Life Science Leader Magazine Supplements

CRO Supplement 2015

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LIFESCIENCELEADER.COM 20 THE CRO LEADERSHIP AWARDS 2015 By E. Miseta THE CHALLENGES OF PERFORMING GLOBAL TRIALS mitigate a lot of that risk. A thorough audit of the depot, as well as the central laboratory for exporting of samples, should always be conducted. That is just good clinical practice. No one wants to invest a million dollars into a trial only to discover you're dealing with a central lab that is not GCP compliant or puts your data at risk. The same is true of a depot. If the drug in question is a biologic that must be maintained in a required temperature range; not auditing that facility would once again put your trial, or worse your patient, at risk. As the sponsor running the study you have the obligation to make sure the vendor you use is following the right practices. In Panama, I think the patients seem to be a bit more apprehensive than they are in Colombia, but that may have more to do with the regulatory infrastructure than anything else. In Colombia they have numerous IRBs and a stronger reg- ulatory authority. I believe they do more trials there as well, which builds more patient trust in them. Patient recruitment and retention is a hot topic in pharma today. Was this a challenge you faced and how were you able to overcome it? The primary issue, as is the case with many trials, is overstatement of the patient recruitment potential by the investigators and sites. Questions which were very relevant to the enrollment issues were raised only after 50 percent to 75 percent of the enrollment had been achieved. The protocol discussions should focus on foreseeable recruit- ment obstacles and their impact on enrollment. When those obstacles and concerns are disregarded on the front end, they may carry a heavy cost on the back end. In addition to recruitment, logistics also became a concern. Patients are often recruited from areas which require travel-reimbursements and even hotel accommodations for spouses and other family members. These payments are reasonable and are generally expected. However, when there is a possibility that travel payments may come into the pic- ture, it is important to have up-front discussions about the areas from which we will be recruiting those patients. In some countries, a city or town just a few hundred kilometers away could end up being a 6- or 7-hour trip. In many cases, the patients must make that journey by bus. This travel is also highly contingent upon other factors. An advanced oncol- ogy patient may not be able to travel great distances. But you may also have patients whose indication is so rare that they are willing to travel great distances to get the help they need. Also a patient won't mind traveling several hours for an inpatient study that might take a week, but would be less willing to do so for a study that requires weekly visits over a period of several months. Were there any specific regulatory issues you had to deal with that made the conduct of trials particularly challenging in this country? We do not find the regulatory environ- ment to be an issue, but at the same time communication with the Colombian regulatory authority is constant. The interaction seemed to be very paper- work-intensive, although this was mainly due to the difference in language and necessary translations, not the Colombian government or its regulatory authority. I was constantly getting cop- ies of the paperwork that was going to regulatory authorities, as opposed to a quarterly or for-cause update. INVIMA (the Colombian National Institute for Food and Drug Surveillance) will provide confirmation of receipt, and there are translations and translation certificates. I do not believe the Panamanian Ministry of Health provides approvals for clinical trials, only the import permit. Panama relies on the EC for the approval. Editor's Note: While language is gen- erally not an issue, in 2013 INVIMA released a communication stating registration materials pertaining to biocompatibility, risk analysis, steriliza- tion, and clinical studies and test reports could be submitted to reviewers in their language of origin. Summaries of study descriptions, methods, and conclusions must be provided in Spanish. Any thoughts on what the future of clinical trials might look like in this country? Are there any changes on the horizon that might make the conduct of them easier or more difficult? I believe the future is evident in the grow- ing number of trials that have shifted away from regulatory-burdensome locations such as Brazil and Argentina, and into Colombia due to the increased stability of the government. Panama has seen an increase in clinical trial activ- ity as well. It is worth noting that many of the physicians have trained and/or practiced in United States or Canada. Panama appears to have some site management organizations that actu- ally operate out of Florida. This makes contractual issues a bit easier. FRANCE No Direct Patient Recruitment Linda Strause has a Ph.D. in neuro- physiology and biochemistry and has spent over 24 years in education and the pharmaceutical industry working for Quintiles, ACRP (Association of Clinical Research Professionals), Vical, Strategic Clinical Consultants, and her current employer, Strategic Clinical Consultants. Much of her experience is in improving the overall conduct of clinical research programs, with a specialty in oncology and global outsourcing selection and oversight. ROUNDTABLE leaders

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