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June 8, 2021 Life Science Consulting

Medical Monitoring: Learning from the Past & Looking Ahead

James Meckstroth Associate Director, Clinical Services

Reflecting on the 1937 Elixir of Sulfanilamide incident we can clearly appreciate the importance of clinical trials and monitoring patient safety today. For those that may not know, Sulfanilamide was used widely and effectively to treat Streptococcal infections. S.E. Massengill Co. developed a liquid alternative, using diethylene glycol as the delivery vehicle, in hopes of making the drug easier to administer. Diethylene glycol also holds the household name, antifreeze. This resulted in over 100 deaths from kidney failure. At that time, regulations did not require tests for toxicity nor were any performed. However, if there were any safety monitoring or review conducted, these deaths would have been preventable. A few simple toxicology studies would have demonstrated the lethal properties of the elixir as well as review of literature already available at the time indicating that diethylene glycol caused kidney damage or failure. Regrettably and fortunately, we learn from history’s mistakes.

Learning from the Past

Today, new drugs, therapies, and devices are paced through thorough risk-based clinical trials which are designed to provide statistical evidence illustrating safety and efficacy. ProPharma Group is privileged with the ability to provide Safety Physician monitoring during these trials. Independent physicians utilized for Medical Monitoring and safety boards add objectivity and robustness to clinical studies and can provide signal detection for whether a trial is meeting its desired endpoints while maintaining subject/patient safety.

These monitoring activities can also prevent unnecessary development costs if early signs show ineffectiveness or increased patient risk, or the trial is recommended to be modified or end early. Effective monitoring translates into protection of trial participants and improvement in study design. Preventing a recurrence of past tragedies like in 1937.

Modern Challenges to Clinical Oversight

As the number and complexity of clinical trial studies grows, new challenges to clinical trial oversight emerge. Challenges such as increased diversity in clinical investigator experience, site infrastructure, treatment choices, and trial design. ProPharma Group’s diverse network of safety physicians and experienced project management team can help sponsors develop monitoring plans and contract research organizations (CROs) manage trials monitoring important risks to human subjects and data quality covering a wide range of therapeutic indications, and provide expert insight and consultation experience.

ProPharma Group has an established history of working with pharmaceutical, medical device, biotech sponsors, as well as contract research organizations globally. Our established project management tools and collaborative approach streamline the process of facilitating meetings, documents, schedules, and other project logistics. This saves CROs valuable time and effort and expands their ability to fulfill their client’s needs.

In addition to supporting the physician monitoring activities, our Clinical services team has direct access to a global spectrum of ProPharma Group’s Compliance, Regulatory Affairs, Pharmacovigilance, and Medical Information experts to support inquiries.

ProPharma Group has the capabilities and experience to coordinate and manage the DSMB and provide the independent medical reviewers through our extensive pool of physicians.

As with each of our clinical services projects, a dedicated Clinical Services Project Administrator is assigned to serve as point person and act as the conduit between the client and the project members. To expedite our services, ProPharma Group maintains established procedures and templates that may be used to facilitate the creation of many of the essential documents, such as confidentiality agreements, conflict of interest statements (or lack thereof), DSMB charters, Medical Monitoring plans, and safety management plans. This administrative support provided by ProPharma Group allows for the client to focus on executing successful study protocols and activities at the investigator sites.

To connect with our clinical services experts, contact our team today!

 

References:
Safety Monitoring in Clinical Trials
Establishment and Operation of Clinical Trial Data Monitoring Committees



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