Key Success Factors of Clinical Trial Management

Clinical trials are often defined as protocol-specific health studies of human beings. People choose to participate in these trials as a way to actively manage their own health care, acquire access to new treatments and contribute to medical research. In order to be successful, however, clinical trial management requires attention to even minute details.

Interpersonal Relationships

• The study of a new drug or medical device involves thousands of people. This includes pharmaceutical representatives, clinical technicians and trial study participants who interact with each other on multiple levels. When relationships are diligently developed, those involved can enjoy effective communication, viable patient safety and drugs that perform as intended. Without human interaction, however, the collective study may lack regard for human safety, miss crucial information and be short of thorough data recording.

Supply Chain Management

• According to Clarkston Consulting, clinical trials often face short drug expiration dates and sporadic patient enrollment that hinder long-term data. These factors also challenge production forecasting, which is necessary for moving clinical trials toward completion. Supply chain management is thus an important means of maintaining sufficient drug supplies while complying with regulatory constrains. Numerous tasks make up the whole of supply management -- including raw material acquisition, drug packaging and labeling and distribution to clinical site trials. To manage these activities, studies should incorporate demand and supply planning, allocate human and technical resources and define supply chain objectives. Such oversight can help studies quickly and efficiently deliver new products to the marketplace.

Patient Recruitment

• Pharmaceutical companies routinely need marketing techniques that promote approved drugs and convey the importance of clinical study trials. The latter is necessary to find participants to commit to a study through completion, thereby saving the company time and money. Sufficient recruitment efforts also ensure participant retention needs are met, data are qualitative and the goals of the clinical trial sponsor are met.

Clinical Site Performance

• According to Clinical Site Services, more than 85 percent of all clinical studies do not meet their projected enrollment timelines. This is perceived as a problem with study site performance rather than patient recruitment, namely because enrollment plans aren't properly executed. To combat the situation, tools such as doctor-to-patient letters and in-office banners can promote clinician awareness, increase the rate of study applicant screening and reduce enrollment timelines. Ultimately, such performance factors minimize costs and help the validity of study results.

Trial Monitoring

• Throughout the course of a study, procedures must be in place so the trial is frequently and objectively monitored. Trial monitoring ensures human study subjects are treated fairly, the study is safely conducted and reported data are accurate and verifiable. Without these elements, the value of a drug may be dismissed or the sponsor may lose credibility in the marketplace. A subject's well-being may also be compromised, particularly when an adverse event isn't reported. So it's important that all data be loaded fully and completely into the database, study subjects meet inclusion criteria and procedures get conducted in sequence.