How Best To Mitigate Risks In Clinical Trials

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Clinical trials are a lengthy and complex process that must pass successfully through multiple stages of completion before being approved for non-study application. Over the course of this process, which sometimes lasts decades, clinical trials are vulnerable to many different risks.

Clinical trial services and supply companies, like Client Pharma, help mitigate these risks through careful coordination and expert understanding of risk management.

What are the typical risks that occur during clinical trials and how can they be mitigated?

Some of the most common risks faced by clinical trials today are:

Staff shortages

One of the growing problems in the clinical research and clinical trial services industry is the lack of qualified clinical research staff. According to experts, as the volume of clinical trials increases, the staffing shortages are only expected to get worse. Reversing this trend will require concerted, industry-wide action on a large scale.

Strategy for mitigation: If there is a high risk of facing staff shortages, then more extensive screening will be required at the site selection stage. Outsourcing the clinical trial to a well-staffed site abroad might also be a viable option. Clinical trial services companies can assist in identifying appropriate sites for outsourcing.

Lack of compliance with patient diary requirement

Patients undergoing clinical trials are often asked to maintain a simple diary to aid the trial process. These diaries help patients track their daily habits, any symptoms they may be exhibiting as a result of their treatment, or as a way for researchers to collect systematic trial data. However, if patients fail to follow the correct protocol while making their diary entries this could impact the validity and quality of the data collected.

Strategy for mitigation: The use of electronic diaries which can prompt patients with reminders to enter their data regularly, is a good way to ensure compliance. Staff can also be trained at the start-up stage to anticipate the problem and help patients with their data entry.

Delays obtaining approvals for the study

Study treatments and protocols require approval from regulatory authorities and ethics committees before they can be undertaken. Delays in obtaining these approvals could adversely impact the study’s timeline and budget. Clinical trials being carried out in multiple international sites are especially vulnerable to approval delays from local government and regulatory bodies.

Strategy for mitigation: Arrange a sponsor meeting with officials from the concerned regulatory bodies at the early stages of trial prep, to discuss the protocols involved and receive insight into the regulations. Ideally, preparing multiple contingency sites would be the best way to prepare for the risk of regulatory delay.

Low patient recruitment

Another common problem faced during a clinical trial is a shortfall in patient recruitment. Research suggests that nearly 80% of clinical trials don’t meet enrolment timelines due to low patient recruitment numbers. This could translate to as much as $8 million lost for every day that the trial is delayed.

Strategy for mitigation: Expand the eligibility criteria, in a manner that will not impact the outcome of the study, to include a larger patient intake.

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