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Trials and Errors

Clinical trials are a veritable minefield of procedures that must be followed to the letter. Failure to comply can be extremely costly — sometimes necessitating a repeat study. The key to a successful study, according to Dr. Yoram Rubin, begins with sound planning.

Despite the vast numbers of clinical trials undertaken each year, there is no magic formula — no ready-made template you can easily replicate. "Every study is different. You can't imitate previous studies, you need to start from scratch," says Dr. Yoram Rubin, CEO of Medicguide, a clinical research organization. "Studies must be tailored to specific needs."

According to Rubin, clinical trials often fail because of poor planning. Choosing an insufficient number of patients, for example, can lead to questionable results and the need to expand the sample size. "If hundreds of patients are needed to complete a study, current resources may be insufficient and strategic partners might have to be sought," he says.

The Means to the End(Points)

It starts with asking the right questions. "You need to understand what the study is trying to achieve — what you are looking for. Your objectives must be clear and attainable." Great care must be taken in drawing up the protocol, which summarizes all the procedures to be undertaken during the study. Rubin emphasizes the importance of a precise study protocol. "If you've left a procedure (no matter how small) out of the protocol, it simply won't be done," he cautions. A crucial aspect is the "endpoints" — the points you are seeking to analyze at the end of the study. "This isn't always clear cut," notes Rubin. "If you don't define the endpoints correctly, the results will be inconclusive and you won't get the clinical outcome you are looking for."

The case report form (CRF) must be accurate and to the point, listing all the relevant information that you require from the patient. Failure to include vital information, such as parts of the patient's clinical history, can lead to the loss of crucial information and wasted time in attempts to retrieve the missing data. "Data management must be meticulous and handled by professionals," states Rubin, adding that bad management can lead to inaccurate statistical results. Rubin likens the clinical trial process to a chain that can be broken anywhere and can compromise the entire study. "There is no room for weak links!" he emphasizes.

Good Practices

Clinical trials must be conducted according to Good Clinical Practice (GCP) guidelines accepted by the United States, Europe, and Japan as part of the International Conference on Harmonization (ICH). The guidelines cover a multitude of issues including informed patient consent. "It is essential that patients are given all the necessary information and are not mislead in any way. Not conforming to the proper standards relating to patient consent can invalidate the study," he warns. "Standard Operating Procedures (SOPs) have to be properly followed."

"So many things can go wrong," says Rubin. "You need to keep your finger on the pulse and pick up on missteps soon." Patient compliance during clinical trials is frequently a problem and needs to be precisely monitored and reported. Patient dropouts need to be managed appropriately. Adverse effects need to be promptly reported and dealt with.

A Strong Team — a Definite Advantage

Rubin attaches great importance to building a strong team: "You need to find the right people to match your needs." A typical clinical trial team will have principal investigators, medical personnel, monitors, auditors, data management experts, regulatory experts, statisticians, and technical writers. Acquiring appropriate sponsors, selecting the right sites, and putting together a team can be a time-consuming and arduous task without specialized support. And where funds are limited, finding sponsors can be crucial. Since clinical trials don't come cheap, running into the hundreds of thousands of dollars, Rubin suggests that companies with limited budgets consider feasibility studies to help raise funds to finance full-fledged clinical trials.

Entrepreneurs planning to embark on clinical trials don't always see the full picture — what it entails both in terms of budgets and resources. "Do your homework," advises Rubin. "If you don't lay the groundwork, plan for every contingency, and pay close attention to protocol, the results will be flawed, and your investment wasted."