Approaches to Boost Clinical Trial Success Igea Luca Dezzani

The role of clinical trials in drug research and development has been emphasized in the past years as the need for new drugs emerged following the discovery of diseases that require a more advanced and effective treatment. Such undertaking entails billions of dollars and years of thorough testing to bring a single product out in the market. In fact, R&D may take up to 10 years to reach the final phase and may cost around $1.2 – $1.8 billion. This total expenditure in R&D is expected to rise in the future, but does not correspond to increase chances of success.

According to Patient Recruiters International, 80% of clinical studies fail to meet the projected timeline. Thus, this situation significantly brings negative impact to the company and the pharmaceutical industry. Some of these depressing effects include cost increase, loss of revenue and loss of investor confidence as it brings down the company’s credibility. New approaches to speed up clinical trials have been noted to benefit both the company and its consumers in terms of reducing the costs of drug R&D and rushing trials of experimental drugs needed in times of outbreak such as in the case of Ebola virus.

To address this concern, several initiatives focus on patient recruitment, site engagement and activation, lab testing, and direct-to-patient care. The following will give us an overview of these approaches currently implemented by various pharmaceutical and biotech companies.

  1. Process Improvement to Promote Patient Convenience

To ensure patient convenience throughout the clinical trial process, protocols are designed to provide patients easier access for follow-ups. For example, instead of going to a single investigative site, mobile phlebotomists go to the patients’ homes to draw blood samples or they may opt to visit storefront laboratories. Aside from this, patients are also given an all-expense paid trip to the investigative site, while other necessary follow-ups are done through phone call, Skype and surveys.

 

  1. Improving site engagement

Improving site engagement can provide an opportunity to discuss the problems that typically arise in an investigative site. Hence, this may serve as an avenue to unite all people involved in R&D in making an action plan to address the concerns raised during the meeting.

 

  1. Use of predictive biomarkers

According to some studies conducted in the US, the use of biomarkers, such as in the case of HER2 in evaluating the effectiveness of a drug that is currently being developed for breast cancer, aids researchers to determine whether a particular drug has the potential to reach the final phase by providing clearer endpoints that are easier to interpret. Through this, companies can prevent ballooning of R&D costs.

 

  1. Use of information technology

With the sophistication of the hi-tech era, different modes of communication can be utilized during the entire clinical trial process. This includes pharmacy claims record which provides direct access to patient and is fully HIPAA-compliant, ailment databases, online patient communities and even social media. Aside from this, the clinical trial management system (CTMS) which is defined as trial automation technology used to  maintain and manage planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones, also showed some benefits in speeding up the clinical trial process.

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