Pharmaceutical Microbiology

The difficulty of clinical trials is a well-known fact. They are expensive and have many problems, including patient enrollment and retention, unforeseen protocol changes, and issues with trial design.

By Tamanna Bhardwaj

We look at pitfalls that sponsors and researchers encounter when creating clinical trials and some solutions to these problems.

Pitfall No. 1: Blurring Lines In Research And Sales

It makes sense for the field sales force to assist in identifying potential clinical research sites, given their understanding of the capabilities and patient populations of their current and potential customers.

However, it should generally refrain from identifying, vetting, and choosing clinical investigators. The most crucial element in a clinical trial's success is the careful selection of clinical investigators.

Therefore, the objective of the clinical research associate, or CRA, is to select researchers with the required trial-related experience, a sizable target patient population, and the dedication and drive to steadily and quickly enroll patients in the study.

Finding the right investigators is a delicate balancing act requiring specialized knowledge, years of experience, and a dash of intuition.

How to Deal: Don't let sales and marketing influence your investigator's choice. It won't do anything but damage the clinical trial.

Pitfall No. 2: Underestimating Technology's Benefit

Electronic data capture (EDC), one of the newest clinical research technologies, helps with regulatory compliance, decision-making, and accountability.

According to studies, generating a single data-entry query, sending it back to the researcher, validating the updated data against the original document, entering the updated data again into the database, and running the edit programs cost up to $100 when using the conventional paper-based approach.

The value of EDC's ability to gather and clean data via the Internet is quickly realized when you multiply this by an average of one to three queries on each of the 10 to 100 case-form pages needed for each of the dozens to hundreds of patients in a typical clinical trial.

EDC is evolving into a crucial tool when you consider its potential to cut weeks off the time needed to lock the clinical trial database and its capacity to analyze the results almost instantly.

Clinical investigators are increasingly accepting of EDC. A majority now favors trials without paper records. With the Internet being almost everywhere, implementation costs have decreased.

Nowadays, most vendors provide their software as a hosted service, removing the need for internal software installation and maintenance. To lower implementation costs, a contract research organization (CRO) has allied with an EDC vendor.

Many businesses now use EDC and related technologies in their operations. Companies are even attempting to develop EDC into a more comprehensive clinical research platform by integrating data collection with tools that quicken the recruitment of investigators and patients and regulatory reporting. Clinical trials conducted entirely without paper may soon become commonplace.

How to Deal: Make the clinical trial process quicker, less expensive, and more effective using the Internet.

Pitfall No.3: Disregarding Qualified Advisors

A well-designed clinical trial necessitates the fusion of regulatory expertise, statistical techniques, fundamental scientific principles, nursing input, and therapeutic knowledge. It is crucial to have a clinical protocol that accounts for all potential problems with patient screening, data needs, and statistical analysis.

In most cases, finding a single person with knowledge in every relevant field is impossible. A team is needed. On this team, be sure to include a representative number of CRAs, study coordinators, investigators, data managers, statisticians, device technical experts, regulatory experts, and, yes, even the marketing team.

How to Deal: To ensure that a range of experts supports the clinical trial, use a team approach.

Pitfall No.4: GCP Compliance Overview

Clinical trials for medical devices must adhere to the same high standards as those for pharmaceuticals, and following proper consent procedures that include thorough procedure descriptions and risk-benefit analyses are crucial.

To ensure they are followed, there also needs to be a quality assurance function and well-written SOPs. Data entry systems must adhere to the latest guidelines and have audit trails, validation records, and design documentation. The investigators' medical records must back up every detail noted in the case report form.

The patient data must be printed, signed, and monitored by a certified CRA because the investigators' patient management software probably needs to comply with FDA regulations.

How to Deal: Remember to maintain good clinical practice compliance, not only for legal requirements but also to lower the risk to the business from potential negative publicity or patient lawsuits.

Pitfall No. 5: Hiring Inappropriate Clinical Research Staff

The typical CRA started in the pharmaceutical industry as a clinical study coordinator.

In contrast, the typical CRA in the medical device industry was previously employed by the company's manufacturing or sales support divisions.

The CRA must be familiar with the therapeutic area to monitor a medical device trial effectively, just as they would with a normal trial. But the CRA also needs to be well-versed in the particular device that is the subject of the problem.

Personnel is frequently transferred from engineering and manufacturing to the clinical department as a new medical device moves from these stages to clinical development to capitalize on its expertise with the device.

However, device knowledge alone is not a sufficient replacement for understanding and practical experience with the clinical research process. It is desirable to have highly skilled CRAs monitoring clinical trials in the current climate of intense scrutiny of the device industry.

Other times, collaborating with a CRO might be preferable. For example, a clinical research staff member for a device company might write the study protocol, keep an eye on the sites, enter the data, write the final report, or even give product training and staff a trade show booth.

The personnel at a CRO are frequently more concentrated on particular tasks, like monitoring or medical writing. Such specialization enables the growth of more specialized expertise and often leads to increased effectiveness.

When the total cost of establishing and maintaining internal clinical research capability is considered, outsourcing the entire project might be less expensive.

How to Deal: Make sure that everyone on your clinical research team, internal or external, has the necessary experience. They are your first line of defence against errors in clinical trials.

Wrapping Up

I can attest that nothing is more thrilling than seeing a small start-up company transform an innovative concept into a compelling new medical device, put it through clinical trials, and then get FDA marketing approval.

This process will become more difficult as the regulatory environment becomes more demanding. However, with careful and knowledgeable management, clinical trials can ensure that the product development process remains fruitful and rewarding for everyone involved—investors, patients, and society.