in the drug development process.
Brian Guza, Vice President, Pharmacovigilance and Patient Safety Technology
Literature Surveillance: Important Information About Patient Safety
Pharmaceutical companies must screen and analyze published literature from the clinical development stage through post-marketing as part of their…
PV Nugget #6 Literature Surveillance
Literature is regarded as a significant source of information in the monitoring of a medicinal product, its safety profile, and benefit-risk balance.…
PV Nugget #7 Pharmacogenomics
Pharmacogenomics (PGx) focuses on how genes and biomarkers can affect how an individual respond to drugs. The goal of PGx is to develop effective,…