6 big challenges facing clinical trial operations

According to the National Institute of Health database, 50,000 clinical trials were registered with ClinicalTrials.gov in 2007. A decade later, the number had increased to more than 250,000 and has since increased by 10-12% every year.

Research and development (R&D) spending has grown exponentially. A growth rate of 1.76% has been recorded every year over the past decade.

Despite significant investment, productivity for the biopharmaceutical industry has remained stagnant. This disconnect points to the challenges affecting the clinical trial market, as well as the processes through which trials are organized and conducted. Let’s examine six major issues:

1. Patient Recruitment Access

The problem of recruiting and retaining respondents is not new to the industry. Initial clinical trials have thousands of subjects participating, with only a few completing. Studies show up to 85% of trials delay, and 48% of them miss their enrollment targets. Noncompliance is another grave issue researchers seek to address.

Various techniques have been developed to help achieve recruitment goals while reducing the dropout rate. One such method is the implementation of microsampling, a less invasive, more user-friendly method of blood collection.

Microsampling can ease recruitment as it incentivizes wider pools of people to participate.

2. Adherence and Compliance

Findings can be fuzzed, and clinical trials can sometimes spin out altogether, when participants fail to comply with requirements, especially when subject retention becomes an issue. That's why clinical trial organizers and contact research organizations are always on the lookout for ways to make the participant experience easier, more pleasant, and more user-friendly.

Microsampling makes the experience more convenient for participants and improves compliance with trial regimens.

3. Disconnect between Clinical Practice and Clinical Research

Community physicians are hardly involved in clinical research studies, yet they interact with the patients every day. This reduces physician referral to clinical studies and the adoption of research findings in daily practice.

Also, the divergence between physicians conducting clinical trials and those in community practice affects the translation of study results.

4. Externalization

CROs (contract research organizations) now conduct most clinical trials. Research shows CROs will run 75% of clinical trials by 2020. The trend has created an opportunity for FSP outsourcing models, which transactional and not based on the outcomes of clinical trials. It has also spawned the adoption of best business practices to create a win-win relationship for the CRO and the sponsors.

5. Lack of Prioritization: Imperative Research Questions

Stakeholders (government, patient advocacy organizations, the industry, and voluntary health organizations) develop research questions that suit their interests. A cost-benefit analysis guides clinical trial decisions, which is often a narrow perspective of pertinent clinical trials.

6. Funding

Clinical trials have become increasingly complex over the last year, creating opportunities for process improvement in clinical trial operations. There is a need to allocate more resources to implement each trial and monitor results as a result. Some companies have made partnerships with third parties, while others have opted to raise capital to fund the trials. Third-party agreements are the most common because both parties have mutual interests.

Before entering an agreement, firms define contractual terms for their responsibilities. Review meetings are also conducted to identify and resolve any risks impeding the timely and successful conclusion of a study.

Dried blood microsampling using capillary blood samples presents a unique set of opportunities for process improvement in clinical trials.