Is your pharmaceutical organization creating new therapies for the treatment of pulmonary arterial hypertension (PAH)? Our latest blog explores how an uncommon CRO may increase the success rate of your PAH clinical trials.
PAH: A Rare Condition with Profound Health Implications
Pulmonary arterial hypertension is a rare condition that causes abnormally high blood pressure in the lungs. The arteries within the lungs experience blockage and then elevate the patient’s blood pressure. And, pinpointing the exact reason can be challenging.
A Typical PAH Patient Profile
Here are some characteristics that make up a traditional pulmonary arterial hypertension patient profile. Paying close attention to these helps create a strong foundation for PAH drug research and development.
- Low Energy: PAH patients are easily exhausted. The trial should be managed in a way that the patient’s visit duration and activities are kept to a minimum to avoid overexertion.
- Mature Patients: A significant portion of the PAH trial subjects will fall between the ages of 45 and 65. Simplifying trial procedures and regularly verifying patient understanding and compliance will boost participation.
- Dependence on Caregivers: It’s common for PAH patients to rely on additional help. Involve caregivers and encourage them to ask questions about their role during the trial.
- Regional nuances in the treatment of PAH: If conducting a global clinical trial, know the regional nuances that affect PAH patient care and trial eligibility.
CROs: A Key Ingredient in Improving Clinical Trial Success Rates
In the past, it was quite common for pharmaceutical organizations to conduct their own clinical trials for drug research and development. This approach not only placed a strain on their financial resources but also added an additional layer of challenges, as companies had to work their way around confusing and often conflicting regulatory policies across various regional markets.
However, in recent years, that approach has undergone a significant change. Pharmaceutical organizations are recognizing the value of specialty CROs conducting clinical trials on their behalf.
Partnering with a CRO that specializes in a specific therapeutic area or indication, rather than choosing a “one-size-fits-all CRO,” can have a profound impact on the success of the clinical trial.
The Advantages of Partnering with a Specialty CRO
- In-Depth Patient Profiling: Understanding the patient base inside and out is the cornerstone of a robust drug development program. A CRO that specializes in your therapeutic area or indication will offer a comprehensive evaluation of the intended patient segment.
- Risk Mitigation: With success rates of lower than 1% from research to commercialization1, it is vital that you take every possible measure to improve the probability of success. Having the right CRO partner, who understands the risks associated with your specific trial can positively impact failure-risk mitigation. The right CRO will offer a strategic approach specific to your program, whereas others may provide a modified standard model that doesn’t address your study’s specific needs.
- Operational Expertise: One of the reasons why pharma-conducted clinical trials have a low success rate is tied back to a lack of operational resources. A CRO with operational experience can offer a streamlined plan to swiftly negotiate hurdles, such as compliance with regional regulations, patient recruitment, and clinical trial efficiency in a global landscape. In addition, CRO operational expertise quickly builds when conducting indication specific clinical trials among pharma- and bio-pharma partners.
- Cost-Sensitive Strategies: Drug discovery and development requires a significant financial investment. An experienced CRO can eliminate the guesswork. Its intimate sector-specific knowledge can allow you develop your drug on time, within budget, and with a strategy that fits your goals.
Worldwide Clinical Trials Offers an Uncommon Advantage to Researchers in Rare Disease Clinical Trials
The rarity of PAH makes it a challenge for researchers. However, partnering with a specialized CRO, such as Worldwide Clinical Trials, offers your research initiative distinct strategic advantages. Our extensive experience in cardiovascular and rare disease research with operational presence in over 60 countries can positively impact the success rate of your PAH drug development program.