Keys to Success with Clinical Trials
Since clinical trials provide access to novel therapies years before they become available on the open market, some physicians may be curious about participating in the clinical trial process. Indeed, becoming a clinical trial investigator can positively impact a private practice in several ways. First, investigational therapies can provide treatment alternatives for difficult or burdensome cases, such as patients with irritable bowel syndrome, refractory inflammatory bowel disease (IBD), and intractable constipation. Participation in clinical trials can also enhance the practice's standing as a cutting edge practice and can increase the practice's revenue stream without the hassle of insurance carriers. Finally, involvement in clinical trials can renew physicians' academic interchange with peers by encouraging participation in meetings, publications, and lecture series.
Preparing to Make the Commitment
Before becoming involved as a clinical trial investigator, physicians need to consider whether they are ready to make this commitment. Clinical trials require the investment of the doctor's time, the practice's personnel, and other resources, so physicians should evaluate their capacity to meet these needs.
Time
Explaining a clinical trial to patients is a task best performed by the principal investigator (PI), and physicians should consider each patient as a potential study candidate. If extra time cannot be allocated for this discussion, then physicians should not consider enrolling as a clinical trial investigator. Since the patient's trust is with the doctor, the physician must be an active player when enrolling patients; support staff cannot be expected to do all the introductory work. All the physicians in a practice should agree to this undertaking.
Once a trial has started, the physician will need to meet with clinical research organization (CRO) monitors, review protocols, sign off on laboratory work, and be available to staff and patients to answer questions or address misunderstandings of protocol requirements. Also, the PI should plan to travel as needed. The PI will be asked to attend investigational meetings and follow-up sessions, and these requirements will detract from the physician's office schedule.
Personnel
In addition to the doctor's time commitment, involvement in a clinical trial also places burdens on office personnel. One way to meet this demand is to hire a dedicated research coordinator. Physicians should not assume that the practice's current staff will willingly accept added responsibilities; indeed, staff often resent the extra work clinical trials entail, and this resentment may lessen recruitment and sustained enrollment. Failure to sustain enrollment is a major concern, since unsuccessful recruitment will damage the practice's reputation for future trials.
Having a dedicated clinical trial coordinator means that the practice will have the personnel needed to review potential protocols and analyze the practice's database to ensure that the appropriate patient population is being considered for the study. Since quick turnaround is expected in the research industry, clinical trial sponsors may be displeased if a practice takes too long to complete the required regulatory paperwork; the clinical trial coordinator can focus on addressing this need for prompt turnarounds. If a practice can negotiate a contract with indemnification language and governing laws, negotiate a budget, and complete the US Food and Drug Administration (FDA) forms and sponsor-specific forms within 5–7 business days, the practice's involvement in future projects will be much more attractive.
When working with clinical trial sponsors, physicians should keep in mind the perspective of the pharmaceutical company, in which the clock starts as soon as the bench work for discovering a new compound is complete. There are a limited number of years during which the company can capitalize on a new drug before the patent expires and generic competitors enter the market, so pharmaceutical companies have time-sensitive goals for site initiation, enrollment of the first patient, completion of enrollment, attainment of primary and secondary endpoints, and data analysis.
Oversight
Finally, practices that participate in clinical trials should be prepared for constant CRO monitor visits, queries, and reviews of accumulated data. By participating in a clinical trial, the practice is opening itself to added scrutiny, as a number of procedures and guidelines must be reviewed; these include good clinical practice (GCP) guidelines, informed consent policies, adverse event reporting guidelines, and instructions for avoiding coercion in certain populations. An experienced clinical research coordinator can ensure that the practice adheres to standards that meet the GCP definition accepted by the FDA and device and pharmaceutical companies.
Because fulfilling all these tasks in-house will involve a great deal of work, physicians may want to consider partnering with a site management organization or a clinical trial management organization. These organizations can assume many burdensome administrative tasks, although they usually do so in exchange for a hefty share of the budget. These organizations are quite knowledgeable and may negotiate better contracts and budgets, as well as lessen the investment needed in terms of site space and staff involvement, and guide the novice physician or practice through the clinical trial.
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Principal Investigator: Education and Responsibilities
As the PI, the physician is responsible for numerous aspects of a clinical trial. The PI's first responsibilities are to ensure that the protocol's inclusion and exclusion criteria are met and to consider whether the benefits of participation in the trial outweigh the potential medical risks. In addition, the PI must monitor participants' compliance with study requirements; this can be done via Interactive Voice Response Systems, medical records, drug accountability, and/or follow-up visits. Failure to monitor patients adequately can sabotage the entire study and damage the site's reputation. The choice of appropriate patients for study enrollment is critical to this process.The PI and his or her team must also ensure adherence to the protocol, fulfillment of regulatory responsibilities, and maintenance of data quality. Finally, the PI must update trial enrollees of any new risks or benefits that evolve as the trial progresses.
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